Post-Marketing Experience with Nevirapine Extended Release (XR) Tablets: Effectiveness and Tolerability in a Population-Based Cohort in British Columbia,Canada

Abstract

Background

Nevirapine 400 mg extended release tablets (nevirapine-XR) are a once-daily alternative to nevirapine 200 mg immediate release tablets (nevirapine-IR). Study objectives were to describe the effectiveness and tolerability of nevirapine-XR in clinical practice and, for patients who switched from once daily 2x200 mg nevirapine-IR to nevirapine-XR, compare virological suppression and plasma nevirapine concentrations during each treatment period.

Methods

HIV-1-infected adults entered the study cohort if they initiated nevirapine-XR in British Columbia (BC) Canada between 1 April 2012 and 30 September 2012 and were followed until 30 September 2013. Demographic and clinical variables were abstracted from the BC Centre for Excellence in HIV/AIDS databases. Patients who switched from once daily nevirapine-IR to nevirapine-XR were monitored for 6 months pre- and post-switch with comparison of virological suppression (McNeamer's test) and median random plasma nevirapine concentrations (Wilcoxon–Mann–Whitney test) in each period.

Results

The 536 nevirapine-XR-treated patients were 96% male, median (IQR) age 49.9 (44.0–56.9) years. Median follow-up was 15.6 (14.7–16.5) months, with 474/536 (88%) maintaining virological suppression. Emergent drug resistance developed in 5/536 (1%), adverse drug reactions in 17/536 (3%) and, although 31/536 (6%) reported ‘whole’ tablets in their stools, this was not associated with adverse outcomes. Among the 305 patients who switched from nevirapine-IR to nevirapine-XR, median (IQR) random plasma nevirapine concentration was higher during nevirapine-IR 5,000 (3,690–6,090) ng/ml than nevirapine-XR 3,930 (3,050–5,150) ng/ml (P<0.001), but there was no difference in virological suppression, 89% and 87% respectively (P=0.414).

Conclusions

This post-marketing study affirms the effectiveness and tolerability of nevirapine-XR as an alternative to nevirapine-IR in adults.

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