The adverse effects of interferon‐free regimens in 149 816 chronic hepatitis C treated Egyptian patients.

Summary: Background: Interferon‐free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. Aim: To evaluate the adverse effects associated with the different direct‐acting antiviral drug (DAA) regimens in Egyptian patients. Methods: This multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149 816 chronic hepatitis C treated Egyptian patients. Patients received sofosbuvir (SOF)/ribavirin (RBV) (n = 21 835), SOF/simeprevir (n = 24 215) SOF/daclatasvir (DCV) (n = 58 477), SOF/DCV/RBV (n = 45 188) and paritaprevir/ombitasvir/ritonavir/RBV (n = 101). The duration of treatment varied between 12 and 24 weeks. All changes in the treatment regimens, discontinuation, mortality, and serious side effects were reported. Results: Adverse effects developed in 2475 (1.7%) (mean age [54 ± 9], male gender [53%]) patients. Serious side effects developed in 68% of these patients, and SOF/RBV was the most common causing regimen (73%, <italic>P</italic> < 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 <italic>P</italic> = 0.045) and mortality (Log rank <italic>P</italic> = 0.025) than patients without liver cirrhosis. Male gender (<italic>P</italic> = 0.012), lower haemoglobin (<italic>P</italic> < 0.001), platelets (<italic>P</italic> < 0.001) and albumin (<italic>P</italic> = 0.001), higher bilirubin (<italic>P</italic> = 0.002) and cirrhosis (<italic>P</italic> < 0.001) were factors associated with serious side effects development. Conclusion: Adverse 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. [ABSTRACT FROM AUTHOR]