Genotype 1 and 3 Response to Velpatasvir and Sofosbuvir in Chronic Hepatitis C in the Kashmiri Population: An Observational Study

Abstract

Background: 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. Methods: All patients with CHC were randomized into two groups: noncirrhotic and cirrhotic. The combination of VEL/SOF was given as recommended. Results: 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 (Â10 3 /mL) 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 (P-value > 0.05). Mean serum alanine aminotransferase (ALT) (U/L) improved from baseline 71.28 ± 59.17 to 35.38 ± 17.39 at SVR12 (P-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 (P-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 (P-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. Conclusion: 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.

Sofosbuvir/Velpatasvir fixed dose combination in Indian patients with chronic hepatitis c virus (HCV) infection: an open-label, single-arm, multicenter phase IV study

“…15 Another Indian study conducted in 100 HCV-infected patients has demonstrated SVR 12 rates of 99%. 16 Compared with the FDA registration trials and other real-world studies, the SVR12 rates in the current study were marginally less. However, the sensitivity analysis conducted using the LOCF approach, complete case, and PPS showed SVR12 response rates of 94.8%, 93.9%, and 94.4%.…”