Tenofovir News and Research

RSS

Gilead's elvitegravir MAA for HIV-1 infection receives EMA validation

Gilead Sciences, Inc. announced today that its Marketing Authorisation Application (MAA) for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA).

19 Jun 2012

China amends intellectual property laws to allow for issuance of compulsory licenses

"China has overhauled parts of its intellectual property laws to allow its drug makers to make cheap copies of medicines still under patent protection in an initiative likely to unnerve foreign pharmaceutical companies," Reuters reports.

12 Jun 2012

Pre-exposure preventive treatment may be effective against suspected HIV

While immediate postexposure treatment for suspected HIV is critical, pre-exposure preventive treatment is a newer method that may be effective for people in high-risk groups, states a review of evidence published in CMAJ (Canadian Medical Association Journal).

29 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

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 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

AIDS, health groups submit comments to FDA prior to agency's review of PrEP

"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] ... as pre-exposure prophylaxis (PrEP) to prevent HIV infection in adult men and women," a press release from AVAC: Global Advocacy for HIV Prevention states.

3 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

NIH study indicates safety of anti-HIV drug tenofovir during pregnancy

Infants born to women who used the anti-HIV drug tenofovir as part of an anti-HIV drug regimen during pregnancy do not weigh less at birth and are not of shorter length than infants born to women who used anti-HIV drug regimens that do not include tenofovir during pregnancy, according to findings from a National Institutes of Health network study.

2 May 2012

International Microbicides Conference 2012 concludes

The conclusion of the 2012 International Microbicides Conference, a gathering of researchers, advocates and funders in the HIV prevention field, wrapped up three days of discussion focused on access to prevention technologies, adherence in clinical trials, innovative financing, dual prevention technologies and new methods of preventing rectal transmission of HIV.

26 Apr 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

International Microbicides Conference to discuss state of HIV prevention research

Researchers, activists and funders are meeting this week in Sydney to discuss the state of HIV prevention research. The biennial International Microbicides Conference, which was opened on Sunday evening by the Honorable Tanya Plibersek MP, Australian Minster of Health, is taking place amid renewed optimism about development and delivery of new HIV prevention options with the potential for ending the AIDS epidemic, including anti-retroviral based microbicides and pre-exposure prophylaxis.

17 Apr 2012

ViiV, Shionogi announce initial results from dolutegravir Phase III study on HIV-1

ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.

2 Apr 2012

Study highlights challenges of adherence in successful deployment of PrEP interventions

"Data presented from the FEM-PrEP trial by Dr. Lut Van Damme Tuesday at the 19th Conference on Retroviruses and Opportunistic Infections in Seattle highlighted the challenge that adherence plays in successfully deploying effective Pre-Exposure Prophylaxis (PrEP) interventions," HIV Medicine Association Executive Director Andrea Weddle writes in this guest post in the Center for Global Health Policy's "Science Speaks" blog.

8 Mar 2012

Study reveals potential strength of different anti-HIV combination drugs

Using a mathematical formula that carefully measures the degree to which HIV infection of immune system cells is stalled by antiretroviral therapy, AIDS experts at Johns Hopkins have calculated precisely how well dozens of such anti-HIV drugs work, alone or in any of 857 likely combinations, in suppressing the virus. Results of the team's latest research reveal how some combinations work better than others at impeding viral replication, and keeping the disease in check.

19 Feb 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