Positive Results Announced for Ribavirin-Free Hepatitis C Treatment

New data from a phase 3 study revealed that 99% of patients with chronic hepatitis C virus (HCV) and compensated cirrhosis achieved sustained virologic response at 12 weeks (SVR12) with the investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir.

An estimated 130 to 150 million individuals worldwide have chronic HCV, with a 15% to 30% risk of developing cirrhosis of the liver within 20 years.

In the EXPEDITION-1 study, 99% of patients with chronic HCV with genotypes 1, 2, 4, 5, or 6 and compensated cirrhosis achieved SVR 12 post-treatment, according to a press release. The new data was presented at The International Liver Congress 2017 in Amsterdam.

“We have already seen great progress in the treatment of HCV patients with compensated cirrhosis,” Xavier Forns, MD, head of hepatitis unit at Hospital Clinic de Barcelona, Spain, said in a press release. “However, the treatment challenges remain related to the use of ribavirin. The positive findings from the EXPEDITION-1 study, along with previously reported data, show that [glecaprevir/pibrentasvir] has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes.”

EXPEDITION-1 is a single-arm, multicenter, open-label study evaluating the safety and efficacy of 12 weeks of glecaprevir/pibrentasvir treatment in adults with HCV genotypes 1, 2, 3, 5, 6 and compensated cirrhosis

The investigators enrolled 146 patients into the study, which included individuals who were new to treatment or were previously administered IFN-based treatments. The primary endpoint was the percentage of patients achieving SVR12.

Ninety-nine percent of patients achieved SVR12, with one GT1a-infected patient who relapsed, according to the press release.

A majority of observed adverse events (AEs) were mild, and none of the patients discontinued treatment due to an AE. The most common AEs were fatigue and headache.

“With our [glecaprevir/pibrentasvir] clinical development program, our goal is to provide a cure for as many patients living with HCV as possible, across all genotypes and regardless of whether their disease has progressed to compensated cirrhosis,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in a release. “The EXPEDITION-1 study results, along with a number of other ILC presentations from our [glecaprevir/pibrentasvir] clinical development program, explore the potential of our regiment in patients with specific treatment challenges.”

Glecaprevir/pibrentasvir is a once-daily, fixed-dose combination of 300 mg of glecaprevir and 120 mg of pibrentasvir. It was granted accelerated assessment by the European Medicines Agency, and priority review designations by the FDA and Japanese Ministry of Health, Labor, and Welfare.