via Morbidity and Mortality Weekly Report In the United States, an estimated 48,100 new human immunodeficiency virus (HIV) infections occurred in 2009 (1). Of these, 27% were in heterosexual men and women who did not inject drugs, and 64% were in men who have sex with men (MSM), including 3% in MSM who inject drugs. In January Read More >>

via Somatosphere, by Marsha Rosengarten One of the more controversial interventions proposed for HIV prevention in those who test HIV antibody negative and perceived to be at risk is pre-exposure prophylaxis (PrEP) – a daily pill comprising one or two antiretroviral drugs manufactured by Gilead Inc. Besides the mixed results from multi-site randomised controlled trials (RCTs) seeking Read More >>

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 >>

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 >>

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 >>

via California HIV/AIDS Research Program In April 2012, the California HIV/AIDS Research Program (CHRP) of the University of California awarded grants totaling $11.8 million to three collaborative teams of investigators to test a potential HIV prevention medication among high-risk HIV-uninfected persons in several communities throughout California. The studies also will examine new strategies to engage and retain Read More >>

via Financial Times, by Christine Livoti Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may Read More >>

via AIDS Foundation of Chicago This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation’s protest of the FDA regarding this review. To read Read More >>

via iPrEx NEws The ANRS (French National Agency for Research on AIDS and Viral Hepatitis) is about to launch in Europe the first pre-HIV exposure prevention trial in men who have sex with men. This phase III trial—ANRS IPERGAY—will start at the end of January 2012, in Paris (Hôpital Saint-Louis, Professor Jean-Michel Molina and Hôpital Tenon, Professor Read More >>