Download the Fact Sheets and Research Articles (.pdf’s)
CDC’s Fact Sheet – PrEP: A New Tool for HIV Prevention
Project Inform’s Fact Sheet – Is Taking PrEP The Right Choice for You?
Science Translational Medicine publication entitled Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men
The New England Journal of Medicine publication entitled Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men
PLOS ONE publication entitled Limited Awareness and Low Immediate Uptake of Pre-Exposure Prophylaxis among Men Who Have Sex with Men Using an Internet Social Networking Site.
Watch a Short Video from Huffington Post Live
Read Positive Frontiers.com’s “My Life On PrEP”
My Life on PrEP – How I Learned to Stop Worrying, and Start Taking The Pill
Editor’s note: PrEP is an HIV prevention option currently available in the U.S. and Truvada is the medication prescribed. PrEP can be a complex issue that raises a number of questions. I wanted to provide a column that captured someone’s authentic experience around PrEP. I wanted it to be honest and frank because issues of gay men’s health must be dealt with candor and sincerity. This is not just a prescription. This is simply one person’s experience with a safe and legal biomedical option for reducing HIV infection. I hope this will be informative and we welcome your feedback.
Over the past three years, I’ve noticed something about my sex life. For a host of reasons that this column will be exploring, I’d all but stopped using condoms. This set-in most clearly during a recent out-of-town trip when a guy who’s Manhunt profile lectured others about “wrapping it up” spit on my hole, shoved it in, and fucked me raw. I was absolutely ecstatic. In that moment – caught off-guard by expectations and overcome with pleasure – I realized just how much my desires had changed.
It occurred to me some days later that maybe this pre-exposure prophylaxis – or PrEP, as it’s commonly known – might be for me. I was clearly the ideal candidate: a bottom with lots of partners who uses condoms inconsistently (read: almost never) and who doesn’t want to test positive. That last bit is hard for some to understand, since many believe that guys who fuck raw must subconsciously desire to be infected. I care about staying negative and have made strategic choices about my sex partners to that end. Well, “strategic” makes it sound scientific. Let’s be real: some of those choices were more like hopeful wishes. But the desire that drove them was the same as any scientific measure: prevent seroconversion.
This column is about my life on PrEP. It’s about how I experience it and how it’s changing my sex. It’s also about the politics of PrEP, which are still being sorted out as we speak – who has access, through what organization, etc. I’m writing because I know there are other guys out there on PrEP who are probably going through the same kinds of experiences and are hungry for any real, down-to-earth talk about it. But I’m also writing because there are HIV-negative guys out there not on PrEP who are curious about it, but too afraid to ask their doctors. They want to know what it’s all about. I’m here to tell them.
How I Got PrEP Covered by Private Health Insurance
As one of the lucky people in the United States whose employer provides comprehensive health insurance, let me just preface this column by saying I know a lot of you guys out there aren’t as fortunate. I’m not ignoring you; the next column will be about how to access PrEP through publicly funded clinical trials and private programs that are popping up. But I wanted to start the access discussion with my experience getting a prescription for Truvada – the only drug currently FDA-approved for PrEP – and getting that prescription filled using my private health insurance.
When I stepped into my doctor’s office to discuss PrEP, I knew it wasn’t going to be a straightforward issue. Even most gay men I know are completely unaware that the FDA approved Truvada for PrEP, much less that it can reduce the risk of contracting HIV by upwards of 90% when taken daily (a recent study found it to be 99% effective among those that took the pill seven days a week). Having been judged plenty of times before by dumbass doctors who didn’t know what they were talking about when it came to gay men’s health, I didn’t go into my appointment with lofty expectations.
Your Guide to Getting PrEP for Free (In The US)
In my column last week, I discussed my experience getting PrEP covered by my private health insurance. But I know many of you folks out there don’t have health insurance. Don’t fret: There are several ways you can get your hands on PrEP without shelling out any dough. Actually, for some of you in urban areas, you might be able to enroll in study that will pay you to participate. There’s a lot of information here, boys, so bear with me.
Let’s start by talking about what these things called “clinical trials” are. There are a few different kinds going on for PrEP and the differences are important. So listen up! In one set of trials, they’re randomly assigning people into different groups that are going to receive a particular drug combination. Once the study is over, they’ll compare the different groups to see if any of the combinations was more or less effective at preventing HIV. Since we already know that PrEP works, nobody in these trials is going to get a “placebo” or fake drug. But some people aren’t going to get Truvada; instead, there are four drug combinations being tested. All of those combinations include powerful drugs that fight HIV – but not all of those combinations have been tested yet.
Learning to Fuck with Poz Guys
A few months before I started taking Truvada for PrEP, I got hit up on Manhunt by a gorgeous HIV-positive guy who wanted to fuck me bare. He was frank about it, telling me that his viral load was undetectable and had been for years and that he wouldn’t cum inside me. In all honesty, I blanched at his frankness.
For years, I had been telling friends (and anyone else who would listen) that choosing to only have sex with guys who think they’re HIV-negative wasn’t really an effective prevention strategy for guys in areas of the country like mine. Where I live, there are plenty of guys who think they’re negative who are actually positive because they haven’t been tested in eons. Transmission is mostly likely going to occur with these guys – not with guys who know they’re HIV-positive.
That may seem confusing at first, but the science behind it is straightforward. When you’re diagnosed as HIV-positive today, most doctors immediately recommend you start taking medication to treat the virus. HIV treatment can fight the virus so effectively that it makes the virus “undetectable” in your system. If the virus is undetectable in your body, it’s virtually impossible for you to transmit the virus. Guys who don’t yet know they’re infected aren’t taking these drugs. Without treatment, there could be tens of thousands or even millions of those tiny little critters in just one milliliter of blood. Having that much virus in your system dramatically increases the odds that the virus will be transmitted during sex.
Feeling Déjà vu: PrEP As The New Condom
Back in the 1980s when gay men in New York were dying left and right from an unidentified disease, a group of activists took a stand to argue for condoms. We didn’t know what was causing AIDS at the time – HIV hadn’t yet been identified – but that didn’t stop AIDS activists Michael Callen and Richard Berkowitz from putting together a pamphlet, “How to Have Sex in an Epidemic,” that encouraged gay men to consider adopting safer sex strategies like using condoms to stay safe.
That pamphlet came out in 1983. It took years for public health institutions to take up the condom message. Let’s revisit a boring but enlightening scientific paper published in 1993 –a fucking decade after Callen and Berkowitz published their groundbreaking advisory to gay men – that urged caution in promoting condoms:
Until more is known about condom effectiveness, condom use promotion may have both positive and negative effects… Condoms will not eliminate risk of sexual transmission and, in fact, may only lower risk somewhat… Empirical data (reviewed in this report) indicate that a 90% reduction in risk due to condom use may be overly optimistic. The protective effect as estimated from human studies, regardless of use definitions, indicates a possible 69% reduction in risk. (p. 1642).
Were gay men listening to what this ivory tower, out-of-touch researcher had to say about condoms? No. We listened to our gay brothers who were quickly figuring out that using condoms for anal sex was an extremely effective method for staying negative and staying alive – all while having meaningful, productive sex lives.
Does Taking PrEP Make Me A Whore?
Hooking up online is always a tricky game of disclosure. You’ve got to show enough of your best assets to turn your audience on without coming across as a desperate slut. Nevermind the fact that most of us online are a) somewhat desperate; and, b) by most standards, extremely promiscuous. It’s all about the fantasy.
I’ve always been terrible at pretend play. I hate Halloween. I loathe charades. And in reaction to the ridiculous obsession with being “straight acting” on websites like Adam4Adam and Manhunt, my online profiles cheekily (but accurately) inform readers that I’m “gay acting.” When it comes to chatting online, I favor honesty over fantasy – a fact that costs me sex on a regular basis.
Let’s take a look at a recent example. Over the Thanksgiving holiday, I was chatting with a 38 year-old guy with the most gorgeous nine-inch cock. He was handsome, built, and wanted to breed me till the sun came up. I was game, but there was just one problem: my ass was still sore from the night before. I always hate making up lame excuses for not hooking up, so I told him point blank my problem:
Me: I’d really love to fuck, but to be totally honest, I’m still sore from getting fucked last night.
Him: Dude, that’s gross. I’m gonna pass. Being first to the party is great, but second… or third… no thanks.
Me: And I say this with all sincerity: nobody on this site is first to any party. Ever.
Him: Whatever. Nobody wants to fuck a whore.
I’ve been faced with encounters like this ever since I started hooking up with guys 15 years ago; generally they involve much harsher language. I’ve never been ashamed about my sex life or my desires. For many guys, that’s a deal breaker. Too many guys out there are deeply ashamed of their sex. It’s embarrassing for them. They’d rather pretend that we’re all boys next door who “never hook up” but make an exception or two (or 264) on their road to monogamy.
When I started taking Truvada for PrEP, I thought somehow that it would help me cut through some of the bullshit out there. I could finally have the sex I wanted, without shame or regret. I suppose I was naïve. Two weeks ago, you may have noticed a column over at The Huffington Post by David Duran bemoaning that only “whores” were lining up to take Truvada. “Having a ‘there’s a pill for that’ attitude is absolutely disgusting,” Duran complained. Reading his woefully inaccurate piece, I found myself face-to-face with the same kind of shaming and pretend play nonsense that has plagued HIV prevention since the beginning.
Does PrEP Have Side Effects?
I brought my pills to work for three days while waiting for my HIV test results. I was eager to start taking Truvada for PrEP, but I knew that I needed to wait for my HIV test results to come back to confirm that I was HIV-negative before I began popping them. My doctor had gone ahead and written me a prescription when I had my blood drawn – before my test results had come back.
I went straight from my doctor’s office to the pharmacy to drop off my prescription. I was eager to get my hands on those pills – in part because I didn’t know if my insurance would cover them. It was only later, when doing research for this column, that I learned that insurance companies have been extremely good at covering PrEP.
The call with my negative result came on an ordinary afternoon while I was working on a project with a friend. I wasted no time, heading directly to the water fountain to wash down the first of many blue pills. I came back to my desk distracted. I was waiting… for what, exactly? Side effects? The feeling of being 92% less likely to contract HIV?
I’ve received a lot of emails from readers inquiring about what side effects I experienced when I started taking PrEP. That day at the office, I was anxiously awaiting the answer. I’ve been taking Truvada for three months now, and the honest answer is that I haven’t experienced any noticeable side effects since.
As it turns out, I’m like most people in that regard. Let’s revisit the iPrEX study results to get a sense of what side-effects participants reported in the original PrEP study. These fell into four main categories, ordered here in most to least common:
- Nausea: 9% of those who received Truvada reported nausea in the first month, compared to 5% of those who received placebo. After the first month, there was no difference in reported rates of nausea among those who received Truvada and those who received a placebo.
- Headaches: 4.5% of participants who received Truvada reported 66 headache events, as compared to 3.3% of those who received the placebo that reported 55 headache events.
- Weight Loss: 2.2% of those who received Truvada reported unintentional weight loss of more than 5%, compared with 1.1% of placebo users
- Small Increases in Serum Creatinine: Truvada is known to cause small increases in serum creatinine, a naturally occurring molecule filtered by the kidneys. In this study, 0.3% of those who received Truvada experienced mild increases in serum creatinine that persisted until the next test. All creatinine elevations resolved with discontinuation of the pill. Four of the 5 participants restarted PrEP without recurrence of the creatinine increase. Investigators monitored renal function throughout the study and found no serious kidney problems.
CDC Fact Sheet (click below to download)
Project Inform’s Fact Sheet (click below to download)
Huffington Post: There’s No Shame in PrEP
For over 30 years gay men have struggled around issues of shame, risk, pleasure, safety, death and life. HIV is an integral part of our daily lives, and we’ve learned what the risks are and how to protect ourselves. Until recently there were two ways to prevent HIV: abstinence and condoms. Now we have a new option in pre-exposure prophylaxis (PrEP). PrEP is a safe, legal and effective option for preventing HIV, and no one should be ashamed of choosing it.
The Stigma Project has taken the proactive step of creating an anti-stigma campaign in regard to PrEP. The groundbreaking campaign is pictured above. Unfortunately stigma is already being used to scare and confuse people about the option of PrEP. And stigma doesn’t just devastate our community; it can claim people’s lives.
The science on PrEP is sound. If an individual takes Truvada every day, as instructed, they will reduce their chances of infection by more than 90 percent. So we have a new tool that is safe and legal and can prevent HIV. Why are we arguing about it?
PrEP provides our community with a great opportunity for self-reflection. Are we still the community that believes that health care is a right and that everyone should have access to medical care regardless of circumstance? Are we the type of community that values privacy and respects the personal medical choices of the individual? Are we committed to sexual health and self-determination? Are we committed to ending the epidemic by pursuing all options to reduce infections?
I believe we are. However, the vitriolic tone of the PrEP debate has given me pause.
We all share the same goal of reducing infections, but you have to ask yourself if you are truly committed to combatting stigma. If you aren’t, if you want to wield stigma as a weapon to impose your point of view, then you are part of the problem. To stigmatize PrEP or the people who take it will only lead to more infections.
To some, PrEP seems to signal complete and total sexual chaos, just like another pill that came onto the scene in the middle of the last century. People opposed the birth control pill because they claimed it was “risky,” or “immoral,” or “promoted promiscuity.” Does any of that sound familiar?
We don’t need to go back to last century to hear those sorts of arguments, because we heard them in 2012 around the contraception debate. Women who believed that contraception should be covered by insurance were derided as “sluts.”
When it comes to PrEP, we don’t have Rush Limbaugh; instead we have people like David Duran writing about “Truvada Whores.”
Women risked their reputations and their lives to take the birth control pill. They understood what choosing the pill could cost them, but they chose self-determination instead. The ability to prevent pregnancy was so important to these women that they risked depression, nausea, weight gain and stroke. They weren’t reckless whores. They were trailblazers for women’s independence and social justice.
Let’s all take a step back and look at the opportunity PrEP provides us. It’s one more tool to prevent HIV. Is it perfect? No. Neither are condoms. But it’s safe, legal and effective.
Why don’t we also stop patronizing gay men? If an individual chooses to go on PrEP, he will be required to visit his doctor and get a prescription. The doctor will draw blood, do an HIV test and counsel the patient about condom use and side effects. The decision to use a condom is an extremely personal one that it is arrived at after consultation with a medical professional. Why should anyone other than the doctor, the patient and the patient’s partner be involved in that process?
Huffington Post: A Pill to Prevent HIV
By Carl Sandler
CEO, MISTER App
Last week a friend posted on Facebook: “It’s been an interesting life. HIV + (positive). 10/9/2012.” He is 24.
Later, I asked my young friend if he had heard of Truvada, the drug recently approved by the FDA for use as pre-exposure prophylaxis, or PrEP, against HIV. It’s a pill to prevent HIV transmission. Like most people I know, he hadn’t ever heard about PrEP and didn’t understand that it was an option available to him.
Sadly, I’m not surprised. The information that has come out about PrEP over the past year has been so vague or confusing that millions of gay men at risk for getting HIV may not understand it. The fact is, a daily dose of Truvada can statistically protect against contracting HIV.
If taken properly and consistently over a period of time prior to an exposure, an HIV-negative person is protected in roughly equivalent rates of protection provided by a condom, or over 90 percent. Researchers have estimated that for gay men, taking Truvada daily (7 pills per week) may be 99-percent effective; four pills a week might be as good as consistent condom use (96 percent).
So why isn’t there a more expansive conversation happening in the gay community about this drug? Where are the front-page headlines? I spoke to some of my own friends about PrEP and quickly realized that many people, both HIV-positive and HIV-negative, have a knee-jerk negative reaction to PrEP, a combination of healthy skepticism, fear, misinformation and confusion.
I’m writing this piece because I don’t want to read any more Facebook postings like that of my young friend. I want people of all ages to have the information they need to decide for themselves about the risks and benefits of Truvada and PrEP.
The Condom Conundrum
Despite decades of safer sex messages, over 50,000 Americans are still newly infected with HIV every year. Gay men, who represent less than 2 percent of the U.S. population, account for over 60 percent of new infections. With statistics like these, you might think that public health departments and HIV organizations would be doing much more to educate the public about this powerful new tool in the fight against HIV. I asked my own doctor’s assistant about PrEP, and he admitted that he didn’t know much about it — and I live in New York City, arguably a health and medical treatment capital of the world.
I can’t help but wonder if the reluctance to promote PrEP may be because there are real limits to what PrEP can and cannot do. PrEP is not a vaccine that can give you 100-percent protection. It is not a Viagra-type pill that can be taken 15 minutes before intercourse. It is not a cure for HIV. And it cannot protect you against hepatitis C, herpes, syphilis, chlamydia or gonorrhea. But still, for many of us, PrEP could be a game changer.
For as long as I can remember, the only real protection we have had against HIV, other than abstinence, has been condoms. But as protective as they are, condoms are also imperfect. They break; they are used incorrectly; they are at every bar when you don’t need them and nowhere to be found when you do.
I also don’t know a lot of people who are able to use condoms 100 percent of the time. Do you? Like anything we try to do 100 percent of the time, it’s actually human to be less than 100-percent. That being said, I am continually amazed by how many presumably HIV-negative people I encounter who seem to think nothing of having sex without a condom. Something else is going on, namely that people are inherently unable to adhere to the “wear a condom every time” warnings. How many times did you slip in the past year? Once? Twice? Too many to count?
It’s high time for a different approach.
Read the entire article on Huffington Post.
- The iPrEx Primary Report (Grant, Lama et al. 2010)
- My PrEP Experience
- Anderson, P. L., D. V. Glidden, et al. (2012). “Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men.” Sci Transl Med 4(151): 151ra125.
- Grant, R. M., J. R. Lama, et al. (2010). “Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.” N Engl J Med 363(27): 2587-2599.
U.S. Food and Drug Administration Approves Gilead’s Truvada(R) for Reducing the Risk of Acquiring HIV
– First Agent Indicated for Uninfected Adults at High Risk of Acquiring HIV Through Sex –
FOSTER CITY, Calif., Jul 16, 2012 (BUSINESS WIRE) — Gilead Sciences, Inc. GILD today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. Truvada is the first agent to be approved for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP). As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Truvada was originally approved in 2004 in combination with other antiretroviral agents as a treatment of HIV-1 infection in adults and is currently the most-prescribed antiretroviral product in the United States.
“Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world, and Gilead is proud to have been a partner in this effort,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “This advancement in the field of HIV prevention was made possible due to the leadership and commitment of the FDA and the Department of Health and Human Services to reduce the number of new HIV infections in the United States and worldwide.”
It is estimated that 1.2 million Americans are currently living with HIV, and, despite the availability of existing prevention tools such as condoms, the incidence rate has remained steady over the past two decades with approximately 50,000 new infections occurring each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men (MSM). In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.
Data supporting the approval of Truvada for PrEP came primarily from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the U.S. National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation, and Partners PrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. The iPrEx and Partners PrEP trials found that Truvada reduced the risk of acquiring HIV infection by 42 percent and 75 percent, respectively. Several other clinical studies also support the use of Truvada for HIV risk reduction.
“This approval is a major milestone in our 30-year fight against AIDS,” said Robert M. Grant, MD, MPH, Betty Jean and Hiro Ogawa Endowed Investigator, Gladstone Institute of Virology and Immunology, University of California, San Francisco and lead investigator of the iPrEx trial. “The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world.”
Based on the iPrEx results, in January 2011 the Centers for Disease Control and Prevention (CDC) issued interim guidance on Truvada as PrEP among high-risk adult MSM. CDC is currently developing formal U.S. Public Health Service guidelines for the use of PrEP among both men and women, which will address procedures for HIV testing and health screening prior to PrEP initiation, as well as ongoing monitoring for cases of HIV infection that may occur despite PrEP use, possible drug resistance among those who become infected, side effects and clinical toxicities.
“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” said Connie Celum, MD, MPH, Professor of Global Health and Medicine at the University of Washington and lead investigator of the Partners PrEP trial. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy. Although the implementation of PrEP will bring challenges, they can be anticipated and systems developed to address these challenges. In particular, systems to provide comprehensive education and support to health care providers and people who use PrEP will be required to ensure appropriate and effective use of this potentially groundbreaking new HIV prevention intervention.”
As part of the REMS developed by Gilead and FDA to ensure safe use of Truvada for PrEP, Gilead has developed FDA-approved materials to educate and inform healthcare providers and uninfected individuals about Truvada for PrEP. These materials highlight the importance of strict adherence to the dosing regimen, emphasize that Truvada must be considered as only one part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and convey that Truvada for PrEP should only be used in individuals who are confirmed HIV negative and HIV-1 screening should be repeated at least every three months while taking Truvada for PrEP. Truvada for PrEP should not be initiated when clinical signs or symptoms consistent with acute HIV-1 infection are present.
As a separate measure to support the safe use of Truvada for PrEP, Gilead also will provide vouchers for free HIV testing and condoms, an opt-in service for regular reminders about HIV testing and subsidized HIV resistance testing for any individual who becomes HIV-positive while taking Truvada for PrEP.
In all studies of Truvada for PrEP, the most commonly reported side effects included headache, stomach discomfort and weight loss. The incidence and types of side effects were consistent with Truvada’s safety and tolerability profile when used as an HIV treatment, which is supported by more than four million years of patient use. Overall, there have been nearly nine million patient years of experience with tenofovir-containing regimens.
Important Safety Information about Truvada:
WARNINGS: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread(R), a component of Truvada, in combination with other antiretrovirals.
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Truvada used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically during use. Drug-resistant HIV-1 variants have been identified with use for Truvada for a PrEP indication following undetected acute HIV-1 infection. Do not initiate Truvada for a PrEP indication if signs and symptoms of acute HIV infection are present unless a negative infection status is confirmed.
Do not use Truvada for pre-exposure prophylaxis in individuals with unknown or positive HIV status. Truvada should be used in HIV-infected patients only in combination with other antiretroviral agents.
New onset or worsening of renal impairment may occur, including acute renal failure and Fanconi Syndrome. Creatinine clearance should be calculated prior to administering Truvada. Truvada for HIV-1 infection should not be used in patients with severe renal disease (CrCl < 30 mL/min), and routine monitoring of CrCl and serum phosphorous all patients at risk for renal impairment is recommended. Avoid administering concurrently with or with recent use of nephrotoxic drugs.
— Do not use Truvada for pre-exposure prophylaxis in individuals with a creatinine clearance (CrCl) below 60 mL/min. Re-assess risk and benefits of using Truvada for PrEP if a decrease in CrCL is observed during use for PrEP.
Decreases in Bone Mineral Density (BMD) may occur. Consider assessing BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. Fat Redistribution has also been observed in patients receiving antiretroviral therapy. Immune Reconstitution Syndrome may occur in HIV-1-infected patients. Autoimmune disorder may occur in the setting of Immune Reconstitution.
Truvada for a PrEP indication:
Comprehensive Management to Reduce the Risk of Acquiring HIV: Truvada for PrEP should only be used as part of a comprehensive prevention strategy that includes other prevention measures such as safer sex practices. A comprehensive prevention strategy includes consistent and correct use of condoms, the individual knowing both their and their partner’s HIV status, getting regular testing for HIV and other sexually transmitted infections, and informing individuals about and supporting their efforts to reduce sexual risk behavior.
Use Truvada for PrEP to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV negative because HIV-1 resistance substitutions may emerge. HIV-1 negative status must be confirmed immediately prior to prescribing and regularly thereafter (at least every three months). Defer initiating Truvada for PrEP if clinical signs and symptoms of acute HIV-1 infection are present or if recent exposure (< 1 month) is suspected, or confirm HIV-1 negative status using a test approved by the FDA to aid diagnosis of acute or primary HIV-1 infection. While individuals are on TRUVADA for PrEP, discontinue if symptoms of acute infection develop after a potential HIV-1 exposure event until negative HIV-1 status can be confirmed using a test approved by the FDA to aid in the diagnosis of acute or primary HIV-1 infection.
Truvada for use with other antiretroviral agents to treat HIV-1 infection: Truvada should not be co-administered with any other antiretroviral agents for HIV that contain emtricitabine or tenofovir disoproxil fumarate, nor should it be co-administered with products containing lamivudine. Do not administer with Hepsera.
Common side effects reported during clinical studies with Truvada (in combination with efavirenz) include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash.
In clinical trials for Truvada for PrEP, the most common side effects associated with Truvada were headache, stomach discomfort and weight loss. Caution should be exercised when co-administering Truvada with didanosine, atazanavir and lopinavir/ritonavir due to the potential for toxicity.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risks that physicians and patients may be reluctant to use Truvada for HIV risk reduction. As a result, there may not be significant use of Truvada as a risk reduction tool. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
Truvada is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE: Gilead Sciences, Inc.