Combination Therapy Clears HCV From Patients With Cirrhosis

According to a study in the May 5, 2015, issue of the Journal of the American Medical Association, a 12-week dose of an investigational, 3-drug combination for hepatitis C virus (HCV) infection cleared the virus in 93% of study volunteers with previously untreated liver cirrhosis.

Bristol-Myers Squibb funded the trial of the 3-drug combination, which consisted of daclatasvir, asunaprevir, and beclabuvir. The US Food and Drug Administration has not yet approved the 3 drugs in combination, but daclatasvir is currently under review. Duke Medicine researchers collaborated on the design and analysis of the trial and authored the report based on the study findings.

The trial recruited patients with HCV-related cirrhosis, 112 of whom were treatment naïve and 90 who had previous unsuccessful therapies, and was conducted between December 2013 and September 2014 at nearly 50 sites across the US, Canada, France, and Australia. All patients were infected with HCV genotype 1, a common strain in North America, Western Europe, and Australia.

For those study participants whose therapies had failed and may have had potential resistance, the drug combination was less successful; HCV was eliminated in 87% of this group. However, adding ribavirin—a commonly used treatment option for HCV infection—appeared to enhance results. When the researchers added the drug to the investigational regimen, success rates in the previously treated participants reached 93%—which was the same rate as those receiving treatment for the first time.

The drugs had minimal adverse events for most participants. According to the study findings, 9 patients experienced serious adverse events, 3 of which were related to treatment.

No vaccine has been developed to protect people from HCV, which is spread through contact with blood. Most people with HCV do not know they are infected until they have symptoms and have already sustained liver damage, says Andrew Muir, MD, MHS, chief of the division of gastroenterology at Duke and the lead author on the study. For this reason, Americans born between 1945 and 1965 should automatically be tested, he urges.

For most of the last 20 years, therapies for hepatitis C relied on interferon drugs, which require regular injections for as long as 1 year and trigger flu-like adverse events that prompt many patients to stop the regimen. Some patients, Muir notes, are ineligible for this treatment if they have anemia, a low platelet count, or other conditions.

“Those with more advanced disease are unlikely to tolerate interferons, and many patients would decide against even getting treatment,” Muir explains. “For those who can tolerate it, it would be only moderately effective.”