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.
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.
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 PrEP...to 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 16 - 30 (of 34 total)
Tom, , 2012-07-18 13:44:24
This started when waitlists were at 10,000. Even after slashing eligibility for assistance, more than 2,000 people languish on them. I know people who've gone without their meds. We see unfair prosecutions, even for nonrisky behavior. Protections against HIV discrimination are worthless. The clinical outlook grows bleaker by the day. All that, but we came out with a pill that is only protective to those who know they're going to IML or the White Party. "We got ours, f**k you" is right.
Mitch, , 2012-07-18 12:20:29
Agree with Keith. Talk about a "We got ours, f**k you" attitude. We've been watching new treatments work their way through the system for nearly a decade. Where is Sangamo's latest breakthrough? Clinical trial Phase 1.928? Is anyone else doing anything like Gero Huetter? A new prophylactic comes along, and BOOM, in the blink of an eye it goes from theoretical concept to commercially available. We're all going to die a slow death on these f***ing pills, and we're being told to shut up?
Sonny Boy, Fandango County, CA, 2012-07-18 12:06:48
...Yeah everyone, think of them as birth control pills! Birth control pills that don't work 60% of the time! Birth control pills that could breed a resistant virus! Birth control pills that are going to drive up the cost of your healthcare by keeping this patent out forever, with Gilead increasing the price year after year after year! So if all you ninny's can't just think of this as Gay Man's Birth Control, you're just crabs in a bucket.
Daddy, Sonoma Coast, California, 2012-07-18 11:19:22
Wow, all the negative comments kinda make me grumpy. I take Truvada everyday, with zero side effects, and believe as part of my daily cocktail of drugs it has saved my life. I only wish I were given the opportunity to take it prior to becoming HIV+. Folks, if it's not right for you leave it ... but, don't deny another person the option. I'd rather think of Truvada as PrEP in the same way I view birth control pills.
Sheldon, Kalamazoo, 2012-07-17 23:22:26
Even with the most compliant patient it's still only 92% effective.
Some fool will still probably be willing to risk unsafe sex with those odds. This is highly irresponsible to release this type of news. Seriously we need to find a cure. Not encourage risky sexual practice and a false sense of protection. I am just dumbfounded.
keith, Dublin, 2012-07-17 19:39:30
How long did they test truvada as a PrEP. Did they rush it out.
I ask because we need to rush out therapeutic vaccines.
While not a cure tests have shown that people have been able to stops meds for 1-5 years after receiving various vaccines - that needs t be pushed out. There is momentum maybe not seen since 96 or so but we need to keep moving forward. AIDS fest next week may shed new light on where we are but I believe with will we can get rid of HAART if not HIV in 2-5 years
nvhorseman, Reno, NV., 2012-07-17 16:41:31
The government seems to be getting their act together at last. Now all that we have to worry about is access. Especially in the south and bible belt where politics is run by conservative evangelicals often not even allowing women access to birth control. The quality and disposition of doctors in such areas who are also evangelical aren't pre-disposed to helping anyone avoid the "curse of AIDS as that is god's punishment for a life of sin". A life that some of them enjoy behind closeted doors.
Frederick Wright, Coachele valley, 2012-07-17 13:49:28
I am all for Gilead making a profit and all for new technology. Still a little bewondered what Gilead is up too. The national press ran the story over and over yesterday . Stating this is all about protecting gay men,hum hum ,not buying it. The ending of the incerted free press was Gilead big and bold,and could this be a PR stunt to sell stock options for the money thinkers, or testing the watersand unity of AIDS advocates. Are any readers using this approach let's here from you.
Survivor, Sf-bay area, 2012-07-17 13:44:14
Five good reasons to avoid truvada.
1. Side Effects
2. Long term cause harm to organs.
3. Cost - are we going to find truvada in a fish bowl like condoms?
4. Condoms are safer.
5. Another case of a pharmasudical
Capitalizing on tax dollars and struggling hard working people,not to mention it drive the cost of health insurance higher...
Keith, Dublin, 2012-07-17 13:30:24
I am still lost on who other than people in serodiscordant relationship are going to take this.
I meen who deems their behaviour so dangerous and risky that they will take a pill everyday but not change their behaviour.
In saying that it is a massive breakthrough and I hope is the start of other PrEP medication including the long awaited vaccine
Andy, , 2012-07-17 08:04:51
Gilead would hock aspirin if it could market it as a chemical condom and keep the patent in the process. Just capitalism at work. Obviously the FDA was bribed. Bureaucrats are always for sale. The real issue is that our "HIV leaders" have become so corrupt they've rolled out the red carpet for the whole mess. Clearly, large swathes of the "activist community" need to go, the sooner the better. How does one trash these orgs and start over?
hopeisvague, Hong Kong, 2012-07-17 03:55:39
We need a CURE, not an old drug already existed for nearly a decade disguised as something new. PrEP is nothing new, just like PEP but you use it regularly regardless of the genuine need to deal with the virus or not. Act up for a cure, not endless repackaging of old drugs for new patent.
Frederick Wright, Coachella Valley, 2012-07-16 21:53:32
iI must agree this is strange . I met with a Gilead Rep and he stated their company did not do the studies or they did not push them, however theydid run to the bank ,I mean FDA for approval. The only thing I can think of for a market is married folks one being HIV and the other not and military dudes in africa to protect democarcy and high in escorts in dubi and new york city. Who can afford 10,OOO dollars a years for a pill that is not needed,. Oh. Plus free research subjects. Very queer
Ethan, , 2012-07-16 21:30:48
This is HORRIBLE news! Not only does this encourage irresponsible sexual behavior, but what about all the HIV+ people who actually NEED the Truvada to NOT DIE! I expect to see shortages of Truvada when Gilead can't keep up with demand. And when people who actually have the virus can't get there meds, blame the FDA for them developing drug resistant strains! Truvada as pRep is WRONG!
Andy, , 2012-07-16 19:18:18
comments 16 - 30 (of 34 total)
Dave, I'll be surprised if they ever publish that 45% figure. The phrase will be "when used properly".
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