Investigational RG-101 could shorten HCV treatment with direct-acting antivirals to four weeks, researchers report in a phase 2 study.
An investigational drug called RG-101 could shorten the treatment time for hepatitis C virus infection to four weeks. That could be good news both for patients and for payers looking for ways to reduce the cost of HCV regimens.
According research presented at the International Liver Congress in Barcelona, when RG-101 was given as an injection with a four-week course of direct-acting antivirals there was a sustained high virologic response rate in patients. The drug is made by San Diego, CA biotech Regulus.
The 79 subjects were treatment naïve and had HCV genotypes 1 and 4.
The study was done by Mihaly Makara, MD of the Buda Hepatology Centre, Budapest, Hungary, and colleagues.
The usual DAA regimen takes eight to 12 weeks but the experimental drug appears to interrupt the virus’ replication cycle earlier and cure patients faster.
Follow-up data will be available in 48 weeks.
Patients got 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 eight 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.