Hospital Dia, Av Dr Arnaldo, 165, Segundo andar, São Paulo, Brazil.
Ramiro Barcelos 2350, CPC Sala, 21216, Porto Alegre, Brazil.
Ann Hepatol. 2021 Jan-Feb;20:100257. doi: 10.1016/j.aohep.2020.09.002. Epub 2020 Sep 17.
Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis.
EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored.
100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported ≥1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed.
Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
ClinicalTrials.gov NCT03219216.
格卡瑞韦/哌仑他韦是一种高效且耐受性良好的丙型肝炎感染治疗药物。巴西患者并未被纳入格卡瑞韦/哌仑他韦的原始研发研究中。本研究旨在评估格卡瑞韦/哌仑他韦在无肝硬化或代偿性肝硬化的初治巴西成年患者中的安全性和疗效。
EXPEDITION-3 是一项在初治的丙型肝炎感染基因型 1-6 的巴西成年患者中开展的 III 期、开放性、多中心研究。无肝硬化（F2 或 F3）或代偿性肝硬化（F4）的患者分别接受 8 或 12 周的格卡瑞韦/哌仑他韦治疗。主要疗效终点为治疗后第 12 周的持续病毒学应答率。次要终点为治疗期间病毒学失败和复发率。在 NS3 和 NS5A 中评估了基线多态性。监测不良事件和实验室异常。
共纳入 100 例患者，75 例患者接受了 8 周的治疗，25 例患者接受了 12 周的治疗；所有患者均完成了治疗。总体而言，治疗后第 12 周的持续病毒学应答率较高（98.0%；98/100；95%置信区间：93.0-99.4），且无论基线病毒或宿主因素如何，该应答率均保持较高水平，包括人口统计学特征、丙型肝炎病毒 RNA 水平、NS3 和/或 NS5A 中的多态性、基因型以及相关合并症。55%的患者报告了≥1 种不良事件，最常见的是头痛（18.0%）。4 例患者报告了严重不良事件；均与药物无关，也未导致研究药物停药。未观察到肝失代偿。
格卡瑞韦/哌仑他韦在无肝硬化和代偿性肝硬化的初治巴西丙型肝炎感染患者中具有疗效且耐受性良好。
ClinicalTrials.gov NCT03219216。
