AbbVie's pan-genotypic HCV regimen achieves 99% cure rate in phase 3 study
A phase 3 study demonstrated that AbbVie's pan-genotypic ribavirin-free HCV regimen of glecaprevir/pibrentasvir (G/P) achieved a 99% cure rate after 12 weeks of treatment.
The trial, dubbed EXPEDITION-1, featured patients having chronic hepatitis C virus (HCV) infected patients with genotype 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A), and subjected to the G/P treatment that was free from ribavirin.
It demonstrated that almost all the patients had achieved virologic response that was sustainable after 12 weeks after treatment (SVR12) with the investigational, pan-genotypic regimen of G/P.
According to AbbVie, high rates of SVR12 were noted in the phase 3 trial in the absence of ribavirin.
AbbVie research and development executive vice president and chief scientific officer Michael Severino said: "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.
"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."
The US-based pharma, which is a spin-off of Abbott Laboratories, stated that patients having specific virus strains usually seen with resistance or with a high virus quantity in bloodstream before start of the treatment were also included in the study.
AbbVie has reported that most of adverse events in the trial were mild like fatigue and headache which did not lead to any discontinuation of treatment in any of the patients.