Open AccessVERxVE 144 week results: nevirapine extended‐release (NVP XR) QD versus NVP immediate‐release (IR) BID with FTC/TDF in treatment‐naïve HIV‐1 patients
Author(s) -
Brinson C,
Bogner J,
Nelson M,
Podzamczer D,
Quinson A,
Drulak M,
Gathe J
Publication year - 2012
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.7448/ias.15.6.18236
Subject(s) - medicine , emtricitabine , discontinuation , nevirapine , clinical endpoint , viral load , gastroenterology , human immunodeficiency virus (hiv) , randomized controlled trial , immunology , antiretroviral therapy
Background Here we report 96‐ and 144‐week follow‐up data from VERxVE, which demonstrated that NVP XR (400 mg QD) was non‐inferior to NVP IR (200 mg BID), each on a backbone of emtricitabine/tenofovir at 48 weeks. Methods VERxVE was a double‐blind, double‐dummy, non‐inferiority study in adults with screening viral‐load (VL) >1000 copies/mL and CD4+ cell count <400 cells/mm 3 (males) and <250 cells/mm 3 (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 non‐inferiority 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.48 Weeks 96 Weeks 144 WeeksNVP IR 200 mg BID NVP XR 400 mg QD NVP IR 200 mg BID NVP XR 400 mg QD NVP IR 200 mg BID NVP XR 400 mg QD% Virologic response 75.9 81.0 66.6 69.3 58.5 63.6 Change from baseline in CD4+ Count (cells/mm 3 ) 207 213 257 275 286 317 Virologic failures (%) 5.9 3.2 10.7 11.1 15.8 15.1 Discontinuation rate (%) 19.2 16.6 26.1 23.6 29.2 25.1 Discontinuations due to AEs 8.3 6.3 9.5 8.3 10.7 8.5Conclusions NVP XR continued to demonstrate non‐inferior 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.