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Merck’s Investigational NNRTI, Doravirine, Meets Primary Efficacy Endpoint of Non-Inferiority to Efavirenz, Both in Combination with Other Antiretroviral Agents, in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection

Merck (MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the DRIVE-AHEAD study, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of doravirine, the company’s investigational, non-nucleoside reverse transcriptase inhibitor (NNRTI), 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-naïve 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. Findings from the ongoing DRIVE-AHEAD Phase 3 trial were featured as part of a late-breaking oral presentation session at the 9th International Conference on HIV Science (IAS 2017) taking place in Paris, France, from July 23-26, 2017.

“Data from DRIVE-AHEAD at 48 weeks show that a fixed-dose combination tablet containing doravirine achieved viral suppression in HIV-1 infected treatment-naïve adults, comparable to a fixed-dose combination containing efavirenz,” said Dr. Kathleen Squires, professor and director of infectious diseases, Thomas Jefferson University, Philadelphia, PA, a study investigator. “The results for doravirine are encouraging, as it may offer appropriate patients a new single-tablet treatment option.”

After 48 weeks of treatment, 84 percent of the 364 treatment-naïve patients taking once-daily DOR/3TC/TDF achieved levels of HIV-1 RNA <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). Increases in mean CD4+ T-cell counts from baseline for the DOR/3TC/TDF and EFV/FTC/TDF groups were 198 and 188 cells/mm3, respectively, with an estimated treatment difference of 10.1 (95 percent confidence interval; -16.1, 36.3). In addition, comparable efficacy was observed across both treatment groups among individuals with high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, which consisted of 69 patients in the DOR/3TC/TDF group and 73 patients in the EFV/FTC/TDF group (Observed Failure approach). Of those patients with a high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, 81 percent in the DOR/3TC/TDF group and 81 percent in the EFV/FTC/TDF group achieved the study’s primary endpoint of <50 copies/mL of HIV-1 RNA, with a treatment difference of 1.0 percent (95 percent confidence interval; -12.4, 14.3).

The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of several...