Doravirine: Phase IIb data

Interim data from 207 treatment-naïve patients with HIV-1 infection from the 2-part, dose-escalation, double-blind, international Phase IIb MK-1439-007 trial showed that once-daily doravirine in combination with once-daily Truvada emtricitabine/tenofovir led to the primary endpoint of virologic response, defined as HIV-1 RNA levels <40 copies/mL at week 24, in 80% of patients at the 25 mg doravirine dose, 76.2% of patients at the 50 mg dose, 71.4% of patients at the 100 mg dose and 78% of patients at the 200 mg dose vs. 64.3% of patients receiving Truvada plus Sustiva efavirenz. Additionally, doravirine plus Truvada increased mean CD4 cell count from baseline to week 24 by 158 cells/µL at the 25 mg dose, 116 cells/µL at the 50 mg dose, 134 cells/µL at the 100 mg dose and 141 cells/µL at the 200 mg dose vs. 121 cells/µL for Truvada plus Sustiva. The most common CNS adverse events at week 8 were dizziness, nightmare, abnormal dreams and insomnia. Based on the 24-week data, Merck selected to evaluate the 100 mg dose of doravirine in the remainder of the trial up to 96 weeks. Data were presented at the Conference on Retroviruses and Opportunistic Infections meeting in Boston. ...