Enanta Announces 99 Percent SVR12 Rate in Chronic HCV Patients with Compensated Cirrhosis Treated with AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P)
- New data demonstrated high SVR12 rates across compensated cirrhotic patients with genotype 1, 2, 4, 5 or 6 chronic hepatitis C virus infection with 12 weeks of treatment1
- No patients discontinued treatment due to adverse events in the Phase 3 EXPEDITION-1 study1
- Study results add to body of data for G/P in patients with compensated cirrhosis across all genotypes
- Glecaprevir is Enanta’s second protease inhibitor being developed
through its collaboration with
AbbVieand is one of the two new direct-acting antivirals (DAAs) in G/P
In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild, and no patients discontinued treatment due to an AE. The most common (≥10 percent) AEs were fatigue and headache.
Approximately 130 to 150 million people worldwide are living with chronic HCV, for whom the risk of cirrhosis of the liver is between 15-30% within 20 years.2 Treatment guidelines around the world recommend that all patients with cirrhosis should be considered for treatment, yet the treatment of specific patients with HCV and compensated cirrhosis is still challenging.3,4
Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the
About the EXPEDITION-1 Study
EXPEDITION-1 is a single arm, multicenter, open-label study evaluating the efficacy and safety of 12 weeks of G/P in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A). The study enrolled 146 patients, including those new to treatment or those who had prior treatment experience with IFN-based treatments (IFN/pegIFN ± RBV, or sofosbuvir + RBV ± pegIFN). The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 (99 percent) patients, with one GT1a-infected patient experiencing relapse.
No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients (7.5 percent) who experienced serious AEs, none were considered treatment-related.
G/P is an investigational, pan-genotypic regimen that is being evaluated by
G/P is an investigational, once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.
Additional information on AbbVie’s clinical trials for G/P is available at www.clinicaltrials.gov.
*Patients who are treatment-naive or had prior treatment experience with IFN-based treatments ([peg]IFN +/- RBV or SOF/RBV +/- pegIFN).
Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with
Forward Looking Statements
This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie’s G/P regimen for HCV. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the efforts of
1 Forns, X et al. EXPEDITION-1: 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™ (ILC) in
3 EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.
4 Spach D, Scott J. Treatment of Hepatitis C in Patients with
Cirrhosis. Hepatitis C Online. http://cdn.hepatitisc.uw.edu/pdf/special-populations-situations/treatment-cirrhosis/core-concept/all
Published 2015. Accessed