INTRODUCTION Pangenotypic, all-oral direct-acting antivirals, such as glecaprevir/pibrentasvir (G/P), are recommended for treatment of hepatitis C virus (HCV) infection. Concerns exist about the impact on efficacy in patients with suboptimal adherence, particularly with shorter treatment durations. These post hoc analyses evaluated adherence (based on pill count) in patients prescribed 8- or 12-week G/P, the impact of nonadherence on sustained virologic response at post-treatment week 12 (SVR12), factors associated with nonadherence, and efficacy in patients interrupting G/P treatment. METHODS Data were pooled from 10 phase 3 clinical trials of treatment-naive patients with HCV genotype 1-6 without cirrhosis/with compensated cirrhosis (treatment adherence analysis) and 13 phase 3 clinical trials of all patients with HCV (interruption analysis). RESULTS Among 2,149 patients included, overall mean adherence was 99.4%. Over the treatment duration, adherence decreased (weeks 0-4: 100%; weeks 5-8: 98.3%; and weeks 9-12: 97.1%) and the percentage of patients with ≥80% or ≥90% adherence declined. SVR12 rate in the intention-to-treat (ITT) population was 97.7% (modified ITT SVR12 99.3%) and remained high in nonadherent patients in the modified ITT population (<90%: 94.4%-100%; <80%: 83.3%-100%). Psychiatric disorders were associated with <80% adherence, and shorter treatment duration was associated with ≥80% adherence. Among 2,902 patients in the interruption analysis, 33 (1.1%) had a G/P treatment interruption of ≥1 day, with an SVR12 rate of 93.9% (31/33). No virologic failures occurred. DISCUSSION These findings support the impact of treatment duration on adherence rates and further reinforce the concept of "treatment forgiveness" with direct-acting antivirals.

中文翻译：

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在给药中断或依从性不佳的患者中，Glecaprevir/Pibrentasvir 具有高持续病毒学缓解率。

简介 全基因型、全口服直接作用抗病毒药物，如 glecaprevir/pibrentasvir (G/P)，被推荐用于治疗丙型肝炎病毒 (HCV) 感染。人们担心依从性不佳的患者对疗效的影响，特别是治疗持续时间较短的患者。这些事后分析评估了服用 8 周或 12 周 G/P 的患者的依从性（基于药丸数量）、不依从性对治疗后第 12 周持续病毒学应答 (SVR12) 的影响、与不依从性相关的因素以及疗效中断 G/P 治疗的患者。方法 汇总了 10 项针对未接受治疗的基因型 1-6 HCV 无肝硬化/代偿性肝硬化患者的 3 期临床试验（治疗依从性分析）和针对所有 HCV 患者的 13 项 3 期临床试验（中断分析）的数据。结果 在纳入的 2,149 名患者中，总体平均依从率为 99.4%。在治疗期间，依从性下降（第0-4周：100%；第5-8周：98.3%；第9-12周：97.1%），并且依从性≥80%或≥90%的患者百分比下降。意向治疗 (ITT) 人群中的 SVR12 率为 97.7%（改良 ITT SVR12 99.3%），改良 ITT 人群中非依从性患者的 SVR12 率仍然很高（<90%：94.4%-100%；<80%：83.3） %-100%）。精神疾病与<80%的依从性相关，较短的治疗持续时间与≥80%的依从性相关。在中断分析中的 2,902 名患者中，33 名 (1.1%) 的 G/P 治疗中断≥1 天，SVR12 率为 93.9% (31/33)。没有发生病毒学失败。