Phase III study of MK-1439 (doravirine) met primary endpoint in HIV infection- Merck Inc

Merck Inc announced results of a pivotal Phase III clinical trial evaluating the safety and efficacy of MK-1439 (doravirine), in which the study met its primary efficacy endpoint of the proportion of participants achieving levels of HIV-1RNA less than 50 copies/mL after 48 weeks of treatment, demonstrating the non-inferiority of once-daily doravirine (DOR) to once-daily ritonavir-boosted darunavir (DRV+r), each administered with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), in previously untreated (treatment-na�ve) adults with HIV-1 infection.

In addition, a secondary endpoint showed that the DOR-treated group had statistically significant lower levels of fasting low density lipoprotein cholesterol (LDL-C), versus the DRV+r group. The rates of reported adverse drug reactions were 31 percent (117/383) for DOR and 32 percent (123/383) for DRV+r. Discontinuations due to adverse events for the DOR and DRV+r treatment groups were 2 percent (6/383) and 3 percent (12/383), respectively. Findings from the ongoing �DRIVE-FORWARD� Phase III trial following 48 weeks of treatment were presented as a late-breaking abstract at the annual Conference on Retroviruses and Opportunistic Infections.