Guidelines for the use of extended-release nevirapine in HIV-infected patients.

Nevirapine (NVP) was the first non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV infection and quickly became one of the most extensively used antiretrovirals (ARVs) worldwide. A new extended-formulation of the drug has now been FDA approved for once-daily use. Two recent, randomized and controlled clinical trials have established the clinical noninferiority of a new, extended-release formulation of NVP (NVP XR), in both treatment-naive and treatment-experienced patients. VERxVE demonstrated the noninferiority of NVP XR in treatment-naive patients. Treatment-experienced patients already stable on the NVP immediate-release formulation (NVP IR) were safely transitioned directly to NVP XR in the TRANxITION study. The advantage of the extended release formulation of NVP is that it permits once-daily dosing, while demonstrating safety and efficacy results that are noninferior to that of the twice-daily formulation. It is expected that patients who are on NVP IR at present will consider switching to NVP XR to achieve regimen simplification by reducing their daily dosing and pill burden. In addition, treatment-naive patients who are considering starting on an NVP-based ARV regimen will probably transition to the extended-release formulation once they have successfully initiated NVP therapy according to current guidelines.