Department of Internal Medicine, Division of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chiayi, Taiwan.
College of Medicine, Chang Gung University, Taoyuan, Taiwan.
PLoS One. 2022 Aug 18;17(8):e0272567. doi: 10.1371/journal.pone.0272567. eCollection 2022.
Real-world data on the effectiveness of glecaprevir/pibrentasvir (GLE/PIB) for patients with HCV infection and compensated cirrhosis is limited, especially for the 8-week regimen and in an Asian population. This retrospective study enrolled 159 consecutive patients with HCV and compensated cirrhosis who were treated with GLE/PIB at a single center in Taiwan. Sustained virological response (SVR) and adverse events (AEs) were evaluated. Among the 159 patients, 91 and 68 were treated with GLE/PIB for 8 and 12 weeks, respectively. In the per protocol analysis, both the 8- and 12-week groups achieved 100% SVR (87/87 vs. 64/64); and in the evaluable population analysis, 95.6% (87/91) of the 8-week group and 94.1% (64/68) of the 12-week group achieved SVR. The most commonly reported AEs, which included pruritus (15.4% vs. 26.5%), abdominal discomfort (9.9% vs. 5.9%), and skin rash (5.5% vs. 5.9%), were mild for the 8- and 12-week groups. Two patients in the 8-week group exhibited total bilirubin elevation over three times the upper normal limit. One of these two patients discontinued GLE/PIB treatment after 2 weeks but still achieved SVR. Both 8- and 12-week GLE/PIB treatments are safe and effective for patients of Taiwanese ethnicity with HCV and compensated cirrhosis.
真实世界中关于 Glecaprevir/pibrentasvir(GLE/PIB)治疗 HCV 感染合并代偿性肝硬化患者的疗效数据有限,尤其是 8 周疗程和亚洲人群的数据。本回顾性研究纳入了在台湾的一家单中心接受 GLE/PIB 治疗的 159 例连续 HCV 合并代偿性肝硬化患者。评估了持续病毒学应答(SVR)和不良事件(AE)。在这 159 例患者中,91 例和 68 例分别接受了 8 周和 12 周的 GLE/PIB 治疗。在方案预设分析中,8 周组和 12 周组均达到了 100%的 SVR(87/87 与 64/64);在可评估人群分析中,8 周组的 95.6%(87/91)和 12 周组的 94.1%(64/68)达到了 SVR。最常见的报告 AE 包括瘙痒(15.4%比 26.5%)、腹部不适(9.9%比 5.9%)和皮疹(5.5%比 5.9%),在 8 周和 12 周组中均为轻度。8 周组中有 2 例患者总胆红素升高超过正常值上限的 3 倍。这 2 例患者中有 1 例在治疗 2 周后停止了 GLE/PIB 治疗,但仍达到了 SVR。GLE/PIB 治疗 8 周和 12 周对台湾 HCV 合并代偿性肝硬化患者均安全有效。