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Experimental HIV Drugs

HIV Attachment Inhibitor BMS-663068 Shows Good Activity in Phase 2a Trial

An experimental HIV attachment inhibitor that acts at the first step of viral entry into cells appeared potent and well-tolerated in a small study presented this week in Boston at the 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011). Based on the promising findings, a Phase 2b study is planned to start this year.

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Gilead Will Extend Phase 3 Elvitegravir Trial to 96 Weeks

Gilead Sciences reported in a financial statement this month that it will follow a U.S. Food and Drug Administration (FDA) recommendation to double the duration of an ongoing Phase 3 clinical trial comparing its experimental integrase inhibitor elvitegravir versus raltegravir (Isentress), the sole approved drug in this class. The FDA asked that the study be extended to 96 weeks to obtain longer-term data on safety and effectiveness. The company said it does not expect the change to affect availability of its "Quad" pill, a single tablet regimen containing elvitegravir, the booster drug cobicistat, and tenofovir/emtricitabine (the drugs in Truvada).

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Bristol-Myers Squibb Acquires Experimental NRTI Festinavir

Bristol-Myers Squibb announced last month that it has reached an agreement with Japan's Oncolys BioPharma to develop and manufacture festinavir (OBP-601), an experimental once-daily nucleoside reverse transcriptase inhibitor (NRTI) originally discovered at Yale University that is currently in Phase 2 clinical trials.

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RNA Interference Combination Strategy Shows Promise in Laboratory Study

Investigators from Johnson and Johnson have devised a set of short hairpin RNA sequences that may be able to inhibit nearly 90% of all known HIV strains, according to findings published in the January 13, 2011 online edition of the open-access journal AIDS Research and Therapy. While HIV can mutate to develop resistance to RNA interference -- as it does to conventional antiretroviral drugs -- combining 4 or more highly conserved hairpin RNA segments may maintain long-term viral suppression.

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Shionogi-ViiV Starts Phase 3 Clinical Trials for New Integrase Inhibitor S/GSK572

The Shionogi-ViiV Healthcare collaboration announced last week that it has started Phase 3 clinical trials to further evaluate its investigational next-generation integrase inhibitor S/GSK1349572 (or S/GSK572 for short). As reported at the XVIII International AIDS Conference (AIDS 2010) this summer in Vienna, S/GSK572 demonstrated potent antiviral activity and good tolerability in Phase 2 studies, including activity against HIV strains with raltegravir (Isentress) resistance mutations. The Phase 3 SPRING-2 trial will enroll treatment-naive participants, while the SAILING trial will enroll treatment-experienced patients.

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