University of Würzburg Medical Center, Würzburg, Germany.
UBN/Praxis, Berlin, Germany.
Liver Int. 2021 Jul;41(7):1518-1522. doi: 10.1111/liv.14937. Epub 2021 May 30.
Glecaprevir/pibrentasvir, a pangenotypic, direct-acting antiviral combination approved for chronic hepatitis C virus treatment, has limited real-world evidence supporting 8-week therapy in compensated cirrhosis. We investigated effectiveness and safety of 187 hepatitis C virus-infected, treatment-naïve, patients with compensated cirrhosis receiving 8-week glecaprevir/pibrentasvir therapy in the German Hepatitis C-Registry between 2 August 2017 and 1 January 2020. Sustained virologic response was 98.4% (127/129) in the per-protocol analysis (excluding patients lost to follow-up or who discontinued treatment due to compliance) and was 85.8% (127/148) in patients with data available in an intention-to-treat analysis. Nineteen patients were lost to follow-up; nine genotype 3 patients, nine nongenotype 3 patients and one mixed genotype patient. One patient relapsed, and one died, unrelated to treatment. Adverse events (>5%) were fatigue and headache. Two serious adverse events occurred; no adverse events resulted in drug discontinuation. An 8-week glecaprevir/pibrentasvir therapy was effective and well-tolerated in this real-world analysis.
格卡瑞韦/哌仑他韦是一种泛基因型、直接作用的抗病毒药物组合，已被批准用于慢性丙型肝炎病毒的治疗，在代偿性肝硬化患者中，其 8 周治疗的真实世界证据有限。我们调查了在德国丙型肝炎注册中心，2017 年 8 月 2 日至 2020 年 1 月 1 日期间，187 例初治、代偿性肝硬化的丙型肝炎病毒感染患者接受格卡瑞韦/哌仑他韦 8 周治疗的有效性和安全性。在方案规定的分析中（排除了因依从性而失去随访或停药的患者），持续病毒学应答率为 98.4%（127/129），在意向治疗分析中，有数据的患者为 85.8%（127/148）。19 例患者失访；9 例基因型 3 患者，9 例非基因型 3 患者和 1 例混合基因型患者。1 例患者复发，1 例患者死亡，与治疗无关。不良事件（>5%）为疲劳和头痛。发生了 2 例严重不良事件；没有因不良事件而停药。在这项真实世界的分析中，格卡瑞韦/哌仑他韦 8 周治疗是有效且耐受良好的。
