Enanta Announces Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-Free HCV Regimen of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates in Challenging-to-Treat Genotype 3 Chronic HCV Patients
- 95 percent of patients infected with genotype 3 (GT3) chronic hepatitis C virus (HCV), without cirrhosis and who are new to treatment achieved SVR12 with 8 weeks of treatment
- Together with previously reported data, these study results support the potential of G/P as an 8-week treatment for the majority of people living with HCV across all genotypes
- GT3 is the second most common genotype worldwide and the most challenging to treat2,3; limited treatment options exist for newly diagnosed patients
- 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 addition to evaluating 8 weeks of treatment with G/P, the ENDURANCE-3 study was designed to evaluate whether 12 weeks of G/P treatment is non-inferior to 12 weeks of sofosbuvir plus daclatasvir (SOF+DCV), a current standard of care for GT3 chronic HCV-infected patients.1 SVR12 rates of 95 percent were seen in both 8 weeks (n=149/157) and 12 weeks (n=222/233) of treatment with G/P.1 Additionally, 12 weeks of treatment with G/P was demonstrated to be non-inferior to 12 weeks of treatment with SOF+DCV (97 percent, n=111/115).1
GT3 is the second most common genotype globally, accounting for 18
percent of patients worldwide and 26 percent of patients in
Full results from ENDURANCE-3 are the latest to be released from AbbVie’s registrational studies in its G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.
In the ENDURANCE-3 study, no patients who received 8 weeks of G/P discontinued treatment due to adverse events (AEs).1 AEs were mostly mild (71 percent) in patients receiving both 8 and 12 weeks of G/P. The most common AEs (≥10 percent) in patients receiving 8 weeks and 12 weeks of G/P were headache (20 and 26 percent), fatigue (13 and 19 percent) and nausea (12 and 14 percent), respectively and with patients receiving 12 weeks of SOF+DCV treatment (headache 20 percent, fatigue 14 percent and nausea 13 percent).1
Authorization applications for G/P are currently under review by
regulatory authorities around the world. G/P has been granted
accelerated assessment by the
The ENDURANCE-3 study will be featured in the official ILC press
About the ENDURANCE-3 Study
ENDURANCE-3 is a Phase 3, open-label, active-controlled study evaluating patients who are new to treatment with HCV GT3 infection without cirrhosis. The study included 505 patients who were randomized to receive either 12 weeks of G/P (Arm A, n= 233) or 12 weeks of SOF+DCV (Arm B, n=115), with subsequently enrolled patients receiving 8 weeks of G/P (Arm C, n=157). The primary endpoint was the percentage of patients achieving SVR12. The rate of virologic failure was 1.7 percent (n=4/233) in Arm A, 0.8 percent (n=1/115) in Arm B and 3.8 percent (n=6/157) in Arm C.
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
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.
*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
**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 Foster, GR et al. ENDURANCE-3: safety and efficacy of
glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in
treatment-naïve HCV genotype 3-infected patients without cirrhosis.
Presented at The International Liver Congress™ (ILC) in
2 Petruzziello, A. et al. Global epidemiology of hepatitis C virus infection: An up-date of the distribution and circulation of hepatitis C virus genotypes. World J Gastroenterol. 2016; 22(34): 7824-7840
3 Asselah T, Thompson AJ, Flisiak R, Romero-Gomez M, Messinger D, Bakalos G, et al. (2016) A Predictive Model for Selecting Patients with HCV Genotype 3 Chronic Infection with a High Probability of Sustained Virological Response to Peginterferon Alfa-2a/Ribavirin. PLoS ONE 11(3): e0150569. doi:10.1371/journal.pone.
4 EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol (2016), http://dx.doi.org/10.1016/j.jhep.2016.09.001.