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Experimental HIV Drugs

6. HIV Drugs: Few New Approvals, but Pipeline Looks Promising

HIV drug development news in 2014 included approval of a new single-tablet regimen and 2 more components of antiretroviral therapy (ART). Promising candidates in the pipeline include a better-tolerated version of tenofovir, a NNRTI with fewer neuropsychiatric side effects, and potential long-acting injectables that may be useful for treatment or pre-exposure prophylaxis.

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European Commission Approves Boosted Darunavir Combo Rezolsta for HIV

The European Commission last month approved a new fixed-dose coformulation -- dubbed Rezolsta -- containing the HIV protease inhibitor darunavir boosted with the novel pharmacoenhancer cobicistat, Janssen recently announced. The combination is currently being evaluated for U.S. approval.

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Gilead Submits Request for FDA Approval of Tenofovir Alafenamide Coformulation

Gilead Sciences this week announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-tablet regimen containing tenofovir alafenamide (TAF) -- a new version of the widely used antiretroviral that causes less kidney and bone toxicity -- coformulated with its new integrase inhibitor elvitegravir, cobicistat, and emtricitabine.

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HIV Drug Therapy: Doravirine Works as Well as Efavirenz with Fewer CNS Side Effects

Once-daily doravirine (MK-1439), an experimental NNRTI, demonstrated viral suppression similar to that of efavirenz at 48 weeks, and the dose selected for further development was associated with fewer central nervous system (CNS) side effects, researchers reported this week at the International Congress on Drug Therapy in HIV Infection in Glasgow.

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HIVR4P 2014: Injectable Rilpivirine Shows Promise, May Work Better for Anal than Vaginal Sex

A Phase 1 dose-finding and safety study in humans of TMC278-LA, a long-acting, injectable formation of the antiretroviral drug rilpivirine, found that a single 1200 mg dose could produce sustained drug levels in rectal tissues that could offer protection against HIV for 3 months, and did in fact suppress viral replication in so-called explants (biopsies of rectal mucosal cells) for that length of time. However -- and to the surprise of researchers presenting this study at the HIV Research for Prevention conference last week in Cape Town -- drug levels in vaginal and cervical cells were only about half of those seen in rectal cells, and viral replication was not suppressed in vaginal and cervical biopsies taken from women given TMC278-LA.

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