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ARTICLE | Clinical News

Doravirine: Additional Phase IIb data

November 17, 2014 8:00 AM UTC

Additional data from 208 treatment-naive patients with HIV-1 infection from the dose-escalation Part 1 of the 2-part, double-blind, international Phase IIb MK-1439-007 trial showed that once-daily doravirine plus once-daily Truvada emtricitabine/tenofovir led to a virologic response rate, defined as HIV-1 RNA levels of <40 copies/mL, at week 48 in 76% of patients vs. 71% of patients receiving Sustiva efavirenz plus Truvada. Patients received 25, 50, 100 or 200 mg doses of doravirine in Part 1 of the trial. The primary safety analysis of the Part 2 expansion phase of the trial (n=132) showed that patients receiving 100 mg doravirine plus Truvada had a significantly lower incidence of >=1 reported CNS adverse event at week 8 compared to Sustiva plus Truvada (22.2% vs. 43.5%, p<0.001). Data were presented at the HIV Drug Therapy meeting in Glasgow. ...