TRANxITION 144 Week Results: Switching Virologically Stable HIV Patients from Immediate-release Nevirapine (NVP IR) to Extended-Release NVP (XR)
- *Corresponding Author:
- Keikawus Arasteh
Rubensstrasse 125 Berlin, Germany 12157
E-mail: [email protected]
Received Date: October 17, 2013; Accepted Date: February 28, 2014; Published Date: March 10, 2014
Citation: Arasteh K, Drulak M, Guo J, Livrozet JM, Orkin C, et al. (2014) TRANxITION 144 Week Results: Switching Virologically Stable HIV Patients from Immediaterelease Nevirapine (NVP IR) to Extended-Release NVP (XR). J AIDS Clin Res 5:292. doi:10.4172/2155-6113.1000292
Copyright: © 2014 Arasteh K, 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.
Purpose: TRANxITION compared efficacy and safety of switching virologically suppressed HIV-1 infected patients from nevirapine (NVP) immediate-release (IR) (200 mg twice-daily) to NVP extended-release (XR) (400 mg oncedaily).
Methods: TRANxITION was an open-label, parallel-group, non-inferiority clinical trial where adult patients with undetectable viral loads, receiving NVP IR plus a fixed-dose NRTI combination, were randomized (2:1) to NVP XR or IR. After week 48, patients initially randomized to IR were allowed to switch to XR.
Summary of results: At week 48, proportions of patients with virologic response (LLOQ=50 copies/mL TaqMan, FAS) were 88.5% (131/148) in the IR arm, and 88.8% (262/295) in the XR arm, observed difference of 0.3% (95% CI -6.1, 6.7). DAIDS grade 3/4 adverse events were similar in the XR and IR arms at week 48: 6.4% (19/295) vs. 6.1% (9/148). After week 48, all but 13 patients in the IR arm switched to XR. At week 144, the proportions of patients with virologic response were 95.0% (115/121) in those switching from IR to XR after week 48 [IR-XR post48], and 95.2% (238/250) in those on XR throughout [XR-XR post48]). DAIDS grade 3 and 4 events at week 144 in IR-XRpost48 (7.7%, [10/130]) differed from the XR-XR post48 group (11.2%, [31/276]).
Conclusions: NVP XR QD resulted in continued virologic suppression at weeks 48 and 144. Up to week 144, rates of serious AEs were modestly higher than at week 24 in both post-week 48 XR arms, most likely due to the openlabel design of the study.