Michael

A real patient on oral PrEP  who has missed daily doses.

Michael: I’ve been taking my PrEP pill every day for 5 years, but it’s still a challenge for me.

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.

Michael: I grew up in Michigan, very small suburban town between Ann Arbor and Detroit. So when I finished school and moved to New York, I kind of felt like, this is it, baby, like, this is where you can spread your wings, and it was a coming-of-age moment for sure.

SUPER: Michael

On daily oral PrEP

Michael: I started daily PrEP about 5 years ago. When I started going to the doctor post-college in New York on my own, I found that I would lie about how many sexual partners I’ve had or, you know, feel uncomfortable if I paused to, like, count them and think about it. And I just had a little bit of an epiphany about how healthcare professionals are singularly there to help keep us healthy. And I’m only really doing me a disservice by lying. Because if you are lying to your doctor, then the advice that they give you might not be right for you.

I have the best PCP in New York City. He has always made me feel super comfortable around these conversations, which is why starting daily PrEP was really easy for me.

Michael: Yeah, I have missed a dose or 2 of PrEP in my day, on those mornings that I sleep in and I’m rushing to work, or X, Y, and Z. You know, it does cause a little anxiety.

With daily PrEP it’s all on you, baby, you know? You have to think about it each day. But with APRETUDE, it lets you address that with your doctor. To have your doctor be administering that takes an element of that responsibility off of me. And that is really appealing to me.

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.

Michael: Taking charge of my sexual health is really what gives me confidence to be open to connecting with other people. It takes an element of fear away from what can be so scary, and any opportunity to not be making fear-based decisions, I say we take.

Dr Hodge: My name is Theo Hodge, and I’m an internist. I have a subspecialty in infectious diseases, and currently I’m serving as the medical director at a nonprofit in Washington, DC.

SUPER: Dr Theo Hodge Internist

Dr Hodge: Empowered. That is the single word that comes to mind when I assess what I heard from Michael. He understands that it’s important to have a good patient–doctor relationship to be able to speak to your doctor and be fully transparent. Patients like Michael, they look at daily PrEP as a responsibility that is all theirs. But, with APRETUDE, it’s a shared responsibility. I also make it very clear to patients, OK, so you don’t want to take a pill every day, but you gotta show up in my office every 2 months. And although it’s not a daily commitment, it’s still a commitment.

Dr Hodge: But my responsibility is making sure their drug is there and giving them an injection. So it’s part of a directly observed therapy, which, you know, I hadn’t thought about until I actually saw that interview. This is my shared responsibility with the patient. That does nothing but strengthen the bond, because you’re like, OK, this person actually cares about me.

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

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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©2023 ViiV Healthcare or licensor.
CBTVID220034 March 2023
Produced in USA.

CBTWCNT230040

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.

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 become infected with 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 HIV-1 uninfected individuals 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.

CBTWCNT230038

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CBTWCNT230037 April 2024

Produced in USA.