New Antiretrovirals, New Formulations and New Strategies for HIV Treatment
August 10, 2015
As HIV pre-exposure prophylaxis (PrEP) and treatment as prevention grabbed the headlines at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, a session on "ART: New Drugs and New Strategies" did not fill the auditorium to capacity as similar sessions often have in the past.
Nevertheless, the session did provide some promising news about novel HIV drugs coming through the pipeline for people with HIV, a new version of an existing drug that improves safety without compromising effectiveness, and a potential new use for an existing medication.
HIV Maturation Inhibitor BMS-955176
Carey Hwang, M.D., Ph.D. from Bristol-Myers Squibb gave a presentation about the company's experimental HIV drug known as BMS-955176, showing that it suppresses viral load as effectively as commonly used antiretroviral drugs already on the market (abstract TUAB0106LB).
BMS-955176 is a maturation inhibitor -- the drug prevents HIV from producing complex "polyproteins" that are cut up by protease enzymes and assembled into new virus particles. If approved, BMS-955176 would be the first HIV medication to work by preventing virus assembly, maturation, and release from infected cells. BMS-955176, in combination with a protease inhibitor, could potentially be a new option for people who cannot tolerate or are resistant to nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs).
Hwang's team conducted a small Phase 2a study of BMS-955176 used in combination with the HIV protease inhibitor atazanavir (Reyataz). This study enrolled 28 HIV-positive adults who were randomly assigned to take BMS-955176 at oral doses of either 40 or 80 mg once daily plus boosted or unboosted atazanavir for 28 days. A control group received standard treatment using tenofovir/emtricitabine (Truvada) plus boosted atazanavir.
BMS-955176 has a long half-life in the body, so participants were able to take a dose once per day. BMS-955176 worked well to prevent viral replication -- HIV RNA fell rapidly in all treatment arms. On the day after the last dose, maximum viral load reductions were similar in the three BMS-955176 arms (-1.86 to -2.23 log) and in the Truvada arm (-2.22 log).
Short-term treatment with BMS-955176 was safe and well tolerated, with no serious adverse events or study discontinuations for this reason. A majority of people who used boosted atazanavir experienced bilirubin elevations (a known atazanavir side effect), but this occurred in just two people using BMS-955176 with unboosted atazanavir.
Bristol-Myers Squibb announced that a pair of Phase 2b studies of BMS-955176 have started this year, one for previously untreated people and the other exploring a NRTI- and booster-sparing regimen for treatment-experienced people. If the drug's safety and effectiveness are confirmed in larger studies, BMS-955176 could become an important treatment option for people who have developed extensive resistance to existing HIV drugs.
This excerpt was cross-posted with the permission of BETAblog.org. Read the full article.
Maintenance HIV Regimen of Rilpivirine and Boosted Darunavir as Effective as Three-Drug Treatment in Early Results
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