Truvada News and Research

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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

Once daily HIV ‘combo’ drug approved in U.S.

The U.S. Food and Drug Administration (FDA) has given its approval to a once daily HIV treatment that combines Gilead Sciences Inc.'s drug Truvada with Johnson & Johnson's drug Edurant, Gilead said Wednesday.

11 Aug 2011

Two new studies support use of PrEP for HIV prevention among heterosexual men and women

"Two new studies done in three African countries have shown for the first time that AIDS drugs taken daily can cut by more than half a person's chance of becoming infected with HIV through heterosexual intercourse," the Washington Post reports.

14 Jul 2011

Pre-exposure prophylaxis reduces risk of HIV infection

In a result that will fundamentally change approaches to HIV prevention in Africa, an international study has demonstrated that individuals at high risk for HIV infection who took a daily tablet containing an HIV medication - either the antiretroviral medication tenofovir or tenofovir in combination with emtricitabine - experienced significantly fewer HIV infections than those who received a placebo pill.

14 Jul 2011

Daily pill ‘combo’ prevents HIV transmission: New African study

According two studies in Africa, taking a daily pill containing either one or two anti-HIV drugs can reduce transmission of the virus by as much as three-quarters among heterosexual couples. This is an encouraging finding that could help focus on AIDS prevention. The results were so compelling that the larger study was halted early and the drugs given to all the participants, researchers said Wednesday.

13 Jul 2011

Gilead, Mylan expand license deal for HIV/AIDS medicines

Mylan Inc. today announced an expanded licensing agreement between Gilead Sciences Inc. and Mylan's Matrix Laboratories Limited.

12 Jul 2011

Gilead announces expansion of global access program for HIV medications

Gilead Sciences, Inc. announced today an expansion of its global access program in an effort to provide accelerated access to Gilead medicines for the treatment of HIV/AIDS.

12 Jul 2011

Physicians urge FDA not to approve Truvada as an HIV prevention pill

Last week, a group of 55 U.S. physicians sent a letter to the U.S. Food & Drug Administration (FDA), urging the agency not to approve the use of Gilead's HIV/AIDS treatment drug Truvada for use as an HIV prevention pill - also known as "pre-exposure prophylaxis" (PrEP).

30 Jun 2011

Tobira commences cenicriviroc Phase IIb clinical trial for HIV infection

Tobira Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies for HIV, announced today that it has initiated a Phase IIb clinical trial for the CCR5/CCR2 inhibitor cenicriviroc (TBR-652).

22 Jun 2011