November 3, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
Biopharma giant Merck has seen positive results from its once-a-day HIV drug, saying Monday that its oral pill doravirine met its goals in a recent Phase 2b clinical trial and showed a more than 20 percent drop in central nervous systems events in patients treated with the experimental therapy.
Merck made the announcement as part of a presentation by Josep Gatell, head of Infectious Siseases and AIDS Units-IDIBAPS, Hospital Clinic, Barcelona, at the 12th International Congress on HIV Drug Therapy being held in Glasgow on Nov. 2-6.
Doravirine combines what’s known as an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) with tenofovir/emtricitabine (TDF/FTC). That’s a difference in treatment from the standard course of efavirenz plus TDF/FTC. The study compared the incidence of central nervous system (CNS) adverse events (AEs) by the eighth week in patients who received doravirine 100 mg plus TDF/FTC versus patients who received efavirenz with TDF/FTC.
The results showed a significantly lower incidence of one or more of reported CNS AEs, including dizziness, insomnia, abnormal dreams and nightmares--meaning patients on doravirine might experience a significantly higher quality of life as they battle HIV.
“This program underscores Merck’s ongoing commitment to the research and development of new therapeutic options for patients with HIV,” said Hedy Teppler, executive director of Infectious Diseases at Merck Research Laboratories, in a statement. “We are encouraged by the antiviral activity and the overall tolerability profile of doravirine and look forward to initiating Phase 3 studies.”
Doravirine appears to work well as a viral treatment: Follow-up data through 48 weeks of treatment showed a 76 percent overall virologic response rate for all doravirine doses (25, 50, 100 and 200 mg), which is slightly higher than the 71 percentreported for patients administered efavirenz (600 mg).
Merck said all treatment groups showed increased CD4 cell counts relative to baseline, consistent with the 24-week findings.
