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Long-term (96 and 144 Week) Efficacy and Safety From the VERxVE Trial Comparing
Nevirapine Extended-Release (NVP XR) 400 mg Once a Day to Nevirapine Immediate-
Release (NVP IR) 200 mg Twice a Day in Combination With Emtricitabine/Tenofovir
in Treatment-Naïve HIV-1 Patients
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Reported by Jules Levin
Glasgow 2012 Nov11-15
Cynthia Brinson1, Johannes R. Bogner,2 Mark Nelson,3 Daniel Podzamczer,4 Anne Marie Quinson,5 Murray Drulak,5 and Joseph Gathe6
1Central Texas Clinical Research, Austin, TX; 2University Hospital of Munich, Germany; 3St Stephen's AIDS Trust, London; 4Hospital Universitari de Bellvitge,
Barcelona, Spain; 5Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; 6Therapeutic Concepts, Houston, TX
ABSTRACT
Background: Here we report 96- and 144-week follow-up data from VERxVE, which demonstrated that NVP XR (400 mg QD) was noninferior to NVP IR (200 mg BID), each on a backbone of emtricitabine/tenofovir at 48 weeks.
Methods: VERxVE was a double-blind, double-dummy, noninferiority study in adults with screening viral load (VL) >1000 copies/mL and CD4+ cell count <400 cells/mm3 (males) and <250 cells/mm3 (females). Randomization was stratified by baseline VL (copies/mL) ≤100,000 or >100,000. Primary endpoint was confirmed virologic response (<50 copies/mL) at week 48. Cochran's statistic incorporating baseline-VL strata tested noninferiority of XR efficacy
to IR. Secondary endpoints included 144-week sustained virologic response and safety.
Results: 1011 patients were randomized and treated; 736 (NVP XR: 378; NVP IR: 358) completed 144 weeks. Virologic response was 63.6% for NVP XR and 58.5% for NVP IR (adjusted difference of 4.8% [95% CI: -1.1%, 10.8%], favoring NVP XR). No significant differences were seen in changes in CD4+ T-cell counts from baseline, virologic failures, and total discontinuation rates between treatment arms regardless of demographic or baseline characteristics.
Conclusions: NVP XR continued to demonstrate noninferior virologic efficacy to NVP IR in prior treatment-naïve HIV-infected patients out to week 144. NVP XR continued to be well tolerated with a safety profile similar to NVP IR.
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