Single pill cures several strains of hepatitis C

A simple 12-week regimen of two antiviral medicines combined in a single tablet eradicated several strains of the hepatitis C virus (HCV) in 99% of patients, according to results of a phase 3 trial published online November 16, 2015 in the New England Journal of Medicine.

“We’re now able to take a very simple, extremely well-tolerated treatment and cure almost everyone with hepatitis C infection,” said the study’s first author Jordan Feld, MD, MPH, Hepatologist, Research Director and Clinician-Scientist at the Toronto Western Hospital Liver Clinic, in Toronto, Canada.

This trial (ASTRAL-1) showed that a once-daily combination of sofosbuvir (400 mg) and velpatasvir (100 mg) for 12 weeks was effective in both previously treated and newly treated patients with HCV genotype 1, 2, 4, 5, and 6, including those with compensated cirrhosis.

In this randomized, double-blind trial, conducted at 81 sites in 8 different countries, 624 patients received a daily tablet of sofosbuvir-velpatasvir and 116 patients received a placebo. After 12 weeks, 99% of treated patients were free of the virus, but none of the patients on placebo were.

A separate study of patients with HCV genotype 3 investigated the same 12-week drug regimen. Results from this study (ASTRAL-3), also reported in the New England Journal of Medicine, found that 95% of patients taking sofosbuvir-velpatasvir had a sustained virologic response.

The authors of the ASTRAL-1 trial noted, “Patients with characteristics that are historically associated with a lower response to treatment—the presence of cirrhosis, prior treatment failure, black race, and non-CC genotype of IL28B—had rates of virologic response similar to those with historically favorable characteristics.”

Serious adverse events occurred in 2% of the ASTRAL-1 treatment group, and none occurred in the placebo group.

“This is truly a one-size-fits-all treatment that is very easy to administer and extremely well tolerated,” Dr. Feld said. “Our challenge now is getting treatment to those who need it.” 

The crux of that challenge: More than half of the 170 million patients worldwide who are infected with HCV remain undiagnosed.

“The big advantage…of having a single treatment for everyone with this infection is that we can move treatment out of specialty clinics so that people all over the country can get access to this treatment, ideally with their family doctors or local health care providers, without needing to go to highly specialized centers,” Dr. Feld said.

The trials were funded by Gilead Sciences.