Clinical trial results for the investigational regimen of glecaprevir (300mg)/pibrentasvir (120mg) (G/P) indicated positive news for patients infected with chronic hepatitis C virus (HCV) with genotype 1,2,4,5, or 6 and compensated cirrhosis (Child-Pugh A).
According to the study, 99% of the HCV patient group “achieved sustained virologic response” at 12 weeks following the pan-genotypic treatment with (G/P), a once-daily regimen combining 2 distinct antiviral agents as three oral tablets.
Researchers from AbbVie Pharmaceuticals today shared their trial results from the Phase 3 EXPEDITITION-1 study at the European Association for the Study of the Liver (EASL) International Liver Congress in Amsterdam, The Netherlands.
EXPEDITION-1, a single arm, multicenter, and open-label study, aimed to assess the safety and efficacy of 12 weeks of G/P in a group of 146 adults with genotypes 1,2,4,5, or 6. Some of the patients included those new to treatment or who had prior treatment experience with IFN-based treatments (IFN/pegIFN ± RBV, or sofosbuvir + RBV ± pegIFN).
The team highlighted that these high SVR12 rates were specifically seen in the G/P treatment without ribavirin. Also, the most commonly reported adverse events, fatigue and headache, were only considered “mild,” so no patients discontinued the treatment.
The primary endpoint was the percentage of patients achieving SVR12
, in this case, 99% (145/146), with only one GT1a-infected patient experiencing relapse.
Interestingly, the researchers noted that despite consistent progress in treatment for HCV patients with compensated cirrhosis, treatment challenges still remain related to the use of ribavirin. “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,” said Xavier Forns, MD, head of the hepatitis unit, Hospital Clinic de Barcelona, Spain.
Officials reported that authorization applications for G/P are currently under review across the globe, but the regimen has been granted accelerated assessment by the European Medicines Agency (EMA0 and priority review designations by the US Food and Drug Administration, Japanese Ministry of Health, and Labor and Welfare.