In an article published in the Journal of the American Medical Association, the new 2-drug regimen of sofosbuvir + ribavirin cured a little more than 2/3 of patients with difficult-to-treat hepatitis C. Characteristics in this study that related to being “difficult to treat” included having genotype 1 (70% with 1a), having unfavorable IL28B gene patterns (about 2/3), and having a high viral load (>800,000).
The SPARE study followed 60 people who had never been treated. Two-thirds were men, 4 out of 5 were African American, and average age was 50. The participants came from the inner-city sections of Washington, DC.
All regimens were 24 weeks long. Ten people with no to moderate fibrosis took once-daily sofosbuvir with a weight-based dose of ribavirin. The other 50 people had varying stages of liver disease (including up to compensated cirrhosis) and took either the same regimen or a regimen with a lower dose of ribavirin to reduce the risk of anemia.
For the weight-based group, 68% had an SVR while 48% on low-dose ribavirin achieved an SVR. Seven people who took weight-based ribavirin and 10 on low-dose ribavirin saw their hepatitis C return after their 24 weeks of treatment.
Four out of the 60 people stopped early (although none due to side effects). Common side effects included headache, anemia, tiredness and nausea. Severe side effects included anemia, neutropenia, nausea, hypophosphatemia and pancreatitis.
For a more detailed analysis, read HIVandHepatitis.com’s coverage.
RESEARCH:
A Osinusi, et al. Sofosbuvir and Ribavirin for Hepatitis C Genotype 1 in Patients With Unfavorable Treatment Characteristics: A Randomized Clinical Trial. Journal of the American Medical Association. August 28, 2013.