Banner image of four individuals on a gradient purple background. Not actual patients.

DISCOVER SOME DETAILS  THAT MAY MATTER TO YOUR PATIENTS

Consider these factors, among others, when discussing PrEP with your patients.

Scenarios and patients are hypothetical and only illustrate concept.

Curious about local ISRs: types, severity, and duration

25 years old

Not an actual patient.

Shane
Bio

Shane is interested in long-acting injectable (LAI) PrEP and has questions about how local injection-site reactions (ISRs) may impact his body. Understanding what he may expect is important to him.
Characteristics

Likes to remain active, going to the beach with friends

Curious about local ISRs, including what type to expect (eg, pain/tenderness, nodules, induration, etc), where on the body they may occur, how severe they may be, and how long they may last
How do you uncover and address questions about injection-site reactions?

See safety profile

Wants a discreet site of administration

32 years old

Not an actual patient.

Scott
Bio

Scott is a private individual who is not currently on PrEP due to concerns about discretion. He is interested in LAI PrEP, but has questions about where on the body the injection is administered and how this may impact discretion.
Characteristics

Asks questions about where on the body the injection is administered and is concerned about it being visible to others

Private individual

Not currently on oral PrEP

Concerned about discretion
How do you support patients who value discretion and have concerns about privacy and stigma? How do you counsel these patients on the potential of injection site visibility when discussing LAI PrEP?

Explore dosing

Likes regular visits with her provider

36 years old

Not an actual patient.

Maya
Bio

Maya is proactive with her sexual health and likes regular check-ins with her provider to monitor for HIV and other STIs.
Characteristics

Likes frequent check-ins with her provider

Prefers to get tested regularly for HIV and other STIs
How would you address patients who want frequent check-ins to support their sexual health, including routine HIV and other STI testing?

Explore dosing

Asks about potential drug-drug interactions

38 years old

Not an actual patient.

Robert
Bio

Robert is actively involved in his care and wonders if other medications he takes will interact with his LAI PrEP.
Characteristics

Prescribed medications through telehealth

Visits his doctor repeatedly during the year for a variety of conditions and checkups

Asks a lot of questions during appointments, especially regarding how his medications may interact
How do you counsel your patients about potential interactions between LAI PrEP options and other medications, supplements, or drugs they may take recreationally?

See DDI profile

Shane

25 YEARS OLD

INTERESTED IN LAI PrEP

CURIOUS ABOUT ISRs

Bio

Shane is interested in long-acting injectable (LAI) PrEP and has questions about how local injection-site reactions (ISRs) may impact his body. Understanding what he may expect is important to him.

Characteristics

Likes to remain active, going to the beach with friends
Curious about local ISRs, including what type to expect (eg, pain/tenderness, nodules, induration, etc), where on the body they may occur, how severe they may be, and how long they may last

How do you uncover and address questions about injection-site reactions?

See safety profile

Scott

32 YEARS OLD

INTERESTED IN LAI PrEP

WANTS DISCREET ADMINISTRATION

Bio

Scott is a private individual who is not currently on PrEP due to concerns about discretion. He is interested in LAI PrEP, but has questions about where on the body the injection is administered and how this may impact discretion.

Characteristics

Asks questions about where on the body the injection is administered and is concerned about it being visible to others
Private individual
Not currently on oral PrEP
Concerned about discretion

How do you support patients who value discretion and have concerns about privacy and stigma? How do you counsel these patients on the potential of injection site visibility when discussing LAI PrEP?

Explore dosing

Maya

36 YEARS OLD

ENGAGED IN CARE

LIKES FREQUENT CHECK-INs

Bio

Maya is proactive with her sexual health and likes regular check-ins with her provider to monitor for HIV and other STIs.

Characteristics

Likes frequent check-ins with her provider
Prefers to get tested regularly for HIV and other STIs

How would you address patients who want frequent check-ins to support their sexual health, including routine HIV and other STI testing?

Explore dosing

Robert

38 YEARS OLD

ENGAGED IN CARE

ASKS ABOUT DDIs

Bio

Robert is actively involved in his care and wonders if other medications he takes will interact with his LAI PrEP.

Characteristics

Prescribed medications through telehealth
Visits his doctor repeatedly during the year for a variety of conditions and checkups
Asks a lot of questions during appointments, especially regarding how his medications may interact

How do you counsel your patients about potential interactions between LAI PrEP options and other medications, supplements, or drugs they may take recreationally?

See DDI profile

Real patient conversations about starting PrEP

Identifying who is ready to start PrEP

Listen to DJ, a real patient taking APRETUDE, share his experiences starting PrEP and Dr Kristin Rager’s recommendations on how to identify who is ready to start PrEP and what option might be right for them.

Play video

Text onscreen:

There is an urgent need

Text onscreen:

to get patients talking about their sexual health

VO:

[Crew] Mark Set. Stand here. Action Talent. Dolly.

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. 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...

Text onscreen:

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.

Text onscreen:

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.

Text onscreen:

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?

Text onscreen:

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.

Text onscreen:

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?

Text onscreen:

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?

Text onscreen:

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.

Text onscreen:

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?

Text onscreen:

ASK ABOUT: SEXUAL PARTNERS

VO:

[Dr. Rager] Like, tell me about the types of partners that you have or have had.

Text onscreen:

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.

Text onscreen:

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.

Text onscreen:

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.

Text onscreen:

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.

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. 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

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. 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.

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. 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?

Text onscreen:

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.

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:

ViiV logo

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Black cisgender women, stigma, and HIV protection

Hear Shae, a cisgender Black woman on APRETUDE, and Dr Marye Bernard discuss the stigmas that exist around sexual health and how to nurture frank conversations about HIV protection and PrEP.

Play video

Text onscreen: There is an urgent need
to get patients talking about their sexual health
to get patients talking about their needs in HIV protection
to get patients talking about their choices in PrEP

VO:

[Crew]

Action Talent.

Text onscreen:

to get patients talking about their choices in PrEP

PrEP=pre-exposure prophylaxis.

We sat down with Dr. Marye Bernard and Shae, 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. Bernard]

Hey!

[Shae]

Hi. How are you?

[Dr. Bernard]

I am doing so good. And yourself?

[Shae]

Great.

[Dr. Bernard]

Good. Good, good, good. So, you are Shae?

[Shae]

I'm Shae.

[Dr. Bernard]

I'm Dr. Marye Bernard.

[Shae]

Nice to meet you.

[Dr. Bernard]

I'm so excited to be able to talk with you today.

[Shae]

Absolutely.

[Dr. Bernard]

So, girl, tell me a little bit about you.

[Shae]

Okay. Well, I am a matchmaker and dating coach.

[Dr. Bernard]

A matchmaker!

[Shae]

Yes ma’am.

[Dr. Bernard]

Oh, we are gonna have a good time talking.

[Shae]

Yes, let’s talk about it.

[Dr. Bernard]

Well let me tell you about me. I live in the South. I live in Memphis.

Text onscreen:

THE UNMET NEED

VO:

[Dr. Bernard]

In Memphis, we've got the second highest infectivity rate in the nation. And we are on that Bible belt.

[Shae]

Yes.

[Dr. Bernard]

And so sometimes it's difficult to have certain conversations without being scrutinized, you know.

[Shae]

Yeah.

[Dr. Bernard]
We have to bring these conversations up with that black cisgender woman.

Text onscreen:

SOCIAL STIGMAS

[Shae]

Absolutely.

[Dr. Bernard]

Because that's where I am seeing increased rates of infectivity. But let me tell you what I figured out. If I don't talk with my clients safely, they won't talk back to me.

[Shae]

Mmm.

[Dr. Bernard]

And I have to approach the subject of sex with my clients. And protecting themselves.

[Shae]

Mm-Hmm.

[Dr. Bernard]

And If I don't talk real talk, I don't get real answers.

[Shae]

That’s right.

Text onscreen:

LISTEN FOR / SEXUAL PARTNERS

VO:

[Dr. Bernard]

I have to talk about your sexual practices.

[Shae]

Mm-Hmm.

[Dr. Bernard]

You know, how many partners?

Text onscreen:

LISTEN FOR / TYPES OF SEX
VO:

[Dr. Bernard]

How do you have sex? What body parts do you use?

[Shae]

Who are you having sex with?

[Dr. Bernard]

But sex is a part of the whole thing.

[Shae]

It should be.

[Dr. Bernard]

And I make my patients laugh. You know what I tell 'em?

[Shae]

What you tell them?

[Dr. Bernard]

I says, child, I hope I'm having sex when I'm 99 years old.

[Shae]

That's right.

[Dr. Bernard]

I don't know with whom, but.

[Shae]

Get your husband! Y'all gonna be 99 together. There's no way that you know for a fact that your partner, I don't care if you're single, married, gay, straight. There's no way that you know what your partner's doing. Because they don't always, people don't always tell you their status. They don't always tell you what they're into, who they're sleeping with, how they're doing it. They don't always tell you the truth.

Text onscreen:

MISCONCEPTIONS ABOUT THE NEED FOR PrEP

VO:

[Dr. Bernard]

Some people think that PrEP is just for men who have sex with men. It's not. It’s for anyone who's sexually active and who's at risk of getting HIV. And in my opinion, if you are having unprotected sex…

[Shae]

Mm-Hmm.

[Dr. Bernard]

You’re at risk for HIV.

[Shae]

A lot of times doctors don't, they just make an assumption that women, like cisgender women, that we don't need PrEP. Like we don't need to protect ourselves from HIV. Like I think sometimes they assume it's only for gay people or only for trans people, or they make assumptions about who should take it. But it's anyone who's having sex.

[Dr. Bernard]

It's anybody. See, and we can't make those assumptions.

Text onscreen:

HESITANCY IN DISCUSSING SEXUAL HEALTH

VO:

[Dr. Bernard]

It's difficult for some of my women, my cisgender women in particular, to want to talk about things like sex.

[Shae]
In the South, most of us grew up in the church. And so sex is not something we talk about. And we all having sex, honey.

[Dr. Bernard]

And I tell my patients this and they laugh. They says Dr. B, I says, girl, I'm serious.

[Shae]
I love that you have these conversations with your patients, ‘cause I have never ever walked into a doctor's office and my doctor said anything about sex. Never.

[Dr. Bernard]
That's a shame. Because we are all sexual beings.

[Shae]

Yeah.

[Dr. Bernard]

It is so important to me when I'm communicating that, that there is no stigma. There's no judgment.

Text onscreen:

UNCOVERING THE CHALLENGE

[Shae]

Well, you know, I'm on PrEP and I've been on PrEP for two years.
[Dr. Bernard]
Oh, how wonderful. Well, how did you end up on PrEP?

[Shae]
I was dating a guy. I wanted to know what could I do to protect myself. Even if I think I'm in a monogamous relationship with one person, I can't guarantee that. I didn't wanna put my life in his hands alone.

[Dr. Bernard]

Oh, very smart.

[Shae]

I'm playing Russian roulette. And I'm not willing to do that. One time I made a post on social media and I was talking about being on PrEP. And somebody was like, well, you must be sleeping with a lot of people. No, I'm sleeping with one person, that I know of. I don't know who my person's sleeping with. 'Cause I don't carry his penis in my pocket, right?

[Dr. Bernard]

Right, right.

[Shae]

I don't know what he's doing. And I don't know who he’s with. And that's important to me. I wanna protect myself.

[Dr. Bernard]

Right.

[Shae]

One of the things I learned as a matchmaker is a lot of people, a lot of relationships and couples are into all kinds of things. You cannot look at a couple and know what they're into. Some of 'em swinging from chandeliers with other people and…

[Dr. Bernard]

Mm-Hmm.

[Shae]

Various…you never know what's going on.

[Dr. Bernard]

You empowered yourself. You didn't wait for someone else to take care of you. But you had information. And so to me, my job is to make sure that information is out there.

[Shae]

Yes.

Text onscreen:

IDENTIFYING PATIENTS FOR PrEP

VO:

[Shae]

Are there any cues that you look for before you ask someone about PrEP? Or do you just offer it to everybody?

[Dr. Bernard]

I let the patient guide the visit, but I make sure that the important things are covered. They have different needs sometimes, but they all have the same need of protection.
Text onscreen:

LISTEN FOR / SEXUAL ACTIVITY

[Dr. Bernard]

As a part of my assessment, I ask questions. And the cues that I have is they're sexually active, period.

[Shae]

Yes.

[Dr. Bernard]

And you know, or able to be sexually active or of age to be sexually active. There's not a particular person that I offer PrEP to. I tell everybody about it. My college girls, when they come in for their birth control, girl, I offer them PrEP too.

Text onscreen:

EDUCATING PATIENTS ABOUT PrEP OPTIONS
PrEP is not always effective in preventing HIV-1 acquisition. Also counsel patients on condom use, STI testing, and knowing status of partner(s).

VO:

[Shae]

I love It. I love it so much.

[Dr. Bernard]

Because just like, you don't wanna have a baby, you get birth control. If you don't wanna have HIV, girl, you can just get HIV control.

[Dr. Bernard]

And the least I can do is tell my patients about all the different options. You know, we got condoms, we got dental dams, we've got, uh, oral PrEP. We got injectable PrEP. I want them to know that they're in charge.

[Shae]

That’s right.

[Dr. Bernard]

I want them to know that they have the power.

[Shae]

They do.

[Dr. Bernard]

And they don't even have to talk about it to their partner.

[Shae]

Nope.

[Dr. Bernard]

It could be a private thing. You know, I know that I've had my injection, or I know that I've had my pill or whatever.

Text onscreen:

WHY APRETUDE? (cabotegravir)

VO:

[Shae]

I'm all about prevention as well. I'm on APRETUDE.

[Dr. Bernard]

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:

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. Bernard]

…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. Bernard]

Any individual diagnosed with HIV must begin a complete HIV treatment. Keep watching for the remaining safety information.

[Dr. Bernard]

What helped you make a decision?

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:

[Shae]
I knew that there were two options. I knew I could take a daily pill or I could do the every-other-month injection. So I called my doctor, and she said, well, you know, I think you'd be a good candidate for APRETUDE, actually. I love always knowing my status.

[Dr. Bernard]
I prefer that they get the injectable, because if they get the injectable, girl, we know you are adherent because we gave it to you.

[Shae]

Yes. You're the one giving it, that's right.

[Shae]
I literally go in, get the shot, get tested for everything under the sun.

Text onscreen:

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using an FDA-approved/cleared HIV-1 diagnostic test.

VO:

[Dr. Bernard]

Yes. And also let them know that there was a clinical trial that focused on cisgender women, in particular.

[Shae]

That’s important.

[Dr. Bernard]

So that makes them feel a little bit more comfortable in hearing more about APRETUDE. HIV protection is for everyone, and everyone deserves to know about APRETUDE.

[Shae]

That was important for me too because I, my question was, is this for me? Can I take it? And so to know that they did a trial, a whole trial with just…

[Dr. Bernard]

A whole trial.

[Shae]

Just cisgender women, it made me feel more comfortable taking it.

[Dr. Bernard]

I'm encouraging my patients to live and they can protect themselves. And I want you to be successful and get to be an old woman like me, girl.

[Shae]

I can't wait. I wanna be just as fabulous.

[Dr. Bernard]

Well, girl, protect yourself.

[Shae]

Yes ma'am.

[Dr. Bernard]

Protect yourself. Protect yourself. Oh, you’re so wonderful, Shea. I'm so glad I got to know you.

[Shae]

I need to be coming to your office in Memphis.

[Dr. Bernard]

Well, well girl, if you ever think you want to, just contact me.

[Shae]

I'll hop on the plane.

[Dr. Bernard]

And I will take good care of you.

[Shae]

I know you would, I know you would.

[Dr. Bernard]

All righty. So good to meet you, yes indeed.

[Shae]

Yes.

Text onscreen: Open conversations can lead to the HIV protection patients need

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)

AVO:

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

AVO:

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.

It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.

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

AVO:

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

AVO:

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 hepatoxicity 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

AVO:

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.

AVO:

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:

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

©2025 ViiV Healthcare or licensor.
PMUS-CBTVID240015 May 2025
Produced in USA.

Real conversations with PrEP-experienced patients

Finding the right PrEP for each patient

Listen to how Kenny, a real patient on APRETUDE, came to find the right PrEP option for him and how Dr Nas Mohamed approaches discussions around PrEP with his patients.

Play video

Text onscreen:

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?

Text onscreen:

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.

Text onscreen:

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.

Text onscreen:

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...

Text onscreen:

LISTEN FOR: RELATIONSHIP CHANGE

VO:

[Dr. Nas] ...their relationship status...

Text onscreen:

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.

Text onscreen:

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...

Text onscreen:

ASK ABOUT: LIFESTYLE

VO:

[Dr. Nas] ...their lifestyle, right...

Text onscreen:

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:

ViiV logo

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Transgender women, PrEP, and accepting healthcare settings

Hear Dr Kristin Rager discuss the barriers transgender women like Kimmy, a real patient on APRETUDE, face when trying to have open conversations around sex and HIV protection with their healthcare providers.

Play video

Text onscreen:

There is an urgent need

VO:

Crew: Action Talent.

Text onscreen:
to get patients talking about their sexual health
to get patients talking about their needs in HIV protection
to get patients talking about their choices in PrEP

PrEP=pre-exposure prophylaxis.

VO:

[Dr. Rager]

Hello, hey.

[Kimmy]

Hi.

Text onscreen:

We sat down with Dr. Kristin Rager and Kimmy, 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. Rager]

I'm Kristin Rager. How are you?

[Kimmy]

Nice to meet you. I'm Kimmy.

[Dr. Rager]

Nice to meet you, Kimmy.

[Kimmy]

I love your style. I love the glasses.

[Dr. Rager]

Oh, thank you. I was actually just gonna say, I'm gonna try to steal those boots from you later. So just know, when they disappear then they might be going home with me.

[Kimmy]

I know, they’re so cute, huh?

[Dr. Rager]

Kimmy, tell me your story. I'm so excited to talk with you today.

[Kimmy]

A little bit about me. I am originally from Seattle, Washington. I moved to Atlanta, Georgia in 2020. I've been here ever since. So tell me about you.

[Dr. Rager]

I am an adolescent medicine and young adult health specialist. The most significant and, uh, joyful part of my career has been, I had private practice for about 10 years where I was seeing all LGBT young adults and youth. And the large bulk of my practice were trans and non-binary young people.

Text onscreen:

THE UNMET NEED

VO:

[Kimmy]

What are some, like kind of, difficulties that you feel like you face when a girl like me walks into your office?

[Dr. Rager]

Trans folks have experienced a lot of medical trauma in general, and that is that their healthcare experiences have not only been unhelpful, but have been hurtful to them.

Text onscreen:

ESTABLISHING TRUST

VO:

[Dr. Rager]

So, for them to be brave enough to even come to me and trust me after they've had horrible experiences prior, that's a huge barrier for them to overcome, right?

[Kimmy]

I would always have to seek out, like, centers.

[Dr. Rager]

Mm-hmm.

[Kimmy]

So, LGBTQ centers or programs that I knew were specifically based for trans women and, um, gay men. I think I took that on my own, in my own hands, because I don't feel like I'm, like, I don't wanna walk on eggshells with who I'm talking about my health with.

[Dr. Rager]

A hundred percent agree. I feel like a, a recurring theme is that the patient herself has to be the empowered one to advocate and to get the care that you need. Like, after, you know, seeking out your own care, how did you find PrEP care, and was that hard for you to find?

[Kimmy]

I came out to my family at 15 years old. My father is first generation American, uh, Latinx man. And when I came out to him, literally, one of his first sentences to me was, AIDS is gonna be your outcome in life. And then after that, I actually, my first relationship with somebody, he had ended up disclosing to me his status of being HIV positive. By the time I was 18 years old, my brother had sat down the whole family to tell us he had tested positive for HIV. I had witnessed all these things that were in a sense, affirming what my father was telling me. That's when I knew, I was like, I have to take this into my own hands. So I hopped in my little Toyota Camry…

[Dr. Rager]

(laughs)

[Kimmy]

And I took myself right up to Seattle and I got on PrEP.

Text onscreen:

PrEP is one HIV prevention option. Also counsel patients on condom use, STI testing, and knowing status of partner(s).

[Dr. Rager]

When you started PrEP, finally, did it give you a sense of relief?

[Kimmy]

It was liberating. But I think there was still that anxiety there, but it still felt a little bit more like I can breathe now. I can date somebody and not get scared.

[Dr. Rager]

What is your theory about why so many transfemme people know about PrEP but are not on it?

Text onscreen:

MISCONCEPTIONS ABOUT THE NEED FOR PrEP

VO:

[Kimmy]

So, I think that a lot of trans women feel like their sexual partners aren’t engaging in certain type of sexual activity. So they're not really at risk. But the fact that they're even engaging in sex, one, at all. And then two, you being a trans woman and they're engaging in sex with you, it, your risks are just ended up just getting higher. So, you know, you're sexually active, so you're at risk. You don't know what that man is doing when he's not in your presence. You need to protect yourself and take your health and your sexual health in your own hands. So I just think it's point blank period, ignorance, or feeling like ignorance is bliss. I'm like, no, baby, it's not bliss. You need to protect yourself.

Text onscreen:

UNCOVERING THE CHALLENGE

VO:

[Kimmy]

I advocate for myself and it's really important for me, but a lot of girls don't advocate for themselves and they take no for an answer.

Text onscreen:

SEXUALITY AND GENDER STIGMA

VO:

[Kimmy]

When you are dealing with people that aren't as open as me, how do you as a healthcare provider open that space?

[Dr. Rager] (09:46)

Just to be brave enough to come in, and then to feel comfortable telling your truth to a doctor, I think is a barrier for many people. I mean, do you have a transphobic doctor sitting across from you?

Text onscreen:

CULTIVATING CONNECTIONS

VO:

[Dr. Rager]

I am really passionate about making sure every provider knows how to ask sexual health questions, and knows to bring up PrEP to every person who is sexually active, and knows about all the PrEP options. I think normalizing sexual health conversations and including them in part of every visit can really lead you down that path, right? If I'm asking people where do they live? Where do they go to school? What's their job? What are their activities? Have you ever had sex before? Let's talk about that.

Text onscreen:

IDENTIFYING PATIENTS FOR PrEP

VO:

[Kimmy]

In your personal experience, what are some cue things that lead you to bringing up PrEP options?

Text onscreen:

LISTEN FOR / REQUESTS FOR STI TESTS

VO:

[Dr. Rager]

I, I think of the most obvious layup of all of them is if someone comes in asking for STI testing, they're already contemplating STIs. They already are perceiving themselves to be at risk. So, that's a really great moment to say, did you know that there's a way to protect yourself from HIV?

Text onscreen:

LISTEN FOR / RELATIONSHIP CHANGES

VO:

[Dr. Rager]

A person who has a change in relationship status. Like, they have a new partner, they have an additional partner, something's different.

Text onscreen:

LISTEN FOR / MISSED DOSES

VO:

[Dr. Rager]

And then a piece of data that would indicate to me maybe someone who is already on PrEP, daily oral PrEP, might need to have a new convo, if they're reporting missed doses.

Text onscreen:

WHY APRETUDE? (cabotegravir)

VO:

[Dr. Rager]

When you first started PrEP, you were probably on daily oral PrEP, because that was all that was available at that time. But as years have passed, APRETUDE became available as well. And so I'm curious, your thought process around switching from daily oral PrEP to APRETUDE.

[Kimmy]

You know, recently I started my APRETUDE journey. And for me, it worked the best for my schedule.

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.

[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…

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

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.

Text onscreen:

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.

[Kimmy]

I had been on oral PrEP for obviously years and years and years. I didn't have like, any horrible experiences on it. Yes, I would miss a dose here and there, you know. But for the most part, I have a regimen, right? You know, with me, obviously I'm hormone replacement therapy, so I am taking, you know, two, like two things a day. And then also injecting myself with estrogen every two weeks, so. I just didn't want anything at home anymore, like it was too much.

Text onscreen:

DOSING FATIGUE

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:

[Kimmy]

It made me feel good that I could get an injection every other month rather than having to daily take a pill. So I can go in, get it from my healthcare professionals and not have to worry about it, not have to see it on my counter, not have to like, oh my god, did I take it?

[Dr. Rager]

Was a potential concern of yours, that it might interact with your hormones?

[Kimmy]

I had heard that, but is like, in your practice, is that something that's true or false or…

[Dr. Rager]

I think it's really important to put out there that APRETUDE does not interact with people's hormones at all. And so that was part of what they studied when they were looking at the trans femme folks in the initial studies for APRETUDE to make sure that it didn't, because they knew people would care about that.

[Dr. Rager]

So, so speaking of helping transgender women feel more comfortable in contemplating APRETUDE, do you have some tips or some advice for other trans women who may be contemplating starting APRETUDE?

[Kimmy]

I would just tell them that for me, it worked out really well with my scheduling with my hormones. So I think I would just advise them that, do your research on your own. Also talk about it with your healthcare provider. And coming from a trans woman, my experience has been great.

[Kimmy]

I appreciate all your education that you gave me today. It was honestly a pleasure.

[Dr. Rager]

Well, I would say back atcha, I mean, the learning was mutual. And it was wonderful and I loved meeting you and, and I really hope we get to hang out again. Okay!

[Kimmy]

Yes.

[Dr. Rager]

Thank you so much. Thank you.

[Kimmy]

Thank you so much.

[Dr. Rager]

Yeah! Bye my friend.

Text onscreen: Open conversations can lead to the HIV protection patients need

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)

AVO:

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

AVO:

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.

It is important to counsel individuals on the importance of adherence to the recommended dosing and testing schedule for APRETUDE.

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

AVO:

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

AVO:

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

AVO:

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.

AVO:

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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PrEP=pre-exposure prophylaxis; STI=sexually transmitted infection.

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