Truvada News and Research

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Reformulated anti-HIV gel may be safe for use in both vagina, rectum

A change in the formulation of tenofovir gel, an anti-HIV gel developed for vaginal use, may make it safer to use in the rectum, suggests a study published online this week in the Journal of Antimicrobial Chemotherapy. In laboratory tests of rectal tissue, researchers from the Microbicide Trials Network (MTN) found that the reformulated gel was less harmful to the lining of the rectum than the original vaginal formulation, and just as effective in protecting cells against HIV.

17 May 2012

Newspapers examine concerns surrounding possible FDA approval of Truvada for PrEP

The New York Times and the Financial Times examine concerns expressed by AIDS activists and members of an FDA panel that last week recommended Gilead Sciences' antiretroviral drug Truvada be approved for pre-exposure prophylaxis (PrEP) to prevent HIV among healthy people at risk of contracting the virus.

16 May 2012

HIV prevention treatment must include medical, behavorial approaches: APA

A drug that has been shown to prevent HIV infection in a significant number of cases must be combined with behavioral approaches if the U.S. health care establishment is to succeed in reducing the spread of the virus, according to the American Psychological Association.

14 May 2012

FDA ADAC recommends approval of Quad for HIV-1 infection

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, for the treatment of HIV-1 infection in treatment-naïve adults.

14 May 2012

FDA panel recommends approval of Truvada as preventive treatment for HIV

"In a move that could lead to a new milestone for treatment in the evolution of the worldwide AIDS epidemic," a Food and Drug Administration (FDA) panel on Thursday recommended Gilead Sciences' Truvada as a treatment for preventing HIV infection among healthy people at risk of contracting the virus, Reuters reports, noting, "It already has FDA approval to treat people infected with the human immunodeficiency virus".

11 May 2012

HIV prevention drug receives FDA panel's backing

The drug has already been approved as a treatment for HIV/AIDS. The FDA is expected to decide about approval by June 15.

11 May 2012

FDA ADAC recommends approval of Gilead’s Truvada for HIV

Gilead Sciences, Inc. today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada(emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP.

11 May 2012

Truvada deemed safe & effective in HIV infection risk reduction

Gilead Sciences Inc's Truvada pills are deemed safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.

9 May 2012

FDA approval of TDF/FTC as PrEP for HIV infection receives support

In public comments submitted this week, a group of 14 leading HIV/AIDS and health organizations stated their support for Food and Drug Administration (FDA) approval of emtricitabine/ tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women.

2 May 2012

Anti-HIV pill could prevent thousands of new infections: Study finds

A once daily pill to prevent HIV infection could significantly reduce the spread of the AIDS-causing virus. However it would only be cost-effective if limited to men at very high risk for HIV infection, according to a new study.

18 Apr 2012

No added HIV risk with hormonal contraceptives

An HIV prevention trial that pre-dates the shift to antiretroviral (ARV)-based approaches is nonetheless helping to answer some of the most relevant and topical questions the field is facing today.

18 Apr 2012

AHF calls on FDA Commissioner Hamburg to step down

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS organization, today called on Food and Drug Administration (FDA) Commissioner Margaret Hamburg to step down in response to the agency's gross mismanagement of new product reviews and a lack of transparency.

29 Mar 2012

AHF dismayed at FDA decision to expedite review for expanded use of Gilead's AIDS drug, Truvada

AIDS Healthcare Foundation (AHF), the nation's largest HIV/AIDS nonprofit medical provider, today expressed its disappointment and dismay at the Food and Drug Administration's (FDA) decision to grant an expedited review for Gilead Sciences' application for expanded use of its blockbuster AIDS drug, Truvada, as a means of preventing HIV infection in non-infected people.

16 Feb 2012

FDA accepts Gilead's Truvada sNDA and grants Priority Review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted a six-month Priority Review for once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection among uninfected adults.

14 Feb 2012

AHF calls for top to bottom shake-up of management at FDA

AIDS Healthcare Foundation (AHF) today called for a top to bottom shake-up of the management at the Food and Drug Administration as well as a Congressional investigation following the publication of a Washington Post news article (1/31/12) that reported, "…the Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients."

3 Feb 2012

Gilead commences GS-7340 Phase 2 trial in HIV

Gilead Sciences, Inc. today announced the initiation of a Phase 2 clinical trial evaluating GS-7340 for the treatment of HIV-1 infection in treatment-naïve adults. GS-7340 is a novel prodrug of tenofovir, the active agent in Viread.

24 Jan 2012

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.

19 Jan 2012

FDA accepts Gilead's Quad HIV regimen NDA for review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

26 Dec 2011

VOICE continues testing daily use of ARV Truvada among women in sub-Saharan Africa

VOICE, an HIV prevention trial that has been evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women - daily use of one of two different ARV tablets or of a vaginal gel - has stopped testing the gel.

29 Nov 2011

Tenofovir gel no more effective than placebo gel in preventing HIV

An independent review of the VOICE study, funded by the National Institute of Allergy and Infectious Diseases (NIAID) and conducted by the Microbicide Trials Network, determined that tenofovir gel was no more effective than placebo gel in preventing HIV.

28 Nov 2011