Mehta Varun, Mahajan Ramit, Midha Vandana, Narang Vikram, Kaur Kirandeep, Singh Arshdeep, Malhotra Anand, Parvez Aslam, Sood Ajit
Department of Gastroenterology, Dayanand Medical College, Ludhiana, Punjab, India.
Department of Internal Medicine, Dayanand Medical College, Ludhiana, Punjab, India.
J Clin Exp Hepatol. 2018 Mar;8(1):7-14. doi: 10.1016/j.jceh.2017.06.003. Epub 2017 Jun 19.
To assess impact of Direct Acting Antiviral (DAA) therapies for treatment of Hepatitis C Virus (HCV) genotypes 1, 3 and 4 in a real-world cohort from India.
Adults with chronic HCV infection treated with Sofosbuvir (SOF) and Ledipasvir (LDV) (genotypes 1 and 4) or SOF and Daclatasvir (DCV) (genotype 3), with or without Ribavirin (RBV) between December 2015 and December 2016 were included. The primary endpoint was Sustained Virological Response at Post-treatment Week 12 (SVR12).
Of the 648 patients, 181 received SOF/LDV (65 with RBV) and 467 received SOF/DCV (135 with RBV). Most patients were males (65.4%), aged 41-60 years (49.4%) and treatment-naïve (92.6%). Genotype 3 (72.1%) was most common, followed by genotypes 1 (22.4%) and 4 (5.6%). Forty two percent patients ( = 271) had cirrhosis (112 patients were decompensated). SVR12 (modified intention-to-treat) was achieved by 98.1% of patients (512/522) (100% in genotypes 1 and 4, and 97.3% (362/372) in genotype 3). On intention to treat analysis, SVR12 was 88.1% (512/581) [genotype 1-96.8% (121/125), genotype 3-85.2%, genotype 4-93.5% (29/31)]. Seventy patients had treatment failure (non response in 6, virological breakthrough in 2, 10 patients relapsed, 2 died and 50 were lost to follow up). High SVR was observed regardless of HCV genotype, presence of cirrhosis or past history of treatment. No major adverse events warranting discontinuation of treatment were noted.
DAA therapy for HCV genotypes 1, 3 and 4 achieves high SVR rates in all patients, including those with cirrhosis and previous non-responders.
评估直接抗病毒药物（DAA）疗法对印度一个真实队列中丙型肝炎病毒（HCV）1、3和4型感染的治疗效果。
纳入2015年12月至2016年12月期间接受索磷布韦（SOF）和来迪派韦（LDV）（1和4型）或SOF和达卡他韦（DCV）（3型）治疗、无论是否联用利巴韦林（RBV）的慢性HCV感染成人患者。主要终点为治疗后第12周的持续病毒学应答（SVR12）。
648例患者中，181例接受SOF/LDV治疗（65例联用RBV），467例接受SOF/DCV治疗（135例联用RBV）。多数患者为男性（65.4%），年龄41 - 60岁（49.4%），且初治患者占92.6%。3型（72.1%）最为常见，其次是1型（22.4%）和4型（5.6%）。42%的患者（n = 271）有肝硬化（112例为失代偿期）。98.1%的患者（512/522）实现了SVR12（改良意向性分析）（1型和4型为100%，3型为97.3%（362/372））。在意向性分析中，SVR12为88.1%（512/581）[1型 - 96.8%（121/125），3型 - 85.2%，4型 - 93.5%（29/31）]。70例患者治疗失败（6例无应答，2例病毒学突破，10例复发，2例死亡，50例失访）。无论HCV基因型、是否存在肝硬化或既往治疗史如何，均观察到高SVR率。未发现需要停药的重大不良事件。
DAA疗法对HCV 1、3和4型感染的所有患者，包括有肝硬化和既往无应答者，均能实现高SVR率。
