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Efficacy and safety of glecaprevir/pibrentasvir in Japanese patients with chronic genotype 2 hepatitis C virus infection

机译：格列卡韦韦/哌替那韦在日本慢性2型丙型肝炎病毒感染患者中的疗效和安全性

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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 2018;67:505‐513).
机译：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），这是一种每天一次配制，所有口服，无利巴韦林（RBV）的直接作用抗病毒方案，其安全性丙型肝炎病毒基因型2（GT2）感染的日本患者（包括肝硬化代偿患者）的疗效和有效性。 CERTAIN-2是一项三阶段，开放标签，多中心研究，评估了初治和干扰素±RBV治疗中每日经验G / P（300/120 mg）的安全性和有效性-经验丰富的无肝硬化但患有GT2感染的日本患者。患者被随机分配为2：1，接受8周的G / P（A组）或12周的Sofosbuvir（400 mg，每天一次）+ 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治疗后第12周（SVR12）的持续病毒学应答，与索福布韦+ RBV相比，G / P不劣。在CERTAIN-1研究中，未接受过治疗和接受过干扰素±RBV治疗的GT2感染和代偿性肝硬化患者接受了G / P治疗12周，也对SVR12进行了评估。 CERTAIN-2总共招募了136例患者。 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100％（18/18）达到了SVR12。每组中有2例无肝硬化的患者出现了治疗紧急的严重不良事件，也没有肝硬化的患者。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。 （Hepatology 2018; 67：505-513）。

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