Investigational Hepatitis C Drug Shows High Sustained Viral Response

AbbVie recently announced positive results from a phase 3 clinical trial of the investigational combination of glecaprevir/pibrentasvir (G/P) without ribavirin for the treatment of hepatitis C virus (HCV).

In the EXPEDITION-1 trial, 99% of patients with HCV treated with G/P without ribavirin achieved a sustained virologic response at 12 weeks (SVR12), according to a press release.

G/P without ribavirin is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS4A inhibitor, which is administered once daily as 3 oral tablets, according to AbbVie.

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

Included in the study were 146 patients with HCV genotype 1, 2, 4, 5, or 6 and compensated cirrhosis who received 12 weeks of G/P without ribavirin. Patients included were either treatment-naïve or had received prior treatment with an interferon-based therapy.

The researchers discovered that a vast majority of patients achieved SVR12 from the experimental ribavirin-free treatment, according to the release. These findings show that G/P without ribavirin may present a beneficial HCV treatment for patients with compensated cirrhosis.

Current treatment guidelines recommend that patients with HCV with compensated cirrhosis receive treatment, but treating this population has remained a challenge, highlighting a clinically unmet need, according to the release.

G/P is a pan-genotypic treatment that is being assessed as a potential HCV cure for patients without cirrhosis. The results from EXPEDITION-1 suggest that this treatment may also be effective among patients with cirrhosis.

"With our G/P 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," said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie. "The EXPEDITION-1 study results, along with a number of other ILC presentations from our G/P clinical development program, explore the potential of our regimen in patients with specific treatment challenges."