Boston ASOs Hopeful About Truvada as PrEP

A major milestone in the fight against HIV/AIDS took place last week with the announcement of the FDA's approval of Truvada, the first-ever HIV prevention pill. And Boston's HIV/AIDS organizations couldn't be happier or more hopeful about its efficacy.

"This approach can prevent many new infections and could dramatically impact HIV transmission worldwide as part of the tools we have available to stop the epidemic," said Kenneth H. Mayer, MD, medical research director and co-chair of the Boston-based Fenway Institute at Fenway Health.

On July 16, the U.S. Food and Drug Administration approved the drug emtricitabine/tenofovir disoproxil fumarate (FTC-TDF), trademarked Truvada, for use by high-risk adults to help reduce the probability of contracting sexually acquired HIV-1, when used in conjunction with safer sex practices. Created by Gilead Sciences, Inc., the drug has been on the market since 2004, when it was approved as treatment for HIV-1 and is currently the most prescribed antiretroviral medication in the United States.

With its new approval status, this once-daily pill will be marketed as a form of pre-exposure prophylaxis, or PrEP, and prescriptions are expected to increase substantially.

In a three-year study conducted by the U.S. National Institute of Health, Truvada was shown to reduce the risk of HIV infection in healthy gay and bisexual men by 42 percent.

In a similar placebo-controlled study by the University of Washington, the drug was shown to cut the risk of infection by 75 percent for heterosexual couples, in which one partner was HIV-positive and one was HIV-negative.

An estimated 1.2 million Americans are HIV-positive, with 50,000 new cases of infection occurring each year. Rates of new infections are highest among Blacks and Latinos.

"Because of high community viral loads, the highest HIV risk factor for these young men is being sexually active within their own communities," said Douglas Brooks, a member of President Obama's Advisory Council on AIDS.

Brooks is the Vice President of Health Services for the Justice Resource Institute in Boston, which serves hundreds of Black and Latino gay men and other men who have sex with men.

"At the same time we're teaching them to see themselves and their brothers as beautiful, loving men, deserving of full lives, inclusive of affectionate relationships, we're also having to consider the likelihood that playing in their own backyard may be dangerous," said Brooks.

Brooks joins many other HIV/AIDS activists who believe that once-daily Truvada pills for PreP has the potential to be a "game changer" for HIV prevention.

In Midst of Optimism, Controversy Over "Vaccine" Continues

While hailed by many as a major breakthrough in the fight against HIV/AIDS, this news has not come without controversy.

Michael Weinstein, president of the AIDS Healthcare Foundation, the largest provider of HIV/AIDS care in the United States, has spoken out against the FDA's approval of Truvada for PrEP, asserting that introducing a "vaccine"-like drug will encourage more risky behavior and lead to a reduction in condom use.

"Why would anyone willingly subject themselves to such drug therapy if they had any intention of using condoms? If someone tells almost any man that it is reasonably safe to have sex without a condom, as this study may suggest, he will likely do so," wrote Weinstein in a December 30, 2010, Facebook post.

In clinical trials there has been no indication that Truvada users are more likely to participate in risky sexual behaviors, and the drug should only be prescribed as part of a comprehensive HIV prevention regimen including regular HIV-1 screenings (every three months while taking Truvada) and risk reduction counseling.

Another concern for many, including the AIDS Healthcare Foundation, is the potential for the emergence of new drug-resistant HIV strains.

An estimated 240,000 Americans do not know they are HIV carriers. Undergoing a regimen of Truvada while already infected could cause these individuals' virus strains to be strengthened and inadvertently passed to their partners.

But as noted in the Fenway Health analysis, "Pre-exposure prophylaxis for HIV prevention: Moving toward implementation," research suggests that, "the risk of emergence of drug-resistant HIV...is small," and that "the clear preventative benefits...outweigh the risks associated with drug resistance."

Gilead Sciences, in an effort to ensure and promote proper use of Truvada, has said that it will provide vouchers for free HIV testing and condoms as well as an opt-in service for reminders about HIV screening. The company's Advancing Access program will provide assistance to low-income or uninsured patients who are eligible for Truvada, and a number of private payers have come forward to help with this mission.

At JRI Health, said Brooks, they choose to focus on their clients' resilience, and not on their deficit. He believed that when given the proper support, at-risk individuals will take the medication as directed and will thrive.

"I don't think any one thing is going to turn the tide to get us to a zero percent new infection rate," said Brooks. "But I believe that having this new intervention, combined with other behavioral interventions, gives us a real opportunity to make a difference and be able to reach a goal of reducing new HIV incidences."