FDA Hearing on Truvada as PrEP - Watch the Webcast!

On May 10, 2012 the FDA Antiviral Drug Advisory Committee strongly recommended that emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) be approved for use as pre-exposure prophylaxis (PrEP) among sexually active adult men and women – particularly gay men and other MSM, serodiscordant heterosexual couples, and other individuals at high risk. It is likely the FDA will follow the committee’s recommendations and issue a new prevention indication for the use of Truvada by mid June.

Watch the recorded webcast here.

Check out the slide presentations here.


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Extensive coverage on breakthrough PrEP results

Earlier this week, two large PrEP studies released results confirming that antiretrovirals (ARVs) can reduce the risk of HIV infection through sexual intercourse by 62-73% among heterosexual couples.

The mainstream media, news websites and independent bloggers have covered this extremely encouraging development extensively. The coverage has brought up important questions around financing and cost, prioritization, and translating clinical research to real-world use. 

Take a look at some of the stories, articles and blog posts across the globe:

CBS News (USA): "Clear evidence" that pills prevent HIV transmission in straight couples

Los Angeles Times (USA): Pills found to be highly effective in preventing HIV transmission

ABC News (USA): New Studies Show a Major Breakthrough in HIV Prevention

New York Times (USA): Two Studies Show Pills Can Prevent H.I.V. Infection

Voice of America (USA): One Pill a Day Helps Prevent HIV Infection

New Vision (Uganda): Drugs prevent HIV infection up to 73%

Daily Nation (Kenya): Daily dose of drug ‘lowers risk of HIV infection’

KBC News (Kenya): New HIV strategy unveiled in Kenya

Mail & Guardian (South Africa): Daily pill can prevent HIV infection

Reuters Africa: Once-daily AIDS pill can slash HIV infection risk

Times of India (India): Antiretroviral drugs reduce HIV risk

Indian Express (India): Once-daily AIDS pill can slash HIV infection

Financial Times (UK): HIV drug sharply cuts infection risk

The Guardian (UK): Daily pill can prevent HIV infection

The Independent (UK): Pills costing 15p are 'major breakthrough' in fighting Aids

Daily Mail (UK): HIV breakthough as scientists discover pill used to treat Aids can also 'prevent disease'

Associated Press: Drug stops HIV among hetero couples, not just gays

Bloomberg: Daily Dose of Gilead Drugs Cuts Heterosexual HIV Infection

AFP: HIV drugs boost prevention hopes

UN Dispatch: An HIV Game Changer

UNAIDS: UNAIDS and WHO hail new results showing that a once-daily pill for HIV-negative people can prevent them from acquiring HIV

POZ/Aidsmeds.com: PrEP Reduces HIV Risk in Two Major Studies

AIDS Beacon: Viread And Truvada May Be Effective At Preventing HIV Infection In Heterosexuals

New Scientist: One cheap pill protects healthy people from HIV

LGBTQ Nation: Inexpensive daily anti-HIV pill found to be effective as preventative measure

TIME – Healthland blog: Anti-HIV Drugs Help Prevent Infection in Heterosexuals

CNN – The Chart Blog: Taking meds before exposure cuts HIV risk for heterosexuals

Newshour.com – The Rundown Blog: Studies: HIV Meds Can Help Prevent New Infections

Fit Perez Blog (Hilton Perez): New Pill Could Prevent HIV

Humanosphere blog: Studies provide proof of powerful new HIV/AIDS prevention strategy

Science Now blog: Anti-HIV Pills Show Powerful Effect Against AIDS

NPR Shots Blog: Who Should Get Pills To Prevent HIV?

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Two large studies show that ARVs can prevent HIV

Today, all of us in the HIV prevention field have woken up to heartening news: two large PrEP studies have shown that taking antiretrovirals (ARVs) can reduce the risk of HIV infection through sexual intercourse by 62-73% among heterosexual couples. This news comes close on the heels of the encouraging results from the IPrEX trial, which showed that ARVs could provide protection against HIV among gay men.

The Partners study, funded by the Bill & Melinda Gates Foundation, took place in Kenya and Uganda. It was stopped a year and a half early because of the highly significant results. Unlike the earlier FEM-PrEP trial, adherence in this case was extremely high: more than 97% of doses dispensed were taken, and 95% of participants stayed in the study. The TDF2 study, conducted in Botswana, concluded as planned.

The results of both these PrEP studies are being called “fundamentally important for HIV prevention” and provide added impetus to the ongoing discussion about ensuring the widespread availability of affordable ARV drugs in developing countries.

To know more, check out Reuters’ coverage of the studies here or The Washington Post’s story here. For more details, read the article on The University of Washington website as well as the CDC website.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

New Studies Show PrEP Works for Heterosexuals Too

via Aidsmap, by Keith Alcorn

Two large studies of pre-exposure prophylaxis – use of antiretroviral drugs by uninfected people to prevent HIV infection – have shown that taking tenofovir or tenofovir plus emtricitabine (Truvada) can cut the risk of HIV infection through sexual transmission by between 62% and 73% in male-female couples. Results from both the Partner study and the TDF2 study were released today.

“This study demonstrates that antiretrovirals are a highly potent and fundamental cornerstone for HIV prevention and should become an integral part of global efforts for HIV prevention,” said Dr Connie Celum, Professor of Global Health and Medicine at the University of Washington, Seattle.

The results, released this morning ahead of the International AIDS Society conference in Rome next week, follow positive results from the IPrEX study of Truvada PrEP in men who have sex with men released in November 2010.

Fuller results from the studies will be presented next week.

Read the rest.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]