via bloomberg.com, by Anna Edney Gilead Sciences Inc. (GILD), the world’s largest maker of AIDS drugs, said U.S. regulators delayed by three months a decision on whether the company can expand use of its HIV treatment Truvada as a therapy to prevent the virus. The Food and Drug Administration moved the target date to Sept. 14 so Read More >>

via Leadership, by Winifred Ogbebo *Mentions IRMA advocate Morenike Ukpong!* Like a breath of fresh air, the news that a combination prevention drug would soon hit the Nigerian market is definitely something to cheer about, given Nigeria’s high prevalence of HIV rate, which is said to be second only to South Africa in the African continent. WINIFRED Read More >>

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 Read More >>

[IRMA highly recommends this one. Brilliant, strategic, thoughtful, sober, forward-thinking – a must read] via POZ, by David Evans Excerpt: Give people the facts–the whole picture–and let them decide whether PrEP is right for them Let’s tell people how effective the drug is when they actually take it as prescribed–over 90 percent effective–and stop quoting statistics from Read More >>

via AIDSmeds Laboratory testing of a modified version of the Viread (tenofovir) microbicide gel provides further evidence that it may be safe for rectal use, according to a paper published online ahead of print by the Journal of Antimicrobial Chemotherapy. The encouraging results contribute to a better understanding of the gel’s tolerability, already evident in preliminary findings Read More >>

Read this excellent explanation/sumary via Medscape, by Janis C. Kelly The US Food and Drug Administration’s (FDA’s) Antiviral Drugs Advisory Committee has strongly backed approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection.In a marathon 12-hour session, the panel recommended approval of a supplemental indication for Truvada (emtricitabine/tenofovir disoproxil fumarate) for preexposure prophylaxis Read More >>

via PRNewswire 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. Their comments, submitted in advance of a May 10 Read More >>

via The New York Times, Denis Grady An advisory panel to the Food and Drug Administration is expected to vote Thursday on whether a drug already used to treat H.I.V. infection should also be approved to prevent it. Such a recommendation, if made, would mark the first time that government advisers have advocated giving antiviral medicine to Read More >>

Here is the letter from leading AIDS advocacy organizations sent to the FDA supporting a prevention indication for Truvada. IRMA is a co-signer,and supporter of these efforts. The FDA will be reviewing Gilead’s application for Truvada as PrEP on Thursday, May 10. Stay abreast of the developments on the PrEP Watch website. Click here for the FDA’s Read More >>

via Pharmalot, by Ed Silverman Late last year, Gilead Sciences took a widely anticipated and controversial step by seeking FDA approval to market its Truvada HIV pill to prevent infection, which is also known as pre-exposure prophylaxis or PrEP. The move was both welcomed and criticized by AIDS activists, reflecting a spectrum of views on making a Read More >>