Comparison of 48 week efficacy and safety of 400 mg QD nevirapine extended release formulation (Viramune XR) versus 200 mg BID nevirapine immediate release formulation (Viramune IR) in combination with Truvada® in antiretroviral (ARV) naïve HIV-1 infected patients (VERxVE)
J. Gathe1, J. Bogner2, S. Santiago3, A. Horban4, M. Nelson5, P.E. Cahn6, J. Andrade7, D. Spencer8, C. Young9, T. Nguyen9, W. Zhang9, M. Drulak9, A.-M. Quinson9
1Therapeutic Concepts, Houston, United States, 2Ludwig-Maximilians University, Munich, Germany, 3Care Resource, Miami, United States, 4Warsaw Medical University and Hospital of Infectious Diseases, Warsaw, Poland, 5Chelsea & Westminster Hospital, London, United Kingdom, 6Fundacion Huesped, Buenos Aires, Argentina, 7Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico, 8Toga Labs, Edenvale, South Africa, 9Boehringer-Ingelheim Pharmaceuticals Inc, Ridgefield, United States
Background: Viramune XR is the extended release formulation of nevirapine. It has the advantage of once-daily (QD) dosing. The purpose of this study is to compare its efficacy and safety with Viramune IR in treatment-naïve patients.
Methods: This double blind, double-dummy parallel group study randomized HIV-1 infected patients >18 years old, viral load (VL) >1000 copies/mL and CD4+ count < 400 cells/mm3 for males and < 250 cells/mm3 for females during screening. After a 14 day lead-in period with 200 mg Viramune IR QD, patients were stratified by VL at baseline (≤100,000 or >100,000 copies/mL) and within each stratum randomized 1:1 to Viramune XR or Viramune IR. Primary endpoint was confirmed virologic response (< 50 copies/mL) through Week 48 using the time-to-loss of virologic response (TLOVR) algorithm. Cochran's statistic incorporating baseline VL stratum was used to test non-inferiority of Viramune XR to IR using the pre-specified non-inferiority margin of -10%.
Results: 1,011 patients were randomized and treated. Baseline HIV-1 VL was 4.7 log10 copies/mL for both arms. Demographics, other disease characteristics and extent of exposure to study drug were similar between groups. Virologic response at week 48 was 75.9% (384/506) for IR and 81.0% (409/505) for XR with an adjusted difference of 4.9% in favor of XR and with a 95% CI of (-0.1%, 10.0%), which demonstrated non-inferiority of Viramune XR to IR. This finding was supported by secondary endpoints. The safety profile of XR was similar to IR, but with numerically less adverse events.
Conclusions: Viramune XR was shown to be non-inferior in efficacy to Viramune IR and demonstrated a trend towards improved efficacy and safety with the added convenience of QD dosing. Viramune XR is demonstrated to be an efficacious and safe component of antiretroviral therapy in HIV-1 infected patients.
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