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Demonstrated long-term safety profile through 96 weeks¹

Nearly all individuals stayed on DESCOVY^® in the DISCOVER Trial^1,2

of participants discontinued
DESCOVY FOR PrEP^®
(n=2694)

of participants discontinued
FTC/TDF
(n=2693)

DESCOVY(n=2694)

FTC/TDF(n=2693)

Diarrhea

5^%

6^%

Nausea

4^%

5^%

Headache

2^%

Fatigue

2^%

3^%

Abdominal pain or discomfort

2^%

The DESCOVY FOR PrEP safety profile at ≥144 weeks was similar to data through 96 weeks.³

Total-cholesterol-to-HDL ratio was similar for DESCOVY and FTC/TDF
Decreases from baseline were seen in LDL-C, HDL-C, and total cholesterol levels in both arms
The DESCOVY arm had increases in triglycerides vs decreases in the FTC/TDF arm; however, both were still within the target level

Mean levels of fasting lipids were mostly stable for those who were on DESCOVY over 144 weeks.³

Participants were excluded from the study if they took lipid-modifying medications at study entry or initiated the medications during the study.⁶

Only participants with both baseline and postbaseline fasting values were included in the above data.⁶

*Value reflects target for individuals assigned male at birth. For full guideline recommendations, see the 2018 AHA/ACC Multisociety Guideline on the Management of Blood Cholesterol.⁴

ACC=American College of Cardiology; AHA=American Heart Association; DDI=drug-drug interaction; FTC/TDF=emtricitabine/tenofovir disoproxil fumarate; HDL=high-density lipoprotein; HDL-C=high-density lipoprotein cholesterol; LDL=low-density lipoprotein; LDL-C=low-density lipoprotein cholesterol.

Impact of PrEP on new HIV diagnoses

Introduction 00:00 / 00:00

Transcript

(0:02)

Introduction

(0:16)

PrEP: An effective HIV prevention strategy

(1:10)

Regional disparities in PrEP uptake and HIV diagnoses

(1:50)

Normalizing PrEP use

(2:38)

PrEP: A potential gateway to routine care

(3:08)

Helping end the HIV epidemic

Introduction [0:02]

My name is Jonathon Anderson, and I am the US Medical Affairs HIV prevention lead at Gilead.

I live in Atlanta with my family. I'm originally from St. Louis, and I've been a pharmacist for about 12 and a half years now.

PrEP: An effective HIV prevention strategy [0:17]

The data has shown that PrEP has made an impact on HIV diagnoses in the United States. When you look at areas where PrEP uptake is the highest, we see the greatest decreases in HIV diagnoses—compared to areas where PrEP uptake was the lowest.

So, it's clear that PrEP is an effective HIV prevention strategy, and the CDC recommends using PrEP to help reduce HIV diagnoses.

For years, people who may benefit from PrEP—even before PrEP existed—had to rely on themselves to protect themselves. And it's time that we as a community—come together to make sure that everyone knows what PrEP is, that everyone knows that it's a socially accepted HIV prevention intervention.

It's one tool in a larger toolbox that we need to do a better job of normalizing.

Regional disparities in PrEP uptake and HIV diagnoses [1:10]

We continue to have the lowest PrEP uptake and the highest number of new HIV diagnoses in the South.

These disparities are driven in large part by social and structural inequalities like racism, stigma, homophobia, poverty—and those all impact access to healthcare.

So if we can identify the solutions that we need to implement—whether it be destigmatization programs, whether it's HIV testing programs—if we can find out what it takes to make an impact for the people of the South, we can identify what it's gonna take to make an impact on the epidemic across the nation.

Normalizing PrEP use [1:50]

The CDC has been very clear about the role that providers can play in normalizing sexual health conversations, specifically as a part of that conversations around HIV prevention and PrEP.

They say that all sexually active individuals should have a conversation with their providers about HIV prevention and PrEP.

If providers take the words of the CDC guidelines and really engage all sexually active adults and adolescents, it's gonna go a really long way to normalize this conversation. It could be as normalized as having a conversation about hypertension or diabetes.

Primary care providers have a real role when it comes to healthcare screenings and HIV prevention, and sexual health should absolutely be a part of that.

PrEP: A potential gateway to routine care [2:38]

I think PrEP can be extremely empowering. People who use PrEP are taking an active part in their sexual health.

And in getting people who may benefit from PrEP into care, you're able to address the other needs that they have, whether it be primary care screenings or understanding what their other healthcare needs are.

This may be the first time that these folks are really engaging in their health, and that's something that we can't lose sight of.

Helping end the HIV epidemic [3:08]

It's time for everybody to get involved in HIV prevention. This epidemic has been going on for far too long, given the tools that we have today.

We need to normalize PrEP as a society. We need to accept the communities that are most impacted by HIV, and we need to acknowledge that those communities deserve the special care and attention that they've lacked for so long. That's the only way we're gonna end the epidemic, and we're at that moment in time.

PrEP use in the Black community

Introduction 00:00 / 00:00

Transcript

(0:02)

Introduction

(0:24)

PrEP use is lowest amongst Black MSM and transgender women

(1:19)

Helping to support PrEP uptake in the Black community

(2:20)

Raising awareness of programs that increase access to HIV prevention

(3:07)

Reframing HIV prevention and emphasizing its importance to sexual health

Introduction [0:02]

My name is David Malebranche. I am a board-certified internal medicine physician with specialties in HIV prevention and treatment as well as LGBTQ health racial inequities in medicine.

I live in Atlanta, Georgia, and I'm currently the Senior Director of Global Medical Affairs at Gilead Sciences.

PrEP use is lowest amongst Black MSM and transgender women [0:24]

Black men, particularly Black MSM, are at the top of the populations most affected by HIV in the United States and demonstrate some of the lowest rates of receiving PrEP. In 2019, Black men accounted for three-quarters of new HIV diagnoses among all Black people in the United States.

A CDC analysis found that Black transgender women accounted for 62% of HIV diagnoses among all trans women with HIV living in seven major US cities.

When it comes to PrEP uptake, you're really thinking about who it's marketed for.

When it initially came out in 2012, the focus a lot was on LGBTQ communities, particularly White LGBTQ communities.

Black communities didn't really feel that PrEP was for them. I heard a lot of people saying, ‘Isn't that that gay drug?’ And by ‘gay’ they meant ‘White gay,’ so they didn't feel it was necessarily for Black communities.

Helping to support PrEP uptake in the Black community [1:19]

We're faced a lot of the societal issues that prevent equitable PrEP uptake in Black communities, and particularly among Black men who have sex with men and transgender women.

Institutionally, some of the ways I've addressed these barriers in my previous practice included flyers and educational information showing Black people. If you don't have brochures or images that reflect the diversity of the community that you're serving or utilize language that encourages sexual health conversations, people may not feel represented or comfortable there.

You could also add prompts on the clinic website or app that mention PrEP use and encourage conversations with your provider, including reminders in the electronic medical record for clinicians to ask about sexual health and discuss HIV testing.

And then finally, actually hiring a lot of people from the community in various roles, whoever it may be that represents the community that you're serving; make people feel like there's a safer space there and that it's for them.

Raising awareness of programs that increase access to HIV prevention [2:20]

Limited access to affordable healthcare coverage is one of the most important factors affecting PrEP use.

Continued assistance programs and policies that allow PrEP to be accessed even when uninsured, as well as financial assistance with lab draws and clinic fees for follow-up, are crucial to reach Black MSM and transgender women.

Providers need to be made aware of and educated on certain PrEP medications and what resources are available to reach Black and transgender communities. For example, in 2019, the United States Preventive Services Task Force issued its highest recommendation Grade A for PrEP medication and ancillary services.

Reframing HIV prevention and emphasizing its importance to sexual health [3:07]

A lot of providers may not be well versed in sexual health or HIV prevention. We need a lot more education to bring them up to speed on where we are right now. There's always room for improvement with the way we approach HIV prevention as part of sexual health; as clinicians, we should work harder at helping people achieve the sexual lives they want instead of being judgmental of the kind of sex they're having.

The goal as a medical provider is not to compound the oppressive forces that people may feel in their day-to-day existence. When they come in to see you, they are looking at you to be the oasis in a desert of stigma and bias.

Providers could help normalize and reframe PrEP by emphasizing sexual health and HIV prevention as part of primary care. When a provider is having a conversation about sexual health, we should be asking what it means to have a healthy sex life. What does that look like for you? What's your priority regarding your sexual health? What would make this visit be successful for you? If you actually approach from that standpoint, where it's not, ‘As the clinician, what I feel is the top priority for your visit today,’ but as the patient, ‘What's your top priority today?’

Then you can have a successful encounter.

PrEP use in the Latinx/o community

Introduction 00:00 / 00:00

Transcript

(0:02)

Introduction

(0:24)

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses

(0:58)

The impact of cultural perceptions and sex in the Latinx/o community

(1:58)

Creating a safe space is the first step in initiating sexual health conversations

(2:50)

Addressing barriers to PrEP uptake in Latinx/o communities

(4:20)

Representation is crucial to increasing PrEP use in the Latinx/o community

Introduction [0:02]

My name is Dr. Cynthia Rivera. I am the Program Director of the Infectious Diseases Fellowship at Mount Sinai Medical Center in Miami Beach, Florida.

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses [0:24]

When we look at our Latinx community, we see amongst men who have sex with men and transgender women the high lifetime risk of HIV, but they have one of the lowest rates of PrEP uptake.

Based on my experience, multiple factors contribute to this high lifetime risk, including socioeconomic status and access to preventative medical care, as well as cultural perceptions and stigmas around HIV.

The impact of cultural perceptions and sex in the Latinx/o community [0:58]

There's a lot of views that favor heteronormativity. I have men who are in heterosexual relationships, with or without children, possibly married, who have sex with men but do not identify themselves as gay.

And that ties into the cultural construct of machismo. That's a difficult-to-define term but it is really encompassing a cultural construct on what it means to be masculine. And that may even include certain sexual practices.

If the question is not specifically asked, we may not be able to really provide the counseling that's specific to that person's sexual practices. So, it's really important to understand the culture within the Latinx community to be able to have those open and honest discussions.

Creating a safe space is the first step in initiating sexual health conversations [1:58]

So, when I'm taking a sexual history, the first thing that I want to convey to patients is that I'm very comfortable having a discussion about sex.

With my Latinx patients, I do have conversations about stigma, about cultural barriers. You know, ‘Have you been able to come out to your parents?’ ‘Who do you share with in your life?’ ‘What body parts do you use?’ ‘How often are you having sex?’ ‘Do you use condoms?’ ‘When was the last time that you were checked for sexually transmitted infections and HIV?’ But before those medical type of questions, really letting the patient know that this is a safe space for them to have an open conversation is where it starts.

Addressing barriers to PrEP uptake in Latinx/o communities [2:50]

What I find is that there is a very low level of awareness of the efficacy and the availability of PrEP in the Latinx community. That has to do with perhaps marketing not being provided in that person's dominant language. Lack of availability of preventative health services.

And so patients will often seek a provider when they are ill because of difficulty accessing preventative health, and just a perception that the cost of PrEP is too high, the cost of labs are too high, or perhaps that testing is not available to them.

So when it comes to increasing uptake for pre-exposure prophylaxis in the Latinx community, ask those patients, ‘What were barriers that you had to coming to see me?’

Getting to the root cause within one's community is central to being able to then have patient navigators in the community to be able to, uh, bring down those barriers. If the transportation costs are prohibitive, we offer vouchers, more availability of telemedicine appointments, we offer mobile clinics, we just find ways to remove the barriers to care.

Representation is crucial to increasing PrEP use in the Latinx/o community [4:20]

Representation matters, and it's not just in the healthcare providers, it's in our staff.

Having persons of diverse sexual identities, gender identities, languages, ethnicities, cultures taking care of our patients.

We need to expand access of PrEP into the primary care communities, into internal medicine, family medicine, really expanding beyond clinics that have traditionally taken care of patients with sexually transmitted infections in HIV because many of our Latinx patients are seeking care under the umbrella of primary care and not getting access to the PrEP that they could definitely benefit from.

PrEP use in young MSM

Introduction 00:00 / 00:00

Transcript

(0:02)

Introduction

(0:25)

HIV diagnoses and PrEP use in young MSM

(1:39)

Approaching sexual health conversations with young MSM

(2:32)

Engaging young MSM in HIV prevention conversations

(3:50)

An opportunity to connect with young individuals

Introduction [0:02]

My name is David Malebranche. My training is in general internal medicine, but as well as specialty in HIV.

I practiced for about 20 years in academic settings.

I live in Atlanta, Georgia, currently, and my position at Gilead Sciences is senior director of Global HIV Medical Affairs.

HIV diagnoses and PrEP use in young MSM [0:25]

According to the 2020 CDC estimates, about 3 out of every 5, or 60%, of new HIV diagnoses in this country are among young MSM, or men who have sex with men, between the ages of 13 and 34.

Now, if you shift gears and look to who is actually getting PrEP, it's not that same population. So only 23% of young men who have sex with men ages 16 to 34 are receiving PrEP.

Some of the barriers that I see commonly among young men who have sex with men when it comes to PrEP uptake have partly to do with what's going on in their individual lives and then what happens once they get into the clinical setting.

So with regards to their individual lives, you're dealing with stigma, especially with young people. They're still figuring out what they like sexually.

And then when they get into the office setting, you basically have some providers that will still ask them questions when they say, “Hey, I want to explore PrEP for HIV prevention.” And people will say, “Well, why don't you just use a condom?”

So, when you hear that immediately, that's a huge barrier because you know, at that point, that the person that you trust to get you HIV prevention is not gonna be receptive to what you're saying.

Approaching sexual health conversations with young MSM [1:39]

HIV prevention is a part of our overall sexual health approach and, for me, it's just a matter of really starting as a clinician with a sexual history and having a conversation with patients or individuals that really makes them feel comfortable.

Particularly when we focus on young men who have sex with men, I'm thinking about some of the experiences that they may have had, with society, with discrimination on different levels.

So, I want to be very sensitive to the stigma part of it.

The 3 tenets I use with a sexual health conversation is 1, to normalize it—let them know that these are questions that we talk about with everybody.

2, explain the rationale so they understand that this helps me take better care of you as a provider. And then 3, you want to reassure them. So let them know that this conversation that's happening between you and them is gonna be private.

Engaging young MSM in HIV prevention conversations [2:32]

The new CDC guidelines upgraded from previous versions…instead of using specific labels of people and groups that would benefit from PrEP, they actually expanded the language to include anyone who is sexually active—adults or adolescents.

It completely changes the game. And so, as clinicians, instead of just looking at people to see if they fit in those boxes about who would benefit from PrEP, it opens it up and encourages us to just have a general sexual health conversation.

MSM may not be a sexual identity that patients actually jive with. And then as far as risk is concerned, when people are having sex, whether it's condomless or not, no one likes to hear that they're necessarily engaging in risky sex.

Our role as healthcare providers is not to be the condom police. We're supposed to listen to what our patients tell us and use our best knowledge and experience to give them the best options for them and their sexual partners.

You want to encourage PrEP for HIV prevention, but you also want to encourage that they adopt or explore other safer sex practices at the same time. Education on condom use is important in helping to protect individuals from STIs.

An opportunity to connect with young individuals [3:50]

Providers may only get one chance to build trust and rapport with patients.

What you say to them can be life-changing and life-affirming instead of the negative messaging they receive every day.

This is that one person, this is that one moment that they have, and you have an opportunity to either turn them away or help them become more engaged.

INDICATION & LIMITATION OF USE

DESCOVY^® for HIV-1 pre-exposure prophylaxis (PrEP) is indicated in at-risk adults and adolescents (≥35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1–negative status must be confirmed immediately prior to initiation.

Limitation of Use: DESCOVY FOR PrEP^® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

DESCOVY FOR PrEP must be prescribed only to individuals confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
Severe acute exacerbations of hepatitis B have been reported in individuals infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of DESCOVY^®. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in individuals with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted

Contraindication

DESCOVY FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions

Comprehensive management to reduce risks:
- Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs)
- HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are 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
- Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs)
- Reduce potential for drug resistance: Only prescribe DESCOVY FOR PrEP to individuals confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking DESCOVY, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only DESCOVY because DESCOVY alone is not a complete regimen for treating HIV-1
- Some HIV tests may not detect acute HIV infection. Prior to initiating DESCOVY FOR PrEP, ask individuals about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection
- If HIV-1 infection is suspected or if symptoms of acute infection are present while taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection
- Counsel on adherence: Counsel individuals to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing products. Do not initiate DESCOVY in individuals with estimated creatinine clearance (CrCl) <30 mL/min. Individuals with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue DESCOVY in individuals who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all individuals (see Dosage and Administration section)
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations

Adverse reactions

Most common adverse reactions (≥2%) in the DESCOVY FOR PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain

Drug interactions

Prescribing information: Consult the full Prescribing Information for DESCOVY for more information, warnings, and potentially significant drug interactions, including clinical comments
Metabolism: Drugs that inhibit P-gp can increase the concentrations of TAF, a component of DESCOVY. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy
Drugs affecting renal function: Coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions

Dosage and administration

Dosage: One tablet (emtricitabine 200 mg/tenofovir alafenamide 25 mg) taken once daily with or without food
HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section)
HBV screening: Test for HBV infection prior to or when initiating DESCOVY
Renal impairment and monitoring: Not recommended in individuals with CrCl <30 mL/min. Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, assess serum phosphorus

Please see full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING.

References: 1. Ogbuagu O, Ruane PJ, Podzamczer D, et al; the DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2021;8(7):e397-e407. doi:10.1016/S2352-3018(21)00071-0 2. Descovy. Package insert. Gilead Sciences, Inc.; 2022. 3. Wohl DA, Spinner CD, Flamm J, et al. HIV-1 infection kinetics, drug resistance, and long-term safety of pre-exposure prophylaxis with emtricitabine plus tenofovir alafenamide (DISCOVER): week 144 open-label extension of a randomised, controlled, phase 3 trial. Lancet HIV. 2024;11(8):e508-e521. 4. About cholesterol. Centers for Disease Control. Published May 15, 2024. Accessed July 10, 2024. https://www.cdc.gov/cholesterol/about/index.html 5. Millán J, Pinto X, Munoz A, et al. Lipoprotein ratios: physiological significance and clinical usefulness in cardiovascular prevention. Vasc Health Risk Manag. 2009;5:757-765. 6. Data on file. Gilead Sciences, Inc.

INDICATION & LIMITATION OF USE

Limitation of Use: DESCOVY FOR PrEP^® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

DESCOVY FOR PrEP must be prescribed only to individuals confirmed to be HIV negative immediately prior to initiation and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate if signs or symptoms of acute HIV-1 infection are present unless HIV-negative status is confirmed
Severe acute exacerbations of hepatitis B have been reported in individuals infected with hepatitis B virus (HBV) who discontinued products containing FTC and/or TDF and may occur with discontinuation of DESCOVY^®. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in individuals with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted

Contraindication

DESCOVY FOR PrEP is contraindicated in individuals with unknown or positive HIV status

Warnings and precautions

Comprehensive management to reduce risks:
- Use DESCOVY FOR PrEP to reduce the risk of HIV-1 infection as part of a comprehensive strategy that includes adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs)
- HIV-1 risk factors: Behavioral, biological, or epidemiologic HIV-1 risk factors may include, but are 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
- Reduce STI risk: Counsel on the use of STI prevention measures (e.g., consistent and correct condom use, knowledge of partner’s HIV-1 viremic status, regular testing for STIs)
- Reduce potential for drug resistance: Only prescribe DESCOVY FOR PrEP to individuals confirmed to be HIV negative immediately prior to initiation, at least every 3 months while taking DESCOVY, and upon an STI diagnosis. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only DESCOVY because DESCOVY alone is not a complete regimen for treating HIV-1
- Some HIV tests may not detect acute HIV infection. Prior to initiating DESCOVY FOR PrEP, ask individuals about potential recent exposure events. If recent (<1 month) exposures are reported or suspected, or symptoms of acute HIV infection (e.g., fever, fatigue, myalgia, skin rash) are present, confirm HIV-negative status with a test approved by the FDA for use in the diagnosis of acute HIV infection
- If HIV-1 infection is suspected or if symptoms of acute infection are present while taking DESCOVY FOR PrEP, convert the DESCOVY FOR PrEP regimen to a complete HIV treatment regimen until HIV-negative status is confirmed by a test approved by the FDA for use in the diagnosis of acute HIV infection
- Counsel on adherence: Counsel individuals to strictly adhere to daily dosing, as efficacy is strongly correlated with adherence. Some individuals, such as adolescents, may benefit from more frequent visits and counseling
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)-containing products. Do not initiate DESCOVY in individuals with estimated creatinine clearance (CrCl) <30 mL/min. Individuals with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue DESCOVY in individuals who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all individuals (see Dosage and Administration section)
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue use if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations

Adverse reactions

Most common adverse reactions (≥2%) in the DESCOVY FOR PrEP clinical trial were diarrhea, nausea, headache, fatigue, and abdominal pain

Drug interactions

Prescribing information: Consult the full Prescribing Information for DESCOVY for more information, warnings, and potentially significant drug interactions, including clinical comments
Metabolism: Drugs that inhibit P-gp can increase the concentrations of TAF, a component of DESCOVY. Drugs that induce P-gp can decrease the concentrations of TAF, which may lead to loss of efficacy
Drugs affecting renal function: Coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions

Dosage and administration

Dosage: One tablet (emtricitabine 200 mg/tenofovir alafenamide 25 mg) taken once daily with or without food
HIV screening: Test for HIV-1 infection immediately prior to initiating, at least every 3 months during use, and upon diagnosis of an STI (see Warnings and Precautions section)
HBV screening: Test for HBV infection prior to or when initiating DESCOVY
Renal impairment and monitoring: Not recommended in individuals with CrCl <30 mL/min. Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, CrCl, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, assess serum phosphorus

Please see full Prescribing Information for DESCOVY FOR PrEP, including BOXED WARNING.

INDICATION & LIMITATION OF USE

Limitation of Use: DESCOVY FOR PrEP^® is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

Tap for Important Safety Information, including BOXED WARNING about the risk of drug resistance in undiagnosed early HIV-1 infection and post-treatment acute exacerbation of hepatitis B.

Demonstrated long-term safety profile through 96 weeks¹

Nearly all individuals stayed on DESCOVY^® in the DISCOVER Trial^1,2

The DESCOVY FOR PrEP safety profile at ≥144 weeks was similar to data through 96 weeks.³

Mean levels of fasting lipids were mostly stable for those who were on DESCOVY over 144 weeks.³

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INDICATION & LIMITATION OF USE

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

INDICATION & LIMITATION OF USE

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Demonstrated long-term safety profile through 96 weeks1

Nearly all individuals stayed on DESCOVY® in the DISCOVER Trial1,2

The DESCOVY FOR PrEP safety profile at ≥144 weeks was similar to data through 96 weeks.3

Mean levels of fasting lipids were mostly stable for those who were on DESCOVY over 144 weeks.3

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Impact of PrEP on new HIV diagnoses

Contents

Transcript

Introduction

PrEP: An effective HIV prevention strategy

Regional disparities in PrEP uptake and HIV diagnoses

Normalizing PrEP use

PrEP: A potential gateway to routine care

Helping end the HIV epidemic

Introduction [0:02]

PrEP: An effective HIV prevention strategy [0:17]

Regional disparities in PrEP uptake and HIV diagnoses [1:10]

Normalizing PrEP use [1:50]

PrEP: A potential gateway to routine care [2:38]

Helping end the HIV epidemic [3:08]

PrEP use in the Black community

Contents

Transcript

Introduction

PrEP use is lowest amongst Black MSM and transgender women

Helping to support PrEP uptake in the Black community

Raising awareness of programs that increase access to HIV prevention

Reframing HIV prevention and emphasizing its importance to sexual health

Introduction [0:02]

PrEP use is lowest amongst Black MSM and transgender women [0:24]

Helping to support PrEP uptake in the Black community [1:19]

Raising awareness of programs that increase access to HIV prevention [2:20]

Reframing HIV prevention and emphasizing its importance to sexual health [3:07]

PrEP use in the Latinx/o community

Contents

Transcript

Introduction

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses

The impact of cultural perceptions and sex in the Latinx/o community

Creating a safe space is the first step in initiating sexual health conversations

Addressing barriers to PrEP uptake in Latinx/o communities

Representation is crucial to increasing PrEP use in the Latinx/o community

Introduction [0:02]

The Latinx/o community has low PrEP uptake despite high rates of HIV diagnoses [0:24]

The impact of cultural perceptions and sex in the Latinx/o community [0:58]

Creating a safe space is the first step in initiating sexual health conversations [1:58]

Addressing barriers to PrEP uptake in Latinx/o communities [2:50]

Representation is crucial to increasing PrEP use in the Latinx/o community [4:20]

PrEP use in young MSM

Contents

Transcript

Introduction

HIV diagnoses and PrEP use in young MSM

Approaching sexual health conversations with young MSM

Engaging young MSM in HIV prevention conversations

An opportunity to connect with young individuals

Introduction [0:02]

HIV diagnoses and PrEP use in young MSM [0:25]

Approaching sexual health conversations with young MSM [1:39]

Engaging young MSM in HIV prevention conversations [2:32]

An opportunity to connect with young individuals [3:50]

INDICATION & LIMITATION OF USE

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

INDICATION & LIMITATION OF USE

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindication

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Demonstrated long-term safety profile through 96 weeks¹

Nearly all individuals stayed on DESCOVY^® in the DISCOVER Trial^1,2

The DESCOVY FOR PrEP safety profile at ≥144 weeks was similar to data through 96 weeks.³

Mean levels of fasting lipids were mostly stable for those who were on DESCOVY over 144 weeks.³

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR PrEP^® IN UNDIAGNOSED EARLY HIV‑1 INFECTION and POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B