Abstract
Objective:To assess the effectiveness of Sofosbuvir (SOF) and Daclatasvir (DCV) in patients with chronic hepatitis C (CHC), compensated cirrhosis (CC) and decompensated cirrhosis (DCLD) either treatment naïve or experienced.Methods:This was a prospective, observational study, conducted from January 2017 to December 2018 at Jinnah Postgraduate Medical Centre, Karachi. All patients above 12 years of age with detectable HCV RNA PCR were included. Patients were divided into three groups: CHC, CC and DCLD. SOF and DCV for 12 or 24 weeks were given. Ribavirin (RBV) was given to treatment experienced and cirrhotic patients. Primary outcome was End of Treatment Response (ETR) and secondary outcome was Sustained Virological Response (SVR) at post treatment week 12 or 24.Results:Total 300 patients with mean age of 40.49 ± 13.86 were enrolled. Majority were females 174 (58%). CHC were 200 (66.6%) while cirrhotic were 100 (33.4%). Treatment naïve patients were 267 (89%) and 33 (11%) patients were experienced. Most common genotype was 3 (83%). ETR was achieved in 292 (97.33%) and SVR in 265 (88.33%) patients respectively.Conclusion:SOF plus DCV with or without RBV is a highly effective treatment for chronic HCV and is still used in many centers of Pakistan. This regimen has excellent results for GT-3. The outcomes are mainly influenced by the presence or absence of cirrhosis.
Highlights
Hepatitis C virus (HCV) has an estimated prevalence of 115 million worldwide.[1]. It can cause acute or chronic hepatitis that leads to cirrhosis in 10-20% and hepatocellular carcinoma (HCC) in 1-5% of the patients.[2]
GT-3 has a higher incidence in Asian countries especially Pakistan and India whereas GT-1 makes up only a fraction of the total cases of HCV here
Compensated Cirrhosis (CC): Patients with active viral replication with evidence of cirrhosis on ultrasound or transient elastography (TE) with liver stiffness measurement score of ≥ 13 KPa or having endoscopic evidence of varices or portal hypertension were included in this category
Summary
Hepatitis C virus (HCV) has an estimated prevalence of 115 million worldwide.[1]. It can cause acute or chronic hepatitis that leads to cirrhosis in 10-20% and hepatocellular carcinoma (HCC) in 1-5% of the patients.[2]. Genotype 1 (GT-1) had the best treatment outcomes, while Genotype-3 (GT-3) had the worst outcomes. All of this changed after the approval of Direct. Daclatasvir (DCV), a NS5A inhibitor was first approved in 2015 by the Food and Drug Authority to be used in combination with SOF for treatment of HCV genotypes 1&3. There is ample data available on the efficacy and safety of the SOF+DCV regimen in treating HCV in the west. Focused researches from Pakistan in this matter are lacking. With such a high rate of viremia[4] in cirrhotics and non cirrhotics, insights into treatment options for HCV in Pakistan are much needed. Through this study we hope to enlighten our society about just one such option
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