Rx+Research

BY HIV Plus Editors

September 01 2010 12:00 AM ET

Upon completion of two Phase III clinical trials, Tibotec Pharmaceuticals says it has submitted a new drug application to the U.S. Food and Drug Administration for TMC278 (rilpivirine), an investigational nonnucleoside reverse transcriptase inhibitor, being studied for once-daily use with other antiretroviral agents.

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Bio-Rad Laboratories has submitted a premarket approval application to the FDA for its fourth-generation HIV assay. Bio-Rad says its GS HIV Combo Ag/Ab enzyme immunoassay can detect HIV antigens as well as antibodies, thus offering early detection of HIV infection as well as acute infection.

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A microbicide gel containing Gilead's tenofovir used by women before and after sex has been shown to reduce their risk of HIV infection by 39% and by 54% among women who used it consistently, according to results of a Centre for AIDS Programme of Research in South Africa study released at AIDS2010, the XVIII International AIDS Conference, held in July in Vienna, Austria. Despite their limited nature, this is the first microbicide in roughly a decade and a half of research to show promising results.

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A clinical trial in Cambodia has found it possible to prolong the survival of untreated HIV-infected adults with very weak immune systems and newly diagnosed tuberculosis by starting anti-HIV therapy two weeks after beginning TB treatment, rather than waiting eight weeks, as has been standard, according to research presented at AIDS2010.

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An investigational, once-daily extended-release formulation of nevirapine (Viramune) is not inferior to the twice-daily immediate-release version of the medication when both were taken in combination with Truvada, according to data from the VERxVE study presented at AIDS2010.

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Most older gay and bisexual men enrolled in a long-term study of HIV used recreational drugs infrequently over a 10-year period, according to a University of Pittsburgh report released at AIDS2010. The study explored the drug use habits of 1,378 HIV-positive and negative gay and bisexual men in the Multicenter AIDS Cohort Study.

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The World Health Organization issued new guidelines at AIDS2010 to improve efforts to prevent mother-to-child HIV transmission, calling for earlier testing for women after they become pregnant and earlier treatment with antiretrovirals to protect mothers' health and halt viral transmission to newborns.

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Shionogi'ViiV Healthcare announced at AIDS2010 that it will move into Phase III clinical trials its once-daily, unboosted investigational integrase inhibitor, currently known as S/GSK1349572 ('572).

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A combination of protease inhibitor Kaletra and integrase inhibitor Isentress performed as well as a regimen of Kaletra and combination nucleotide/nucleoside drug Truvada, according to data from a 48-week study presented by Abbot at AIDS2010. The results, while not definitive, researchers say, suggest that the nucleoside-sparing regimen may be an alternative treatment option for patients new to HIV therapy.

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Emotional barriers (such as stigma, fear, denial, and shame) and structural barriers (such as lack of knowledge, transportation, and insurance coverage) can prevent HIVers from seeking care and treatment, according to data from a national survey presented by Bristol-Myers Squibb at AIDS2010. Researchers recommend targeted programs, such as the Positive Charge project, to reach HIVers in communities facing such barriers.

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