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|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|
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
Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.
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
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.