Comparing Daclatasvir plus Sofosbuvir, with or without Ribavirin, for Hepatitis C virus genotype 3 Management.

Abstract

Objectives: to evaluate the sustained virology response rate of Daclatasvir (DCV) + Sofos (SOF) with and without Ribavirin (RBV) for 12 and 24 weeks in patients presented with advance liver disease. Study Design:  Randomized control trial. Setting: Department of gastroenterology, Services hospital, Lahore. Period: January 2018 to January 2019. Material & Methods: Patients advance hepatitis genotype 3 infection was enrolled through non probability consecutive sampling technique. Main outcome variable is sustained virology response rate. SPSS version 23 was used for data analysis. Mean and standard deviation and frequency percentages were calculated for numerical and qualitative data respectively. P value ≤0.05 was considered as significant. Results: One way ANOVA was used to check the differences between four groups, while chi-square test was used for categorical variables. Overall SVR12 rates and causes of treatment failure for the primary (actual duration) for patients who received DCV+SOF for 24 weeks, overall SVR12 (mITT) was 64.4% with RBV and 11.9% without RBV and treatment failure was found 31.3% without RBV and 28.1% with RBV. Sensitivity analyses (duration initially considered), SVR12 in terms of mITT for 24 weeks treatment is 58.4% and without RBV and 15.6% with RBV. Treatment failure is 47.1% without and 23.5% with RBV. Conclusion: Daclatasvir with sofosbuvir is an effective treatment for hepatitis C genotype 3 infections as it achieved high sustained virology response rate in patients of advance liver disease or cirrhotic patients. Without addition of ribavirin this treatment is effective when given for 24 weeks.