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FDA Declines Approval of Elvitegravir and Cobicistat as Stand-alone HIV Meds

The U.S. Food and Drug Administration (FDA) has rejected approval of Gilead Sciences' integrase inhibitor elvitegravir and pharmacoenhancer cobicistat -- components of the 4-in-1 Stribild quad pill -- as single agents for treatment of HIV, the company announced last week.

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U.S. Preventive Services Task Force Recommends Routine HIV Screening for Adolescents and Adults

On April 30 the U.S. Preventive Services Task Force (USPSTF) issued a "Grade A," or highest-level, recommendation that all adolescents and adults ages 15 through 65 years should receive routine HIV screening. "These recommendations...reinforce the importance of people everywhere knowing their HIV status and, if positive, accessing care, receiving treatment and other prevention services," said CDC's Jonathan Mermin.

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NIH Halts HIV Vaccine Study Due to Lack of Effectiveness

 

The National Institutes of Institute of Allergy and Infectious Diseasesannounced this week that it will halt administration of an experimental HIV vaccine in the HVTN 505 trial, after an interim data analysis found that it neither prevented new HIV infections nor lowered viral load among people who did become infected.

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FDA Approves Efavirenz (Sustiva) for HIV+ Children Ages 3 Months to 3 Years

The U.S. Food and Drug Administration (FDA) announced on May 3 that it has approved a supplemental new drug application for use of efavirenz (Sustiva) by infants and young children with HIV. The new dosing recommendation includes the option to sprinkling capsule contents on food for children who are unable to swallow pills.

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Reformulated Tenofovir Gel Found Safe and Acceptable for Anal Sex

Men and women found a microbicide gel containing 1% tenofovir -- which has been shown to reduce the risk of HIV infection during vaginal sex -- to also be acceptable for anal use after it was reformulated to reduce the amount of an ingredient that led to irritation in an earlier study, according to a report in the April 3, 2013, edition of PLoS ONE.

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Atripla Label Adds Drug Interactions with Hepatitis C Protease Inhibitors Boceprevir and Telaprevir

The U.S. Food and Drug Administration (FDA) announced this week that the product label information for Atripla -- the HIV single-tablet regimen containing efavirenz/tenofovir/emtricitabine -- has been updated to include information about drug-drug interactions with the hepatitis C virus protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek or Incivo).

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Antiretroviral Therapy May Have Protective Effect on HIV+ Children's Hearts

Long-term use of combination antiretroviral therapy (ART) does not impair heart function in children and adolescents with perinatal HIV infection, and in fact appears to have a "cardioprotective" effect, according to a study published in the April 22, 2013, advance online edition of JAMA Pediatrics.

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