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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

Gilead submits Quad NDA to FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing 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 adults.

28 Oct 2011

Microbicide Trials Network stops tenofovir arm of study after findings show drug less effective than anticipated

"The Microbicide Trials Network (MTN), which is funded by the U.S. National Institutes of Health, on Wednesday announced that it decided to stop one arm of a study involving more than 5,000 women in South Africa, Zimbabwe, and Uganda" after "an interim review of the ongoing trial by an independent monitoring board found that the drug tenofovir when used as pre-exposure prophylaxis (PrEP) had less effect in protecting women than anticipated," Science Magazine's "Science Insider" blog reports.

30 Sep 2011

Oral tenofovir discontinued in HIV clinical trial

A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective.

29 Sep 2011

VOICE HIV prevention trial to discontinue use of tenofovir tablets

VOICE, an HIV prevention trial 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 - will be dropping one of the oral tablets from the study.

29 Sep 2011

Gilead announces EMA CHMP positive opinion for HIV-1 drug, Eviplera

Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorisation Application for the once-daily single-tablet regimen, Eviplera.

23 Sep 2011

FDA denies FOIA regarding Gilead Sciences' Truvada correspondence, AHF sues

AIDS Healthcare Foundation (AHF) today filed a lawsuit against the Food and Drug Administration (FDA) over its denial of AHF's Freedom of Information Act (FOIA) requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to the FDA to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals.

23 Sep 2011

Gilead’s new 4 in 1 combo HIV pill works

Gilead Sciences Inc's four-drug experimental HIV pill worked as well as a regimen containing protease inhibitor Reyataz in the second pivotal trial of the drug, the company announced this Monday. Although the trial succeeded, it did not show the experimental pill, called the Quad, was superior to the Reyataz regimen and Gilead shares fell less than a percentage point.

20 Sep 2011

Gilead’s Quad Phase 3 clinical study in treatment-naïve HIV-1 patients meets 48-week primary objective

Gilead Sciences, Inc. today announced that the second pivotal Phase 3 clinical trial of its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, being evaluated for HIV-1 infection in treatment-naïve patients, met its primary objective of non-inferiority at week 48 as compared to ritonavir-boosted atazanavir plus Truvada.

20 Sep 2011

AHF shares The Lancet's concerns over use of Gilead's Truvada as HIV prevention pill

Today AIDS Healthcare Foundation (AHF) commented on an editorial published in the September 2011 issue of The Lancet Infectious Diseases that raises concerns about the use of the HIV treatment drug Truvada, manufactured by Gilead Sciences Inc., as an HIV prevention pill or pre-exposure prophylaxis (PrEP), agreeing with the publication's public health concerns.

25 Aug 2011

AHF: Gilead's campaign for FDA approval of Truvada leads to black marketing in Florida

Today AIDS Healthcare Foundation (AHF) decried the fact that the recent campaign by Gilead Sciences Inc. to obtain approval by the U.S. Food & Drug Administration for Truvada as PrEP (pre-exposure prophylaxis) has led to a "black market" for the drug in Florida.

20 Aug 2011

PrEP raises questions regarding 'risk disinhibition' and drug resistance

Nature News reports on "the possibility of unintended public-health consequences" of pre-exposure prophylaxis (PrEP) for HIV and pharmaceutical company Gilead's plan to ask the FDA to evaluate its combination antiretroviral (ARV) drug Truvada for use in healthy people.

18 Aug 2011

FDA approves Gilead's Complera for treatment of HIV-1 infection

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Complera, a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.

11 Aug 2011