CROI 2017: New NNRTI Doravirine Shows Good Efficacy in Phase 3 Study

Published on Monday, 20 February 2017

Written by Liz Highleyman

Doravirine, an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) from Merck, reduced HIV viral load as well as boosted darunavir in a Phase 3 clinical trial of people starting antiretroviral therapy (ART) for the first time, but it had a better lipid profile, according to a late-breaking presentation at the Conference on Retroviruses and Opportunistic Infections last week in Seattle.

Current first-line ART regimens are safe and highly effective, but having multiple potent and well-tolerated drugs available in multiple antiretroviral classes offers more options for constructing optimized regimens.

Doravirine (formerly MK-1439) is active against HIV with common NNRTI-resistance mutations including K103N. It can be taken once-daily with or without food and has low potential for drug-drug interactions. As previously reported, a Phase 2 trial showed that doravirine suppressed viral load as well as efavirenz (Sustiva), but with fewer neuropsychiatric side effects.

At CROI Kathleen Squires from Thomas Jefferson University in Philadelphia presented results from DRIVE-FORWARD, a Phase 3 trial comparing doravirine against ritonavir-boosted darunavir for first-line therapy.

The study analysis included 769 previously untreated adults with HIV. Most (84%) were men, nearly 80% were white, and the average age was 35 years.At baseline the mean CD4 T-cell count was approximately 420 cells/mm3 and the mean viral load was 4.4 log copies/mL; 20% had high viral load above 100,000 copies/mL. At baseline they had no genotypic resistance to any study drugs.

filed under: HIV