JT

A real patient on APRETUDE.

JT: If I struggled to take my PrEP every day, I had to ask myself, is this really the best option to help protect me from HIV?

SUPER: PrEP=pre-exposure prophylaxis.

All participants compensated by ViiV Healthcare.

AVO: APRETUDE is for PrEP to reduce the risk of sexually acquired HIV infection for HIV-negative adults and adolescents who weigh at least 35 kg and are at risk of sexually acquiring HIV.

SUPER: INDICATION
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. 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.

AVO: There is a Boxed Warning for APRETUDE, shown in full here, which describes a risk of drug resistance 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. Any individual diagnosed with HIV must begin a complete HIV treatment.

SUPER: 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 become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

AVO: Keep watching for the remaining select safety information.

SUPER: Keep watching for the remaining select safety information. Please see full Prescribing Information, including Boxed Warning, for APRETUDE on this website.

JT: I love music. And what I love about it, it has an opportunity to tell a story. And I just love that it has that way to bring us together.

SUPER: JT

On APRETUDE

JT: But relationships, you know, I look at relationships differently. You know, I started having situations left and right that had me better wanting to protect myself against HIV. For me, it was in one of my personal relationships. You know, the person didn’t know their status. So that conversation was something different and new for me. We were young and in love and just doing everything together. So it was like, of course, why not go get tested together? And, you know, we started off that journey getting tested together, but then it started to dwindle down. I’m like, OK, I understand, life happens, but, you know, for me, I’m gonna keep my regimen of, you know, going to get tested, you know, just making sure I’m on the up-and-up.

JT: So I started my PrEP journey, and then as I continued to learn more about PrEP, it wasn’t how sexually active I am, but it’s more how proactive do you want to be in protecting yourself? It wasn’t just about PrEP. It was a holistic approach. It’s, you know, the condoms, it’s the consent, it’s the communication, it’s the testing. I did have a daily pill case, you know, the days of the week. But then, you know, my days look different. So sometimes I’d take it in the morning, sometimes I’d take it at night. My nights look different Monday through Thursday versus Friday, Saturday, and Sunday. So I was like, OK, got to be adherent. You got to do this but it’s like wait.

JT: APRETUDE, you know, that’s a no-brainer, because now instead of taking a daily pill, I can go ahead and get a shot every 2 months versus taking something every day. And that was, that’s a bit challenging because life happens, you know?

SUPER: APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Adherence to the dosing schedule is strongly recommended.

JT: With the shot, I don’t have to worry about that. I just have to make sure that I’m in my window and that’s what I love that they emphasize, you know, 7 days before or 7 days after, you’re able to make sure that you’re coming for your injection. So with APRETUDE I definitely look at it as a great opportunity to add to that safety belt and add to that safety net of protection against HIV.

SUPER: APRETUDE injections can be given up to 7 days before or after the scheduled injection date.

Dr Tims-Cook: My name is Zandraetta Tims-Cook, and I’m an infectious diseases physician based in Atlanta, Georgia.

SUPER: Dr Zandraetta Tims-Cook

Infectious Diseases Physician

Dr Tims-Cook: JT’s story strikes me as one who’s the prototype patient who epitomizes how to be proactive in one’s sexual health and sexual experiences, to not leave something as important as an HIV transmission to chance.
For a patient like JT who has a busy lifestyle, I would encourage providers to delve deeper into the lifestyle features of their patient, to take all of those features into consideration and make a joint plan.
We’re always encouraged as providers to look at each patient as an individual from their family history to their lifestyle to their profession, and tailor a therapy to that individual.

Dr Tims-Cook: So a daily oral tablet may not be the best fit for everyone. And so providers should be armed with knowledge and the ability to educate their patients on these options. For patients who have a demanding lifestyle that requires distant travel or long periods away from home, having a dosing option that isn’t daily, but that can allow them to schedule their dosing and their visits and also have their other health issues addressed at the same time, has been invaluable for them.

SUPER: Adherence to the every-2-month dosing schedule is strongly recommended.

SUPER: What could APRETUDE mean for your patients like JT?

AVO: APRETUDE is contraindicated in individuals with unknown or positive HIV status; with previous hypersensitivity reaction to cabotegravir; or with drugs where significant decreases in cabotegravir plasma concentrations may occur.

Use APRETUDE as part of a comprehensive HIV prevention strategy.

There is a potential risk of resistance if an individual acquires HIV either before, while taking, or following discontinuation of APRETUDE. Test before each injection to confirm HIV-negative status. Reassess risk of HIV acquisition and test before each injection to confirm HIV-negative status.

SUPER:

CONTRAINDICATIONS

APRETUDE is contraindicated in individuals with unknown or positive HIV status; with previous

hypersensitivity reaction to cabotegravir; or with drugs where significant decreases in cabotegravir

plasma concentrations may occur.

WARNINGS AND PRECAUTIONS

Use APRETUDE as part of a comprehensive HIV prevention strategy.
There is a potential risk of resistance if an individual acquires HIV either before, while taking, or following discontinuation of APRETUDE. Test before each injection to confirm HIV-negative status. Reassess risk of HIV acquisition and test before each injection to confirm HIV-negative status.

AVO: Because APRETUDE is long-acting, residual concentrations of cabotegravir may remain in the systemic circulation up to 12 months or longer.

Hypersensitivity has been reported with other integrase inhibitors, and hepatotoxicity has been reported with cabotegravir. Discontinue immediately if signs or symptoms of either develop.

Depressive disorders have been reported. Prompt evaluation is recommended.

The most common adverse reactions, all grades, observed in at least 1 percent of patients, 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.

SUPER:

Because APRETUDE is long-acting, residual concentrations of cabotegravir may remain in the systemic circulation up to 12 months or longer.
Hypersensitivity has been reported with other integrase inhibitors, and hepatotoxicity has been reported with cabotegravir. Discontinue immediately if signs or symptoms of either develop.
Depressive disorders have been reported. Prompt evaluation is recommended.

ADVERSE REACTIONS

AVO: Refer to the full PI for important drug interactions with APRETUDE. Drugs that induce UGT1A1 may significantly decrease plasma concentration.

If patient is breastfeeding an infant, assess the benefit-risk of using APRETUDE. APRETUDE is not recommended for use in pediatric individuals weighing less than 35 kilograms.

Please see the full Important Safety Information and Prescribing Information, including Boxed Warning, on this website.

SUPER:

DRUG INTERACTIONS

Refer to the full PI for important drug interactions with APRETUDE. Drugs that induce UGT1A1* may significantly decrease plasma concentration.

*uridine diphosphate glucuronosyltransferase

USE IN SPECIFIC POPULATIONS

If patient is breastfeeding an infant, assess the benefit-risk of using APRETUDE. APRETUDE is not recommended for use in pediatric individuals weighing less than 35 kilograms.

Please see the full Important Safety Information and Prescribing Information, including Boxed Warning, on this website.

SUPER: 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.

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

INDICATION

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.

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)
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 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 in association with other integrase inhibitors and could occur with APRETUDE
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

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
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

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.

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