Clinical Research Directory

Efficacy of 12 Weeks Versus 24 Weeks Treatment of Directly Acting Antiviral Therapy in Patients With Hepatitis C Related Chronic Liver Disease

Sponsor: Indus Hospital and Health Network

Summary

This randomized controlled trial proposes to compare the treatment outcomes of 12 weeks versus 24 weeks of direct-acting antiviral (DAA) therapy in patients with HCV-related chronic liver disease, addressing the ongoing debate over the ideal treatment duration. To be conducted at the Department of Gastroenterology, Indus Hospital Health Network over nine months, the study will enroll 192 treatment-naive patients (96 per group) aged over 16 with chronic HCV, while excluding those with hepatocellular carcinoma, decompensated cirrhosis, other liver diseases, prior treatment failure, HBV/HIV co-infection, or various exclusionary lab parameters. Using consecutive sampling and draw randomization, Group A will receive 12 weeks and Group B will receive 24 weeks of a regimen comprising sofosbuvir, daclatasvir, and ribavirin, with all patients followed for 12 weeks post-treatment to assess the primary outcome of sustained virologic response (SVR, defined as HCV RNA \<25 IU/ml). Data will be analyzed in SPSS v25 using t-tests and chi-square tests, with a p-value ≤0.05 considered significant, ultimately aiming to determine whether 12 weeks of therapy is sufficient or whether extending to 24 weeks offers meaningful benefit.

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