The adverse effects of interferon-free regimens in 149816 chronic hepatitis C treated Egyptian patients

BackgroundInterferon-free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. AimTo evaluate the adverse effects associated with the different direct-acting antiviral drug (DAA) regimens in Egyptian patients. MethodsThis multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149816 chronic hepatitis C treated Egyptian patients. Patients received sofosbuvir (SOF)/ribavirin (RBV) (n=21835), SOF/simeprevir (n=24 215) SOF/daclatasvir (DCV) (n=58477), SOF/DCV/RBV (n=45 188) and paritaprevir/ombitasvir/ritonavir/RBV (n=101). The duration of treatment varied between 12 and 24weeks. All changes in the treatment regimens, discontinuation, mortality, and serious side effects were reported. ResultsAdverse effects developed in 2475 (1.7%) (mean age [549], male gender [53%]) patients. Serious side effects developed in 68% of these patients, and SOF/RBV was the most common causing regimen (73%, P<0.001). Anaemia and hyperbilirubinemia were the most common side effects (731/149816, 0.5% and 463/149816, 0.3%, respectively) and SOF/RBV (588/21835, 3% and 353/21835, 1.6%, respectively) showed the highest incidence in the treated patients. Hepatocellular carcinoma and mortality were reported in 0.02% and 0.06% of all treated patients, respectively. Patients with liver cirrhosis showed higher incidence of serious side effects (Log rank P=0.045) and mortality (Log rank P=0.025) than patients without liver cirrhosis. Male gender (P=0.012), lower haemoglobin (P<0.001), platelets (P<0.001) and albumin (P=0.001), higher bilirubin (P=0.002) and cirrhosis (P<0.001) were factors associated with serious side effects development. ConclusionAdverse effects associated with DAAs are few, anaemia being the most common. SOF/RBV regimen showed the highest rate of side effects while SOF/DCV showed the least.