Pharmacy Service, Universitary Hospital of A Coruña, A Coruña, Spain.
Division of Clinical Virology, Biomedical Research Institute of A Coruña (INIBIC), Universitary Hospital of A Coruña (CHUAC), Sergas, University of A Coruña (UDC), A Coruña, Spain.
Eur J Hosp Pharm. 2020 Mar;27(e1):e41-e47. doi: 10.1136/ejhpharm-2019-002060. Epub 2020 Feb 7.
Sofosbuvir/velpatasvir±ribavirin (SOF/VEL±RBV) and glecaprevir/pibrentasvir (GLE/PIB) are the drug combinations of choice for treating individuals with genotype 3 hepatitis C virus (G3-HCV) infection. The objective of this study was to evaluate the effectiveness and safety of SOF/VEL±RBV compared with GLE/PIB for treating G3-HCV infection under routine clinical practice conditions.
We conducted a prospective observational cohort study of individuals with G3-HCV infection who initiated treatment with SOF/VEL +/-RBV or GLE/PIB between April 2017 and July 2018. Prisoners and children were excluded. The outcome variable of effectiveness was sustained virological response 12 weeks after completing treatment (SVR12). The safety variable was withdrawal secondary to severe adverse events (SAEs). Covariates included sex, age, HIV co-infection, previous liver transplant, cirrhosis, hepatic fibrosis and previous antiviral treatment. Statistical significance was calculated using Fisher's exact test or the Mann-Whitney -test.
A total of 76 patients were included in the analysis, of whom 46 were treated with SOF/VEL±RBV and 30 were treated with GLE/PIB. No baseline differences were observed between treatment groups with respect to age, sex, HIV co-infection, fibrosis stage, cirrhosis and previous antiviral treatment. Of the patients treated with SOF/VEL±RBV and GLE/PIB, 95.7% and 96.7% reached SVR12, respectively (P=0.7). Of patients with and without cirrhosis, 83.3% and 98.4% reached SVR12, respectively (P=0.09). Of the patients with low-grade hepatic fibrosis (F0-2) and advanced fibrosis (F3-4), 100% and 85.7% reached SVR12, respectively (P=0.03). In treatment-naïve and treatment-experienced patients, 95.7% and 100% reached SVR12, respectively (P=0.57), without significant differences independent of the treatment group (P=0.28 for SOF/VEL±RBV; P=0.18 for GLE/PIB). The incidence of AEs was 21.1% (95% CI 11.3% to 30.9%). None of the patients developed an SAE or required antiviral treatment withdrawal.
SOF/VEL±RBV or GLE/PIB are safe and effective for treating G3-HCV-infections, with a lower effectiveness in patients with advanced fibrosis F3-4.
索非布韦/维帕他韦（SOF/VEL）联合利巴韦林（RBV）和格卡瑞韦/哌仑他韦（GLE/PIB）是治疗基因 3 型丙型肝炎病毒（G3-HCV）感染患者的首选药物组合。本研究旨在评估在常规临床实践条件下，SOF/VEL±RBV 与 GLE/PIB 治疗 G3-HCV 感染的疗效和安全性。
我们进行了一项前瞻性观察性队列研究，纳入了 2017 年 4 月至 2018 年 7 月期间接受 SOF/VEL±RBV 或 GLE/PIB 治疗的 G3-HCV 感染患者。排除囚犯和儿童。疗效的结局变量为完成治疗后 12 周的持续病毒学应答（SVR12）。安全性变量为因严重不良事件（SAE）而停药。协变量包括性别、年龄、HIV 合并感染、既往肝移植、肝硬化、肝纤维化和既往抗病毒治疗。采用 Fisher 确切检验或曼-惠特尼 U 检验计算统计学显著性。
共纳入 76 例患者进行分析，其中 46 例接受 SOF/VEL±RBV 治疗，30 例接受 GLE/PIB 治疗。两组患者在年龄、性别、HIV 合并感染、纤维化分期、肝硬化和既往抗病毒治疗方面无基线差异。SOF/VEL±RBV 和 GLE/PIB 治疗组的患者分别有 95.7%和 96.7%达到 SVR12（P=0.7）。肝硬化患者和无肝硬化患者的 SVR12 分别为 83.3%和 98.4%（P=0.09）。低级别肝纤维化（F0-2）和高级纤维化（F3-4）患者的 SVR12 分别为 100%和 85.7%（P=0.03）。初治和经治患者的 SVR12 分别为 95.7%和 100%（P=0.57），两组之间无显著差异，且与治疗组无关（SOF/VEL±RBV 为 P=0.28；GLE/PIB 为 P=0.18）。AE 的发生率为 21.1%（95%CI 11.3%至 30.9%）。无患者发生 SAE 或需要抗病毒治疗停药。
SOF/VEL±RBV 或 GLE/PIB 治疗 G3-HCV 感染安全有效，F3-4 期高级纤维化患者疗效较低。
