Merck announced positive results from the pivotal Phase 3 study of doravirine (MK-1439), evaluating its efficacy and safety for the treatment of HIV-1 infection.

DRIVE-FORWARD is a multicenter, double-blind, randomized, non-inferiority Phase 3 trial evaluating doravirine (DOR) 100mg vs. darunavir 800mg plus ritonavir 100mg (DRV+r), in combination with either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), in 769 treatment-naïve HIV patients. The primary endpoint was the proportion of participants with HIV-1 RNA copies of <50 copies/mL at Week 48. Secondary endpoints included evaluation of the effects of DOR and DRV+r on fasting serum lipids, change from baseline in CD4+ T-cell count, and evaluation of safety and tolerability. 

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Results showed that the study met its primary endpoint, demonstrating the non-inferiority of once-daily doravirine to once-daily ritonavir-boosted darunavir as part of a combination therapy for treatment-naïve patients with HIV-1 infection. The proportion of patients achieving HIV-1 RNA <50 copies/mL at Week 48 was 83.8% in the DOR arm vs. 79.9% in the DRV+r arm (95% CI: 3.9; -1.6, 9.4). Additionally, 81% of patients with baseline HIV-1 RNA levels of >100,000 copies/mL in the DOR arm achieved levels <50 copies/mL at Week 48 compared to 76.4% in the DRV+r arm (95% CI: 3; -11.2, 17.1).

In addition, DOR-treated patients had statistically significant lower levels of fasting LDL-C compared to patients treated with DRV+r. However, no statistically significant differences were found in the change from baseline in CD4+ T-cell count between the two treatment groups. The rates of adverse events were similar for DOR and DRV+r, with the most common reactions presenting as diarrhea (14% vs. 22%), headache (14% vs. 11%), nausea (11% vs. 12%) and nasopharyngitis (8% vs. 10 %), respectively. Preliminary data from the ongoing study were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) on Feb. 13-16, 2017.

Doravirine (DOR) is an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI).

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