Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Yunlin, Taiwan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Taiwan.
J Viral Hepat. 2020 Sep;27(9):866-872. doi: 10.1111/jvh.13305. Epub 2020 May 12.
Data on direct-acting antiviral agent (DAA) treatment for mixed genotype hepatitis C virus (HCV) infection are scant. This study examined the effectiveness of glecaprevir/pibrentasvir (GLE/PIB) and ledipasvir/sofosbuvir (LDV/SOF) for mixed HCV genotype infection in a real-world setting in Taiwan. We analysed the data from all patients with mixed HCV genotype infections treated with GLE/PIB or LDV/SOF from 2017 to 2019 in three Chang Gung Memorial Hospitals in Taiwan. The primary treatment outcome was sustained virologic response 12 weeks after treatment cessation (SVR12). Adverse events (AEs) were also evaluated. A total of 5190 HCV patients received DAA treatment during this time period. Among them, 116 patients (2.2%) had mixed infections of any 2 or 3 genotypes of 1a, 1b, 2, 3 and 6. Fifty-four patients received GLE/PIB and 62 received LDV/SOF. SVR12 rates for LDV/SOF vs GLE/PIB therapy were 96.6% (56/58) vs 100% (51/51) by the per-protocol analysis and 90.3% (56/62) vs 94.4% (51/54) by the evaluable population analysis. Two patients with 1b + 6 and 1b + 2 genotype infections in the LDV/SOF group had relapse. Evaluating the GLE/PIB vs LDV/SOF groups for the most common AEs revealed pruritus (16.7% vs 4.8%), abdominal discomfort (5.6% vs 8%) and fatigue (5.6% vs 4.8%). One patient with AE-related treatment discontinuation presented with liver decompensation after 4-week GLE/PIB therapy. DAA-related significant laboratory abnormalities occurred in two patients with >3× elevated bilirubin level in the GLE/PIB group. GLE/PIB and LDV/SOF are well tolerated and achieve high SVR12 rates for patients with mixed HCV genotype infection.
直接作用抗病毒药物(DAA)治疗混合基因型丙型肝炎病毒(HCV)感染的数据很少。本研究在台湾的三个长庚纪念医院中,在真实环境下研究了 glecaprevir/pibrentasvir(GLE/PIB)和 ledipasvir/sofosbuvir(LDV/SOF)治疗混合 HCV 基因型感染的效果。我们分析了 2017 年至 2019 年间在台湾三个长庚纪念医院接受 GLE/PIB 或 LDV/SOF 治疗的所有混合 HCV 基因型感染患者的数据。主要治疗结局是治疗停止后 12 周持续病毒学应答(SVR12)。还评估了不良反应(AE)。在此期间,共有 5190 例 HCV 患者接受了 DAA 治疗。其中,116 例(2.2%)患者混合感染了 1a、1b、2、3 和 6 型的任何 2 种或 3 种基因型。54 例患者接受 GLE/PIB 治疗,62 例患者接受 LDV/SOF 治疗。LDV/SOF 与 GLE/PIB 治疗的 SVR12 率分别为按方案分析的 96.6%(56/58)和 100%(51/51),以及可评估人群分析的 90.3%(56/62)和 94.4%(51/54)。LDV/SOF 组中 2 例 1b+6 和 1b+2 基因型感染患者复发。评估 GLE/PIB 与 LDV/SOF 组最常见的 AEs 发现瘙痒(16.7%比 4.8%)、腹部不适(5.6%比 8%)和疲劳(5.6%比 4.8%)。1 例因 AE 相关治疗停药的患者在接受 GLE/PIB 治疗 4 周后出现肝功能失代偿。GLE/PIB 组有 2 例患者胆红素水平升高超过 3 倍,出现 DAA 相关显著实验室异常。GLE/PIB 和 LDV/SOF 耐受性良好,混合 HCV 基因型感染患者的 SVR12 率高。