Seventeen prospective and retrospective studies (1,133 patients, range 12 to 106) were included in the review: four randomised controlled trials (279 patients) and 13 cohort studies (854 patients).
Antiviral treatment was stopped early due to severe adverse events in 165 out of 1,133 (14.5%) patients. Where reported (116 patients), the most common severe adverse events that led to premature discontinuation were severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anaemia (11.2%). The mortality rate was 0.3% (four out of 1,133 patients); causes of death were severe sepsis, decompensation of heart disease, hepatocellular carcinoma and severe hepatic failure.
The rate of severe adverse events leading to antiviral treatment discontinuation was significantly higher in patients with Child-Pugh class B and C than in patients with Child-Pugh class A (22% versus 11.4%; p=0.003; 10 studies). The rate of severe adverse events leading to antiviral treatment discontinuation was similar for pegylated interferon alpha 2a and pegylated interferon alpha 2b (14.2% versus 13.7%). Significantly more patients with hepatitis C virus genotype 1 discontinued antiviral treatment due to severe adverse events than patients with hepatitis C virus genotype 3 (30% versus 8.5%; p=0.02; three studies).
Results were reported on the number of patients in whom doses of pegylated interferon and/or ribavirin were reduced and the sustained virological response rate.