Gorka Suresh, Gulzar Ghulam M, Yattoo Ghulam N, Sodhi Jaswinder S, Dar Gulzar A, Laway Mushtaq A, Kaushik Saurabh, Dhar Neeraj, Mushfiq Syed, Aziz Riffat A
Department of Gastroenterology, SKIMS, Srinagar 190011, India.
J Clin Exp Hepatol. 2020 Mar-Apr;10(2):155-162. doi: 10.1016/j.jceh.2019.07.003. Epub 2019 Jul 19.
Our data is one of the earliest study from the Indian subcontinent on Velpatasvir/Sofosbuvir (VEL/SOF) combination in chronic hepatitis C (CHC). The primary end point was to evaluate sustained virologic response (SVR) 12 in CHC-infected patients and to determine its effect in patients with hepatitis C virus-related cirrhosis. The secondary end point was to observe any adverse events related to treatment.
All patients with CHC were randomized into two groups: noncirrhotic and cirrhotic. The combination of VEL/SOF was given as recommended.
One hundred patients with CHC infection treated with the VEL/SOF regimen were evaluated. A total of 79 (79%) of 100 patients were noncirrhotic, and 21 (21%) were cirrhotic. We achieved SVR12 in 99 (99%) of 100 patients. Among cirrhotics, the mean serum bilirubin (mg/dl), albumin (g/dl), and platelet count (×10³/μL) improved from baseline 1.82 ± 0.87, 3.22 ± 0.69, and 80.19 ± 46.03 to 1.74 ± 0.87, 3.48 ± 0.72, and 85.05 ± 42.50, respectively, at SVR12 (-value > 0.05). Mean serum alanine aminotransferase (ALT) (U/L) improved from baseline 71.28 ± 59.17 to 35.38 ± 17.39 at SVR12 (-value < 0.024). Baseline mean liver stiffness measurement (LSM) in cirrhotic patients was 28.24 ± 10.87 kPa, which decreased to 24.04 ± 9.33 kPa at SVR12 (-value, 0.02). The baseline Model for End-Stage Liver Disease (MELD) score was 13.47 ± 3.66, which decreased to 12.33 ± 5.46 at SVR12 (-value, 0.28). The Child-Turcotte-Pugh score improved by 1 point in 33.33% (7/21) patients and 2 points in 9.52% (2/21) patients, and in the majority, that is, 38.09% (8/21), the score remained as it is.
A single daily dose of the tablet SOF/VEL combination is safe and effective in all types of CHC. There was a significant improvement in the mean transaminase level and LSM at SVR12. And the MELD score improved by 1 point at SVR12 among cirrhotics.
我们的数据是印度次大陆关于慢性丙型肝炎（CHC）患者使用维帕他韦/索磷布韦（VEL/SOF）联合治疗的最早研究之一。主要终点是评估CHC感染患者的12周持续病毒学应答（SVR），并确定其对丙型肝炎病毒相关肝硬化患者的疗效。次要终点是观察与治疗相关的任何不良事件。
所有CHC患者被随机分为两组：非肝硬化组和肝硬化组。按照推荐给予VEL/SOF联合治疗。
对100例接受VEL/SOF方案治疗的CHC感染患者进行了评估。100例患者中共有79例（79%）为非肝硬化患者，21例（21%）为肝硬化患者。100例患者中有99例（99%）实现了SVR12。在肝硬化患者中，SVR12时血清总胆红素（mg/dl）、白蛋白（g/dl）和血小板计数（×10³/μL）的均值分别从基线时的1.82±0.87、3.22±0.69和80.19±46.03改善至1.74±0.87、3.48±0.72和85.05±42.50（P值>0.05）。SVR12时血清丙氨酸氨基转移酶（ALT）（U/L）均值从基线时的71.28±59.17改善至35.38±17.39（P值<0.024）。肝硬化患者基线时的平均肝脏硬度值（LSM）为28.24±10.87 kPa，SVR12时降至24.04±9.33 kPa（P值，0.02）。终末期肝病模型（MELD）基线评分是13.47±3.66，SVR12时降至12.33±5.46（P值，0.28）。Child-Turcotte-Pugh评分在33.33%（7/21）的患者中提高了1分，在9.52%（2/二十一）的患者中提高了2分，而在大多数患者中，即38.09%（8/21），评分保持不变。
每日一次服用SOF/VEL联合片剂对所有类型的CHC均安全有效。SVR12时平均转氨酶水平和LSM有显著改善。肝硬化患者在SVR12时MELD评分提高了1分。
