HIV Treatment Receives Stronger Label Warnings After Call From Advocates

Advocacy groups moved the FDA to call for packaging of Truvada to bear a “black box warning” after its earlier approval as an HIV prevention pill.

AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, welcomed the news today the boxed warning label (also called the ‘black box warning’) on Gilead Sciences’ blockbuster AIDS treatment Truvada for use as a form of an HIV prevention pill appears much stronger than proposed versions of the label earlier this year. The new warning label is being welcomed by AIDS advocates from AHF and other organizations who were astounded by a recommendation by a Food and Drug Administration (FDA) Advisory Panel to allow Gilead to market use of Truvada as a form of HIV prevention in uninfected individuals, particularly when the panel—comprised of 23 physicians, scientists and members of the general public—also recommended that the FDA allow Gilead to market the drug for such use without any requirement for HIV testing whatsoever.

“From the beginning, AHF and many other advocates strenuously opposed use of this well-established AIDS treatment as a form of an HIV prevention pill, concerned about both the efficacy of the treatment as well as medication adherence issues among uninfected high-risk populations,” said Michael Weinstein, President of AIDS Healthcare Foundation. “It is difficult for many of those who are already infected with HIV to properly comply with daily drug regimens. Expecting uninfected people to remember to take a drug every day for a disease that they don’t have is an even more daunting challenge. At least now the ‘black box warning’ label on Truvada for prevention recommends HIV testing every three months. It is good to see that the FDA and Gilead have finally come to this realization. I believe it was in part because of our advocacy over the past year opposing the drug for this use that this warning label is now stronger.”

The FDA Advisory Panel took place in May in Silver Spring, MD, at FDA headquarters. Nearly 30 advocates from AHF and other groups spoke against use of the drug for HIV prevention to the panel, which nevertheless indicated it would give preliminary approval to Gilead for use as HIV prevention.

Later in the summer, at the ‘Controlling the HIV Epidemic with ARVs’ Summit, held in London June 11-12, a Gilead official publicly disclosed in a plenary session in which he was participating that use of its blockbuster AIDS treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to prevent possible HIV infection would have labeling indicating that a negative HIV test will be required before a prescription.

Following is what the Truvada packaging and printed drug warning inserts now state regarding use of the drug for pre-exposure prophylaxis (PrEP) for HIV prevention:

For PrEP:

"When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:
    prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [See Warnings and Precautions (5.9)];
    counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [See Warnings and Precautions (5.9)];
    confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. [See Warnings and Precautions (5.9)]; and
    screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP."
 
About AIDS Healthcare Foundation
 
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 individuals in 27 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe.
 
Source: AIDS Healthcare Foundation via Business Wire
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