Ribavirin-inclusive HCV therapies increased the frequencies of serious adverse events (SAEs) resulting in higher dropout rates and increased patient morbidity, according to a study of 128 patients with chronic HCV infection who were treated with sofosbuvir-based therapies that included ribavirin. Researchers found:

• SAEs appeared in 16% to 54% of ribavirin-inclusive treated patients vs 5% in the ribavirin-free regimen.

• Peginterferon and sofosbuvir plus ribavirin had the highest frequencies of fatigue, headache, and rash vs either 12 or 24 weeks of ribavirin and sofosbuvir.

• However, sofosbuvir and ribavirin regimens led to a significant increase in dyspnea, need for for ribavirin dose reductions, and withdrawal from treatment due to SAEs.

• Anemia was more frequent in ribavirin-inclusive combinations.

• Conversely, sofosbuvir plus simeprevir reached similar sustained virologic response rates at week 12 post-treatment compared to all ribavirin containing regimens, but with significantly fewer adverse events.

• At week 12 post-treatment, 38.2 % of cirrhosis patients experienced viral relapse vs 15.7% of non-cirrhosis patients.

Citation: Tong MJ, Chang PW, Huynh TT, Rosinski AA, Tong LT. Adverse events associated with ribavirin in sofosbuvir based therapies for patients with chronic hepatitis C: A community practice experience. [Published online ahead of print January 8, 2016]. J Dig Dis. doi: 10.1111/1751-2980.12313.