Response of Sofosbuvir and Daclatasvir combination in Chronic Hepatitis C with Hemodialysis Pakistani Patients: A Single Centre Study

Abstract

Background: Globally, Hepatitis C is the primary causes of acute and chronic hepatitis in end-stage renal disease patients and highly prevalent in hemodialysis patients. In Asia, Hepatitis C Virus (HCV) infection has become a serious public health problem, whereas, in Pakistan, 26.02% hemodialysis patients are infected with HCV infection. The advent of direct-acting antivirals (DAAs) has brought HCV treatment into a revolutionized era. Among the approved DAAs, sofosbuvir (SOF) is the only one that has a significant renal elimination whereas daclatasvir (DAC) is not eliminated by the kidneys. The aims of the study were to assess the effectiveness and safety of SOF and DAC combination in HCV infected patients on Hemodialysis (HD) in the local population as per routine Pakistani practice.

Methodology: An observational, prospective, single-centre study was conducted from December 2017 till September 2018 at the Nawaz Sharif Kidney Hospital, Swat, Pakistan. Total 27 HCV- HD subjects on SOF/DAC regime for 12 weeks, were enrolled in the study. The study was conducted as per the ICH-GCP Guidelines. The collected data was analyzed using SPSS Software version 19 and p-value < 0.05 was considered significant.  

Results: As per the results of 27 subjects’, (n= female 12, 44.5% and n = male 15, 55.5 %), 21 subjects were naive and 6 belonged to treatment experienced group with a mean age of 35.5±9.6 years. On SOF/DAC treatment for 12 weeks, the sustained virological response rate was 100% (27 of 27) at 12 weeks. 95% confidence interval, (95 to 100). No patients had a virologic failure during treatment. The reported adverse events (AE’s) were mainly nausea, headache and fatigue, no serious AE reported. Moreover, no treatment discontinuation due to side effects was observed.

Conclusions: The regime of full dose SOF and DAC therapy is well tolerated, safe and with a high rate of Sustained Viral Response (SVR) in both naive and treatment experienced group of HD Pakistani patients with HCV.