Gayam Vijay, Tiongson Benjamin, Khalid Mazin, Mandal Amrendra K, Mukhtar Osama, Gill Arshpal, Garlapati Pavani, Shrestha Binav, Khalid Mowyad, Chakraborty Sandipan, Guss Debra, Sherigar Jagannath, Mansour Mohammed, Mohanty Smruti
Department of Medicine and Gastroenterology, Interfaith Medical Center.
Department of Medicine, Detroit Medical Center, Wayne State University, Detroit, Michigan, USA.
Eur J Gastroenterol Hepatol. 2018 Oct;30(10):1200-1207. doi: 10.1097/MEG.0000000000001233.
Direct-acting antiviral (DAA) drugs have been highly effective in the treatment of chronic hepatitis C (HCV) infection. Limited data exist comparing the safety, tolerability, and efficacy of DAAs in African-American (AA) patients with chronic hepatitis C genotype 1 (HCV GT-1) in the community practice setting. We aim to evaluate treatment response of DAAs in these patients.
All the HCV GT-1 patients treated with DAAs between January 2014 and January 2018 in a community clinic setting were retrospectively analyzed. Pretreatment baseline patient characteristics, treatment efficacy with a sustained virologic response at 12 weeks post-treatment (SVR12), and adverse reactions were assessed.
Two-hundred seventy-eight patients of AA descent were included in the study. One-hundred sixty-two patients were treated with ledipasvir/sofosbuvir (SOF)±ribavirin, 38 were treated with simeprevir/SOF±ribavirin, and 38 patients were treated with SOF/velpatasvir. Overall, SVR at 12 weeks was achieved in 94.6% in patients who received one of the three DAA regimens (93.8% in ledipasvir/SOF group, 92.1% in simeprevir/SOF group, and 97.4% in SOF/velpatasvir group). Previous treatment experience, HCV RNA levels and HIV status had no statistical significance on overall SVR achievement (P=0.905, 0.680, and 0.425, respectively). Compensated cirrhosis in each of the treatment groups did not influence overall SVR of 12. The most common adverse effect was fatigue (27%). None of the patients discontinued the treatment because of adverse events.
In the real-world setting, DAAs are safe, effective, and well tolerated in African-American patients with chronic HCV GT-1 infection with a high overall SVR rate of 94.6%. Treatment rates did not differ on the basis of previous treatment and compensated cirrhosis status.
直接抗病毒(DAA)药物在慢性丙型肝炎(HCV)感染的治疗中具有高效性。在社区实践环境中,比较DAA药物在非裔美国(AA)慢性丙型肝炎基因1型(HCV GT-1)患者中的安全性、耐受性和疗效的数据有限。我们旨在评估这些患者中DAA药物的治疗反应。
对2014年1月至2018年1月在社区诊所接受DAA药物治疗的所有HCV GT-1患者进行回顾性分析。评估治疗前患者的基线特征、治疗12周时的持续病毒学应答(SVR12)治疗疗效以及不良反应。
278名非裔患者纳入研究。162名患者接受来迪派韦/索磷布韦(SOF)±利巴韦林治疗,38名患者接受simeprevir/SOF±利巴韦林治疗,38名患者接受SOF/维帕他韦治疗。总体而言,接受三种DAA治疗方案之一的患者12周时的SVR率为94.6%(来迪派韦/SOF组为93.8%,simeprevir/SOF组为92.1%,SOF/维帕他韦组为97.4%)。既往治疗经历、HCV RNA水平和HIV状态对总体SVR的实现无统计学意义(P值分别为0.905、0.680和0.425)。各治疗组中的代偿期肝硬化不影响12周时的总体SVR。最常见的不良反应是疲劳(27%)。没有患者因不良事件而停止治疗。
在现实环境中,DAA药物在慢性HCV GT-1感染的非裔美国患者中安全、有效且耐受性良好,总体SVR率高达94.6%。治疗率不因既往治疗和代偿期肝硬化状态而有所不同。