Enanta Announces High SVR12 Rates Achieved in Genotype 1 Chronic HCV Infected Japanese Patients with Eight Weeks of Treatment with AbbVie’s Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P)
- In the CERTAIN-1 study, 99 percent (n=105/106) of genotype 1 (GT1) chronic hepatitis C virus (HCV)-infected Japanese patients without cirrhosis achieved SVR12 with 8 weeks of G/P treatment
Japanhas one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those are GT11,2,3
- G/P includes Enanta’s second protease inhibitor, glecaprevir (ABT-493)
These data are the first to be released by
Approximately 1 million people are living with hepatitis C in
The CERTAIN-1 study compared the safety and efficacy of 8 weeks of treatment with the investigational G/P regimen to 12 weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), in GT1 chronic HCV-infected patients. The primary endpoint of the study was met, as 8 weeks of G/P was shown to be non-inferior to 12 weeks of OBV/PTV/r (100 percent SVR12; n=52).
Additionally, in sub-study 1 evaluating GT1 patients (treated with G/P) without cirrhosis and who were new to treatment with direct-acting antivirals (DAA), no patients discontinued treatment due to adverse events (AEs). In patients treated with OBV/PTV/r, there was one who discontinued treatment due to AEs. In patients receiving the G/P regimen, the most common AEs, occurring at a rate greater than 5 percent, were nasopharyngitis (inflammation of the throat and nasal passages) and pruritus (itchiness).
About the CERTAIN-1 Study
The CERTAIN-1 study is a Phase 3, multicenter study evaluating the efficacy, safety and pharmacokinetics (PK) of G/P in Japanese adults. Sub-study 1 is a randomized, open-label and active-controlled study in genotype 1 (GT1) chronic HCV-infected patients without cirrhosis who are new to DAA treatment. Patients who tested negative for the Y93H resistance associated variant received either 8 weeks of G/P or 12 weeks of OBV/PTV/r (2:1 randomization ratio). All Y93H positive patients were assigned to receive 8 weeks of G/P and all (n=23/23) achieved SVR12. The primary objectives were safety and non-inferiority of G/P compared to OBV/PTV/r.
Sub-study 2 is a non-randomized, open-label study evaluating GT1-6 HCV patients with specific treatment challenges, including those with compensated cirrhosis (Child-Pugh A), chronic kidney disease (CKD) and those who were not cured with previous DAA treatment.
About AbbVie’s G/P Clinical Development Program
AbbVie’s glecaprevir/pibrentasvir (G/P) clinical development program was
designed to investigate a faster path to virologic cure* for all major
HCV genotypes (GT1-6) and with the goal of addressing treatment areas of
continued unmet need. In
G/P is an investigational, pan-genotypic regimen that is being evaluated
as a potential cure in 8 weeks for HCV patients without cirrhosis who
are new to treatment with direct-acting antivirals (DAA). Patients with
these characteristics constitute the majority of HCV patients.
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.
Glecaprevir is Enanta’s second protease inhibitor being developed
through its collaboration with
G/P is an investigational product and its safety and efficacy have not
been established in
|*Patients with a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.|
Enanta has discovered novel protease inhibitors that are members of the
direct-acting-antiviral (DAA) inhibitor classes designed for use against
the hepatitis C virus (HCV). These protease inhibitors, developed
through Enanta’s collaboration with
Enanta has discovered EDP-305, an FXR agonist product candidate for NASH and PBC, currently in Phase 1 clinical development, and has identified a clinical candidate for RSV, EDP-938, now, in preclinical development. Enanta is also developing early lead candidates for HBV. Please visit www.enanta.com for more information on Enanta’s programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s G/P regimen in
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
2 Gower, E. Global epidemiology and genotype distribution of
the hepatitis C virus infection.
3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. Available from: http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
4 Chung H, Taisuke U, Masatoshi K. Changing Trends in
Hepatitis C Infection over the Past 50 Years in