Verxve 144-Week Results: Nevirapine Extended Release (NVP XR) Qd Versus NVP Immediate Release (IR) Bid with FTC/TDF in Treatment-Naive HIV-1 Patients
- *Corresponding Author:
- Cynthia Brinson
Central Texas Clinical Research
Austin, TX 78751
E-mail: [email protected]
Received Date: June 24, 2013; Accepted Date: August 20, 2013; Published Date: August 25, 2013
Citation: Brinson C, Bogner JR, Nelson M, Podzamczer D, Quinson AM, et al. (2013) Verxve 144-Week Results: Nevirapine Extended Release (NVP XR) Qd Versus NVP Immediate Release (IR) Bid with FTC/TDF in Treatment-Naïve HIV-1 Patients. J AIDS Clin Res 4:233. doi:10.4172/2155-6113.1000233
Copyright: © 2013 Brinson C, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background: We report 96- and 144-week follow-up data from VERxVE, demonstrating that nevirapine (NVP) extended release (XR) 400 mg once daily was non-inferior to NVP immediate release (IR) 200 mg twice daily, each administered on a backbone of emtricitabine/tenofovir. 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/mm3 (males) or <250 cells/mm3 (females). Randomisation was stratified by baseline VL (copies/mL) ≤ 100,000 or >100,000. The 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 versus IR. Secondary endpoints included 144-week sustained virologic response and safety. Results: In all, 1011 patients were randomised and treated with NVP: 736 (XR n=378; IR n= 358) completed 144 weeks. Virologic response was 63.6% for NVP XR and 58.5% for NVP IR (adjusted difference of 4.8% [95% confidence interval –1.1% to 10.8%] favouring NVP XR). No significant differences were seen in changes in CD4+ T-cell counts from baseline, virologic failures or total discontinuation rates between treatment arms, regardless of demographic or baseline characteristics. Conclusions: NVP XR demonstrated non-inferior virologic efficacy to NVP IR in treatment-naïve HIV-infected patients and was well tolerated out to week 144, with a safety profile similar to NVP IR.