For patients with hepatitis C infection, an experimental oral antiviral drug combination of daclatasvir and sofosbuvir may be an effective and safe treatment option, research published in the New England Journal of Medicine suggests.
To evaluate the safety and efficacy of combination daclatasvir plus sofosbuvir, the investigators conducted an open-label study. Study participants (n=211) were randomly assigned to receive sofosbuvir for 1 week, then daclatasvir and sofosbuvir for 23 weeks; daclatasvir and sofobuvir for 24 weeks; or daclatasvir, sofosbuvir, and ribavirin for 24 weeks.
Overall, most patients had a sustained virologic response, including 98% of patients with genotype 1 infection — the most common hepatitis infection strain in the United States — and 91% of patients infected with genotype 2 or 3.
Daclatasvir plus sofosbuvir was associated with high rates of sustained virologic response among patients with characteristics that were previously associated with a poor response to treatment — HCV genotypes 1a and 3, the non-CC IL28B genotype, and black race.
Chronic infection with hepatitis C virus (HCV) affects more than 170 million patients globally, and since 2007, HCV-related deaths have surpassed deaths attributed to HIV, noted the researchers.
“This research paves the way for safe, tolerable and effective treatment options for the vast majority of those infected with hepatitis C,” said Mark S. Sulkowski, MD, of Johns Hopkins University in Baltimore, Maryland, in a university press release.
“Standard treatments for the disease are going to improve dramatically within the next year, leading to unprecedented advances for the treatment of patients infected with the hepatitis C virus.”
The study was funded by Gilead Sciences and Bristol-Myers Squibb. Sulkowski is a paid consultant to both Gilead Sciences and Bristol-Myers Squibb.