January 17, 2014
This article was reported by Health Newsline.
Health Newsline reported on a study using a combination of two oral antiviral drugs -- daclatasvir and sofosbuvir -- to treat hepatitis C virus (HCV) infection. Mark Sulkowski, MD, medical director of the Johns Hopkins Center for Viral Hepatitis, and colleagues conducted a clinical trial to determine safety and efficacy of the combination drug treatment. The drug sofosbuvir (brand name Sovaldi), manufactured by Gilead Sciences, received US Food and Drug Administration approval in December, while daclatasvir is in the approval process.
The participants comprised 211 HCV patients at 18 medical centers in the United States and Puerto Rico. The participants received a daily combination of 60 milligrams of daclatasvir and 400 milligrams of sofosbuvir, with and without ribavirin. At 12 weeks, approximately 98 percent of patients had what doctors call a functional cure -- the treatment eliminated the virus and stopped it from replicating, even in patients who could not take or did not respond to current treatment.
Patients tolerated the combination therapy well, and patients with all three HCV genotypes showed very high cure rates. Common adverse effects were nausea, anemia, upper respiratory tract infection, and headache, but these were mild and no one discontinued treatment due to adverse effects.
Sulkowski said that if daclatasavir and other new HCV drugs receive approval, then HCV treatment could change from injections that have significant toxicity to oral combination pill therapy. He noted that the research paved the way for safe, tolerable, and effective treatments for the many people infected with HCV, and predicted that standard treatments will improve dramatically in the next year.