View Dr Koppany Visnyei as he explains clinical efficacy and safety of APRETUDE:
- Perspectives in HIV PrEP
- Overview of Clinical Studies
- Patient Ambassador Stories
Dr Visnyei is joined by Stephon, an APRETUDE patient ambassador, for the Patient Ambassador Story.
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KOPPANY VISNYEI, MD, PhD has been compensated by ViiV Healthcare
ViiV Healthcare logo
[Dr Visnyei] Hello, I’m Dr Koppany Visnyei, and I’m an internist from West Hollywood, California. My practice focuses on men’s health and supporting LGBTQ+ patients, and I’ve been prescribing PrEP since 2017.
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PATIENTS & PROVIDERS
PARTNERS IN PrEP
KOPPANY VISNYEI, MD, PhD has been compensated by ViiV Healthcare
ViiV Healthcare logo
[Dr Visnyei] I would like to welcome you to “Patients and Providers: Partners in PrEP.”
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Today’s topics
PERSPECTIVES IN HIV PrEP
OVERVIEW OF CLINICAL STUDIES
PATIENT AMBASSADOR STORY
ViiV Healthcare logo
[Dr Visnyei] Today, I’ll be providing an overview of two PrEP clinical trials. I’m also excited to be joined by our amazing patient ambassador Stephon, who will share his experience as a participant in these trials.
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Despite more than a decade of PrEP use, the HIV epidemic remains an urgent public health challenge1-3
TODAY, THERE’S MORE WORK TO BE DONE
ViiV Healthcare logo
[Dr Visnyei] PrEP has been available for over a decade, and while we have made progress, too many of our patients are still receiving an HIV diagnosis.
In the US alone, there were approximately 38,000 new diagnoses in 2022, and around 70% of those were among Black and Latinx people.
Today, we must do more to help end the HIV epidemic!
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ViiV Healthcare logo
[Dr Visnyei] We know that PrEP can drastically reduce the chance of our patients acquiring HIV, but uptake is still too low.
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Ask your patients about the Ps of sexual activities to understand if they need PrEP1
Partners
Have sex partner(s) who are of unknown HIV status or are HIV+ with detectable/unknown viral load
Practices
Inconsistent condom use?
Past STI
A history of STI diagnosis1-3
THE NEED IS MORE URGENT IF ONE OF THESE Ps APPLY:
Population
Belong to a demographic group (such as race/ethnicity, gender identity, or sexual orientation) that is disproportionately affected by HIV?
Places
Live in geographic location where HIV is prevalent?
ViiV Healthcare logo
[Dr Visnyei] I like to ask my patients about their sexual wellness and find the P framework really helps me to identify those who might benefit from PrEP. If they have sexual partners of unknown HIV status, inconsistent condom use, or a history of STIs, I automatically discuss PrEP with them.
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Ask your patients about the Ps of sexual activities to understand if they need PrEP1
Practices
Inconsistent condom use?
ViiV Healthcare logo
[Dr Visnyei] When we think about sexual practices, consistency of condom use is an extremely important part of the conversation.
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When considering PrEP for your patients, it’s important to think about their prescription and recreational drug use
Recreational drugs:
- Reports have shown that MSM using some recreational drugs are more likely to engage in unprotected sex, which increases their need for PrEP1
- A study that used surveys to evaluate recreational drug use in MSM (n=176) found that up to 42% self-reported using a recreational drug in the previous 3 months2
Prescription and OTC medications/supplements3:
- PrEP medications may have drug-drug interactions. Ask your patients about all the medicines they take, including prescription and OTC medicines, vitamins, and herbal supplements prior to starting or switching PrEP
ViiV Healthcare logo
[Dr Visnyei] But it’s important to look beyond just condom use. We also need to consider what our patients might be taking, from recreational drugs (which can lead to more unprotected sex) to prescription medications (which could interact with a PrEP option.)
One study found that up to 42% of men who have sex with men reported using recreational drugs in the past 3 months – demonstrating just how important it is that we ask our patients about their sexual practices, without fear or judgment.
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Counsel your patients on HIV-1 testing and PrEP adherence
In a retrospective claims analysis of daily oral TRUVADA users in the US (N=24,232)1:
0.6% (n=141/24,232) were diagnosed with HIV during the follow-up period
60.3% (n=85/141) of those individuals with newly identified HIV had PrEP on hand at the time of HIV diagnosis
- Individuals required to have ≥6 months continuous pre-index commercial insurance enrollment; mean follow-up period was 504 days (SD: +/-408 days)
- Limitations: laboratory values were not available to confirm HIV diagnosis or time of acquisition; pharmacy dispensings do not guarantee adherence to PrEP, and coding errors may exist in administrative claims; analysis was limited to commercially insured patients, so findings may not be generalizable to other patient types
While HIV diagnosis following PrEP initiation was infrequent, these findings suggest challenges unexplained by PrEP access, which underscores the importance of HIV testing and PrEP adherence.
ViiV Healthcare logo
[Dr Visnyei] Once you've determined that a patient is a good candidate for PrEP, you need to counsel them on the importance of adherence and HIV testing.
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Counsel your patients on HIV-1 testing and PrEP adherence
In a retrospective claims analysis of daily oral TRUVADA users in the US (N=24,232)1:
0.6% (n=141/24,232) were diagnosed with HIV during the follow-up period
60.3% (n=85/141) of those individuals with newly identified HIV had PrEP on hand at the time of HIV diagnosis
- Individuals required to have ≥6 months continuous pre-index commercial insurance enrollment; mean follow-up period was 504 days (SD: +/-408 days)
- Limitations: laboratory values were not available to confirm HIV diagnosis or time of acquisition; pharmacy dispensings do not guarantee adherence to PrEP, and coding errors may exist in administrative claims; analysis was limited to commercially insured patients, so findings may not be generalizable to other patient types
While HIV diagnosis following PrEP initiation was infrequent, these findings suggest challenges unexplained by PrEP access, which underscores the importance of HIV testing and PrEP adherence.
ViiV Healthcare logo
[Dr Visnyei] This study shows that while very few patients receiving PrEP were diagnosed with HIV, the majority of those PrEP patients who did acquire HIV had PrEP on hand at the time of the diagnosis. This illustrates the importance of HIV testing and PrEP adherence while starting or continuing PrEP.
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Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Dr Visnyei] I’m now excited to share why I prescribe APRETUDE, the first long-acting injectable PrEP that helps provide 2 months of powerful and continuous HIV protection.
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Too many people will receive an HIV diagnosis this year
DON’T I DESERVE POWERFUL HIV PROTECTION?
An in-depth look at APRETUDE –
Help protect your patients with 2 months of continuous HIV protection with the first long-acting PrEP
APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.
APRETUDE logo
[Dr Visnyei] Before we dive in, let’s review the indication and some Important Safety Information.
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Too many people will receive an HIV diagnosis this year
DON’T I DESERVE POWERFUL HIV PROTECTION?
An in-depth look at APRETUDE –
Help protect your patients with 2 months of continuous HIV protection with the first long-acting PrEP
APRETUDE is administered as an intramuscular injection by a healthcare professional every
2 months after 2 initiation injections administered 1 month apart.
APRETUDE logo
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INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg or 77 pounds who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now we’ll cover the Important Safety Information for APRETUDE.
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested and confirmed to be HIV negative prior to starting PrEP with either oral or long-acting injectable cabotegravir and with each subsequent injection of APRETUDE. The test used to screen for HIV should be approved or cleared by the FDA for diagnosis of acute or primary HIV-1. Drug-resistant HIV variants have been identified with use of APRETUDE in the presence of undiagnosed infection. If a person becomes infected with HIV while receiving APRETUDE, they must transition to a complete HIV treatment regimen.
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IMPORTANT SAFETY INFORMATION (cont’d)
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is contraindicated in those with unknown or positive HIV status. Additionally, do not use APRETUDE in people who have had a hypersensitivity reaction to cabotegravir or in combination with the medicines listed on the slide.
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RANDOMIZED, DOUBLE-BLIND, MULTINATIONAL, CONTROLLED TRIALS OF APRETUDE VS TRUVADA IN DIVERSE STUDY POPULATIONS1,2
Proven in diverse and comprehensive HIV PrEP trials
2 of the largest head-to-head prevention trials conducted through the HIV Prevention Trials Network (HPTN) in cooperation with National Institute of Allergy and Infectious Diseases (NIAID).
~8000 participants
>10,000 person-years
APRETUDE logo
[Dr Visnyei] Let’s dive into the 2 pivotal clinical trials for APRETUDE: HPTN 083 and 084.
These two trials were conducted by the HIV Prevention Trials Network and are significant not just because they were two of the largest head-to-head trials ever conducted for HIV prevention, but also because they enrolled diverse populations at risk for acquiring HIV.
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HEAD-TO-HEAD STUDY DESIGN AND PRIMARY ENDPOINT1,2
HPTN 083 and HPTN 084 evaluated the safety and efficacy of APRETUDE every 2 months vs TRUVADA for HIV-1 prevention in adults at risk of acquiring HIV-1.1-4
PRIMARY ENDPOINT: Incidence of HIV-1 infections
APRETUDE logo
[Dr Visnyei] In both HPTN 083 and 084, after 5 weeks of oral lead-in, participants were randomized to receive APRETUDE injections every 2 months with a daily placebo pill or a daily TRUVADA pill with placebo injections every 2 months. The primary endpoint was the incidence of HIV-1 infections.
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HEAD-TO-HEAD STUDY DESIGN AND PRIMARY ENDPOINT1,2
HPTN 083 and HPTN 084 evaluated the safety and efficacy of APRETUDE every 2 months vs TRUVADA for HIV-1 prevention in adults at risk of acquiring HIV-1.1-4
Based on the efficacy results at the first preplanned interim analyses, it was determined that the prespecified criteria for stopping the blinded portions had been met.
PRIMARY ENDPOINT: Incidence of HIV-1 infections
APRETUDE logo
[Dr Visnyei] HPTN 083 and 084 were ended early because the interim analysis revealed that APRETUDE was more effective than TRUVADA in preventing HIV infection.
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HEAD-TO-HEAD STUDY DESIGN AND PRIMARY ENDPOINT1,2
HPTN 083 and HPTN 084 evaluated the safety and efficacy of APRETUDE every 2 months vs TRUVADA for HIV-1 prevention in adults at risk of acquiring HIV-1.1-4
Based on the efficacy results at the first preplanned interim analyses, it was determined that the prespecified criteria for stopping the blinded portions had been met.
Open-label extension
Following the unblinded phase, all participants were offered open-label APRETUDE or TRUVADA.
PRIMARY ENDPOINT: Incidence of HIV-1 infections
APRETUDE logo
[Dr Visnyei] Afterward, an open-label extension allowed participants to choose between APRETUDE or TRUVADA.
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INCLUSION AND EXCLUSION CRITERIA AND BASELINE CHARACTERISTICS
HPTN 083
Selected inclusion criteria1:
- HIV-1 negative at screening and enrollment
- Age >18
- Cisgender men and transgender women who have sex with men and are at risk of acquiring HIV infection through sex
Selected exclusion criteria:
- Active or recent (90 days prior to enrollment) illicit intravenous drug use1
- Current or chronic history of liver disease2
- Surgically placed or injected buttock implants or fillers1
Selected baseline characteristics1:
- 87% were MSM
- 13% were transgender women
- 68% were <30 years
In the US, 50% were Black.
APRETUDE logo
[Dr Visnyei] And before I continue sharing the results, I want to talk about the diversity of these trials. HPTN 083 included cisgender men and transgender women who have sex with men.
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INCLUSION AND EXCLUSION CRITERIA AND BASELINE CHARACTERISTICS
HPTN 084
Selected inclusion criteria1:
- HIV-1 negative at screening and enrollment
- Cisgender women, 18 to 45 y/o
- At high risk of sexually acquiring HIV-1 infection
- If of reproductive potential:
- Negative pregnancy test
- Use of long-acting contraception
Selected exclusion criteria1:
- History of liver disease
- Pregnant or currently breastfeeding
Selected baseline characteristics1:
- 50% were <25 years
- 55% had ≥2 sex partners
- >99% were non-White
APRETUDE logo
[Dr Visnyei] . . . and HPTN 084 enrolled cisgender women, aged 18 to 45 years, who were at high risk for sexually acquiring HIV-1 infection.
These are some of the most diverse trials to date, and they give me confidence that APRETUDE has been thoroughly studied in patient populations that I serve.
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APRETUDE logo
[Dr Visnyei] So, let’s talk about the efficacy outcomes. In both trials, APRETUDE demonstrated clear superiority over TRUVADA.
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THROUGH THE BLINDED PHASE OF HPTN 083, APRETUDE OFFERED MORE POWERFUL HIV PREVENTION THAN TRUVADA
Superior efficacy with APRETUDE vs TRUVADA
HIV-1 ACQUISITIONS OCCURRED >3X LESS OFTEN WITH APRETUDE THROUGH WEEK 153
69% reduction in the risk of acquiring HIV-1 infection with APRETUDE (0.37/100 person-years) vs TRUVADA (1.22/100 person-years) (hazard ratio [95% CI]: 0.31 [0.16-0.58]; P=0.0003)
APRETUDE logo
[Dr Visnyei] In HPTN 083 (studying men who have sex with men and transgender women), participants on APRETUDE acquired HIV more than 3 times less often than those on TRUVADA. . .
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THROUGH THE BLINDED PHASE OF HPTN 084, APRETUDE OFFERED MORE POWERFUL HIV PREVENTION THAN TRUVADA
Superior efficacy with APRETUDE vs TRUVADA
HIV-1 ACQUISITIONS OCCURRED 12x LESS OFTEN WITH APRETUDE THROUGH WEEK 153
90% reduction in the risk of acquiring HIV-1 infection with APRETUDE (0.15/100 person-years) vs TRUVADA (1.85/100 person-years) (hazard ratio [95% CI]: 0.10 [0.04-0.27]; P<0.0001)
APRETUDE logo
[Dr Visnyei] . . . and the results in HPTN 084 (studying cisgender women) were remarkable, with HIV acquisitions occurring 12 times less often with APRETUDE compared to daily oral TRUVADA.
The superior efficacy of APRETUDE in both of these trials is very impressive. It’s a big factor in why I recommend APRETUDE to my patients and is something that I share with them when discussing PrEP options.
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RESISTANCE MUTATIONS THROUGH THE BLINDED PHASE OF HPTN 083 and HPTN 084
TEST TO CONFIRM HIV-NEGATIVE STATUS BEFORE EVERY INJECTION
- Of the prevalent infections, 1 INSTI-associated mutation was detected in the APRETUDE arm, and 2 NRTI-associated mutations were detected in the TRUVADA arm1
HIV-1 RNA testing may allow for earlier detection of HIV, potentially reducing the risk of resistance while on PrEP2
APRETUDE logo
[Dr Visnyei] Overall, resistance mutations with APRETUDE were infrequent. In HPTN 083, 4 participants developed mutations, and in HPTN 084, no participants developed mutations. For comparison, in the TRUVADA arm, there were 4 NRTI-associated mutations in 083 and 1 in 084.
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APRETUDE logo
[Dr Visnyei] We’re now going to talk about safety. Safety data is especially important when it comes to PrEP because the goal is to protect our patients from acquiring HIV without exposing them to unnecessary risks.
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THROUGH THE BLINDED PHASE OF HPTN 083,
SAFETY PROFILE ESTABLISHED IN >3200 PARTICIPANTS
Adverse drug reactions (all grades) reported in at least 1% of participants receiving APRETUDE
DISCONTINUATION RATES
6% of participants receiving APRETUDE and 4% of participants receiving TRUVADA discontinued due to adverse events (all causality).
3% of participants who received at least 1 injection of APRETUDE and experienced an ISR discontinued APRETUDE as a result of ISRs.
APRETUDE logo
[Dr Visnyei] The established safety profile for APRETUDE gives me confidence in prescribing. Across both trials, injection-site reactions were the most frequently observed adverse drug reactions with APRETUDE. For other common adverse drug reactions observed with APRETUDE, the reported frequency was similar for the TRUVADA arm. In HPTN 083, 6% of participants discontinued APRETUDE due to adverse events. . . .
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THROUGH THE BLINDED PHASE OF HPTN 084,
SAFETY PROFILE ESTABLISHED IN >3200 PARTICIPANTS
Adverse drug reactions (all grades) reported in at least 1% of participants receiving APRETUDE
DISCONTINUATION RATES
1% of participants receiving APRETUDE and 1% of participants receiving TRUVADA discontinued due to adverse events.
0% of participants receiving APRETUDE in HPTN 084 discontinued study drug due to ISRs.
APRETUDE logo
[Dr Visnyei] ....and in HPTN 084, it was 1%.
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THROUGH THE BLINDED PHASE OF HPTN 083,
FREQUENCY OF REPORTED ISRs DECREASED OVER TIME
Frequency of reported ISRs decreased over time
4 days Median duration of ISRs was 4 days with APRETUDE
97% of ISRs were Grade 1 or 2
3% of participants discontinued APRETUDE as a result of ISRs
Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.
APRETUDE logo
[Dr Visnyei] Across both studies, we also see that the frequency of reported injection-site reactions decreases over time. Most reported reactions were mild or moderate, and the median duration was 4 days in the HPTN 083. . .
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THROUGH THE BLINDED PHASE OF HPTN 084,
FREQUENCY OF REPORTED ISRs DECREASED OVER TIME
Frequency of reported ISRs decreased over time
8 days Median duration of ISRs was 8 days with APRETUDE
99% of ISRs were Grade 1 or 2
0% of participants discontinued APRETUDE as a result of ISRs
Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.
APRETUDE logo
[Dr Visnyei] ...and 8 days in the HPTN 084.
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A SUBSET ANALYSIS FROM THE BLINDED PHASE (SECONDARY ENDPOINT)
BONE MINERAL DENSITY CHANGE WITH APRETUDE VS TRUVADA1
Subgroup analysis of HPTN 083 comparing changes in BMD
- A loss of bone mineral density (BMD) by DXA scans was observed in the TRUVADA arm, consistent with previous findings in other TDF-containing regimens1,2
- A statistically significant difference in BMD was seen between the two arms at Weeks 57 and 105, favoring the APRETUDE arm1
- The long-term clinical significance of these changes is not known (eg, fracture risk)1
Consider how these BMD data may inform your PrEP prescribing decisions for patients
APRETUDE logo
[Dr Visnyei] Lastly, I want to discuss bone mineral density with PrEP. Here you can see results from DXA scans showing a loss in bone mineral density in the TRUVADA arm and a statistically significant difference in bone mineral density between the 2 arms, favoring APRETUDE.
Although these results are descriptive and the long-term clinical significance is not known, I still consider these BMD data when prescribing PrEP.
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APRETUDE logo
[Dr Visnyei] As I mentioned at the beginning, before we prescribe PrEP to any patient, we need to think about potential drug-to-drug interactions. Moreover, when we are prescribing long-acting injectable PrEP (with a longer half life), we need to think about DDIs that could occur now and in the future.
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APRETUDE ESTABLISHED AND OTHER POTENTIALLY SIGNIFICANT DRUG INTERACTIONS
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration.
- Cabotegravir is primarily metabolized by UGT1A1 with some contribution from UGT1A9. Strong inducers of UGT1A1 or 1A9 are expected to decrease cabotegravir plasma concentrations. Coadministration of APRETUDE with these drugs is contraindicated.
APRETUDE logo
[Dr Visnyei] The 2 classes of drugs with known and potentially significant interactions with APRETUDE are shown here. In my practice, I see very few PrEP patients who are receiving these medications — although I always be sure to check!
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APRETUDE LOGO
[Dr Visnyei] Now, I’m excited to introduce Stephon, who actually participated in the HPTN 083 trial.
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STEPHON
A real patient receiving APRETUDE and has been compensated by ViiV Healthcare
APRETUDE logo
[Stephon] Hey, Dr V.
[Dr Visnyei] Hi. So great to have you here.
[Stephon] Oh no, thank you for having me.
[Dr Visnyei] How are you?
[Stephon] I'm well, how are you?
[Dr Visnyei] Awesome. Thank you for asking.
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APRETUDE logo
[Dr Visnyei] So, Stephon, why don't you tell us a little bit about yourself and your experience in the clinical trial.
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APRETUDE logo
[Stephon] Sure. Hey everyone. My name's Stephon and I'm an APRETUDE Ambassador from Memphis, Tennessee.
So, I joined the clinical trial as someone who was completely new to PrEP. After some personal events in my life that had me worried about HIV, I went to visit a healthcare provider to get tested and thankfully I was negative. As I left that appointment, I was approached by a PrEP advocate who told me about the APRETUDE clinical trial. I decided that it was time to take control, so I called the number on the flyer, and I enrolled in the study.
The idea of having the option to take a drug with dosing that works with my schedule and meant that as long as I attended my injection appointments, I can go on vacations and not have to worry about forgetting a bottle of pills. It was really appealing to me. What I remember most during the trial is that at each visit I felt supported, never judged by my provider, and I felt comfortable to talk openly about my sexual wellness. The regular HIV and STI testing also strengthened the trust I had in my providers.
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APRETUDE logo
[Dr Visnyei] I’m really pleased that you had a positive experience, Stephon – it demonstrates just how important our words and actions are when talking about PrEP with our patients. Now, could you tell me why you chose APRETUDE when the study was unblinded, Stephon?
[Stephon] Absolutely. When the unblinded phase wrapped up and I learned about the study outcomes, I jumped at the chance to choose APRETUDE because it was clearly the best option for me. It also helped that I didn't have to remember to take a pill every day. When it came to side effects, I had pain and tenderness with the injection itself. But that cleared up quickly and it improved over time. Now, from a vanity perspective, what I appreciate most is that it's in a discreet location and no one will ever see a bottle of PrEP pills in my house.
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WHEN GIVEN THE CHOICE IN THE HPTN 083/084 OPEN-LABEL
EXTENSIONS, MOST PARTICIPANTS SELECTED APRETUDE OVER TRUVADA
Individuals preferring an oral method of administration may not have chosen to enroll in HPTN 083/084.
Participants were told the results of the blinded study phase and offered the choice of APRETUDE or TRUVADA.1-3
HPTN 083 (N=4566)
CISGENDER MEN AND TRANSGENDER WOMEN
96%
Chose APRETUDE (770/803)
4% Chose TRUVADA (33/803)1
- Of the 1698 participants originally included from the US, 803 (47%) continued into the open-label extension and had regimen choice data available1
HPTN 084 (N=3224)
CISGENDER WOMEN
78%
Chose APRETUDE (1931/2472)
22% Chose TRUVADA (536/2472)3
- Of the 3028 participants originally included from 7 countries in sub-Saharan Africa, 2472 (81%) continued into the open-label extension and had regimen choice data available3
APRETUDE logo
[Dr Visnyei] Thanks, Stephon. Your experience is relevant to another part of the trial: the patient choice assessment for the open-label extension phase. Of the participants who continued into the open-label extension, 96% of patients from the HPTN 083 and 78% from the HPTN 084 chose APRETUDE.
This data is great because it validates what Stephon told us and matches what I hear from patients. It’s also the reason why I always recommend APRETUDE to my appropriate patients whether they have taken oral PrEP for years or they are brand new to PrEP.
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APRETUDE logo
[Dr Visnyei] Thank you, Stephon. Your experience really resonates with what I hear from my patients.
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DON’T I DESERVE POWERFUL HIV PROTECTION?
PROVEN
Efficacy and safety evaluated in two large-scale head-to-head clinical trials, including some of the most diverse patient populations in PrEP trials to date1,2
POWERFUL
Superior efficacy versus a daily oral PrEP (TRUVADA) demonstrated in two clinical trials1,2
- >3X reduction in HIV-1 incidence in HPTN 083 (cisgender men and transgender women): HR 0.31 (95% CI: 0.16-0.58); P=0.0003
- 12X reduction in HIV-1 incidence in HPTN 084 (cisgender women): HR 0.10 (95% CI: 0.04-0.27); P<0.0001
CONTINUOUS PROTECTION
Two months of continuous HIV protection with each injection (after two initiation doses)
APRETUDE logo
[Dr. Visnyei] Based on what we have discussed, we hope you will consider APRETUDE for your next appropriate patient with its proven, powerful, and continuous protection.
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APRETUDE logo
[Dr Visnyei] And now, let’s review the Important Safety Information.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition.
Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network.
Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs).
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now, we’ll cover the Warnings and Precautions. Use APRETUDE as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices. APRETUDE is not always effective in preventing HIV-1 acquisition. This slide outlines some but not all additional risk factors for HIV acquisition, including:
- condomless sex
- past or current STIs
- self-identified HIV risk
- having sexual partners of unknown HIV-1 status, or
- sexual activity in a high prevalence area or network.
It is important to inform, counsel, and support individuals on the use of a comprehensive prevention strategy.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment.
Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).
If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE should only be used in individuals who are confirmed to be HIV-1 negative as previously highlighted in the Boxed Warning. Resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection.
Along with testing for HIV prior to initiation, seronegative individuals should be asked about potential exposure events in the preceding month and evaluated for current or recent signs or symptoms of acute HIV infection such as those listed here.
If recent exposures (defined as less than 1 month) to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs.
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment.
Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] This slide reiterates the importance of HIV testing prior to each APRETUDE injection and provides rationale for additional testing.
Testing should be repeated upon diagnosis of any other STIs, if an HIV test indicates possible infection, or when symptoms of possible HIV infection are present following potential exposure.
Remember that individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Potential Risk of Resistance with APRETUDE:
There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE.
To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status.
Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. This is why it’s important to test before each injection to confirm negative status.
For those wishing to discontinue APRETUDE, yet who remain at risk to HIV acquisition, alternative forms of PrEP should be considered, and, if used, started within 2 months of the final injection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Long-Acting Properties and Potential Associated Risks with APRETUDE:
Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer).
Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Because of its long-acting nature, APRETUDE drug levels slowly decrease over 12 months or longer.
Take this characteristic into consideration and carefully select individuals who agree to the every-2-month dosing schedule, because lack of adherence could lead to HIV acquisition and development of resistance.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Hepatotoxicity:
Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors.
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
Voiceover: Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome/toxic epidermal necrolysis. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Hepatotoxicity has been reported in a limited number of patients on cabotegravir with or without pre-existing hepatic disease or identifiable risk factors. Hepatic monitoring should be considered. Discontinue APRETUDE if hepatotoxicity is suspected.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE.
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See the Prescribing Information for additional details.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] The most common adverse reaction occurring with APRETUDE was injection site reactions. The other most common adverse reactions with an incidence of at least 1% of all grades are listed in this slide.
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IMPORTANT SAFETY INFORMATION (cont’d)
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATION
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Please see full Prescribing Information for a list of potentially significant drug interactions. Use caution when using APRETUDE with drugs that can induce UGT1A1 as these may significantly decrease plasma concentrations of cabotegravir.
When using APRETUDE in specific populations, consider the following: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the risk of adverse reactions and that the medicine may stay in the systemic circulation for up to 12 months or longer after discontinuation.
When considering the use of APRETUDE with pediatric patients, remember that it is not recommended in individuals weighing less than 35 kilograms.
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APRETUDE logo
[Dr Visnyei] That brings us to the end of our presentation. I hope that you have enjoyed it and learned something new, whether from the clinical data or from our fabulous patient ambassador Stephon.
[Stephon] It was my pleasure.
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APRETUDE logo
[Dr Visnyei] Bye, guys!
[Stephon] Bye, everyone!
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ViiV Healthcare logo
TRUVADA is owned by Gilead Sciences, Inc. All other trademarks are owned by or licensed to the ViiV Healthcare group of companies.
© 2025 ViiV Healthcare or licensor. PMUS-CBTVID250031 August 2025 Produced in USA.
APRETUDE logo
See Dr Marisa Brizzi as she discusses dosing and administration of APRETUDE:
- Dosing and Administration
- Alternative Sites of Care & APRETUDE Sample Starter Program
- A Patient Ambassador’s Experience with APRETUDE
Dr Brizzi is joined by Kimmy, an APRETUDE patient ambassador, for the Patient Ambassador’s Experience.
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ViiV Healthcare logo
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PATIENTS AND PROVIDERS
APRETUDE Every-2-Month Dosing Schedule
MARISA BRIZZI, PharmD has been compensated by ViiV Healthcare
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
ViiV Healthcare logo
[Dr Brizzi] Hi, everyone, I’m Dr Marisa Brizzi. I’m a pharmacist in Cincinnati, Ohio, and I help to manage our long-acting injectable program for HIV prevention and treatment.
Please join us for a discussion on the dosing and administration for APRETUDE.
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TODAY’S TOPICS
KEY CONSIDERATIONS FOR DOSING AND ADMINISTRATION
ALTERNATIVE SITES OF CARE AND APRETUDE STARTER SAMPLE PROGRAM
A PATIENT AMBASSADOR’S EXPERIENCE WITH APRETUDE
MARISA BRIZZI, PharmD has been compensated by ViiV Healthcare
APRETUDE logo
[Dr Brizzi] Today, I'm going to be sharing everything you need to know about the dosing and administration of APRETUDE to your patients.
I also have the pleasure of being joined by Kimmy, an APRETUDE ambassador, who is going to share her experience with the every-2-month dosing schedule.
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APRETUDE logo
[Dr Brizzi] Before we dive in, let’s review the Indication and some Important Safety Information.
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INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg or 77 pounds who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now, we’ll cover the Important Safety Information for APRETUDE.
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested and confirmed to be HIV negative prior to starting PrEP with either oral or long-acting injectable cabotegravir and with each subsequent injection of APRETUDE. The test used to screen for HIV should be approved or cleared by the FDA for diagnosis of acute or primary HIV-1. Drug-resistant HIV variants have been identified with use of APRETUDE in the presence of undiagnosed infection. If a person becomes infected with HIV while receiving APRETUDE, they must transition to a complete HIV treatment regimen.
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IMPORTANT SAFETY INFORMATION (cont’d)
CONTRAINDICATIONS
Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is contraindicated in those with unknown or positive HIV status. Additionally, do not use APRETUDE in people who have had a hypersensitivity reaction to cabotegravir or in combination with the medicines listed on the slide.
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APRETUDE logo
[Dr Brizzi] Hi, Kimmy. To start, can you please tell us a little bit about yourself and what motivated you to start PrEP?
[Kimmy] Sure. I'm Kimmy, a proud Latina trans woman originally from Seattle, now living in Atlanta. I first got on PrEP when I was 19 years old after finding out that my brother was HIV positive and discovering that the first person I cared for romantically was also HIV positive. I knew that I had to educate myself and take every precaution possible to prevent HIV and help end the stigma. I started with daily oral pills and switched to APRETUDE for PrEP in 2023.
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APRETUDE logo
[Dr Brizzi] Thanks so much for sharing, Kimmy. Can I ask what made you decide to switch to APRETUDE after being on the daily oral pills for so long?
[Kimmy] Yeah, I didn't want to worry about tracking pills or remembering if I had missed one if I didn't have to. In that respect, APRETUDE gives me peace of mind. After starting off with a monthly injection for the first two months, one injection every other month is all I need. Privacy is also important to me. I appreciate the APRETUDE injections are in a discreet location, and I don't have to worry about having pill bottles lying around. Plus, with APRETUDE, I get tested for HIV prior to each injection and other STIs every two months, which gives me the regular reassurance that I want.
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CONFIRM HIV-1–NEGATIVE STATUS BEFORE ADMINISTERING APRETUDE
1 Individuals must be tested prior to initiating APRETUDE or oral cabotegravir and with each subsequent injection
2 Use a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection
If an antigen/antibody test was used and was negative, confirm results with an HIV RNA test
- Results of confirmatory HIV RNA test can be pending at time of administration
3 HIV-1 testing should also occur:
- When recent exposure to HIV is suspected or clinical symptoms consistent with HIV-1 (eg, fever, fatigue, myalgia, skin rash) are present
- Upon diagnosis of any other STI
If positive HIV-1 status is confirmed, transition to a complete HIV-1 treatment regimen.
When a payer covers PrEP, HIV testing should also be covered.1 The payer or your lab can help you understand which tests may be covered and available.
APRETUDE logo
[Dr Brizzi] That leads me nicely onto our first topic, HIV testing. It’s required to have a negative HIV-1 test before each APRETUDE injection. The test should be FDA-cleared or approved for diagnosing acute or primary HIV-1 infection. If the result is negative with an antigen or antibody test, a confirmatory RNA test is also needed, though the RNA test results can be pending at the time of the injection. Patients should also be tested for HIV-1 if you suspect infection based on exposure or symptoms, or if another STI is detected.
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APRETUDE logo
[Dr Brizzi] Now let’s talk about the dosing kit and the storage recommendations for APRETUDE.
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CONSIDERATIONS PRIOR TO GETTING STARTED WITH APRETUDE IN YOUR PRACTICE
PATIENT CONSIDERATIONS
- Meet the clinical considerations in the label
- Understand the importance of and willingness to adhere to the required every-2-month dosing and testing schedule
- Prefer less frequent dosing
HCP CONSIDERATIONS
- APRETUDE must be administered by a healthcare professional
- The APRETUDE kit contains cabotegravir extended-release injectable suspension in a single-dose vial
- APRETUDE is a suspension that does not need further dilution or reconstitution
- APRETUDE is for gluteal intramuscular use only
- The ventrogluteal site is recommended
- Store APRETUDE at 36°F to 77°F(2°C to 25°C) in the original carton until ready to use. Exposure up to 86°F(30°C) permitted. Do not freeze
APRETUDE logo
[Dr Brizzi] APRETUDE comes in a ready-to-use kit that includes the cabotegravir vial, a syringe, an adapter, and a needle. It’s stored at room temperature and doesn’t require further dilution or reconstitution.
APRETUDE is administered as a gluteal intramuscular injection by a healthcare provider. For some patients, especially those with higher BMI or more subcutaneous fat in the gluteal area, a longer needle might be necessary to reach the muscle.
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[Dr Brizzi] Before starting APRETUDE, it’s important to select patients who are committed to the every-2-month dosing schedule and emphasize the need for adherence to these visits.
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STARTING YOUR PATIENTS ON APRETUDE
2 MONTHS OF CONTINUOUS HIV PROTECTION WITH EACH INJECTION
Before initiating APRETUDE, reiterate the importance of adhering to the dosing and testing schedule to reduce the risk of HIV-1 acquisition and development of resistance
APRETUDE is administered by a healthcare provider as a single 600-mg (3-mL) gluteal intramuscular injection.
Please see Prescribing Information for details about how to continue with APRETUDE after missed injections.
Optional oral lead-in may be used prior to the initiation of APRETUDE to assess the tolerability of cabotegravir.
DOSING WINDOW
APRETUDE injections can be given up to 7 days before or after the scheduled injection date
APRETUDE logo
[Dr Brizzi] APRETUDE is given as a single 3-mL injection, followed by another one a month later. After the initiation period, dosing occurs every 2 months.
An optional oral lead-in is available to assess tolerability, although it’s not mandatory.
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APRETUDE logo
[Dr Brizzi] Kimmy, you mentioned that APRETUDE was a better fit for your lifestyle. What specifically about APRETUDE works for you?
[Kimmy] That's a great question. I find that getting injections every other month suits me well. I really appreciate the flexibility of having a 7-day window before or after my target injection date, just in case I need it.
Personally, I ask my healthcare provider to schedule my appointments for the entire year, so I can mark those dates on my calendar and plan my other commitments around them.
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APRETUDE logo
[Dr Brizzi] Fantastic, Kimmy. Planning a full year in advance is such a great tip!
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CONTINUING APRETUDE AFTER PLANNED MISSED INJECTIONS
Adherence to the injection dosing schedule is strongly recommended. Individuals who miss their Target Injection Date should be clinically reassessed to ensure resumption of APRETUDE remains appropriate.
If your patient plans to miss their Target Injection Date by >7 days, daily oral cabotegravir can be prescribed for a duration of up to 2 months to replace 1 missed scheduled every-2-month injection of APRETUDE.*
The first dose of oral cabotegravir should be taken approximately 2 months after the last injection dose of APRETUDE.
Restart injections with APRETUDE on the day oral dosing completes or within 3 days.
<1 month since missed Target Injection Date
- Resume injections on final day of oral cabotegravir or within 3 days
- Continue with every-2-month dosing schedule thereafter
>1 month since missed Target Injection Date
- Repeat initiation injections (2 injections 1 month apart) on the final day of oral cabotegravir or within 3 days
- Continue with every-2-month dosing schedule thereafter
APRETUDE logo
[Dr Brizzi] If your patient's unable to make an appointment within their injection window, you can prescribe daily oral cabotegravir for up to 2 months to cover one missed injection of APRETUDE. We refer to this as a planned missed injection. If they have an unplanned missed injection and more than a month has passed since their target injection date, they will need to repeat the initiation injections.
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ALTERNATIVE SITE OF CARE (ASOC)
For HCPs interested in having APRETUDE injections administered outside of their clinic, an ASOC may be an option.
Possible ASOCs include infusion centers, pharmacies, etc.
When used, the ASOC will conduct the benefits verification, acquire the medication, and collect the copay or coinsurance.
The ASOC Locator Tool may help you and the patient find a local ASOC at http://www.viivconnect.com/hcp/asoc.
Network ASOCs are ASOCs that provide defined services for APRETUDE to support patient adherence. These services include benefits verification, prior authorization coordination, ViiVConnect and Patient Savings Program navigation, clinician-led onboarding call for patients, regular communication with your office, and multiple patient appointment reminders.
Visit viivconnect.com/HCP/ASOC or scan QR code to find an ASOC
APRETUDE logo
[Dr Brizzi] If your practice may not be able to administer injections on-site, it’s worth considering an Alternate Site of Care or ASOC. These include infusion centers and pharmacies, and they usually handle everything from benefits verification and product acquisition to administering the injections.
If you want to locate an ASOC near you, scan the QR code on the screen.
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SAME-DAY PrEP TRIAL IS POSSIBLE WITH STARTER SAMPLE PROGRAM
APRETUDE Starter Sample Program
- Is available
- Enables rapid initiation and trial of APRETUDE
- Appropriate for new patients
Restrictions apply; see full program terms and conditions for the Starter Sample Program.
To request samples and additional information, talk to your ViiV Healthcare representative.
Need a ViiV contact? Scan this QR code.
APRETUDE logo
[Dr Brizzi] If you or a patient are curious about APRETUDE and want to see how it works for them, you might want to consider the APRETUDE Starter Sample Program. This enables rapid initiation and trial of APRETUDE.
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APRETUDE logo
[Dr Brizzi] Next, we will review the Important Safety Information.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition.
Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network.
Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now, we’ll cover the Warnings and Precautions. Use APRETUDE as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices. APRETUDE is not always effective in preventing HIV-1 acquisition. This slide outlines some but not all additional risk factors for HIV acquisition, including:
- condomless sex
- past or current STIs
- self-identified HIV risk
- having sexual partners of unknown HIV-1 status, or
- sexual activity in a high prevalence area or network.
It is important to inform, counsel, and support individuals on the use of a comprehensive prevention strategy.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment.
Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).
If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE should only be used in individuals who are confirmed to be HIV-1 negative as previously highlighted in the Boxed Warning. Resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection.
Along with testing for HIV prior to initiation, seronegative individuals should be asked about potential exposure events in the preceding month and evaluated for current or recent signs or symptoms of acute HIV infection such as those listed here.
If recent exposures (defined as less than 1 month) to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs.
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment.
Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] This slide reiterates the importance of HIV testing prior to each APRETUDE injection and provides rationale for additional testing.
Testing should be repeated upon diagnosis of any other STIs, if an HIV test indicates possible infection, or when symptoms of possible HIV infection are present following potential exposure.
Remember that individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Potential Risk of Resistance with APRETUDE:
There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE.
To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1 negative status.
Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. This is why it’s important to test before each injection to confirm negative status.
For those wishing to discontinue APRETUDE, yet who remain at risk to HIV acquisition, alternative forms of PrEP should be considered, and, if used, started within 2 months of the final injection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Long-Acting Properties and Potential Associated Risks with APRETUDE:
Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer).
Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover]
Take this characteristic into consideration and carefully select individuals who agree to the every-2-month dosing schedule, because lack of adherence could lead to HIV acquisition and development of resistance.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN).
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Hepatotoxicity:
Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors.
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome/toxic epidermal necrolysis. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Hepatotoxicity has been reported in a limited number of patients on cabotegravir with or without pre-existing hepatic disease or identifiable risk factors. Hepatic monitoring should be considered. Discontinue APRETUDE if hepatotoxicity is suspected.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE.
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See the Prescribing Information for additional details.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] The most common adverse reaction occurring with APRETUDE was injection site reactions. The other most common adverse reactions with an incidence of at least 1% of all grades are listed in this slide.
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IMPORTANT SAFETY INFORMATION (cont’d)
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Please see full Prescribing Information for a list of potentially significant drug interactions. Use caution when using APRETUDE with drugs that can induce UGT1A1 as these may significantly decrease plasma concentrations of cabotegravir.
When using APRETUDE in specific populations, consider the following: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the risk of adverse reactions and that the medicine may stay in the systemic circulation for up to 12 months or longer after discontinuation.
When considering the use of APRETUDE with pediatric patients, remember that it is not recommended in individuals weighing less than 35 kilograms.
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APRETUDE logo
[Dr Brizzi] That brings us to the end of our presentation. I hope that you’ve enjoyed it and learned something new, whether from the considerations for dosing and administration or from our amazing patient ambassador Kimmy.
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APRETUDE logo
[Dr Brizzi] Bye!
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ViiV Healthcare logo
TRUVADA is owned by Gilead Sciences, Inc. All other trademarks are owned by or licensed to the ViiV Healthcare group of companies.
© 2025 ViiV Healthcare or licensor. PMUS-CBTVID250033 August 2025 Produced in USA.
APRETUDE logo
Watch Dr Alexea Gaffney-Adams as she explores patient choice:
- Perspectives in HIV PrEP
- Overview of Clinical Studies
- Patient Ambassador Stories
Dr Gaffney-Adams is joined by Mikki and Ben, APRETUDE patient ambassadors, for the Patient Ambassador Stories.
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The PrEP Journey THE IMPORTANCE OF PATIENT AND PROVIDER PERSPECTIVES
ViiV Healthcare logo
Alexea Gaffney-Adams, MD has been compensated by ViiV Healthcare
PrEP=pre-exposure prophylaxis.
[Dr Gaffney-Adams] Hi, I’m Alexea Gaffney-Adams, a triple board-certified physician practicing in Stony Brook, Long Island, and I’ve been prescribing PrEP since 2013.
Welcome to “The PrEP Journey: The Importance of Patient and Provider Perspectives.”
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Today’s topics
PERSPECTIVES IN HIV PrEP
OVERVIEW OF CLINICAL STUDIES
PATIENT AMBASSADOR STORIES
[Dr Gaffney-Adams] Today we’re going to explore perspectives in PrEP and discuss the efficacy and safety of a PrEP option.
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[Dr Gaffney-Adams] Before we dive in, I’m excited to introduce Mikki and Ben, two of our patient ambassadors, who’ll be sharing their journey to starting their current PrEP option.
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[Ben] Hello, I'm Ben and I'm a pharmacist living in Denver, Colorado. However, I'm here to share my experiences as a patient.
[Mikki] Hi, I’m Mikki. I’m a life coach, I’m a proud mom of one son, and I live in Atlanta, Georgia.
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SUPER: Despite more than a decade of PrEP use, the HIV epidemic remains an urgent public health challenge1-3
TODAY, THERE’S MORE WORK TO BE DONE
[Dr Gaffney-Adams] Although we’ve made progress, we’re still seeing new HIV infections and disparities across communities, with Black and African American and Latinx people making up about 70% of new HIV diagnoses. We, as providers, have an obligation to change that.
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Ask your patients about the Ps of sexual activities to understand if they need PrEP1
Partners
Have sex partner(s) who are of unknown HIV status or are HIV+ with detectable/unknown viral load
Practices
Inconsistent condom use?
Past STI
A history of STI diagnosis1-3
THE NEED IS MORE URGENT IF ONE OF THESE Ps APPLY1:
Population
Belong to a demographic group (such as race/ethnicity, gender identity, or sexual orientation) that is disproportionately affected by HIV?
Places
Live in geographic location where HIV is prevalent?
ViiV Healthcare logo
[Dr Gaffney-Adams] As a provider, I’m aware that conversations about sexual health and wellness can sometimes feel a bit awkward, but they are essential to comprehensive patient care. So I like to use the Ps to guide my discussions with patients and identify those who might benefit from PrEP.
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[Dr Gaffney-Adams] Mikki, do you think ciswomen like yourself are having these types of conversations with their providers?
[Mikki] In my experience, up until a few years ago, I had never had any open conversations around sexual wellness with my former provider, and I certainly didn’t know that PrEP was an option for me. After I learned about it, I told my friends the HIV statistics, and they, like me, were shocked.
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[Dr Gaffney-Adams] So Mikki, what motivated you to start PrEP?
[Mikki] As a Black polyamorous woman living near Atlanta, I learned from my current provider that it was possible for me to become HIV positive. After a few conversations, I realized that being on PrEP was the most logical thing for me.
[Dr Gaffney-Adams] That’s great to hear, Mikki. Ben, can you share your motivation for starting PrEP?
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[Ben] For me, the idea of PrEP didn’t enter my mind until I tested positive for gonorrhea. My healthcare provider reminded me that it only takes one sexual encounter to contract HIV, and sexual orientation does not matter. This was really a wake-up call, and it pushed me to be open about my sexual health and to find a way to better protect myself from HIV. Having a good relationship with my healthcare provider helped me feel comfortable about talking about my sexual wellness.
[Dr Gaffney-Adams] Thanks, Ben. Clearly, you and your provider have built a really strong relationship, and for me, that’s what makes discussing PrEP much easier.
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When considering PrEP for your patients, it’s important to think about their prescription and recreational drug use
Recreational drugs:
- Reports have shown that MSM using some recreational drugs are more likely to engage in unprotected sex, which increases their need for PrEP1
- A study that used surveys to evaluate recreational drug* use in MSM (n=176) found that up to 42% self-reported using a recreational drug in the previous 3 months2
Prescription and OTC medications/supplements3:
- PrEP medications may have drug-drug interactions. Ask your patients about all the medicines they take, including prescription and OTC medicines, vitamins, and herbal supplements prior to starting or switching PrEP
ViiV Healthcare logo
[Dr Gaffney-Adams] This is especially true when it comes to some of the more challenging conversations we have to have when prescribing PrEP.
One study found that up to 42% of men who have sex with men use recreational drugs, and those using recreational drugs are more likely to engage in unprotected sex, which increases their need for PrEP.
For this reason, when I get to the Practices part of my Ps discussion, I always ask my patient if they are taking anything I might not be aware of.
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Too many people will receive an HIV diagnosis this year
DON’T I DESERVE POWERFUL HIV PROTECTION?
An in-depth look at APRETUDE –
Help protect your patients with 2 months of continuous HIV protection with the first long-acting PrEP
APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Dr Gaffney-Adams] Now I'm excited to share some of the data on APRETUDE, the first long-acting injectable that helps provide 2 months of continuous HIV protection. Before we get started, let’s review the Indication and some Important Safety Information.
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INDICATION
APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg or 77 pounds who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now, we’ll cover the Important Safety Information for APRETUDE.
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested and confirmed to be HIV negative prior to starting PrEP with either oral or long-acting injectable cabotegravir and with each subsequent injection of APRETUDE. The test used to screen for HIV should be approved or cleared by the FDA for diagnosis of acute or primary HIV-1. Drug-resistant HIV variants have been identified with use of APRETUDE in the presence of undiagnosed infection. If a person becomes infected with HIV while receiving APRETUDE, they must transition to a complete HIV treatment regimen.
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IMPORTANT SAFETY INFORMATION (cont’d)
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE is contraindicated in those with unknown or positive HIV status. Additionally, do not use APRETUDE in people who have had a hypersensitivity reaction to cabotegravir or in combination with the medicines listed on the slide.
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HEAD-TO-HEAD STUDY DESIGN AND PRIMARY ENDPOINT1,2
HPTN 083 and HPTN 084 evaluated the safety and efficacy of APRETUDE every 2 months vs TRUVADA for HIV-1 prevention in adults at risk of acquiring HIV-1.1-4
PRIMARY ENDPOINT: Incidence of HIV-1 infections
APRETUDE logo
[Dr Gaffney-Adams] Let’s dive into the 2 pivotal clinical trials for APRETUDE: HPTN 083 and 084. In both trials, after 5 weeks of oral lead-in, participants were randomized to receive APRETUDE injections every 2 months with a daily placebo pill or a daily TRUVADA pill with placebo injections every 2 months. The primary endpoint was incidence of HIV-1 infections. Both studies were ended early because the interim analysis revealed that APRETUDE was more effective than TRUVADA in preventing HIV infection. Afterward, open-label extensions allowed participants to choose between APRETUDE or TRUVADA.
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DON’T I DESERVE POWERFUL HIV PROTECTION?
PROVEN
Efficacy and safety evaluated in two large-scale head-to-head clinical trials, including some of the most diverse patient populations in PrEP trials to date1,2
APRETUDE logo
[Dr Gaffney-Adams] Before I review the results, I want to note that these trials were 2 of the largest head-to-head clinical trials conducted through the HIV Prevention Trials Network. They enrolled a diverse patient population including men who have sex with men, transgender women, and cisgender women.
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[Dr Gaffney-Adams] In HPTN 083, 87% were MSM, 68% were below the age of 30, and 50% were Black in the US. In 084, 99% of participants were non-white, 50% were under 25, and 55% had 2 or more sexual partners.
The diversity of these trials reassures me as a clinician that APRETUDE has been thoroughly studied in the patients that I typically serve.
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DON’T I DESERVE POWERFUL HIV PROTECTION?
PROVEN
Efficacy and safety evaluated in two large-scale head-to-head clinical trials, including some of the most diverse patient populations in PrEP trials to date1,2
POWERFUL
Superior efficacy versus a daily oral PrEP (TRUVADA) demonstrated in two clinical trials1,2
- >3x reduction in HIV-1 incidence in HPTN 083 (cisgender men and transgender women):
HR 0.31 (95% CI: 0.16-0.58); P=0.0003 - 12X reduction in HIV-1 incidence in HPTN 084 (cisgender women): HR 0.10 (95% Cl: 0.04-0.27); P<0.0001
APRETUDE logo
[Dr Gaffney-Adams] Moving on to efficacy. The primary endpoint for both trials was incidence of HIV-1 infections, and I’m excited to discuss the results.
In both trials, APRETUDE demonstrated clear superiority compared to TRUVADA. In HPTN 083, participants on APRETUDE were more than 3 times less likely to acquire HIV-1 than those on TRUVADA, and in HPTN 084, they were 12 times less likely, proving that APRETUDE was the more powerful option for HIV prevention in these studies.
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DON’T I DESERVE POWERFUL HIV PROTECTION?
PROVEN
Efficacy and safety evaluated in two large-scale head-to-head clinical trials, including some of the most diverse patient populations in PrEP trials to date1,2
POWERFUL
Superior efficacy versus a daily oral PrEP (TRUVADA) demonstrated in two clinical trials1,2
- >3x reduction in HIV-1 incidence in HPTN 083 (cisgender men and transgender women):
HR 0.31 (95% CI: 0.16-0.58); P=0003 - 12X reduction in HIV-1 incidence in HPTN 084 (cisgender women): HR 0.10 (95% Cl: 0.04-0.27); P<0.0001
CONTINUOUS PROTECTION
Two months of continuous HIV protection with each injection (after two initiation doses)*
APRETUDE logo
[Dr Gaffney-Adams] And that powerful protection continues for 2 months with each APRETUDE injection, giving you and your patients confidence about protection against HIV.
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[Dr Gaffney-Adams] And let’s not forget safety, which is especially important when we think about preventative medicines.
The established safety profile for APRETUDE gives me confidence in prescribing. Across both trials, injection-site reactions were the most frequently observed adverse drug reaction with APRETUDE.
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THROUGH THE BLINDED PHASE OF HPTN 083,
SAFETY PROFILE ESTABLISHED IN >2200 PARTICIPANTS
Adverse drug reactions* (all grades) reported in at least 1% of participants receiving APRETUDE
DISCONTINUATION RATES
6% of participants receiving APRETUDE and 4% of participants receiving TRUVADA discontinued due to adverse events (all causality).
3% of participants who received at least 1 injection of APRETUDE and experienced an ISR discontinued APRETUDE as a result of ISRs.†
THROUGH THE BLINDED PHASE OF HPTN 084,
SAFETY PROFILE ESTABLISHED IN >3200 PARTICIPANTS
Adverse drug reactions (all grades) reported in at least 1% of participants receiving APRETUDE
DISCONTINUATION RATES
1% of participants receiving APRETUDE and 1% of participants receiving TRUVADA discontinued due to adverse events.
0% of participants receiving APRETUDE in HPTN 084 discontinued study drug due to ISRs.
APRETUDE logo
[Dr Gaffney-Adams] For other common adverse drug reactions observed with APRETUDE, the reported frequency was similar for the TRUVADA arm. In HPTN 083, 6% of participants discontinued APRETUDE due to adverse events, and in HPTN 084, it was 1%.
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WHEN GIVEN THE CHOICE IN THE HPTN 083/084 OPEN-LABEL
EXTENSIONS, MOST PARTICIPANTS SELECTED APRETUDE OVER TRUVADA
Individuals preferring an oral method of administration may not have chosen to enroll in HPTN 083/084.
Participants were told the results of the blinded study phase and offered the choice of APRETUDE or TRUVADA.1-3
HPTN 083
CISGENDER MEN AND TRANSGENDER WOMEN
96%
Chose APRETUDE (770/803)
4% Chose TRUVADA (33/803)1
- Of the 1698 participants originally included from the US, 803 (47%) continued into the open-label extension and had regimen choice data available1
HPTN 084
CISGENDER WOMEN
78%
Chose APRETUDE (1931/2472)
22% Chose TRUVADA (536/2472)3
- Of the 3028 participants originally included from 7 countries in sub-Saharan Africa, 2472 (81%) continued into the open-label extension and had regimen choice data available3
APRETUDE logo
[Dr Gaffney-Adams] Next, I want to talk about patient choice. In both trials, the double-blinded phase was followed by an unblinded phase and open-label extensions that were open to participants wishing to continue in the trial upon hearing the results.
During the open-label extensions, the subsets of participants continuing in both studies were given a choice between APRETUDE and TRUVADA. Of the participants who continued into the open-label extensions, 96% of participants from HPTN 083 and 78% from HPTN 084 chose APRETUDE.
As a clinician, I feel this gives me further information about the data and provides additional insight when recommending APRETUDE to my appropriate patients.
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[Dr Gaffney-Adams] Mikki, now that we’ve reviewed the trial results, can you tell us what made you switch from daily oral PrEP to APRETUDE?
[Mikki] As someone who doesn’t take any other medications, I found it really hard to take a pill every day at the same time, and I know how important it is to adhere to PrEP in order for it to work. Switching to APRETUDE with its every-2-month injections made it so that I didn’t have to worry about taking a pill every day, which made a huge difference for me.
[Dr Gaffney-Adams] I’m glad to hear that APRETUDE works better with your schedule.
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STARTING YOUR PATIENTS ON APRETUDE
2 MONTHS OF CONTINUOUS HIV PROTECTION WITH EACH INJECTION
Before initiating APRETUDE, reiterate the importance of adhering to the dosing and testing schedule to reduce the risk of HIV-1 acquisition and development of resistance
APRETUDE is administered by a healthcare provider as a single 600-mg (3-mL) gluteal intramuscular injection.
Please see Prescribing Information for details about how to continue with APRETUDE after missed injections.
Optional oral lead-in may be used prior to the initiation of APRETUDE to assess the tolerability of cabotegravir.
DOSING WINDOW
APRETUDE injections can be given up to 7 days before or after the scheduled injection date†
Patients should also be tested for HIV-1 if you suspect infection based on exposure or symptoms, or if another STI is detected
APRETUDE logo
[Dr Gaffney-Adams] Before starting APRETUDE, it’s important to select patients who are committed to the every-2-month dosing schedule and emphasize the need for adherence to these visits. APRETUDE is given as a single 3-mL injection, followed by another one a month later. After the initiation period, dosing occurs every 2 months.
It’s also required to have a negative HIV-1 test before each APRETUDE injection.
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[Dr Gaffney-Adams] Ben, what role does APRETUDE play in your journey to help protect yourself from HIV?
[Ben] Now I feel confident knowing that I am doing my part to protect myself from HIV. That confidence has made me more comfortable starting conversations about safe sex and HIV prevention with partners. Also, getting checked for HIV and STDs every 2 months has really helped give me peace of mind. I feel less worried about the what-ifs because I have regular confirmation of status.
[Dr Gaffney-Adams] Ben, I think it’s really great that you are able to have that reassurance.
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[Dr Gaffney-Adams] Mikki, what’s one piece of advice that you would give a provider who isn’t currently talking about PrEP with their sexually active patients?
[Mikki] Providers owe it to their patients to discuss PrEP and help stop the spread of HIV. These discussions are necessary to provide the best care possible.
[Dr Gaffney-Adams] Mikki, I agree. As providers we always make our patients’ health a priority.
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[Dr Gaffney-Adams] Ben, why do you think other patients should be offered APRETUDE?
[Ben] Providers should discuss all PrEP options with their patients. I know how easy it is to forget daily medications, and APRETUDE simplifies staying on track for me by allowing me to go into the clinic for my injections every 2 months.
[Dr Gaffney-Adams] I’m glad that APRETUDE works well for you.
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DON’T I DESERVE POWERFUL HIV PROTECTION?
PROVEN
Efficacy and safety evaluated in two large-scale head-to-head clinical trials, including some of the most diverse patient populations in PrEP trials to date1,2
POWERFUL
Superior efficacy versus a daily oral PrEP (TRUVADA) demonstrated in two clinical trials1,2*
- >3x reduction in HIV-1 incidence in HPTN 083 (cisgender men and transgender women):
HR 0.31 (95% CI: 0.16-0.58); P=0.0003 - 12X reduction in HIV-1 incidence in HPTN 084 (cisgender women): HR 0.10 (95% Cl: 0.04-0.27); P<0.0001
CONTINUOUS PROTECTION
Two months of continuous HIV protection with each injection (after two initiation doses)†
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[Dr Gaffney-Adams] Based on what we've discussed, we hope you'll consider APRETUDE for your next appropriate patient with its proven, powerful, and continuous protection.
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SUPER: APRETUDE logo
[Dr Gaffney-Adams] And now, let’s review the ISI.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition.
Risk for HIV-1 acquisition includes, but is not limited to:
CONDOMLESS SEX, PAST OR CURRENT STIs, SELF-IDENTIFIED HIV RISK, HAVING SEXUAL PARTNERS OF UNKNOWN HIV-1 VIREMIC STATUS, SEXUAL ACTIVITY IN A HIGH PREVALENCE AREA OR NETWORK
Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs).
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Now, we’ll cover the Warnings and Precautions. Use APRETUDE as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices. APRETUDE is not always effective in preventing HIV-1 acquisition. This slide outlines some but not all additional risk factors for HIV acquisition, including:
- condomless sex
- past or current STIs
- self-identified HIV risk
- having sexual partners of unknown HIV-1 status, or
- sexual activity in a high prevalence area or network.
It is important to inform, counsel, and support individuals on the use of a comprehensive prevention strategy.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment.
Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).
If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] APRETUDE should only be used in individuals who are confirmed to be HIV-1 negative as previously highlighted in the Boxed Warning. Resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection.
Along with testing for HIV prior to initiation, seronegative individuals should be asked about potential exposure events in the preceding month and evaluated for current or recent signs or symptoms of acute HIV infection such as those listed here.
If recent exposures (defined as less than 1 month) to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Comprehensive Management to Reduce the Risk of HIV-1 Infection: (cont’d)
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs.
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment.
Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] This slide reiterates the importance of HIV testing prior to each APRETUDE injection and provides rationale for additional testing.
Testing should be repeated upon diagnosis of any other STIs, if an HIV test indicates possible infection, or when symptoms of possible HIV infection are present following potential exposure.
Remember that individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Potential Risk of Resistance with APRETUDE:
There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE.
To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status.
Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. This is why it’s important to test before each injection to confirm negative status.
For those wishing to discontinue APRETUDE, yet who remain at risk to HIV acquisition, alternative forms of PrEP should be considered, and, if used, started within 2 months of the final injection.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Long-Acting Properties and Potential Associated Risks with APRETUDE:
Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer).
Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Because of its long-acting nature, APRETUDE drug levels slowly decrease over 12 months or longer.
Take this characteristic into consideration and carefully select individuals who agree to the every-2-month dosing schedule, because lack of adherence could lead to HIV acquisition and development of resistance.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Hypersensitivity Reactions:
Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
Hepatotoxicity:
Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors.
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
Voiceover: Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome/toxic epidermal necrolysis. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Hepatotoxicity has been reported in a limited number of patients on cabotegravir with or without pre-existing hepatic disease or identifiable risk factors. Hepatic monitoring should be considered. Discontinue APRETUDE if hepatotoxicity is suspected.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
Voiceover: Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
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IMPORTANT SAFETY INFORMATION (cont’d)
WARNINGS AND PRECAUTIONS (cont’d)
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE.
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See the Prescribing Information for additional details.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE.
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IMPORTANT SAFETY INFORMATION (cont’d)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
Voiceover: The most common adverse reaction occurring with APRETUDE was injection site reactions. The other most common adverse reactions with an incidence of at least 1% of all grades are listed in this slide.
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IMPORTANT SAFETY INFORMATION (cont’d)
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see Important Safety Information for APRETUDE throughout.
Please see accompanying full Prescribing Information, including Boxed Warning, for APRETUDE.
APRETUDE logo
[Voiceover] Please see full Prescribing Information for a list of potentially significant drug interactions. Use caution when using APRETUDE with drugs that can induce UGT1A1 as these may significantly decrease plasma concentrations of cabotegravir.
When using APRETUDE in specific populations, consider the following: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the risk of adverse reactions and that the medicine may stay in the systemic circulation for up to 12 months or longer after discontinuation.
When considering the use of APRETUDE with pediatric patients, remember that it is not recommended in individuals weighing less than 35 kilograms.
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[Dr Gaffney-Adams] I hope you enjoyed the presentation of the data and the discussion with Mikki and Ben. Thanks so much for tuning in!
Everyone: Bye!
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SUPER: ViiV Healthcare logo
TRUVADA is owned by Gilead Sciences, Inc. All other trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2025 ViiV Healthcare or licensor. PMUS-CBTVID240025 August 2025 Produced in USA.
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