Treatment News : FDA Approves Truvada as PrEP - by Tim Horn

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July 16, 2012

FDA Approves Truvada as PrEP

by Tim Horn

The U.S. Food and Drug Administration (FDA) has approved Truvada (tenofovir plus emtricitabine) as the first prescription drug—to be used daily and in conjunction with condoms and other safer-sex measures—to prevent HIV among those at high risk for the infection. Truvada’s approval as pre-exposure prophylaxis (PrEP) was announced via statements from both the FDA and Truvada’s manufacturer, Gilead Sciences.

“As part of PrEP, HIV-uninfected individuals who are at high risk will need to take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus,” the FDA said. “Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling, consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually transmitted infections. Truvada is not a substitute for safer-sex practices.”

The approval follows the May 10 recommendation by the FDA’s Antiviral Drugs Advisory Committee to approve the drug  as pre-exposure prophylaxis (PrEP) in various high-risk populations: men who have sex with men, HIV-negative partners in serodiscordant relationships and other individuals at risk for acquiring HIV through sexual activity.

“The only way we are going to end the epidemic is through a combination approach,” said Susan Buchbinder, MD, of the San Francisco Department of Health, at the May advisory committee meeting. Noting that condoms are not 100 percent effective—in part because of improper use and breakage—and that behavioral intervention strategies aren’t universally successful, she explained that what’s needed “are new treatments and prevention strategies to have a major impact on the US epidemic.”

“This is an enormous turning point, a real game changer, in the fight against HIV,” said Jim Pickett, AIDS Foundation of Chicago’s director of prevention advocacy and gay men’s health. “The toolbox we have been working for decades to expand now has Truvada as PrEP.”

Numerous data sets from the clinical trials were reviewed by the FDA, including results from the National Institutes of Health (NIH)-funded international iPrEx study and the University of Washington’s Partners PrEP study conducted in Kenya and Uganda. These studies found that Truvada reduced the risk of acquiring HIV infection by 42 and 75 percent, respectively, with even higher rates of effectiveness among trial volunteers who strictly adhered to their daily regimen.

Safety First

As a part of its approval, the FDA is strengthening the warning section of Truvada’s package insert to alert health care providers and at-risk individuals that Truvada for PrEP must only be used by those who are confirmed to be HIV negative prior to prescribing the drug. The FDA also notes that HIV testing should be conducted at least every three months while Truvada-as-PrEP is being used to reduce the risk of developing HIV resistant to tenofovir and/or emtricitabine.

The FDA has also required a Risk Evaluation and Mitigation Strategy (REMS). According to Gilead, this will include a Truvada medication guide with each Truvada PrEP prescription and training and education through a program for health care providers. Both initiatives will address not only HIV acquisition and the development of drug resistance, but will also underscore another serious risk: The need for careful prescribing, adherence and follow-up practices for individuals with chronic hepatitis B virus (HBV) infection, who can experience acute liver disease exacerbations if tenofovir and emtricitabine (both are effective against HBV) are not taken correctly or are stopped abruptly.

Gilead is also required to collect blood samples from individuals who acquire HIV while taking Truvada so that their HIV can be tested for resistance to tenofovir and/or emtricitabine. Additionally, the company is required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada for PrEP and to conduct a trial to evaluate levels of drug adherence and their relationship to adverse events, risk of seroconversion, and resistance development in those who do become infected with the virus while using the drug.

Gilead has committed to provide national drug utilization data in order to better characterize individuals who utilize Truvada as PrEP and to develop a PrEP registry project to assess adherence over time.

During the advisory committee hearing, Gilead also committed to providing vouchers for free HIV testing, HBV testing and condoms. The company will also provide assistance for drug-resistance testing for individuals who become infected with HIV while using Truvada and an opt-in testing reminder service.

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.

Looking Forward

Many HIV oranizations are embracing the approval of Truvada as PrEP, while also stressing the need for careful access planning in the real world. 

“Access is paramount," said the HIV prevention advocacy group AVAC in a statement. "We will monitor and advocate that FDA approval is followed by implementation that ensures daily oral PrEP using [Truvada] is affordable through government assistance programs, Gilead's patient assistance program and through private health insurance. State of the art HIV prevention is a right and a public health imperative, not a privilege. It is important that we explore all avenues for access and affordability of [Truvada] as PrEP.”

Judith Aberg, MD, of the HIV Medicine Association agrees, stressing that implementation of PrEP must not contribute to HIV-related healh care disparities. "This is a particular concern because the low income and minority populations most heavily affected by HIV infection are less likely to be engaged in health care and are more likely to be uninsured or rely on Medicaid coverage," she said.

To reduce disparties, Aberg raises a number of key issues. For starters, she says, "funding for safety-net programs serving people with HIV, such as the Ryan White program, should not be diverted to support PrEP." She adds that "further studies of PrEP among women, especially women of color, should be conducted" and, importantly, that  "the U.S. Prevention Services Trask Force should be encouraged to review coverage for faciliate coverage by insurers, including Medicaid programs." 

“It’s going to take time for health care systems around the country to figure out how to offer PrEP,” Dan Van Gorder of the San Francisco-based advocacy group Project Inform explains. “But that doesn’t mean that people who perceive themselves to be at high risk for HIV shouldn’t have conversations with their doctors about it now.”

Search: fda, truvada, tenofovir, emtricitabine, prep, pre-exposure prophylaxis, prevention, transmission, gilead

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  comments 1 - 15 (of 35 total)     next > >>

juan huitron, minneapolis, 2013-08-21 03:59:12
I been taking Truvada for over 2 weeks and feel just fine no side effects.

keith, , 2012-08-13 19:53:57
David I hope and pray you are right about a cure been "around the corner" I am new to this not on meds, Body hurting today. Looking at a life ahead of me of stigma and rejection. I hope a cure will come or an easy treatment like once a year injections personally its in this that my faith is in. They are to start a new series of tests in germany on Vacc 4 and general P1 tests with Vacc 5. I just read and article that quotes Michel Sidibé as saying a functional cure could be here is 6-10 years

JörG€N, Sweden, 2012-08-05 17:55:20
I do not remember the name of a physician who won the Nobel Prize a few years ago on cell communication with the outside. But in any case - then it was not HIV + - but remember there critical commentary against the pharmaceutical industry to receive the Nobel Prize. He said that all illnesses were resolved in laboratories, but for the pharmaceutical industry's interest that there is not healthy. The important thing is to chronic diseases in order to have a lot of patients and consumers, which would benefit economicallythe Pharmaceutical Industries.

Frederick Wright, Coachella valley, 2012-08-02 18:19:12
You guys are making Pharma to powerful and to evil, they are just about making a buck, not stopping a cure, this makes them more motivated, for the research is where they make the big bucks with products like Viagra a bonus while researching on live HIVers. 40 percent reduction in new HV cases could be a gift in Africa and I am sure many are thinking of front loading PREP and PEP in Africa whille we debate it in the states for years on who can afford it and who is going to writte the scrip.

Farmer Mitch, , 2012-07-31 13:18:20
(cont) I find it really, really conspicuous that just as soon as this drug got approved, the conversation shifted to suggesting it will be most beneficial for (identified) serodiscordants (whose partners should already be treated, and are thus at negligible risk), with reminders that this drug is only effective when taken religiously. I see the makings of a conversation that has shifted from "its your fault for not using a condom" to "its your fault for missing a dose" in the near future.

Farmer Mitch, Des Moines, 2012-07-31 13:08:45
Well, something's up, though i'm not sure it's a cure they're afraid of. It'd be naive to think that Big Pharma would sell anything that would decrease the total number of HIV+ who are chained to ARVs for life. In farming, that's called "selling your seed corn", and its understood as a desperate last resort. Pharma ain't desperate though. I think if you're not seeing some kind of conspiracy... surrounding this bareback party pill, you're not paying attention.

David, Philadelphia, 2012-07-30 22:24:17
I can't speculate but I will try. Could it be that pharma companies want to get their drugs passed as PrEP because they may see a cure in sight for those living with HIV? And in order to continue to make a profit they now want to sell the drugs to HIV- people to fund their past and future costs and research? Hmmm...we all know that a cure would mean less money for the big pharma companies. Just thining out loud.

Mitch, , 2012-07-21 00:55:27
Oh hey, speaking of the distinct pattern... July 19, researchers at Scripps happened across something new in dealing with the reservoir. Google it. The pattern continues. The revolution will be covered up and forgotten.

keith, dublin, 2012-07-20 11:54:07
If you've googled HIV cure over the last two days you will have seen a lot of reports about this new 'road map to a cure' that was announced yesterday and that a cure will be found in the near future. Tomorrow there is a conference on about cure research and Bionor are meant to deliver Phase 2 details so here is hoping.

Frederick Wright, Choachella Vally, 2012-07-19 19:05:11
I like the Norway ideai if these people would buy into it. Some time ago some suggested a Global Prize for a cure for AIds for it could be motivating and for the World Bank to underwrite 10 billion pound Purse and in return for patient rights being given to all courtiers. I agree Europe needs to way in more for the USA and the Crown seems to be doing most of the charity support for AIDS , on the other hand , the USA would save 10's billions as an affordable cure is unveiled to all HIVers

Keith, Dublin, 2012-07-19 15:17:34
The FDA seem stuck in a mind set that HAART is the only game in town. There seems little move to test and experiment in any meaningful way. I am european and I think europe should take some of a lead here. For example Vacc 4x the Norweigin government should ask and allow bionor to test the vaccine on ALL hivers in Norway its only like 4,0000 and try and "cure" hiv in one country. That works then spread it to the rest of europe

Mitch, , 2012-07-19 13:58:42
It has been frequently brought up on here and other sites that there was a distinct pattern, where news about PrEP was released immediately before or after other HIV breakthroughs were announced, as if to eclipse them and interest in interest in real solutions. It has been pointed out that this is inidcative of classic and very heavy PR manipulation.

keith, dublin, 2012-07-18 20:59:17
the same day as the FDA announcement there were articles around the net about new tests and possibility of a preventative vaccine by 2019 We'll see

Mitch, , 2012-07-18 18:27:49
"a 30pc reduction in HIV cases is better than none approve it at 30% and continue the research for 100% effectiveness" LOL, I'd totally forgotten about the thai vaccine trial. 30% all of the time is way better than 40% as occasionally used by those who know they need it, yet we trashed the thai vaccine. For absolute proof that the system is corrupt, you've brought up a powerful point.

Frederick, Coachella Valley, 2012-07-18 15:56:32
I clearly understand your position for I never thought of this as a Wong direction in priorities and that this action could deeply effect HIVers, By your zeal and action I do understand the seemly despect, and in all fairness this theory has been in discusion for 4 years ,when Obama open up free and a lot of expression and HIViers asked to unlock new technlogy.Your passion and well educated critical thinking skills are needed more than ever in the Poz Army to move forward the Cure and Healing

comments 1 - 15 (of 35 total)     next > >>

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