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AHF calls for reasonable pricing of Gilead’s Quad AIDS drug

Today AIDS Healthcare Foundation, in response to recent press reports regarding drug manufacturer Gilead Sciences, Inc.'s new four-drug HIV/AIDS pill, known as the "Quad," renewed its call for company to price the drug reasonably, particularly in light of the fact that it represents only a marginal improvement over existing medications.

7 Jul 2012

Gilead submits cobicistat NDA with FDA for treatment of HIV

Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain commercially available protease inhibitors, including atazanavir and darunavir, in order to enable once-daily dosing.

29 Jun 2012

AHF urges Gilead to set initial price on latest HIV/AIDS drug combination

AIDS Healthcare Foundation (AHF) announced that California State Treasurer Bill Lockyer has sent a letter to California-based drug company, Gilead Sciences, Inc. urging the company to set an initial price on its latest HIV/AIDS drug combination—which is known as the 'Quad'—that is "…sensitive to ongoing state budget difficulties," and which will also "…provide the means to keep people with HIV/AIDS alive and as healthy as possible."

28 Jun 2012

Gilead submits elvitegravir NDA with FDA for treatment of HIV-1 infection

Gilead Sciences, Inc. announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.

28 Jun 2012

USA Today features Q&A on Truvada's potential as prevention tool

USA Today features a Q&A on Truvada, an antiretroviral drug that a Food and Drug Administration (FDA) panel in May recommended be approved for pre-exposure prophylaxis (PrEP) to prevent HIV among healthy people at risk of contracting the virus.

27 Jun 2012

Longer looks: When is a life too long?; The rising cost of children's health care

I will tell you, what I feel most intensely when I sit by my mother's bed is a crushing sense of guilt for keeping her alive. Who can accept such suffering - who can so conscientiously facilitate it? ... In 1990, there were slightly more than 3 million Americans over the age of 85. Now there are almost 6 million. By 2050 there will be 19 million - approaching 5 percent of the population.

25 May 2012

Bill introduced in U.S. Senate is latest push to award prizes for new drug development

"As Washington prepares for a major international AIDS conference this summer, developments on the drug front are once again elevating the subject of the continuing epidemic in the public eye," CQ HealthBeat reports.

22 May 2012

IAS’ XIX International AIDS Conference to take place in Washington D.C.

This summer, more than 25,000 leading scientists, public health experts, policy-makers, community members, and experts in the HIV/AIDS field from around the world will gather in our nation's capital for the International AIDS Society's XIX International AIDS Conference.

19 May 2012

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