Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: A randomized, double‐blind, active‐controlled trial

作者：Stephen K. Tyring, Stephanie Plunkett, Anita Scribner, Robert Broker, John N. Herrod, Lane T. Handke, John M. Wise, Paul A. Martin, for the Valomaciclovir Zoster Study Group · 发表于：Journal of Medical Virology · 年份：2012 · DOI：10.1002/jmv.23329 · 被引用次数：31 · 研究领域：Herpesvirus Infections and Treatments、Acne and Rosacea Treatments and Effects、Drug-Induced Adverse Reactions

Herpes zoster is a common infectious disease that can result in significant acute and chronic morbidity. The safety and efficacy of once-daily oral valomaciclovir (EPB-348) was evaluated for non-inferiority to 3-times daily valacyclovir, an approved therapy. In this study, 373 immunocompetent adults with onset of a herpes zoster rash within the preceding 72 hr were randomly assigned to receive one of four treatments for 7 days: (1) EPB-348 1,000 mg once-daily; (2) EPB-348 2,000 mg once-daily; (3) EPB-348 3,000 mg once-daily; or (4) valacyclovir 1,000 mg 3-times daily. A 20% margin was the reference for non-inferiority assessment. For the primary efficacy measure of time to complete crusting of the zoster rash by Day 28, non-inferiority criteria were met for once-daily EPB-348 2,000 mg and once-daily EPB-348 3,000 mg compared to 3-times daily valacyclovir. Additionally, EPB-348 3,000 mg significantly shortened the time to complete rash crusting by Day 28 compared to valacyclovir. For secondary efficacy measures, non-inferiority was achieved for the EPB-348 1,000 and 2,000 mg groups compared to the valacyclovir group for time to rash resolution by Day 28. No EPB-348 group was non-inferior to valacyclovir for time to cessation of new lesion formation or time to cessation of pain by Day 120, though no significant differences occurred between treatment groups. Nausea, headache, and vomiting were the most common adverse events. Based on these results, additional studies are warrant...