Abstract
BackgroundDirect-acting antivirals (DAAs) therapeutic regimens are highly effective against chronic hepatitis C virus (HCV) infection. However, HCV patients with genotype 3 (GT3) respond in a suboptimal way. This study aims to identify which of the DAAs-based therapeutic regimens are the best option for GT3.MethodsMultiple governments and private tertiary care hospitals were involved in this real-life study of HCV-GT3 patients treated with DAAs. The efficacy and safety of generic sofosbuvir+daclatasvir±ribavirin (SOF+DCV±RBV) and sofosbuvir/velpatasvir±ribavirin (SOF/VEL±RBV) were assessed under the National Hepatitis C Program of Pakistan.ResultsOut of 1,388 participants, 70% of patients received SOF+DCV in government tertiary care hospitals and 30% received SOF/VEL in private tertiary care hospitals. The overall sustained virological responses (SVR) was 95.5%. The SVR rates at 12 weeks were comparable between SOF+DCV (94.4%) and SOF/VEL (94.7%) in chronic HCV patients. However, The SVR rates at 24 weeks were high in cirrhotic patients treated with SOF/VEL+RBV (88%) then SOF+DCV+RBV (83%). Non-responders were high in SOF-DCV than SOF-VEL (4.1 vs 3.8%, P = 0.05) regimen. In multivariate models, the significant predictors of non-SVR were age >60 years (odds ratio [OR] 4.46; 95% CI, 2.35–8.46, P = <0.001) and cirrhosis (OR 53.91; 95% CI, 26.49–109.6, P = <0.001). Skin rash (51 vs 44%) and oral ulcers (45 vs 40%) were high in patients receiving SOF-DCV then SOF-VEL.ConclusionsOverall, the generic SOF+DCV ±RBV and SOF/VEL ± RBV achieved equally high SVR12 rates. However, SOF/VEL+RBV achieved a high SVR rate in cirrhotic patients then SOF+DCV+RBV. Old age and cirrhosis were significant predictors of reduced odds of SVR regardless of the regimen. Furthermore, the regimens were well tolerated in chronic HCV patients.
Highlights
Chronic hepatitis C (CHC) infection is one of the major causes of liver abnormalities and hepatocellular carcinoma (HCC) globally (Baumert et al, 2019)
The sustained virological responses (SVR) rates at 12 weeks were comparable between SOF+DCV (94.4%) and SOF/VEL (94.7%) in chronic Hepatitis C virus (HCV) patients
The significant predictors of non-SVR were age >60 years and cirrhosis
Summary
Chronic hepatitis C (CHC) infection is one of the major causes of liver abnormalities and hepatocellular carcinoma (HCC) globally (Baumert et al, 2019). In the list of Hepatitis C virus (HCV) highest-burden countries, Pakistan ranked 2nd after Egypt with prevalence (4.5–8.2%) (Sievert et al, 2011; Umer and Iqbal, 2016; Organization, 2017). HCV has seven major genotypes, genotype 3a (GT3a) is the most prevalent (69.1%) form in Pakistan followed by GT1 (7.1%), 2 (4.2%), and 4 (2.2%) (Umer and Iqbal, 2016; Khan et al, 2019). The transmission of HCV is mainly driven via therapeutic injections, blood transfusion, syringe reuse, surgery, hospitalization, piercing, and shaving from barbers (Umer and Iqbal, 2016; Trickey et al, 2017; Al Kanaani et al, 2018). Direct-acting antivirals (DAAs) therapeutic regimens are highly effective against chronic hepatitis C virus (HCV) infection. This study aims to identify which of the DAAs-based therapeutic regimens are the best option for GT3
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