Real world experience with the all-oral interferon free regimen for the treatment of chronic hepatitis c virus infection in the Lebanese population

Abstract

Introduction: The treatment of hepatitis C has dramatically improved since the introduction of the new Direct-Acting Antivirals (DAAs). The aim of this study is to assess the effectiveness and safety of all oral DAAs with or without ribavirin in the treatment of hepatitis C virus (HCV) in treatment naïve and experienced Lebanese population.

Methodology: We reviewed all cases approved for hepatitis C treatment with DAAs according to the Lebanese guidelines for treatment of HCV at the Ministry of Public Health from October 2015 till December 2016. Available data concerning age, sex, mode of transmission, genotype (GT) and subtype, fibrosis stage, previous treatment (if present), new DAAs treatment, and sustained virological response at week 12 (SVR12) were collected.

Results: During a period of 15 months (October 2015 to December 2016), 186 patients were treated with DAAs. 57% were male and the mean age was 54.3 years. The source of infection was unknown in 51% of cases and blood transfusion in 35.5% of cases. Genotype 1 was the most predominant genotype (45%), followed by GT4 (34%) and GT3 (12%). 71.6% of patients had advanced fibrosis before starting DAAs and 57% were cirrhotic. 42% of patients were treatment experienced (85% pegylated interferon and ribavirin). Different DAAs regimens were used according to the Lebanese guidelines for treatment of HCV: Ledipasvir/Sofosbuvir (38.7%), Sofosbuvir/Daclatasvir (16.1%), Sofosbuvir/Velpatasvir (1.6%), Sofosbuvir/RBV (7.5%), Ombitasvir/Paritaprevir/Ritonavir (17.5%) and Ombitasvir/Paritaprevir/Ritonavir -Dasabuvir (18.8%). Ribavirin was used in 51.6% of cases. SVR12 was achieved in 93% of patients (relapse in 4%, loss of follow up and/or severe adverse effect in 3%). SVR 12 was achieved in 93%, 96% and 94% of GT1, GT3 and GT4 cases respectively. SVR12 was seen in 91.3% of cirrhotic patients vs. 98.7% of F0-F3 patients. (p = 0.047).  There was no difference in SVR12 between treatment naïve and experienced patients. Hepatocellular carcinoma developed in 5 patients (2.9%) during the study period.

Conclusion: This is the first real world Lebanese data of HCV treatment with DAAs. The study population was significant for a large number of patients with cirrhotic (50%) and treatment experienced patients (42%). SVR12 was achieved in 93% of patients with no difference between treatment naïve and experienced patients. SVR12 was lower in patients with cirrhosis compared to patients with lower stage of fibrosis (91.3% vs. 98.7%).