Two phase III trials of MK 1439 (doravirine) combination meet primary endpoint in HIV-1 infection- Merck Inc

Merck Inc announced the presentation of results from the DRIVE-AHEAD study, the second of two pivotal Phase III clinical trials evaluating the efficacy and safety of MK 1439 (doravirine), for the treatment of HIV-1 infection. At 48 weeks, the study showed that a once-daily single tablet, fixed-dose combination of doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) met its primary efficacy endpoint of non-inferiority based on the proportion of participants achieving levels of HIV-1 RNA less than 50 copies/mL at 48 weeks of treatment, compared to a fixed-dose combination of efavirenz (EFV), emtricitabine (FTC), and TDF, in treatment-na�ve adults infected with HIV-1.

In addition, through 48 weeks, statistically significantly fewer patients taking DOR/3TC/TDF reported pre-specified categories of neuropsychiatric events (dizziness, sleep disorders and disturbances, and inability to think clearly or concentrate) than patients receiving the EFV/FTC/TDF regimen. Treatment with DOR/3TC/TDF also showed a statistically significant lower change from baseline in fasting low density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) compared to EFV/FTC/TDF at Week 48.

After 48 weeks of treatment, 84 percent of the 364 treatment-na�ve patients taking once-daily DOR/3TC/TDF achieved levels of HIV-1 RNA less than 50 copies/mL compared to 81 percent of the 364 patients taking once-daily EFV/FTC/TDF, with an estimated treatment difference of 3.5 percent (95 percent confidence interval; -2.0, 9.0). The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of several pre-specified neuropsychiatric adverse events compared to EFV/FTC/TDF by Week 48, including dizziness (8.8 percent versus 37.1 percent); sleep disorders and disturbances (12.1 percent versus 25.5 percent); and inability to think clearly or concentrate (4.4 percent versus 8.2 percent). Findings from the ongoing trial were featured at the 9th International Conference on HIV Science.