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There is an urgent need
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to get patients talking about their sexual health
VO:
[Crew] Hey on my mark. Action Talent.
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to get patients talking about their needs in HIV protection
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to get patients talking about their choices in PrEP
PrEP=pre-exposure prophylaxis.
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We sat down with Dr. Nas Mohamed and Kenny, a real patient, for a candid conversation about helping patients find the PrEP that’s right for them.
All participants compensated by ViiV Healthcare.
VO:
[Dr. Nas] Hi.
[Kenny] Hey, good morning.
[Dr. Nas] How are ya?
[Kenny] Doing good. Kenny.
[Dr. Nas] Nas.
[Kenny] Nas. Nice to meet you.
[Dr. Nas] Good to meet you.
VO:
[Dr. Nas] Where are you at, Kenny?
[Kenny] Ah, well I live in Houston.
[Dr. Nas] Awesome.
[Kenny] Um, I work as a hairdresser, but I get to work with a lot of people in the LGBTQ community, and out, so.
[Dr. Nas] Yeah.
[Kenny] Um, it’s, it’s a lot of fun.
VO:
[Kenny] What do you do for a living and where are you?
[Dr. Nas] I’m a physician based in San Francisco. I really like caring for like, you know, the gay community and pivoted into like outpatient practice that’s really focused on a lot of LGBT medicine, including HIV, um, care.
[Kenny] That’s really awesome. It’s good to have a, a healthcare provider who’s so passionate about working within our community.
[Dr. Nas] Um, so, we’re gonna talk about sex now (laughs).
[Kenny] I’m ready.
[Dr. Nas] Tell me about, like, your dating life.
VO:
[Kenny] Um, well I’m currently in a relationship, I like to say we’re monogamish. Um, you know, we practice monogamy, but we have, uh, the ability to talk to each other about expanding that at different times. So, uh, for me, I’m, it’s really important to make sure that I have a healthcare provider I can talk to.
[Dr. Nas] And you said you’re in Houston, or, now...
[Kenny] Houston, yeah.
[Dr. Nas] How has it been, like, connecting to care where you are?
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THE UNMET NEED
VO:
[Kenny] Um, I have a very good friend who works in a clinic that specializes in, um, HIV research and, uh, treatment and prevention. So when I got there, I was able to start my PrEP journey. When it first came out, I was aware of it, but since I was in a committed long-term relationship, I didn’t really feel like it applied to me. And then over the years of that relationship, we decided to, uh, open up our relationship and practice consensual nonmonogamy.
[Dr. Nas] Yeah.
[Kenny] And so that, that was the jumpstart into my PrEP journey when I was taking oral PrEP.
VO:
[Dr. Nas] How were you doing with the oral regimen?
VO:
[Kenny] I’m not horrible at remembering to take a pill.
[Dr. Nas] Okay.
[Kenny] Um, but with what I do for work and my busy schedule... so that became, you know, the anxiety with that was not worth it.
VO:
[Dr. Nas] So to you it was like, oh, like I, if, if I had an option, I would switch. You were not necessarily completely struggling on the oral pill, but then when something else was on the table you’re like, this fits better.
[Kenny] Definitely. So I have a question for you. Do you tend to find that your patients coming in, um, are pretty forthcoming about whether they’ve intentionally missed dosages of oral PrEP or maybe accidentally?
VO:
[Dr. Nas] I feel like this is one of the things that’s kind of like background knowledge, but nobody talks about. They don’t come in and be like, “Hey doctor, guess what? I didn’t really take the medicines the way they’re prescribed.” Like, nobody says that. Also, when people come in for their follow-up visits, there are hints that they are not taking them as prescribed.
VO:
[Dr. Nas] So there are, like, all of these signs that they’re not taking their medications daily. But some of the reasons they were struggling with taking the pills were not necessarily related to their sexual um, history. Some of them have to do with like other medical conditions. Some have to do with their lifestyle. And this is why, like, I always like to tell people what their options are all the time.
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UNCOVERING THE CHALLENGE
VO:
[Kenny] So then how do you have that conversation with them?
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PrEP is one HIV prevention option. Also counsel patients on condom use, STI testing, and knowing status of partner(s).
VO:
[Dr. Nas] I put it on the table for everybody. Whether they’re coming in to engage with care for the first time or if they’re currently on a, on a regimen, I would still let them know what other options are available to them. I do this regularly to, one, remain informed myself, but also to make sure that people stay on PrEP and can choose what they want.
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LISTEN FOR: CHANGES IN ROUTINE
VO:
[Kenny] Sure, I mean, and keeping them informed also helps keep them feeling more comfortable, right?
[Dr. Nas] Yeah. And people’s stories change all the time, right? Like, it’s like, just like, you know, like people’s jobs...
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LISTEN FOR: RELATIONSHIP CHANGE
VO:
[Dr. Nas] ...their relationship status...
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LISTEN FOR: OTHER LIFESTYLE CHANGES
VO:
[Dr. Nas] ...their life crisis could happen and then your healthcare decisions have to shift.
[Kenny] Yeah.
[Dr. Nas] Right, like, life happens. Because like you, you, you mentioned, um, some aspects about your relationship, right? Some people go from being with somebody to being polyamorous or they can go back to being single.
[Kenny] Right.
VO:
[Dr. Nas] They change all the time and as they change, I think it’s good for people to know that there are tools that can fit different stories that they have going on in their lives.
[Kenny] Right.
[Dr. Nas] There’s still other options on the table that they can choose from.
[Kenny] Definitely.
[Dr. Nas] Yeah.
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REASSESSING PATIENTS’ PrEP REGIMENS
VO:
[Kenny] Like are there any cues you look out for that you, that will help guide you into what you think might be best for them?
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ASK ABOUT: OVERALL HEALTH & MEDICATIONS
VO:
[Dr. Nas] I try to avoid making decisions for people, even though like my approach is tailored to the person, the things I bring up are pretty much consistent. I like to make sure that the pros and cons of each option are listed for the patient and that includes taking into consideration their medical conditions...
VO:
[Dr. Nas] ...medications that they take, um, recreational drug use. Um, if they do use any drugs...
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ASK ABOUT: LIFESTYLE
VO:
[Dr. Nas] ...their lifestyle, right...
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ASK ABOUT: ADHERENCE CHALLENGES
VO:
[Dr. Nas] ...their ability to adhere to the medication and then help them select the best medication that fits in their life. You can come talk to me about it. You can share anything you want to share and I would be able to support you. So I always lead with that. But then sometimes I walk in and just like, you know, I get all the tea immediately (laughs).
VO:
[Kenny] And I think it’s kinda the same way that I deal with clients in my chair as a hairdresser. It’s funny because sometimes people come in and have a very direct concise conversation about their wants and other times it takes a lot of discovery on my end to figure out their personality, you know?
[Dr. Nas] Yeah.
[Kenny] Their lifestyle and things. So I know what best suits them, and I’d imagine the conversations I have with my clients are very similar to conversations you have to have with your patients to get them to, to get to discover.
[Dr. Nas] Yeah.
VO:
[Dr. Nas] But then I always like to make sure the patient is the one driving this a little bit because they’re the ones living their lives. They know more than I do.
VO:
[Kenny] You give them their options, you give them choices and kinda empower them to make the choice that’s best for them.
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WHY APRETUDE (cabotegravir)?
VO:
[Kenny] Uh, like I said, when I moved to Houston, I, uh, started oral PrEP, so I was doing fine taking it every day.
VO:
[Kenny] Right around the time that APRETUDE, uh, started becoming available, my healthcare team let me know that there was something available and they felt like with what I do for work, that it might fit my lifestyle and my busy schedule a lot better for me.
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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.
VO:
[Dr. Nas] APRETUDE is for PrEP to reduce the risk of sexually acquired HIV infection for HIV-negative adults and adolescents who weigh at least 35 kilograms and are at risk of sexually acquiring HIV. There is a boxed warning for APRETUDE shown in full here, which describes a risk of drug resistance...
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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.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Nas] ...if APRETUDE is used in people with HIV. Don’t give APRETUDE or oral cabotegravir until the patient is confirmed to be HIV negative with a test that can diagnose acute or primary HIV.
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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.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Nas] Any individual diagnosed with HIV must begin a complete HIV treatment. Keep watching for the remaining safety information.
VO:
[Dr. Nas] So do you see yourself staying on APRETUDE for a while?
[Kenny] I do. In my experience, it helps provide that continuous protection and not having to take that daily oral pill has been a lot more easy for me to manage.
[Dr. Nas] That’s awesome.
[Kenny] Definitely.
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APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Healthcare providers should counsel patients on the importance of adherence to help reduce the risk of HIV-1 acquisition.
VO:
[VO] APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Healthcare providers should counsel patients on the importance of adherence to help reduce the risk of HIV-1 acquisition.
VO:
[Dr. Nas] I have to say, like, in my experience, some, some of my patients that I didn’t expect to switch to a shot opted for it.
[Kenny] Yeah, I think that’s great.
[Dr. Nas] We need to make sure people are on the right regimen for them. Right. Like, because if you’re not gonna take it, it’s not gonna work. So you need to just, like, be on the thing that you know is gonna work for you the best.
[Kenny] Definitely. Yeah. That’s, that’s really important.
VO:
[Kenny] So thank you so much for being here today. I feel like I can talk to you about this forever, but I really appreciate you coming and sharing your knowledge.
[Dr. Nas] Yeah, thank you. I know this is a very like, vulnerable conversation for a lot of people, but I love how you own it and approach it with confidence and the need to advocate for yourselves. Thank you for your time today, Kenny, it was really good to talk to you and learn more about you.
VO:
[Kenny] Yeah. Thank you for your time today too. I, I think that you being here in the healthcare provider space hopefully gets more people comfortable, uh, having these difficult conversations.
VO:
[Dr. Nas] Awesome.
[Kenny] Yeah, great to meet you today.
[Dr. Nas] Yeah, it’s good to meet you. I’m gonna grab some coffee, do you wanna go?
[Kenny] Yeah let’s go.
[Dr. Nas] Let’s go.
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Open conversations can lead to the HIV protection patients need
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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
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)
VO:
IMPORTANT SAFETY INFORMATION CONTINUED
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.
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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- 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
- 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
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
VO:
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.
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.
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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
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
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
VO:
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for 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. 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.
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.
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.
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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
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
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
VO:
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.
Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
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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- 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
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.
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
VO:
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.
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.
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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 full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
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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