New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.
"We are pleased to see that the VERxVE study met its primary endpoint, and provided data on the efficacy and safety of an investigational, extended-release formulation of nevirapine," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.
The investigational, extended-release formulation of nevirapine had a similar safety profile to immediate release VIRAMUNE in the trial.
VERxVE was a randomized, double-blind, double-dummy, parallel group, active controlled trial that evaluated the antiviral efficacy of the extended-release formulation of nevirapine in comparison to immediate release VIRAMUNE, both in combination with Truvada®, in treatment-naive HIV-1 infected patients. A total of 1,068 patients enrolled in VERxVE and 1,011 patients were randomized and received either the extended-release (400 mg QD) formulation of nevirapine or immediate release VIRAMUNE (200 mg BID) after a required 14-day lead-in period with immediate release VIRAMUNE for all patients. All patients also received a NRTI backbone of Truvada®.
The study's primary endpoint was confirmed virologic response through 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured on two consecutive occasions at least two weeks apart prior to or at week 48 and without subsequent rebound or change of therapy prior to or at week 48. VERxVE follow-up is currently planned to continue for a total of 144 weeks.
Boehringer Ingelheim Pharmaceuticals, Inc. is working with regulatory authorities to make the extended-release formulation of nevirapine available.
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