Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once-daily, all oral, ribavirin (RBV)-free, direct-acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Japanese patients, including those with compensated cirrhosis. CERTAIN-2 is a phase 3, open-label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in treatment-naive and interferon ± RBV treatment–experienced Japanese patients without cirrhosis but with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (arm A) or 12 weeks of sofosbuvir (400 mg once daily) + RBV (600-1000 mg weight-based, twice daily) (arm B). The primary endpoint was noninferiority of G/P compared to sofosbuvir + RBV by assessing sustained virologic response at posttreatment week 12 (SVR12) among patients in the intent-to-treat population. SVR12 was also assessed in treatment-naive and interferon ± RBV treatment-experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the CERTAIN-1 study. A total of 136 patients were enrolled in CERTAIN-2. SVR12 was achieved by 88/90 (97.8%) patients in arm A and 43/46 (93.5%) patients in arm B. No patient in arm A experienced virologic failure, while 2 did in arm B. The primary endpoint was achieved. In CERTAIN-1, 100% (18/18) of GT2-infected patients with compensated cirrhosis achieved SVR12. Treatment-emergent serious adverse events were experienced by 2 patients without cirrhosis in each arm and no patient with cirrhosis. Conclusion: The results demonstrate high efficacy and favorable tolerability of G/P in GT2-infected Japanese patients. (Hepatology 2017).

中文翻译：

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格列卡韦韦/匹布那他韦在日本慢性2型丙型肝炎病毒感染患者中的疗效和安全性

评价了Glecaprevir（非结构蛋白3 / 4A蛋白酶抑制剂）和pibrentasvir（非结构蛋白5A蛋白酶抑制剂）（G / P），这是一种每天一次，口服，无利巴韦林（RBV）且直接作用的抗病毒方案，其处方为每日一次丙型肝炎病毒基因型2（GT2）感染的日本患者（包括代偿性肝硬化患者）的疗效和有效性。CERTAIN-2是一项3期，开放标签，多中心研究，评估了初治和干扰素±RBV治疗的经验丰富的日本无肝硬化但有GT2感染的日本患者每天一次G / P（300/120 mg）的安全性和有效性。 。患者按2：1的比例随机接受8周的G / P（A组）或12周的索非布韦（每天400 mg一次）+ RBV（600-1000 mg体重，每天两次）（B组）。主要终点是通过评估意向治疗人群中患者治疗后第12周（SVR12）的持续病毒学应答，与索非布韦+ RBV相比，G / P的非劣效性。在CERTAIN-1研究中，未经初治和干扰素±RBV治疗且经历过GT2感染和代偿性肝硬化的患者接受了G / P治疗12周，也对SVR12进行了评估。共有136位患者参加了CERTAIN-2。A组中88/90（97.8％）的患者和B组中43/46（93.5％）的患者实现了SVR12。A组中没有患者发生病毒学失败，而B组中有2人达到病毒学衰竭。达到了主要终点。在CERTAIN-1中，GT2感染的代偿性肝硬化患者中有100％（18/18）达到了SVR12。结论：结果表明，G / P对GT2感染的日本患者具有很高的疗效和良好的耐受性。（H流行病学2017）。