Dr Kevin Hatfield
Family Practice Physician
Watch Dr Hatfield discuss identifying appropriate patients for APRETUDE and the importance of having PrEP patients make return visits to his office.
Dr Hatfield: I’m Kevin Hatfield. I’m a family practice doc.
SUPER: Dr Kevin Hatfield
Family Practice Physician
Compensated by ViiV Healthcare.
Dr Hatfield: And my practice is part of a multispecialty group, but I see a wide variety of patients. And I do see, as a trans provider in town, a lot of transgender adults as well. I call it providing gender care, because I feel like it’s just, it normalizes the fact that, you know, that’s one of the other things that I do. I have about a thousand patients plus.
Dr Hatfield: So I think that the interest in APRETUDE for me in my practice is far higher than I expected it because we’re so used to giving daily pills. But that doesn’t fit with everyone’s lifestyle.
Dr Hatfield: APRETUDE for PrEP is 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.
Dr Hatfield: 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: 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.
Dr Hatfield: Keep watching for the remaining safety information.
SUPER: Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
SUPER: Every-2-month dosing
Dr Hatfield: So long-acting PrEP for the patients that I see is beneficial for many reasons.
SUPER: PrEP=pre-exposure prophylaxis.
Dr Hatfield: Part of what I like about having patients come back every 2 months is that I get to reconnect with them.
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.
Dr Hatfield: And that’s something that I can actually ask more about, how it’s going, you know, what their sexual health is like. Do they have any new concerns?
Dr Hatfield: The other thing that makes it a wonderful point of reconnection for me is, if someone’s coming in every 2 months, I know they’re not missing doses.
SUPER: “If someone’s coming in every 2 months, I know they’re not missing doses”
Dr Hatfield: And so if I’m prescribing 90 days’ worth of tablets, I’m hoping in the back of my mind that they’re compliant.
Dr Hatfield: That is something that with APRETUDE I don’t necessarily have to worry as much about. So when I have patients come back to the office every 2 months for the injection and I give it to them,...
SUPER: APRETUDE should be used to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections.
Dr Hatfield: ...they know that it is in the background and it is helping to prevent them from getting HIV. And so that’s actually a really reassuring thing for me.
SUPER: “They know that it is in the background and it is helping to prevent them from getting HIV”
SUPER: Identifying appropriate patients
Dr Hatfield: I prescribe APRETUDE for any appropriate patient that wants to be on it. And that is a sentence I say with a full stop.
SUPER: Appropriate patients must meet the clinical considerations in the label and agree to the required dosing and testing schedule.
Dr Hatfield: My desire for them is to be on what they feel would be easiest.
SUPER: “My desire for them is to be on what they feel would be easiest”
Dr Hatfield: So with that said, then there are other things that come in in a more nuanced level. I usually will think about the age of the patient and whether or not they’re taking any other medicines routinely. Is daily PrEP going to be something that they could just add in to something else that they take on a daily basis?
Patients with daily medicines might be perfect, but many people aren’t. And I feel like most of the patients that I talk to, no matter what medicines they’re on when they’re on a daily tablet of any kind, will end up saying, “Oh yeah. I missed a pill here. I missed a pill there.” And we know that, you know, being in the game of preventing HIV,...
Dr Hatfield: ...adherence is key.
SUPER: “Adherence is key”
Dr Hatfield: With APRETUDE, if I’m delivering it to them when I see them every 2 months, I can also rest assured that APRETUDE is in the background helping to prevent HIV with that patient as well.
SUPER: Patient reactions to APRETUDE
Dr Hatfield: When I present APRETUDE, a lot of patients are intrigued by the idea that they could actually just have an injection that’s going to last for 2 months.
SUPER: “They could actually just have an injection that’s going to last for 2 months”
Dr Hatfield: Then they want to know the ins and outs of how we’ll go ahead and do it for them. I always talk about the loading dose. They’re going to get 1 shot. A month later, they’re going to get a second shot. And then after that, it’s a 2-month, 2-month visit to come in and get the next one. And the surprise usually very quickly will turn into enthusiasm because they’re like, “Oh, that sounds like that would really work well for me.”
SUPER: Diverse and comprehensive participant population
Dr Hatfield: So I think one of the amazing things about the trials that brought APRETUDE to market for HIV prevention is the fact that...
SUPER: HPTN 083:
87% cisgender men and 12% transgender women who have sex with men
HPTN 084:
>99% cisgender women
HPTN=HIV Prevention Trials Network.
Dr Hatfield: ...they were very inclusive of the patient population that I see personally with a large, you know, gender care practice.
SUPER: “They were very inclusive of the patient population that I see personally”
Dr Hatfield: If folks that weren’t included before in high numbers are now included in the studies, which they were, it’s even more reassuring that APRETUDE is effective when taken appropriately. And the groups that were not included as much have now been included, is just really nice to be able to say that to patients. So for, you know, the patients that I see every day, especially for the gender care patients, I can say that you were included.
SUPER
HPTN 083 (N=4,566) and HPTN 084 (N=3,224) were randomized, double-blind, controlled trials of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected adults who have evidence of high-risk behavior for HIV-1 infection. The primary endpoints were rate of incident HIV-1 infection.
TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
SUPER: What could APRETUDE mean for the patients in your practice?
SUPER and VO:
IMPORTANT SAFETY INFORMATION (cont’d)
The heading “IMPORTANT SAFETY INFORMATION (cont’d)” appears only as an onscreen SUPER and is not voiced over
CONTRAINDICATIONS
The subheading “CONTRAINDICATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “WARNINGS AND PRECAUTIONS” appears only as an onscreen SUPER and is not voiced over.
SUPER and VO:
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
The subheading “Comprehensive Management to Reduce the Risk of HIV-1 Infection:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER and VO:
- 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:
The subheading “Potential Risk of Resistance with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Long-Acting Properties and Potential Associated Risks with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER and VO:
Hypersensitivity Reactions:
The subheading “Hypersensitivity Reactions:” appears only as an onscreen SUPER and is not voiced over
- 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:
The subheading “Hepatotoxicity:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Depressive Disorders:” appears only as an onscreen SUPER and is not voiced over.
- 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 subheading “Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO
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 subheading “ADVERSE REACTIONS” appears only as an onscreen SUPER and is not voiced over.
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
The subheading “DRUG INTERACTIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “USE IN SPECIFIC POPULATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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 the full Prescribing Information, including Boxed Warning, on this website.
SUPER:
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2023 ViiV Healthcare or licensor.
CBTVID230007 June 2023
Produced in USA.
Dr Theo Hodge
Internist
See Dr Hodge reflect on having the conversation about sexual health with patients and the relevance of a diverse and comprehensive clinical trial population.
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, D.C.
SUPER: Dr Theo Hodge
Internist
Compensated by ViiV Healthcare.
Dr Hodge: And for the past nearly 30 years, I have been out in the community trying my best to uplift those living with HIV. And I have a big mouth when it comes to prevention of HIV as well.
Dr Hodge: APRETUDE for PrEP is 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.
Dr Hodge: 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: 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.
Dr Hodge: Keep watching for the remaining safety information.
SUPER: Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
SUPER: Discussing sexual health
Dr Hodge: I love talking about sex. So I love it. First of all, you have to normalize it.
Dr Hodge: And the only way that I can assess your entire medical health is to also discuss your sexual health. So the first question is “Are you sexually active?” “Who are you having sex with?” “Which parts of your body do you use when you have sex?”
SUPER: “The only way that I can assess your entire medical health is to also discuss your sexual health”
Dr Hodge: And of course, during those questions, if things come up that would say to me, as a healthcare provider, that you’re at risk for HIV,...
SUPER: PrEP should be used to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections.
Dr Hodge: ...then we need to talk about PrEP.
SUPER: PrEP=pre-exposure prophylaxis.
Dr Hodge: To my colleagues: Hey, y’all. You need to take a sexual history. You need to take the time and speak to your patients.
SUPER: Uncovering missed PrEP doses
Dr Hodge: So how might I uncover how a patient misses their daily oral PrEP? One of those questions is, “Hey, did you miss any doses since the last time you were up in my office?” Or I may say, “OK, over the last month, less than 5 doses that you missed? Less than 10 doses?” It’s important for me to know, particularly now that I know that there’s another option.
SUPER: Patient reactions to APRETUDE
Dr Hodge: So in terms of my patients’ reaction to APRETUDE, they really, you know, so many of them are just amazed that they actually can have a 2-month period of time where a drug, in this case APRETUDE, will help to protect them from sexual acquisition of HIV.
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.
Dr Hodge: And that’s wonderful because 2 months—60 days—that they don’t have to worry about being covered in terms of helping to prevent HIV.
SUPER: “60 days that they don’t have to worry about being covered in terms of helping to prevent HIV”
Dr Hodge: Other reactions have been, “I can finally get rid of taking this pill every day. And you’re telling me I have an option where I don’t have to do that.”
Dr Hodge: So for me it’s, again, all about options.
SUPER: “It’s all about options”
Dr Hodge: I love, as I’ve said earlier, to make sure that my patients are aware of all the options. I love having the conversations about what their lifestyle will accommodate.
SUPER: “I love having the conversations about what their lifestyle will accommodate”
SUPER: Diverse and comprehensive participant population
Dr Hodge: Inclusivity is very important.
Dr Hodge: So when we look at who actually is being infected with HIV, you see African Americans in general, Latino populations, men who have sex with men—African American in particular—who are disproportionately represented in those numbers.
Dr Hodge: Overwhelming resonating point for me when we look at the APRETUDE trials is that, particularly with men who have sex with men and transgender women, 50%, 50% of those patients that were in that trial were from the African American community,...
SUPER:
HPTN 083:
87% cisgender men and 12% transgender women who have sex with men
In the US, 50% were Black
HPTN 084:
>99% cisgender women
HPTN=HIV Prevention Trials Network.
Dr Hodge: ...a community that is disproportionately represented in terms of new infections.
SUPER: HPTN 083 (N=4,566) and HPTN 084 (N=3,224) were randomized, double-blind, controlled trials of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1– uninfected adults who have evidence of high-risk behavior for HIV-1 infection. The primary endpoints were rate of incident HIV-1 infection. TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
Dr Hodge: So for me it speaks directly to my heart. The patients that look like me, who are very much represented in terms of new infection, were actually in this trial.
SUPER: “The patients that look like me, who are very much represented in terms of new infection, were actually in this trial”
Dr Hodge: And that is important information that I love to convey to my patients when we talk about that particular option.
SUPER: What could APRETUDE mean for the patients in your practice?
SUPER AND VO:
IMPORTANT SAFETY INFORMATION (cont’d)
The heading “IMPORTANT SAFETY INFORMATION (cont’d)” appears only as an onscreen SUPER and is not voiced over.
CONTRAINDICATIONS
The subheading “CONTRAINDICATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “WARNINGS AND PRECAUTIONS” appears only as an onscreen SUPER and is not voiced over.
SUPER AND VO:
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
The subheading “Comprehensive Management to Reduce the Risk of HIV-1 Infection:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
- 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:
The subheading “Potential Risk of Resistance with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Long-Acting Properties and Potential Associated Risks with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
Hypersensitivity Reactions:
The subheading “Hypersensitivity Reactions:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Hepatotoxicity:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Depressive Disorders:” appears only as an onscreen SUPER and is not voiced over.
- 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 subheading “Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
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 subheading “ADVERSE REACTIONS” appears only as an onscreen SUPER and is not voiced over.
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
The subheading “DRUG INTERACTIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “USE IN SPECIFIC POPULATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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 the full Prescribing Information, including Boxed Warning, on this website.
SUPER:
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2023 ViiV Healthcare or licensor.
CBTVID230008 June 2023
Produced in USA.
Dr Zandraetta Tims-Cook
Infectious Diseases Physician
View Dr Tims-Cook speak about her experience helping African American women prevent HIV infection and why it is highly important to have adequate inclusion of the hardest-hit patient populations in clinical trials.
Dr Tims-Cook: My name is Zandraetta Tims-Cook, and I am an infectious diseases physician based in Atlanta, Georgia.
SUPER: Dr Zandraetta Tims-Cook
Infectious Diseases Physician
Compensated by ViiV Healthcare.
Dr Tims-Cook: What inspired me to do the work that I do is, at the time that I was training to be a physician, a woman of my age and my ethnicity at that time had HIV as the leading cause of death. And I wanted to learn more about it. I wanted to be a part of the solutions to change that dynamic for African American women.
Dr Tims-Cook: APRETUDE for PrEP is 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.
Dr Tims-Cook: 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: 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.
Dr Tims-Cook: Keep watching for the remaining safety information.
SUPER:
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
SUPER: Discussing sexual health with women
Dr Tims-Cook: For women in my practice when we discuss their sexual health, we start really with the basics. Tell me about the last time you had sex. Did you enjoy it? Why didn’t you enjoy it? How do you protect yourself from pregnancy? How do you protect yourself from sexually transmitted infections? And so they’re open-ended questions that allow each woman to be able to tell her story.
Dr Tims-Cook: And then in areas where I see there may be knowledge gaps or gaps in terms ofperceived risk, that gives me the opportunity as a provider to fill those gaps for the patient.
SUPER:
“That gives me the opportunity as a provider to fill those gaps”
Dr Tims-Cook: So PrEP is one aspect of that,...
SUPER: PrEP=pre-exposure prophylaxis.
Dr Tims-Cook: ...whether it’s through every-other-month injections or daily tablets.
SUPER:
Every-2-month dosing with APRETUDE
Dr Tims-Cook: When discussing APRETUDE as a PrEP option and explaining that the dosing is every 2 months, patients generally are quite excited to know that they have an option that provides...
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.
Dr Tims-Cook: ...them the protection that they’re seeking with dosing that doesn’t require remembering or taking it every day.
SUPER:
“The protection that they’re seeking with dosing that doesn’t require remembering or taking it every day”
Dr Tims-Cook: And so anything else that can have a lesser frequency and yet still provide the safety net or at least a tool that can assist in that is desired.
SUPER:
APRETUDE should be used to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections.
Dr Tims-Cook: The benefit to me in having patients visit every 2 months for their injectable therapy is having a chance to physically see them and hear from them to know what’s, what’s new and different from a health or social standpoint, to have a chance to know...
Dr Tims-Cook: ...that they are adherent, and that is something I’m tangibly able to see.
SUPER:
“That is something I’m tangibly able to see”
SUPER:
Diverse and comprehensive participant population
Dr Tims-Cook: The APRETUDE trials incorporated patients who are within the demographics who are currently hardest hit in terms of HIV transmissions: men who have sex with men, transgendered women, cisgendered women.
SUPER:
HPTN 083:
87% cisgender men and 12% transgender women who have sex with men
In the US, 50% were Black
HPTN 084:
>99% cisgender women
HPTN=HIV Prevention Trials Network.
Dr Tims-Cook: And so having trials that included those individuals such that we could offer some generalizability as we discuss this option with patients who fit in that category, to allow them some confidence that this option is, is one that fits them and that has included them in the process.
SUPER:
HPTN 083 (N=4,566) and HPTN 084 (N=3,224) were randomized, double-blind, controlled trials of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected adults who have evidence of high-risk behavior for HIV-1 infection. The primary endpoints were rate of incident HIV-1 infection.
TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
Dr Tims-Cook: But I think it’s highly important that we have adequate inclusion. Knowing that APRETUDE included patients who have been hardest hit is very important.
SUPER:
“I think it’s highly important that we have adequate inclusion”
SUPER:
What could APRETUDE mean for the patients in your practice?
SUPER AND VO:
IMPORTANT SAFETY INFORMATION (Cont’d)
The heading “IMPORTANT SAFETY INFORMATION (Cont’d) appears only as an onscreen SUPER and is not voiced over.
CONTRAINDICATIONS
The subheading “CONTRAINDICATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “WARNINGS AND PRECAUTIONS” appears only as an onscreen SUPER and is not voiced over.
SUPER AND VO:
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
The subheading “Comprehensive Management to Reduce the Risk of HIV-1 Infection:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
- 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:
The subheading “Potential Risk of Resistance with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Long-Acting Properties and Potential Associated Risks with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
Hypersensitivity Reactions:
The subheading “Hypersensitivity Reactions:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Hepatotoxicity:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Depressive Disorders:” appears only as an onscreen SUPER and is not voiced over.
- 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 subheading “Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
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 subheading “ADVERSE REACTIONS” appears only as an onscreen SUPER and is not voiced over.
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
The subheading “DRUG INTERACTIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “USE IN SPECIFIC POPULATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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 the full Prescribing Information, including Boxed Warning, on this website.
SUPER:
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2023 ViiV Healthcare or licensor.
CBTVID230009 June 2023
Produced in USA.
Erick Suarez
Nurse Practitioner
Watch Erick Suarez recall his excited reaction to the every-2-month* dosing option of APRETUDE.
*After initiation injections.
Erick: My name is Erick Suarez. I am a nurse practitioner in Orlando, Florida. I currently work for a nonprofit organization.
SUPER: Erick Suarez Nurse Practitioner
Compensated by ViiV Healthcare.
Erick: I’m the chief medical officer and nurse practitioner there, which is a very exciting role because we get to implement all sorts of healthcare and community strategies, such as the prevention of HIV. The general reaction in our office to APRETUDE has been one of excitement. The reason I use the word “excitement” is because many of our patients have been waiting for an option like APRETUDE.
Erick: APRETUDE for PrEP is 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.
Erick: 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 individuals diagnosed with HIV must begin a complete HIV treatment.
SUPER: 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.
Erick: Keep watching for more safety information.
SUPER:
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE on this website.
SUPER:
Reactions to APRETUDE
Erick: APRETUDE has worked really well for a variety of our different patients that we take care of. Flight attendants being one who are crossing international borders back and from and do not want to carry antiviral medications with them.
SUPER:
Appropriate patients must meet the clinical considerations in the label and agree to the required dosing and testing schedule.
Erick: Nurses working chaotic schedule in hospital settings who want to have APRETUDE as part of an overall HIV prevention strategy and because of their chaotic schedules are unable to, to take oral daily PrEP.
SUPER: PrEP=pre-exposure prophylaxis.
Erick: The part that excites me as a healthcare provider has been that of, like, patient assurance and compliance,...
SUPER:
The part that excites me as a healthcare provider has been that of patient assurance and compliance”
Erick: ...and that we are able to administer the medication for them and know that they will be cared for with this medication for the next 2 months.
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.
Erick: While it’s recommended that it be provided on exactly a 2-month interval, we do take advantage of that 7-day window.
Erick: So when life happens and they are unable to attend because of a wedding, funeral, or travel, unexpected travels,...
SUPER:
APRETUDE injections can be given up to 7 days before or after the scheduled injection date.
Erick: ...we have the comfort in knowing that we can reschedule, be on time, and continue with adherence.
SUPER:
“We have the comfort in knowing that we can reschedule, be on time, and continue with adherence”
APRETUDE injections can be given up to 7 days before or after the scheduled injection date.
SUPER:
Diverse and comprehensive participant population
Erick: As a healthcare provider, I have to say that seeing a trial that was as inclusive as APRETUDE really demonstrates to our patient base.
SUPER:
HPTN 083:
87% cisgender men and 12% transgender women who have sex with men
In the US, 50% were Black
HPTN 084:
>99% cisgender women
HPTN=HIV Prevention Trials Network.
Erick: So knowing that they’re included in the studies, it actually reflects and it says something closer to them. It’s like, “I was included.”
SUPER:
HPTN 083 (N=4,566) and HPTN 084 (N=3,224) were randomized, double-blind, controlled trials of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1– uninfected adults who have evidence of high-risk behavior for HIV-1 infection. The primary endpoints were rate of incident HIV-1 infection.
TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.
Erick: “They took the time and effort to include me as part of this trial, and that I can see that the clinical evidence that is provided as a result of this reflects my real world, my possible real-world experience with it.”
SUPER:
“They took the time and effort to include me as part of this trial”
SUPER:
Getting started with APRETUDE
Erick: For offices or clinics that have not yet started the use of APRETUDE, I would encourage them to present all options to patients that are available.
SUPER:
“Present all options to patients that are available”
Erick: The process of bringing APRETUDE into our clinic has been a multiprong approach, where we have a variety of people that are involved—from the healthcare provider, who identifies risks and helps the patient and guides and navigates to appropriate treatments, to our case manager, who helps navigate patient benefit access and patient assistance programs, to even down to our medical assistant, who identifies the frequency and return visits and compliance assistance with keeping up with APRETUDE.
Erick: I feel like APRETUDE has changed the tone on how we talk to our patients. We know that our patients have been looking for a long-acting injectable option.
SUPER:
“We know that our patients have been looking for a long-acting injectable option”
SUPER:
What could APRETUDE mean for the patients in your practice?
SUPER and VO:
IMPORTANT SAFETY INFORMATION (cont’d)
The heading “IMPORTANT SAFETY INFORMATION (cont’d)” appears only as an onscreen SUPER and is not voiced over.
CONTRAINDICATIONS
The subheading “CONTRAINDICATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “WARNINGS AND PRECAUTIONS” appears only as an onscreen SUPER and is not voiced over.
SUPER and VO:
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
The subheading “Comprehensive Management to Reduce the Risk of HIV-1 Infection:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER and VO:
- 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:
The subheading “Potential Risk of Resistance with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Long-Acting Properties and Potential Associated Risks with APRETUDE:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER and VO:
Hypersensitivity Reactions:
The subheading “Hypersensitivity Reactions:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Hepatotoxicity:” appears only as an onscreen SUPER and is not voiced over.
- 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:
The subheading “Depressive Disorders:” appears only as an onscreen SUPER and is not voiced over.
- 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 subheading “Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:” appears only as an onscreen SUPER and is not voiced over.
- 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
SUPER AND VO:
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 subheading “ADVERSE REACTIONS” appears only as an onscreen SUPER and is not voiced over.
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
The subheading “DRUG INTERACTIONS” appears only as an onscreen SUPER and is not voiced over.
- 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
The subheading “USE IN SPECIFIC POPULATIONS” appears only as an onscreen SUPER and is not voiced over.
- 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 the full Prescribing Information, including Boxed Warning, on this website.
SUPER:
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2023 ViiV Healthcare or licensor.
CBTVID230010 June 2023
Produced in USA.
