University of Maryland Medical Centre, 29 South Greene Street, Pharmacy Services, Suite 400, Baltimore, MD 21201, USA.
Expert Opin Pharmacother. 2011 Dec;12(17):2713-8. doi: 10.1517/14656566.2011.630391. Epub 2011 Oct 29.
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.
奈韦拉平（NVP）是首个获得批准用于治疗 HIV 感染的非核苷类逆转录酶抑制剂（NNRTI），并迅速成为全球应用最广泛的抗逆转录病毒药物（ARV）之一。目前，一种新的延长剂型药物已获得美国 FDA 批准，每日仅需服用一次。
最近两项随机对照临床试验已经证实，一种新的奈韦拉平（NVP）延长释放制剂（NVP XR）在初治和经治患者中具有临床等效性。VERxVE 研究表明，NVP XR 在初治患者中具有非劣效性。在 TRANxITION 研究中，已经稳定使用奈韦拉平即时释放制剂（NVP IR）的经治患者可直接安全转换为 NVP XR。
NVP 延长释放制剂的优势在于可以每日给药一次，同时显示出与每日两次给药的制剂相同的安全性和疗效。预计目前正在使用 NVP IR 的患者将考虑转换为 NVP XR，以通过减少每日剂量和服药次数来简化治疗方案。此外，对于正在考虑开始基于 NVP 的 ARV 治疗方案的初治患者，一旦根据当前指南成功开始 NVP 治疗，可能会过渡到延长释放制剂。
