Wong R J, Nguyen M T, Trinh H N, Huynh A, Ly M T, Nguyen H A, Nguyen K K, Yang J, Garcia R T, Levitt B, da Silveira E, Gish R G
Division of Gastroenterology and Hepatology, Alameda Health System - Highland Hospital, Oakland, CA, USA.
Silicon Valley Research Institute, San Jose, CA, USA.
J Viral Hepat. 2017 Jan;24(1):17-21. doi: 10.1111/jvh.12609. Epub 2016 Sep 27.
Sofosbuvir/ledipasvir (SOF/LDV) is the first all-oral ribavirin-free treatment approved for chronic hepatitis C virus (HCV) genotype 6, offering a safe and highly efficacious treatment option. Large studies evaluating real-world outcomes of this regimen are lacking. We aim to evaluate real-world treatment outcomes for HCV genotype 6. A retrospective cohort study evaluated 65 adults (age ≥18) with chronic HCV genotype 6 treated with SOF/LDV without ribavirin at a community gastroenterology clinic in the United States from November 2014 to May 2016. Rates of undetectable virus at week 4 on treatment, at end of treatment (EOT) and SVR12 were stratified by the presence of cirrhosis and prior treatment (treatment naïve vs treatment experienced). Among 65 patients with chronic HCV genotype 6 treated with SOF/LDV (52.3% male, mean age 66.3 years [SD 9.7], 41.5% cirrhosis and 15.4% treatment experienced), 97.3% had undetectable virus at week 4 on treatment, 96.9% had undetectable virus at EOT and 95.3% achieved SVR12. SVR12 was 100% in females vs 91.2% in males, P=.096, and 92.3% in patients with cirrhosis vs 97.4% in those without cirrhosis, P=.347. Resistance testing of treatment failures was attempted but unsuccessful due to lack of conforming primers to define the possible resistance mutations. Among the largest U.S. community-based real-world cohort of Asian chronic HCV genotype 6 patients treated with all-oral SOF/LDV without ribavirin, SVR12 was similar to SVR12 reported in clinical trials, confirming the safety and effectiveness of this regimen and validating current HCV genotype 6 treatment guideline recommendations.
索磷布韦/来迪派韦（SOF/LDV）是首个获批用于治疗6型慢性丙型肝炎病毒（HCV）的全口服、不含利巴韦林的疗法，提供了一种安全且高效的治疗选择。目前尚缺乏评估该治疗方案实际疗效的大型研究。我们旨在评估6型HCV的实际治疗效果。一项回顾性队列研究对2014年11月至2016年5月在美国一家社区胃肠病诊所接受SOF/LDV且未使用利巴韦林治疗的65名年龄≥18岁的慢性6型HCV成年患者进行了评估。根据肝硬化的存在情况和既往治疗史（初治患者与经治患者），对治疗第4周、治疗结束时（EOT）以及治疗后12周病毒学应答（SVR12）时病毒检测不到的发生率进行了分层分析。在65例接受SOF/LDV治疗的慢性6型HCV患者中（男性占52.3%，平均年龄66.3岁[标准差9.7]，41.5%有肝硬化，15.4%为经治患者），97.3%在治疗第4周时病毒检测不到，96.9%在EOT时病毒检测不到，95.3%实现了SVR12。女性的SVR12为100%，男性为91.2%，P = 0.096；有肝硬化患者的SVR12为92.3%，无肝硬化患者为97.4%，P = 0.347。因缺乏用于确定可能耐药突变的合适引物，对治疗失败患者进行耐药检测的尝试未成功。在接受全口服SOF/LDV且未使用利巴韦林治疗的美国最大的基于社区的亚洲慢性6型HCV患者真实世界队列中，SVR12与临床试验报告的结果相似，证实了该治疗方案的安全性和有效性，并验证了当前6型HCV治疗指南的推荐。
