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Experimental HIV Drugs

Gilead Begins First Phase 3 Clinical Trials of Boosted Elvitegravir Quad Pill

Gilead Sciences announced this week that the first participants have started receiving therapy in Phase 3 trials of the "Quad" pill, a 4-in-1 coformulation containing the experimental integrase inhibitor elvitegravir, the new booster cobicistat (GS 9350), tenofovir, and emtricitabine. As reported recently at the 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010), the Quad pill performed as well as Atripla (the 3-in-1 efavirenz, tenofovir, and emtricitabine coformulation) in a head-to-head Phase 2 trial. The Phase 3 trials will compare the Quad pill versus efavirenz and boosted atazanavir (Reyataz) in treatment-naive patients.

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CROI 2010: LEDGF/p75 Integrase Inhibitors and Capsid Assembly Inhibitors Offer New Approaches for Blocking HIV Replication

While the drug development pipeline is not as full as it has been in recent years, researchers continue to work on new approaches to antiretroviral therapy. Two such novel approaches -- LEDGF integrase inhibitors and capsid assembly inhibitors -- were described in oral presentations at the recent 17th Conference on Retroviruses and Opportunistic Infections (CROI 2010) last month in San Francisco.

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Experimental CCR5 Antagonist Vicriviroc Appears Safe and Well Tolerated in HIV/HCV Coinfected Patients

The investigational CCR5 antagonist vicriviroc, now undergoing clinical trials for treatment of HIV, appeared to be safe and well tolerated in a 28 day study of individuals with HIV/HCV coinfection, according to a study described in the January 1, 2010 Journal of Acquired Immune Deficiency Syndromes. Vicriviroc did not affect hepatitis C virus (HCV) levels, but it also did not lower HIV viral load as intended.

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CROI 2010: Investigational Drug TBR-652 Demonstrates Dual Activity against CCR5 and CCR2 Co-receptors

Tobira Therapeutics' investigational CCR5 antagonist TBR-652 was shown to have potent anti-HIV activity and it appeared safe and well-tolerated in its first small trial in people with HIV, researchers reported last week at the 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010) in San Francisco. The drug also blocked CCR2, suggesting it might be useful as an anti-inflammatory agent.

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Avexa Closes Trial of Experimental NRTI Apricitabine, Will Evaluate 24-week Data

Avexa recently announced that it will close a Phase 3 study of its investigational nucleoside reverse transcriptase inhibitor (NRTI) candidate apricitabine, and will analyze 24-week data ahead of schedule. The company did not specify why the study is being halted at this time. Results from the pending analysis are expected early next year.

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