Abstract

BackgroundThis study aimed to evaluate the efficacy, safety and tolerability of SOF/DCV ± RBV in a cohort of Egyptian patients with chronic hepatitis C (CHC)-induced cirrhosis with decompensation (class B7–B9).ResultsAfter excluding the 9 patients who withdrew, SVR12 rate according to per protocol analysis was 82.9% (92/111), non-response and relapse rates were 2.7% (3/111) for each, 4 patients died secondary to hematemesis, and 8.1% stopped therapy due to worsening of Child’s class. SVR12 rate was significantly higher among patients with higher baseline WBCs count and lower among patients with Child-Pugh class B9. All treatment intolerant patients had ascites in pre-treatment assessment (P = 0.02). There was a significant decline in the levels of hemoglobin, ALT and AST, and serum bilirubin (P < 0.001) and a significant increase in albumin level (P < 0.001) at the end of treatment when compared to their pre-treatment levels. Follow-up of the three HCC did not show evidence of tumor recurrence.ConclusionsThe SOF/DCV combination ± ribavirin is an effective and safe regimen for patients with CHC induced cirrhosis with mild decompensation. Treatment did not increase the risk of HCC recurrence.

Highlights

  • This study aimed to evaluate the efficacy, safety and tolerability of SOF/DCV ± RBV in a cohort of Egyptian patients with chronic hepatitis C (CHC)-induced cirrhosis with decompensation

  • The initial goal of hepatitis C treatment is to eradicate hepatitis C virus (HCV) which is specified by a sustained virological response (SVR), defined as undetectable HCV

  • The current study aimed to evaluate the efficacy, safety, and tolerability of SOF/DCV ± RBV in a cohort of Egyptian patients with CHC induced decompensated cirrhosis with Child scoreB7–B9

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Summary

Introduction

This study aimed to evaluate the efficacy, safety and tolerability of SOF/DCV ± RBV in a cohort of Egyptian patients with chronic hepatitis C (CHC)-induced cirrhosis with decompensation (class B7–B9). Egypt had the highest prevalence of hepatitis C virus infection in the world, and genotype 4 virus is found in more than 90% of patients [1]. Since 2014 several direct acting antivirals (DAAs) have been approved enabling interferon-free antiviral treatments with high SVR rates, and some of them are giving the chance for decompensated (cirrhotic) patients [4]. Sofosbuvir (SOF) is an inhibitor of NS5B-polymerase.It has effectiveness against all genotypes with a high resistance barrier and good tolerability with once daily oral dosing [5]. Reported results from previous clinical studies demonstrated that SOF and DCV combination therapy, have a good tolerability, limited drug to drug interactions, and a high rates

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