Mason

A real patient on oral PrEP  who struggles taking pills  every day.

Mason: When I first heard about APRETUDE, definitely got excited.

SUPER:

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.

Mason: Hey, I’m Mason. I’m 25, actually, no, just turned 26. I grew up in Cleveland, Ohio. I grew up in the suburbs, but everyone just says Cleveland because no one knows what Strongsville, Ohio, is. I lived there until I was 18, and then I moved to New York City right after.

I grew up dancing and now I work in film. I film dancers for, for a living. And it’s...it’s amazing.

SUPER: Mason
On daily oral PrEP

Mason: My PrEP journey really began when I started hearing about it from my friends. Getting to New York and realizing, like, there’s a lot of people in New York City. And I’m a young guy, so I was like, I want to explore, I want to date, but I want to do that in a way that, that is safe. And I didn’t have a doctor in New York. I didn’t feel like I could pick up the phone and call someone and just be like, hey, can we schedule an appointment? I think, you know, my PrEP journey really has been kind of like a self-start sort of moment. I saw an ad on social media that kind of directed me to an organization that got me hooked up with an appointment.

SUPER: PrEP=pre-exposure prophylaxis.

Mason: The doctor who is helping me out with this PrEP journey is actually not my primary care provider. When I go to see him, when I go to that facility, it’s really the entire visit is kind of centered around, you know, my PrEP experience. With the consistency of taking PrEP, you know, if I’m on a shoot late at night one day and wake up late the next morning, I might forget to take my dose. Or if I’m out celebrating with some friends and have a little bit of a wild night. It’s just kind of like those life moments that are unpredictable that would throw me off track.
So my doctor never really said anything about APRETUDE to me. As a queer person, I would just love for my doctor to be like, hey, here’s all your options. You know, have a provider that is going to give me, you know, a full array of options that, you know, might benefit me or work better for my life. When I first heard about APRETUDE, definitely got excited.

Mason: You know, the thought of not having to take a pill every single day, 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.

Mason: : PrEP for me is the sense of protection, and the fact that it really helps lower the risk of me potentially contracting HIV is really the main draw for me.

You know, you have one body, you know, you have one body, one mind, one set of all of this.

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: I have patients like Mason in my practice. You have so many people moving into Washington from the Midwest or rural places. So my patients come in, and they’re like, hey, Dr Hodge, you know what, I couldn’t do any of this stuff when I was living at home with my family and friends. And they’re telling me all the time, well you know, Dr Hodge, I was at the party, I was at the club, and you know what, I don’t know if I took my pill. And for patients like Mason, I think it’s very important that their healthcare provider offer guidance that doesn’t have to be elicited by the patient. And the second thing that was very resonant with me is that the PrEP provider had not mentioned APRETUDE as an option.

Dr Hodge: I think it’s important that all options be presented so that the patient can actively participate in their healthcare. We talk about APRETUDE as an option. What does APRETUDE mean in terms of adherence, because adherence is still just as important for the injectable as they are for the oral options. However, there’s one big difference. The oral option is every day versus the injectable, where it’s every 2 months. And so to me, in terms of providing an option to a patient, giving them the chance not to have to make that choice every day, I think patients like Mason could benefit from APRETUDE.

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

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

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.

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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CBTVID220032 March 2023
Produced in USA.

CBTWCNT230040

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.

PMUS-CBTWCNT240070

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PMUS-CBTWCNT240070 October 2024

Produced in USA.