Effectiveness and safety of rilpivirine, a non-nucleoside reverse transcriptase inhibitor, in treatment-naive adults infected with HIV-1: a meta-analysis.

Objective: The aim of this study was to determine the effectiveness and safety of rilpivirine in treatment-naive adults infected with HIV-1.

Methods: We ran duplicate searches of multiple databases and searchable Web sites of major HIV conferences (May to October 2013) to identify randomized controlled trials reporting the effectiveness and safety of rilpivirine in treatment-naive adults infected with HIV-1. Reference lists from retrieved articles were also reviewed. Data were extracted independently in duplicate using predefined data fields. All analyses used random effects models to calculate the summary treatment effect estimates.

Results: Four randomized controlled trials with a total of 2,522 patients were included. The primary efficacy endpoint was the proportion of patients with confirmed HIV-1 RNA levels of <50 copies/mL (viral load) at 48 weeks. Rilpivirine demonstrated noninferior antiviral efficacy in viral load comparable with efavirenz at 48 weeks (relative risk [RR], 1.03; 95% CI, 0.99-1.07). The mean changes from baseline in CD4 count were similar in both rilpivirine and efavirenz (RR, 1.05; 95% CI, 0.85-1.24). Rilpivirine showed higher and significant difference in virological failure rates compared with the efavirenz group (RR, 1.70; 95% CI, 1.21-2.38). The incidences of the most commonly reported adverse events related to study medication, including rash and neurological events, were lower with rilpivirine than with efavirenz (RR, 0.11; 95% CI, 0.03-0.33; RR, 0.52; 95% CI, 0.45-0.60, respectively).

Conclusions: Current evidence suggests a range of favorable effects and a generally favorable safety profile of rilpivirine in treatment-naive adults infected with HIV-1 at week 48.