New PrEP starts: It’s important to talk to all sexually active patients about PrEP
New PrEP starts, or patients newly seeking HIV prevention with PrEP, are taking an important step toward protecting their health.
This is the opportunity to facilitate an informed decision that best suits the patient’s needs—and helps them feel supported through the process.
New PrEP starts: It’s important to talk to all sexually active patients about PrEP
New PrEP starts, or patients newly seeking HIV prevention with PrEP, are taking an important step toward protecting their health.
This is the opportunity to facilitate an informed decision that best suits the patient’s needs—and helps them feel supported through the process.
When talking to patients who have not taken PrEP before, listen for:
An open conversation about starting PrEP
DJ, a real patient, and Dr. Kristin Rager discuss the importance of having open and honest conversations about sex and HIV protection. Listen to DJ share his experience starting his PrEP journey and Dr. Rager's recommendations to identify who is ready to start PrEP and what option is right for them.
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There is an urgent need
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to get patients talking about their sexual health
VO:
[Crew] Mark Set. Stand here. Action Talent. Dolly.
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to get patients talking about their needs in HIV protection
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to get patients talking about their choices in PrEP
PrEP=pre-exposure prophylaxis.
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We sat down with Dr. Kristin Rager and DJ, a real patient, for a candid conversation about helping patients find the PrEP that’s right for them.
All participants compensated by ViiV Healthcare.
VO:
[DJ] Hi.
[Dr. Rager] Hi. Hey, How are you? I'm Kristin Rager.
[DJ] I’m more of a hugger.
[Dr. Rager] I’m a hugger too.
VO:
[Dr. Rager] Oh. So good to meet you. So good to meet you.
[DJ] Yeah, nice meeting you.
[Dr. Rager] Okay. So you’re gonna have to tell me a little bit about you.
VO:
[DJ] I am a film producer and I love telling stories. Any bit of happiness I can share. I love to get. But what do you do?
[Dr. Rager] I am an adolescent and young adult health specialist. I personally think it’s the most important kind of doctor that there is because think about all the things you decide when you’re 12 to 25, right? Are you gonna have sex? Who are you gonna have it with? Are you gonna protect yourself when you’re doing that? I love having those conversations with people.
VO:
[DJ] Wow. So I think that’s cool that you have to create those conversations.
[Dr. Rager] So what’s been your experience as far as people bringing up...
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OPEN CONVERSATIONS
VO:
[Dr. Rager] ...sexy talk with you in your healthcare visits?
VO:
[DJ] OK. So I wasn’t very sexually active until I was in my first relationship. So I feel like sometimes I just avoided talking about it because I don’t think I was doing it enough to have the conversation.
VO:
[Dr. Rager] So it sounds like you’re saying nobody actually directly asked you; you felt like the onus was on you to bring up your sexual health, and also you felt like unless you were like really getting some <laugh> that, that it wasn’t warranted to bring it up yet.
VO:
[DJ] I guess it was feeling like you only talk to them if you’re having a whole whole lot of sex. But in hindsight, if I was having sex, I should have been talking to the doctor. Tell me, how do you even bring up sex to a patient?
VO:
[Dr. Rager] You know, we’re talking about providers discussing PrEP with patients, but in my experience, many providers don’t even feel comfortable talking about sex with their patients at all. There’s two layers to it, right?
VO:
[Dr. Rager] Like one of ‘em is me providing you for an environment where you feel comfortable talking comfortably, openly, and honestly about sex. And then part of it is, is me being comfortable asking you stuff. And it’s just not something that is necessarily routinely taught to folks.
VO:
[Dr. Rager] And so if you’ve got discomfort coming from both sides, that’s gonna, that’s gonna be an environment where the person’s needs are probably not gonna get met.
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1/3 of people in the US who could benefit from PrEP were prescribed it in 2022.
VO:
[Dr. Rager] In the US right now, only about a third of people who could benefit from PrEP are actually on it, which is shocking and really saddens me.
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THE UNMET NEED
VO:
[Dr. Rager] What do you think are reasons why that many people who could benefit from PrEP aren’t on it right now?
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LACK OF EDUCATION
VO:
[DJ] I work in a space where I talk about PrEP and learn about it, but the friends, or even people I’ve dated in the last couple of years, they were living in smaller towns, so they were not around this many people in a community that could even tell them about PrEP. And I’m like, the doctor probably is the same one as their, um, their, their parents use.
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PRIVACY AND FEAR
VO:
[DJ] So there’s this privacy and fear thing they have. And this, some of these people who talk to me have HIV now. So when I talk to ‘em about PrEP, they’re like, it’s too late. I didn’t know about this. I wished our doctor would’ve asked them.
[Dr. Rager] Yeah.
[DJ] These questions about sex, even if they were afraid about asking about sex. Just trying to educate them on, Hey, if you plan on having sex.
[Dr. Rager] Mm-Hmm. <affirmative>
[DJ] Here are PrEP options.
[Dr. Rager] Yeah.
VO:
[Dr. Rager] I’m curious, when you went to see your provider, did you go to them and say, I would like to start PrEP, or you were there for something else and they said, Hey, DJ, have you thought about PrEP before?
VO:
[DJ] No. Um, I had to bring that up and that was because I was in that relationship. I was in a committed relationship. Monogamous to me, but probably not to him. So I was aware that this person probably was not being honest, but that was me being like, baby, can I control something and be on this PrEP?
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IDENTIFYING PATIENTS FOR PrEP
VO:
[DJ] So Dr. Rager, how do you know to put your patients on PrEP?
VO:
[Dr. Rager] I ask everybody all the things. Tell me what’s going on with your life. What are you doing? You know? And...
[DJ] I wouldn’t have told you my man might be cheating on me though.
VO:
[Dr. Rager] Maybe you wouldn’t just be like, blah, guess I’m worried my man’s cheating on me.
[DJ] <laugh>.
[Dr. Rager] But, but I will say I have had a lot of people say those sorts of things. If somebody has a primary care person that they feel connected with and they trust them, maybe you feel comfortable going, you remember that guy I told you about the last time, I was really excited about him?
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ASK ABOUT: CHANGE IN RELATIONSHIP
VO:
[Dr. Rager] Well, mm-Hmm. I’m, I’m worried like if there’s signs. I think it’s importance of having a relationship with somebody that you would feel comfortable saying, I need to talk to you about something.
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ASK ABOUT: SEXUAL ACTIVITY
VO:
[DJ] What do you do to even start that conversation?
[Dr. Rager] And I’ll say, have you ever had sexual contact with anybody else before?
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ASK ABOUT: SEXUAL PARTNERS
VO:
[Dr. Rager] Like, tell me about the types of partners that you have or have had.
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ASK ABOUT: TYPE OF SEX
VO:
[Dr. Rager] Do you have sex using your mouth? Do you have sex using your genitals? And how can I ask these questions in a way that makes people feel comfortable to answer them truthfully and not like, oh, this chick is about to judge me. I say this to all my patients. Like, we're just having a conversation here. Like, and the, and the goal of it is not for me to make any sort of like judgments on you.
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PrEP is one HIV prevention option. Also counsel patients on condom use, STI testing, and knowing status of partner(s).
VO:
[DJ] What factors go into you recommending PrEP options to patients?
VO:
[Dr. Rager] Then, we go through sort of the reasons why one option might work better in their life than another. I think one thing that I want to emphasize is when I’m talking with my patients, that I really just wanna make sure that I’m giving them all the information to make that best choice.
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ASK ABOUT: ADHERENCE CHALLENGES
VO:
[Dr. Rager] Do you have any experience taking a pill every single day? Was it easy for you? Was that hard? And then I’m like, well, how, how does that factor into this? And at the end of our discussion, I want you to be able to pick the thing that’s gonna work the best for you.
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WHY APRETUDE (cabotegravir)?
VO:
[DJ] Yeah. I feel like with my experience of being on this APRETUDE injection...
VO:
[DJ] ...I know that I’m helping protect myself against HIV by using the APRETUDE injection.
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INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
VO:
[Dr. Rager] APRETUDE is for PrEP to reduce the risk of sexually acquired HIV infection for HIV-negative adults and adolescents who weigh at least 35 kilograms and are at risk of sexually acquiring HIV. There is a Boxed Warning for APRETUDE, shown in full here, which describes a risk of drug resistance
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Rager] if APRETUDE is used in people with HIV. Don’t give APRETUDE or oral cabotegravir until the patient is confirmed to be HIV negative with a test that can diagnose acute or primary HIV.
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IMPORTANT SAFETY INFORMATION
BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Rager] Any individual diagnosed with HIV must begin a complete HIV treatment. Keep watching for the remaining safety information.
VO:
[Dr. Rager] If you don’t mind telling me, like, like really where’s that positive vibe around APRETUDE coming from?
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APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.
VO:
[DJ] What I love about being on the APRETUDE injection is that as I’m dating, I know that I am helping myself be protected from HIV, right? So it helps continuously protect me. And as I’m dating these stupid snotty-nose boys, I cannot replace that reassurance and confidence I have now.
VO:
[Dr. Rager] Yeah, I love this. I wanna keep on talking to you more, but you know, we got jobs <laugh>. Um, but, but I, I, I love it because it gave us both the opportunity to give each sort of side of the equation that you don’t often get, right?
VO:
[DJ] Yeah. I think that’s very amazing that you’re here today. I’m so honored and I’m thankful that you as a doctor and a healthcare practitioner, were just so open to talking about this.
VO:
[Dr. Rager] The thing that is the most important to me, really out of all this is, is that we are hopeful, right? That folks will see this and more people will get started on PrEP. More people will be empowered to help protect themselves from acquiring HIV.
VO:
[Dr. Rager] Like how amazing is that? Right? And, and amazing that we can be a part of it. So thank you.
[DJ] Oh, thank you.
[Dr. Rager] Thank you.
[DJ] Awww you're going to give me a big ole hug.
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Open conversations can lead to the HIV protection patients need
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IMPORTANT SAFETY INFORMATION (CONT’D)
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
VO:
IMPORTANT SAFETY INFORMATION CONTINUED
APRETUDE is contraindicated in those with unknown or positive HIV status.
Additionally, do not use APRETUDE in people who have had a hypersensitivity reaction to cabotegravir or in combination with the medicines listed on the slide.
Now we’ll cover the Warnings and Precautions.
Use APRETUDE as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices
APRETUDE is not always effective in preventing HIV-1 acquisition. This slide outlines some but not all additional risk factors for HIV acquisition, including:
- condomless sex
- past or current STIs
- self-identified HIV risk
- having sexual partners of unknown HIV-1 status, or
- sexual activity in a high prevalence area or network.
It is important to inform, counsel, and support individuals on the use of a comprehensive prevention strategy.
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- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to
VO:
APRETUDE should only be used in individuals who are confirmed to be HIV-1 negative as previously highlighted in the Boxed Warning. Resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection.
Along with testing for HIV prior to initiation, seronegative individuals should be asked about potential exposure events in the preceding month and evaluated for current or recent signs or symptoms of acute HIV infection such as those listed here.
If recent exposures (defined as less than 1 month) to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
This slide reiterates the importance of HIV testing prior to each APRETUDE injection and provides rationale for additional testing.
Testing should be repeated upon diagnosis of any other STIs, if an HIV test indicates possible infection, or when symptoms of possible HIV infection are present following potential exposure.
Remember that individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
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test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
VO:
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.
There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. This is why it’s important to test before each injection to confirm negative status.
For those wishing to discontinue APRETUDE, yet who remain at risk to HIV acquisition, alternative forms of PrEP should be considered, and, if used, started within 2 months of the final injection.
Because of its long-acting nature, APRETUDE drug levels slowly decrease over 12 months or longer.
Take this characteristic into consideration and carefully select individuals who agree to the every-2-month dosing schedule, because lack of adherence could lead to HIV acquisition and development of resistance.
Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome/toxic epidermal necrolysis. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
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Hepatotoxicity:
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
VO:
Hepatotoxicity has been reported in a limited number of patients on cabotegravir with or without pre-existing hepatic disease or identifiable risk factors. Hepatic monitoring should be considered. Discontinue APRETUDE if hepatotoxicity is suspected.
Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See the prescribing information for additional details.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE.
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- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
VO:
The most common adverse reaction occurring with APRETUDE was injection site reactions. The other most common adverse reactions with an incidence of at least 1% of all grades are listed in this slide.
Please see full prescribing information for a list of potentially significant drug interactions. Use caution when using APRETUDE with drugs that can induce UGT1A1 as these may significantly decrease plasma concentrations of cabotegravir.
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USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
When using APRETUDE in specific populations, consider the following:
Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the risk of adverse reactions and that the medicine may stay in the systemic circulation for up to 12 months or longer after discontinuation.
When considering the use of APRETUDE with pediatric patients, remember that it is not recommended in individuals weighing less than 35 kilograms.
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Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
©2025 ViiV Healthcare or licensor. PMUS-CBTVID250010 May 2025 Produced in USA.
When talking to patients who are experienced with PrEP, listen for:
A real chat about finding the right PrEP for each patient
Kenny, a real patient on PrEP, and Dr. Nas Mohamed have a candid conversation about reassessing a patient's PrEP regimen. Listen to how Kenny came to find the right PrEP option for him and how Dr. Nas approaches these discussions around PrEP with his patients.
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There is an urgent need
Text onscreen:
to get patients talking about their sexual health
VO:
[Crew] Hey on my mark. Action Talent.
Text onscreen:
to get patients talking about their needs in HIV protection
Text onscreen:
to get patients talking about their choices in PrEP
PrEP=pre-exposure prophylaxis.
Text onscreen:
We sat down with Dr. Nas Mohamed and Kenny, a real patient, for a candid conversation about helping patients find the PrEP that’s right for them.
All participants compensated by ViiV Healthcare.
VO:
[Dr. Nas] Hi.
[Kenny] Hey, good morning.
[Dr. Nas] How are ya?
[Kenny] Doing good. Kenny.
[Dr. Nas] Nas.
[Kenny] Nas. Nice to meet you.
[Dr. Nas] Good to meet you.
VO:
[Dr. Nas] Where are you at, Kenny?
[Kenny] Ah, well I live in Houston.
[Dr. Nas] Awesome.
[Kenny] Um, I work as a hairdresser, but I get to work with a lot of people in the LGBTQ community, and out, so.
[Dr. Nas] Yeah.
[Kenny] Um, it’s, it’s a lot of fun.
VO:
[Kenny] What do you do for a living and where are you?
[Dr. Nas] I’m a physician based in San Francisco. I really like caring for like, you know, the gay community and pivoted into like outpatient practice that’s really focused on a lot of LGBT medicine, including HIV, um, care.
[Kenny] That’s really awesome. It’s good to have a, a healthcare provider who’s so passionate about working within our community.
[Dr. Nas] Um, so, we’re gonna talk about sex now (laughs).
[Kenny] I’m ready.
[Dr. Nas] Tell me about, like, your dating life.
VO:
[Kenny] Um, well I’m currently in a relationship, I like to say we’re monogamish. Um, you know, we practice monogamy, but we have, uh, the ability to talk to each other about expanding that at different times. So, uh, for me, I’m, it’s really important to make sure that I have a healthcare provider I can talk to.
[Dr. Nas] And you said you’re in Houston, or, now...
[Kenny] Houston, yeah.
[Dr. Nas] How has it been, like, connecting to care where you are?
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THE UNMET NEED
VO:
[Kenny] Um, I have a very good friend who works in a clinic that specializes in, um, HIV research and, uh, treatment and prevention. So when I got there, I was able to start my PrEP journey. When it first came out, I was aware of it, but since I was in a committed long-term relationship, I didn’t really feel like it applied to me. And then over the years of that relationship, we decided to, uh, open up our relationship and practice consensual nonmonogamy.
[Dr. Nas] Yeah.
[Kenny] And so that, that was the jumpstart into my PrEP journey when I was taking oral PrEP.
VO:
[Dr. Nas] How were you doing with the oral regimen?
VO:
[Kenny] I’m not horrible at remembering to take a pill.
[Dr. Nas] Okay.
[Kenny] Um, but with what I do for work and my busy schedule... so that became, you know, the anxiety with that was not worth it.
VO:
[Dr. Nas] So to you it was like, oh, like I, if, if I had an option, I would switch. You were not necessarily completely struggling on the oral pill, but then when something else was on the table you’re like, this fits better.
[Kenny] Definitely. So I have a question for you. Do you tend to find that your patients coming in, um, are pretty forthcoming about whether they’ve intentionally missed dosages of oral PrEP or maybe accidentally?
VO:
[Dr. Nas] I feel like this is one of the things that’s kind of like background knowledge, but nobody talks about. They don’t come in and be like, “Hey doctor, guess what? I didn’t really take the medicines the way they’re prescribed.” Like, nobody says that. Also, when people come in for their follow-up visits, there are hints that they are not taking them as prescribed.
VO:
[Dr. Nas] So there are, like, all of these signs that they’re not taking their medications daily. But some of the reasons they were struggling with taking the pills were not necessarily related to their sexual um, history. Some of them have to do with like other medical conditions. Some have to do with their lifestyle. And this is why, like, I always like to tell people what their options are all the time.
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UNCOVERING THE CHALLENGE
VO:
[Kenny] So then how do you have that conversation with them?
Text onscreen:
PrEP is one HIV prevention option. Also counsel patients on condom use, STI testing, and knowing status of partner(s).
VO:
[Dr. Nas] I put it on the table for everybody. Whether they’re coming in to engage with care for the first time or if they’re currently on a, on a regimen, I would still let them know what other options are available to them. I do this regularly to, one, remain informed myself, but also to make sure that people stay on PrEP and can choose what they want.
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LISTEN FOR: CHANGES IN ROUTINE
VO:
[Kenny] Sure, I mean, and keeping them informed also helps keep them feeling more comfortable, right?
[Dr. Nas] Yeah. And people’s stories change all the time, right? Like, it’s like, just like, you know, like people’s jobs...
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LISTEN FOR: RELATIONSHIP CHANGE
VO:
[Dr. Nas] ...their relationship status...
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LISTEN FOR: OTHER LIFESTYLE CHANGES
VO:
[Dr. Nas] ...their life crisis could happen and then your healthcare decisions have to shift.
[Kenny] Yeah.
[Dr. Nas] Right, like, life happens. Because like you, you, you mentioned, um, some aspects about your relationship, right? Some people go from being with somebody to being polyamorous or they can go back to being single.
[Kenny] Right.
VO:
[Dr. Nas] They change all the time and as they change, I think it’s good for people to know that there are tools that can fit different stories that they have going on in their lives.
[Kenny] Right.
[Dr. Nas] There’s still other options on the table that they can choose from.
[Kenny] Definitely.
[Dr. Nas] Yeah.
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REASSESSING PATIENTS’ PrEP REGIMENS
VO:
[Kenny] Like are there any cues you look out for that you, that will help guide you into what you think might be best for them?
Text onscreen:
ASK ABOUT: OVERALL HEALTH & MEDICATIONS
VO:
[Dr. Nas] I try to avoid making decisions for people, even though like my approach is tailored to the person, the things I bring up are pretty much consistent. I like to make sure that the pros and cons of each option are listed for the patient and that includes taking into consideration their medical conditions...
VO:
[Dr. Nas] ...medications that they take, um, recreational drug use. Um, if they do use any drugs...
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ASK ABOUT: LIFESTYLE
VO:
[Dr. Nas] ...their lifestyle, right...
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ASK ABOUT: ADHERENCE CHALLENGES
VO:
[Dr. Nas] ...their ability to adhere to the medication and then help them select the best medication that fits in their life. You can come talk to me about it. You can share anything you want to share and I would be able to support you. So I always lead with that. But then sometimes I walk in and just like, you know, I get all the tea immediately (laughs).
VO:
[Kenny] And I think it’s kinda the same way that I deal with clients in my chair as a hairdresser. It’s funny because sometimes people come in and have a very direct concise conversation about their wants and other times it takes a lot of discovery on my end to figure out their personality, you know?
[Dr. Nas] Yeah.
[Kenny] Their lifestyle and things. So I know what best suits them, and I’d imagine the conversations I have with my clients are very similar to conversations you have to have with your patients to get them to, to get to discover.
[Dr. Nas] Yeah.
VO:
[Dr. Nas] But then I always like to make sure the patient is the one driving this a little bit because they’re the ones living their lives. They know more than I do.
VO:
[Kenny] You give them their options, you give them choices and kinda empower them to make the choice that’s best for them.
Text onscreen:
WHY APRETUDE (cabotegravir)?
VO:
[Kenny] Uh, like I said, when I moved to Houston, I, uh, started oral PrEP, so I was doing fine taking it every day.
VO:
[Kenny] Right around the time that APRETUDE, uh, started becoming available, my healthcare team let me know that there was something available and they felt like with what I do for work, that it might fit my lifestyle and my busy schedule a lot better for me.
Text onscreen:
INDICATION APRETUDE is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
VO:
[Dr. Nas] APRETUDE is for PrEP to reduce the risk of sexually acquired HIV infection for HIV-negative adults and adolescents who weigh at least 35 kilograms and are at risk of sexually acquiring HIV. There is a boxed warning for APRETUDE shown in full here, which describes a risk of drug resistance...
Text onscreen:
IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Nas] ...if APRETUDE is used in people with HIV. Don’t give APRETUDE or oral cabotegravir until the patient is confirmed to be HIV negative with a test that can diagnose acute or primary HIV.
Text onscreen:
IMPORTANT SAFETY INFORMATION BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1 INFECTION
Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.
Keep watching for the remaining safety information.
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
[Dr. Nas] Any individual diagnosed with HIV must begin a complete HIV treatment. Keep watching for the remaining safety information.
VO:
[Dr. Nas] So do you see yourself staying on APRETUDE for a while?
[Kenny] I do. In my experience, it helps provide that continuous protection and not having to take that daily oral pill has been a lot more easy for me to manage.
[Dr. Nas] That’s awesome.
[Kenny] Definitely.
Text onscreen:
APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Healthcare providers should counsel patients on the importance of adherence to help reduce the risk of HIV-1 acquisition.
VO:
[VO] APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Healthcare providers should counsel patients on the importance of adherence to help reduce the risk of HIV-1 acquisition.
VO:
[Dr. Nas] I have to say, like, in my experience, some, some of my patients that I didn’t expect to switch to a shot opted for it.
[Kenny] Yeah, I think that’s great.
[Dr. Nas] We need to make sure people are on the right regimen for them. Right. Like, because if you’re not gonna take it, it’s not gonna work. So you need to just, like, be on the thing that you know is gonna work for you the best.
[Kenny] Definitely. Yeah. That’s, that’s really important.
VO:
[Kenny] So thank you so much for being here today. I feel like I can talk to you about this forever, but I really appreciate you coming and sharing your knowledge.
[Dr. Nas] Yeah, thank you. I know this is a very like, vulnerable conversation for a lot of people, but I love how you own it and approach it with confidence and the need to advocate for yourselves. Thank you for your time today, Kenny, it was really good to talk to you and learn more about you.
VO:
[Kenny] Yeah. Thank you for your time today too. I, I think that you being here in the healthcare provider space hopefully gets more people comfortable, uh, having these difficult conversations.
VO:
[Dr. Nas] Awesome.
[Kenny] Yeah, great to meet you today.
[Dr. Nas] Yeah, it’s good to meet you. I’m gonna grab some coffee, do you wanna go?
[Kenny] Yeah let’s go.
[Dr. Nas] Let’s go.
Text onscreen:
Open conversations can lead to the HIV protection patients need
Text onscreen:
IMPORTANT SAFETY INFORMATION (CONT’D)
CONTRAINDICATIONS
- Do not use APRETUDE in individuals:
- with unknown or positive HIV-1 status
- with previous hypersensitivity reaction to cabotegravir
- receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS
Comprehensive Management to Reduce the Risk of HIV-1 Infection:
- Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
VO:
IMPORTANT SAFETY INFORMATION CONTINUED
APRETUDE is contraindicated in those with unknown or positive HIV status.
Additionally, do not use APRETUDE in people who have had a hypersensitivity reaction to cabotegravir or in combination with the medicines listed on the slide.
Now we’ll cover the Warnings and Precautions.
Use APRETUDE as part of a comprehensive prevention strategy that includes adherence to the administration schedule and safer sex practices.
APRETUDE is not always effective in preventing HIV-1 acquisition. This slide outlines some but not all additional risk factors for HIV acquisition, including:
- condomless sex
- past or current STIs
- self-identified HIV risk
- having sexual partners of unknown HIV-1 status, or
- sexual activity in a high prevalence area or network.
It is important to inform, counsel, and support individuals on the use of a comprehensive prevention strategy.
Text onscreen:
- Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
- When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
- Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
- Counsel individuals without HIV-1 to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:
- There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to
VO:
APRETUDE should only be used in individuals who are confirmed to be HIV-1 negative as previously highlighted in the Boxed Warning. Resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection.
Along with testing for HIV prior to initiation, seronegative individuals should be asked about potential exposure events in the preceding month and evaluated for current or recent signs or symptoms of acute HIV infection such as those listed here.
If recent exposures (defined as less than 1 month) to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection.
This slide reiterates the importance of HIV testing prior to each APRETUDE injection and provides rationale for additional testing.
Testing should be repeated upon diagnosis of any other STIs, if an HIV test indicates possible infection, or when symptoms of possible HIV infection are present following potential exposure.
Remember that individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment.
Text onscreen:
Test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:
- Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
Hypersensitivity Reactions:
- Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
- Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
VO:
It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.
There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. This is why it’s important to test before each injection to confirm negative status.
For those wishing to discontinue APRETUDE, yet who remain at risk to HIV acquisition, alternative forms of PrEP should be considered, and, if used, started within 2 months of the final injection.
Because of its long-acting nature, APRETUDE drug levels slowly decrease over 12 months or longer.
Take this characteristic into consideration and carefully select individuals who agree to the every-2-month dosing schedule, because lack of adherence could lead to HIV acquisition and development of resistance.
Serious or severe hypersensitivity reactions have been reported with APRETUDE, including Stevens-Johnson syndrome/toxic epidermal necrolysis. Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated.
Text onscreen:
Hepatotoxicity:
- Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
- Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Depressive Disorders:
- Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
- Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:
- The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
VO:
Hepatotoxicity has been reported in a limited number of patients on cabotegravir with or without pre-existing hepatic disease or identifiable risk factors. Hepatic monitoring should be considered. Discontinue APRETUDE if hepatotoxicity is suspected.
Depressive disorders, including those listed, have been reported with APRETUDE; promptly evaluate patients with depressive symptoms.
The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE. See the prescribing information for additional details.
Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE.
Text onscreen:
- Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.
DRUG INTERACTIONS
- Refer to the full Prescribing Information for important drug interactions with APRETUDE
- Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
VO:
The most common adverse reaction occurring with APRETUDE was injection site reactions. The other most common adverse reactions with an incidence of at least 1% of all grades are listed in this slide.
Please see full prescribing information for a list of potentially significant drug interactions. Use caution when using APRETUDE with drugs that can induce UGT1A1 as these may significantly decrease plasma concentrations of cabotegravir.
Text onscreen:
USE IN SPECIFIC POPULATIONS
- Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
- Pediatrics: Not recommended in individuals weighing less than 35 kg
Please see full Prescribing Information, including Boxed Warning, for APRETUDE.
VO:
When using APRETUDE in specific populations, consider the following:
Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the risk of adverse reactions and that the medicine may stay in the systemic circulation for up to 12 months or longer after discontinuation.
When considering the use of APRETUDE with pediatric patients, remember that it is not recommended in individuals weighing less than 35 kilograms.
Text onscreen:
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References:
- Mayer KH, Agwu A, Malebranche D. Barriers to the wider use of pre-exposure prophylaxis in the United States: a narrative review. Adv Ther. 2020;37(5):1778-1811. doi:10.1007/s12325-020-01295-0
- Sidebottom D, Ekström AM, Strömdahl S. A systematic review of adherence to oral pre-exposure prophylaxis for HIV: how can we improve uptake and adherence? BMC Infect Dis. 2018;18:581. doi:10.1186/s12879-018-3463-4
- Hannaford A, Arens Y, Koenig H. Real-time monitoring and point-of-care testing: a review of the current landscape of PrEP adherence monitoring. Patient Prefer Adherence. 2021;15:259-269. doi:10.2147/PPA.S248696
- Koss CA, Hosek SG, Bacchetti P, et al. Comparison of measures of adherence to human immunodeficiency virus preexposure prophylaxis among adolescent and young men who have sex with men in the United States. Clin Infect Dis. 2018;66(2):213-219. doi:10.1093/cid/cix755
- Martin LR, Williams SL, Haskard KB, DiMatteo MR. The challenge of patient adherence. Ther Clin Risk Manag. 2005;1(3):189-199.
- Musinguzi N, Muwonge T, Ngure K, et al; Partners Mobile Adherence to PrEP (PMAP) Team. Comparison of short messaging service self-reported adherence with other adherence measures in a demonstration project of HIV preexposure prophylaxis in Kenya and Uganda. AIDS. 2018;32(15): 2237-2245. doi:10.1097/QAD.0000000000001955
