Experimental Drug May Lessen Hepatitis C Treatment Duration

An investigational drug called RG-101 could shorten the treatment time for hepatitis C virus (HCV) infection to 4 weeks. That could be good news both for patients and for payers looking for ways to reduce the cost of HCV regimens.

According to research presented at the International Liver Congress in Barcelona, when RG-101 was given as an injection with a 4-week course of direct-acting antivirals (DAA), there was a sustained high virologic response rate in patients. The drug is made by San Diego, CA biotech Regulus.

The trial enrolled 79 subjects who were treatment naïve and had HCV genotypes 1 and 4.

The study was done by Mihaly Makara, MD, of the Buda Hepatology Centre in Budapest, Hungary, and colleagues.

The usual DAA regimen takes 8 to 12 weeks, but the experimental drug appears to interrupt the replication cycle of the virus earlier and cure patients faster. Follow-up data will be available in 48 weeks.

Patients received the injections twice, on the first day of treatment and on the 29th day.

According to the researchers, RG-101 works on microRNA-122, which the virus uses to replicate. The drug interferes with that process.

The DAAs the patients received were either ledipasvir/sofosbuvir, simeprevir, or daclatasvir.

Interim analysis showed that 97.4% and 100% of patients at 8 and 12 weeks, respectively, had high virologic response, meaning they had HCV levels “below the lower limit of quantification.”

Side effects were mild, mostly headache and fatigue in 11.4% of patients.