Medical University of Vienna, Vienna, Austria.
Department of Gastroenterology and Hepatology, ZNA Stuivenberg, Antwerp, Belgium.
J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5.
Ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin (OBV/PTV/r ± DSV ± RBV) regimens show high efficacy and good tolerability in clinical trials for chronic hepatitis C virus (HCV) genotypes (GT) 1 or 4. To evaluate whether these results translate to clinical practice, data were pooled from observational studies across 13 countries. Treatment-naïve or -experienced patients, with or without cirrhosis, received OBV/PTV/r ± DSV ± RBV according to approved local labels and clinical practice. Sustained virologic response at post-treatment Week 12 (SVR12), adverse events (AEs) and comedication management were assessed for patients initiating treatment before 1 June 2017. The safety population included 3850 patients who received ≥1 dose of study drug. The core population (N = 3808) further excluded patients with unknown GT or cirrhosis status, or who received off-label treatment. Patients had HCV GT1a (n = 732; 19%), GT1b (n = 2619; 69%) or GT4 (n = 457; 12%). In 3546 patients with sufficient follow-up data at post-treatment Week 12, the SVR12 rate was 96% (n/N = 3401/3546 [95% CI 95.2-96.5]). In patients with or without cirrhosis, SVR12 was comparable (96%). In patients with HCV GT1a, GT1b or GT4, SVR12 rates were 93%, 97% and 94%. In GT1b-infected patients with planned treatment for 8 weeks, SVR12 was 96%. In patients with ≥1 comorbidity (67%), SVR12 was 95%. 58% of patients received ≥1 comedication, and there was minimal impact on SVR12 rates using comedications for peptic ulcers and gastro-esophageal reflux disease, statins, antipsychotics or antiepileptics. Most comedications were maintained during treatment although 58% of patients changed their statin medication. AEs and serious AEs occurred in 26% and 3% of patients. Post-baseline Grade 3-4 laboratory abnormalities were rare (<3%), and discontinuation rates were low (<4%). Real-world evidence confirms the effectiveness of OBV/PTV/r ± DSV ± RBV in patients with HCV GT1 or GT4, regardless of common comorbidities or comedications, and is consistent with clinical trial results. Adverse safety outcomes may be limited by underreporting in the real-world setting.
奥比帕利/帕利瑞韦/利托那韦+达萨布韦+利巴韦林（OBV/PTV/r+DSV+RBV）方案在慢性丙型肝炎病毒（HCV）基因型（GT）1 或 4 的临床试验中显示出高疗效和良好的耐受性。为了评估这些结果是否转化为临床实践，我们从 13 个国家的观察性研究中汇集了数据。治疗初治或经治、有或无肝硬化的患者根据批准的当地标签和临床实践接受 OBV/PTV/r+DSV+RBV 治疗。在 2017 年 6 月 1 日前开始治疗的患者，在治疗后第 12 周（SVR12）评估持续病毒学应答（SVR12）、不良事件（AE）和伴随药物管理。安全性人群包括接受至少一剂研究药物的 3850 名患者。核心人群（N=3808）进一步排除了 GT 或肝硬化状态未知或接受标签外治疗的患者。患者的 HCV GT1a（n=732；19%）、GT1b（n=2619；69%）或 GT4（n=457；12%）。在 3546 名在治疗后第 12 周有足够随访数据的患者中，SVR12 率为 96%（n/N=3401/3546[95%CI 95.2-96.5]）。在有或无肝硬化的患者中，SVR12 是可比的（96%）。在 HCV GT1a、GT1b 或 GT4 患者中，SVR12 率分别为 93%、97%和 94%。在计划治疗 8 周的 GT1b 感染患者中，SVR12 为 96%。在有≥1 种合并症的患者中（67%），SVR12 为 95%。58%的患者接受了≥1 种伴随药物治疗，使用治疗消化性溃疡和胃食管反流病、他汀类药物、抗精神病药或抗癫痫药的伴随药物对 SVR12 率几乎没有影响。尽管 58%的患者改变了他们的他汀类药物治疗，但大多数伴随药物在治疗期间得到了维持。26%的患者发生了 AE，3%的患者发生了严重 AE。治疗后基线时出现的 3-4 级实验室异常罕见（<3%），停药率低（<4%）。真实世界证据证实了 OBV/PTV/r+DSV+RBV 在 HCV GT1 或 GT4 患者中的有效性，无论常见合并症或伴随药物如何，这与临床试验结果一致。在真实世界环境中，不良反应的安全结果可能受到报告不足的限制。
