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Experimental HIV Drugs

FDA Approves Elvitegravir and Cobicistat Booster as Stand-alone Drugs

The U.S. Food and Drug Administration (FDA) this week approved Gilead Sciences next-generation HIV integrase inhibitor elvitegravir (brand name Viteka) and pharmacoenhancer cobicistat (Tybost) as stand-alone agents to be used in combination antiretroviral therapy. The 2 drugs were already available as part of the Stribild single-tablet regimen.

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Tenofovir Alafenamide Pill Matches Stribild, Gilead Will Seek Approval Soon

A new single-tablet regimen containing tenofovir alafenamide (TAF), elvitegravir, cobicistat, and emtricitabine worked as well as Stribild at 48 weeks in a pair of Phase 3 trials, but had less detrimental effects on the kidneys and bones, Gilead Sciences announced this week. These findings set the stage for evaluation by the U.S. Food and Drug Administration and European regulators.

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ICAAC 2014: NRTI BMS-986001 Safe and Effective, but Associated with Resistance

BMS-986001, an experimental HIV nucleoside reverse transcriptase inhibitor, was shown to be as effective as tenofovir with less bone loss, but more people who took it developed resistance, researchers reported at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy this week in Washington, DC. Bristol-Myers Squibb has announced it will end its development of the drug.

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ICAAC 2014: Cobicistat Long-term Efficacy Matches Ritonavir as PI Booster

Long-term rates of viral suppression and side effects were similar among people using cobicistat and those using ritonavir as a booster for atazanavir (Reyataz), according to 3-year data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy last week in Washington, DC. Another study found that cobicistat was well-tolerated by people with mild-to-moderate kidney impairment.

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ICAAC 2014: PK Study Shows Feasibility of Long-acting Integrase Inhibitor Cabotegravir

A pharmacokinetic (PK) analysis presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy this week in Washington, DC, confirmed that the long-acting HIV integrase inhibitor cabotegravir (formerly GSK1265744) reaches adequate target levels in the blood, setting the stage for efficacy trials for HIV treatment and pre-exposure prophylaxis (PrEP).

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