A Study to Assess the Efficacy of the Sofosbuvir/Daclatasvir Combination as a Pan-genotypic Treatment for Hepatitis C without HCV Genotype Determination

Background: Viral hepatitis C (HCV) is a global health challenge affecting at least 3.3% of the world’s population. Saharan Africa still battles with the under-diagnosis and poor access to diagnostic facilities occasioned by a lack of manpower/facilities to treat infected persons bringing about an increase in HCV-associated morbidity and mortality. The goal of this prospective observational study is to assess the efficacy of the sofosbuvir/daclatasvir combination as a pan-genotypic treatment for hepatitis C without HCV genotype determination in patients with hepatitis C attending the hepatology clinic at Rivers State University Teaching Hospital (RSUTH).

Methodology: 150 HCV RNA-positive patients were enlisted into the study. Their socio-demographic factors and clinical and laboratory parameters including HCV RNA pre- and post-treatment were assessed. Treatment-eligible patients received sofosbuvir 400mg and Daclatasvir 60/90mg for 12 weeks which was extended to 24 weeks in patients with decompensated liver disease. Treatment success was defined as undetectable HCV RNA 12 weeks after completion of therapy (SVR-12).

Results: 109 of the 150 recruited patients were eligible for treatment. The male to female ratio of the study population was 79(52.7%):71(49.3%) with a mean age of 47.78±13.39 (18-74) years. 86(78.9%) of the 109 treated patients had undetectable HCV RNA at SVR-12 and this was most likely to occur in patients with low viremia (OR=2.52, 95%CI=0.985-6.436, p=0.050). Extension of treatment duration played no apparent role in the achievement of SVR-12 (SVR-12=33.3%) however, previously treated HCV patients had a better outcome.

Conclusion: Sofosbuvir/daclatasvir pan-genotypic therapy is modestly effective for the treatment of HCV patients without genotyping.