Phase 3 Study Finds Pan-Genotypic HCV Regimen Highly Efficacious
SVR at 12 weeks post-treatment was achieved in 99% of patients. Photo Credit: By Nephron, via Wikimedia Commons.
Patients with genotype (GT) 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection and compensated cirrhosis achieved a high rate of sustained virologic response at 12 weeks (SVR12) when treated with glecaprevir/pibrentasvir (G/P), supporting the efficacy of this novel pan-genotypic HCV regimen, according to research presented at the 2017 International Liver Congress™ held April 19-23 in Amsterdam, The Netherlands.1
In a phase 3, single arm, multicenter, open-label study (EXPEDITION-1; ClinicalTrials.gov identifier: NCT02642432), Xavier Forns, MD, PhD, head of the liver unit at the Hospital Clinic in Barcelona, Spain, and colleagues, evaluated the efficacy and safety of G/P without ribavirin in 146 treatment-naïve or treatment-experienced adults with chronic HCV GT1, 2, 4, 5 or 6 infection and compensated cirrhosis.
Patients received G/P (300 mg/120 mg) once daily for 12 weeks. Efficacy variable was SVR12 post treatment. Safety was evaluated in all patients who received at least 1 dose of the investigational regimen.
Findings showed that 99.3% of patients with HCV GT1 (59.6%), GT2 (23.3%), GT4 (11.0%), GT5 (1.4%), or GT6 (4.8%) infection achieved SVR12 with the G/P regimen. One patient with a GT1a infection experienced relapse post-treatment Week 8.
G/P was found to be well-tolerated, with mild adverse events (AEs) and no drug-related discontinuations. Fatigue and headache were the most common AEs and no patients experienced ALT elevations ≥Grade 3.
"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 Dr Forns in a press release.2 "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."
The researchers report financial relationships with Abbott Laboratories, AbbVie, Achillion Pharmaceuticals, Inc, Bayer, Baxter, Boehringer-Ingelheim, Bristol-Myers Squibb, Eisai, Gilead Sciences, Idenix Pharmaceuticals, Inc, Ikaria, Intercept Pharmaceuticals, Inc, Janssen Global Services, LLC, Merck & Co, Inc, Merck Sharp & Dohme, Mochida Pharmaceutical Co, Ltd, Novartis, Ocera Therapeutics Inc, Pendopharm, Roche, Salix Pharmaceuticals, Santaris, Sundise, Taigen, Takeda Pharmaceuticals, and Vertex Pharmaceuticals.
- Forns X, Lee S, Valdes J, et al. EXPEDITION-I: Efficacy and safety of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis. Presented at: The International Liver Congress™ 2017. Amsterdam, The Netherlands; April 19-23, 2017. Abstract GS-006.
- AbbVie's investigational, pan-genotypic, ribavirin-free regimen of glecaprevir/pibrentasvir (g/p) achieved 99 percent SVR(12) rate in chronic hepatitis C patients with compensated cirrhosis [press release]. North Chicago, IL: AbbVie Inc. Published April 20, 2017. Accessed April 28, 2017.