Nevirapine extended-release for the treatment of HIV-1 infection

Abstract

Non-nucleoside antiretroviral combination therapy is the standard of care with a robust virologic efficacy and a good safety profile. One of the most frequently used non-nucleosides, nevirapine (NVP), has been available as a every 12 h, immediate-release (IR) tablet since 1996. In order to enhance convenience and adherence, a new pharmaceutical formulation was devised for once-daily use. This is the NVP extended-release (XR) tablet containing 400 mg of NVP. Preclinical and clinical studies were performed to establish the optimal pharmaceutical release form and to establish data on comparability with the conventional NVP-IR. The VERXVE study has shown noninferiority of the new NVP-XR formulation in treatment-naive patients. Safety and tolerability was found to be at least as good as with NVP-IR. NVP-XR is likely to become a convenient treatment option in first-line therapy and will also be a welcome alternative to patients already on NVP.

Keywords::

• antiretroviral therapy
• extended-release
• HIV
• nevirapine

Disclaimer

Data included in the tables and figures of this manuscript are cited from congress poster presentations and as such may not be consistent with the final verified and analyzed trial data published in the peer-reviewed literature elsewhere.

Financial & competing interests disclosure

J Bogner has recieved lecture honoraria from Abbott, Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Essex, Bristol Myers Squibb, Gilead, MSD, Novartis, Pfizer, Roche, ViiV and advisory board participation honoraria from Abbott, Boerhinger Ingelheim, Janssen, ViiV. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.