(HealthDay News) – In patients with chronic hepatitis C virus (HCV) with unfavorable treatment characteristics, treatment with sofosbuvir and ribavirin reduces viral load to undetectable levels in many patients, according to a study published in the Aug. 28 issue of the Journal of the American Medical Association.
Anuoluwapo Osinusi, MD, MPH, from the National Institutes of Health in Bethesda, MD, and colleagues studied a total of 60 treatment-naive patients infected with HCV with liver fibrosis. Of these, 10 with early to moderate fibrosis were treated with sofosbuvir (400mg/day) and ribavirin (weight-based) for 24 weeks. The remaining 50 (with all stages of liver fibrosis) were randomly assigned to sofosbuvir (400mg/day) and either weight-based or low-dose (600mg/day) ribavirin for 24 weeks.
The researchers found that, of the 10 patients, 90% had a sustained virologic response (SVR; undetectable HCV viral load) at the end of the study. Of the 50 patients, 28% of the weight-based group and 40% of the low-dose group relapsed, giving an SVR of 68% and 48%, respectively. A pharmacokinetic study showed that relapsers had a slower rate of loss of infectious virus. Headache, anemia, fatigue, and nausea were the most common adverse events. Although there were seven grade 3 events, there were no deaths or discontinuations due to adverse events.
“In conclusion, treatment with a 24-week regimen of sofosbuvir and ribavirin resulted in an SVR rate of 68% in the weight-based ribavirin regimen and 48% in the low-dose ribavirin regimen among patients with chronic HCV and unfavorable traditional predictors of treatment response who are representative of the demographics of the U.S. HCV epidemic,” Osinusi and colleagues write.
Several authors disclosed financial ties to pharmaceutical companies, including Gilead Sciences, which provided sofosbuvir for the study.