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

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:

Back to home » Treatment News » July 2012

Most Popular Links
Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

15 Years Ago In POZ


More Treatment News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to news@poz.com.


emailprint

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 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


Scroll down to comment on this story.



Name:

(will display; 2-50 characters)

Email:

(will NOT display)

City:

(will display; optional)

Comment (500 characters left):

(Note: The POZ team reviews all comments before they are posted. Please do not include either ":" or "@" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules



Hide comments

Previous Comments:


  comments 30 - 35 (of 35 total)     << < previous

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
Dave, I'll be surprised if they ever publish that 45% figure. The phrase will be "when used properly".

Tom, , 2012-07-16 18:57:41
Oh, they'll never hear that it's "40-75% effective". They'll hear "when used as directed, truvada has been shown to be more than 92% effective at reducing the chance of HIV infection". Never mind that of all the hundreds of people studied, only like, a dozen, managed to use it "as directed". Never mind that real world outcomes are always worse than research ones. The FDA has sold out the gay, poz and at risk communities here.

Dave, Philly, 2012-07-16 18:14:47
This is the most asinine thing I have ever heard. It's like playing Russian roulette . What a compete and total waste of taxpayers dollars. Who would want to take these meds if u really do not have to. Cost....long term side effects....etc. Colossal waste of money to do this study. Would u jump off a cliff with a parachute that opened 40-75% of the time?.????? Honestly someone should sue the NIH for conducting this "research" Unbelievable

Tom, Saginaw, 2012-07-16 17:19:04
If Prep is being given away for free but we're forced to pay $1000 a month with huge annual price hikes, I don't see how anyone can pretend that this doesn't amount to a diversion of funds. The fact that Ryan White isn't directly paying for it is immaterial, as this pill is clearly indirectly funded by RW and our insurance. "State of the art HIV prevention" might be a right, but god help you when (not if) this stuff fails.

Jeton Ademaj, Harlem, NYC, 2012-07-16 14:36:42
this is EXCELLENT news. we have now entered a new Safer Sex era. Prevention is no longer the enemy of sexual pleasure, and HIV- people now have protective options that do not burden sexual expression. This approval by the FDA will happily set off an arms race for better PrEP options (such as injections that last a month or longer, drastically improving the ease of adherence) and HIV+ people will benefit greatly as a result. rather than attacking people who use PrEP, we must encourage adherence!

comments 30 - 35 (of 35 total)     << < previous


[Go to top]


Join POZ Facebook Twitter Google+ MySpace YouTube Tumblr Flickr
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar


    Drew949
    South Orange County
    California


    TanyaB
    Delray Beach
    Florida


    max38man
    Chicago
    Illinois


    pozsmith1
    East Bay
    California
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Survey
Pop Watch

more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.