A 24-week combination regimen of sofosbuvir and weight-based or low-dose ribavirin was associated with a sustained virologic response to treatment of 68% and 48%, respectively, among patients deemed unlikely to respond to treatment, Anuoluwapo Osinusi, MD, MPH, from the National Institutes of Health in Bethesda, Md., and colleagues reported in the Journal of the American Medical Association.
A separate, smaller group of patients with early to moderate liver fibrosis had a 90% sustained virologic response at 24 weeks to sofosbuvir with weight-based ribavirin, the researchers found.
Hepatitis C is common in urban areas with large populations of patients that have unfavorable predictors of treatment response, such as black race, advanced liver fibrosis, IL28B CT or TT genotypes high baseline viral loads and prior treatment experience, according to background information in the study.
Although recent studies have shown favorable outcomes with interferon-free, direct-acting antiviral regimens, data are not available on populations with poor treatment responses.
So Osinusi and colleagues studied the safety and efficacy of a sofosbuvir and weight-based or low-dose ribavirin regimen in 60 patients with hepatitis C who were in various stages of liver fibrosis.The primary endpoint was undetectable viral load at 24 weeks after treatment completion.
Participants had hepatitis C genotype 1 infections, chronic disease confirmed with liver biopsy, were treatment-naive and hepatitis B and HIV negative. Absolute neutrophil counts were 750 cells/uL or greater, platelet counts were 50,000 cells/uL and hemogloblin was 11 g/dL or greater in women and 12 g/dL in men.
