Two injections of RG-101 in combination with a four-week course of direct-acting antiviral (DAA) therapy has been shown to clear hepatitis C in patients at both 12 and 24 weeks after treatment in the majority of patients, according to research that will be presented on November 12 at a meeting of the American Association for the Study of Liver Disease. RG-101 is a newly developed injectable therapy that targets microRNA, a molecule that is essential for hepatitis C virus (HCV) to continue to replicate in the liver.
Researchers in Europe recently assessed the safety and efficacy of a four-week treatment that combined RG-101 with oral DAA therapy in 79 subjects with HCV genotypes 1 and 4. The subjects’ average age was approximately 45 years, and 54% were women. The subjects were assigned to one of three DAA treatment groups––ledipasvir/sofosbuvir (group 1), simeprevir (group 2), or daclatasivr (group 3)––and received these medications along with a 2-mg/kg injection of RG-101 at days 1 and 29.
At the beginning of the study, the average HCV viral load was 638,000 IU/mL. Seventy-seven percent of the participants had viral genotype 1, and 86% had stage 0 or stage 1 fibrosis.
One hundred percent of the subjects in group 1, 96% of those in group 2, and 92% of those in group 3 had undetectable levels of HCV after 12 weeks of treatment, according to the investigators. After 24 weeks of treatment, 29 subjects were available for follow up. Among these individuals, 100% of group 1, 80% of group 2, and 89% of group 3 were free from HCV.
“This study showed promising results that curing chronic hepatitis C infection is possible with a very short course of treatment,” said lead investigator Mihály Makara, MD.
Source: PR Newswire; November 11, 2016.