Eight Weeks of Treatment with AbbVie's Investigational, Pan-Genotypic, Ribavirin-free Regimen of Glecaprevir/Pibrentasvir (G/P) for Chronic Hepatitis C Achieved High SVR[12] Rates in Genotype 1 Japanese Patients
- 99 percent (n=105/106) of genotype 1 (GT1) chronic HCV-infected Japanese patients without cirrhosis achieved SVR[12] with 8 weeks of G/P
- Japan has one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those GT1[1,2,3]
- Results demonstrated in CERTAIN-1 study are consistent with recently announced 8-week, GT1 data from the global registrational studies for G/P
- 99 percent (n=105/106) of genotype 1 (GT1) chronic HCV-infected Japanese patients without cirrhosis achieved SVR[12] with 8 weeks of G/P
- Japan has one of the highest rates of hepatitis C infection in the industrialized world affecting approximately 1 million people, 60 to 70 percent of those GT1[1,2,3]
- Results demonstrated in CERTAIN-1 study are consistent with recently announced 8-week, GT1 data from the global registrational studies for G/P
NORTH CHICAGO, Ill., Jan. 9, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced high SVR12 rates with 8 weeks of treatment with its investigational, pan-genotypic, ribavirin (RBV)-free regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis. In top-line results from the Phase 3 CERTAIN-1 study, 99 percent (n=105/106) of patients without cirrhosis, which represents the majority of HCV patients, and without the Y93H variant achieved sustained virologic response at 12 weeks post treatment (SVR12). The only patient in whom SVR12 was not documented in this intent to treat (ITT) population was lost to follow-up. All 23 patients with the Y93H variant were assigned to the G/P arm and achieved SVR12.
These data are the first to be released from registrational studies in Japan as part of AbbVie's global G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes and with the goal of addressing treatment areas of continued unmet need.
"These initial data in GT1-infected patients, which is the most common type of hepatitis C in Japan, may help to further advance our understanding on how we care for patients in this country," said Stefan Zeuzem, M.D., Chief of the Department of Medicine at the Goethe University Hospital in Frankfurt, Germany. "In the CERTAIN-1 study with the G/P regimen, we see for the first time that 8 weeks of treatment achieved high cure rates in these GT1-infected Japanese patients without cirrhosis."
Japan has one of the highest rates of hepatitis C infection in the industrialized world.2 Approximately 1 million people are living with hepatitis C in Japan, with 60 to 70 percent of those infected with GT1 chronic HCV.1,3 Patients included in the CERTAIN-1 study were further representative of the HCV-infected patient population in Japan, where the prevalence of HCV infection increases with age, by including a majority of patients over 65 years of age.4
"Due to patient characteristics and virological considerations, people living with HCV in Japan have specific treatment challenges and needs," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie's dedicated G/P registrational clinical development program in Japan reflects our continued commitment to make a real difference in the lives of Japanese patients."
The CERTAIN-1 study compared the safety and efficacy of 8 weeks of treatment with the investigational G/P regimen, to 12 weeks of 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 substudy 1 evaluating GT1 patients (treated with G/P) without cirrhosis and who are 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. Substudy 1 is randomized, open-label, active-controlled, in genotype 1 (GT1) chronic HCV-infected patients without cirrhosis and who are new to DAA treatment. Patients who tested negative for 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.
Substudy 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.
Additional data will be presented at an upcoming scientific congress.
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 Japan, AbbVie studied the G/P regimen in additional dedicated clinical trials due to patient and viral characteristics specific to the Japanese HCV patient population.
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.
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 (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
These data are the first to be released from registrational studies in Japan as part of AbbVie's global G/P clinical development program, designed to investigate a faster path to virologic cure* for all major HCV genotypes and with the goal of addressing treatment areas of continued unmet need.
"These initial data in GT1-infected patients, which is the most common type of hepatitis C in Japan, may help to further advance our understanding on how we care for patients in this country," said Stefan Zeuzem, M.D., Chief of the Department of Medicine at the Goethe University Hospital in Frankfurt, Germany. "In the CERTAIN-1 study with the G/P regimen, we see for the first time that 8 weeks of treatment achieved high cure rates in these GT1-infected Japanese patients without cirrhosis."
Japan has one of the highest rates of hepatitis C infection in the industrialized world.2 Approximately 1 million people are living with hepatitis C in Japan, with 60 to 70 percent of those infected with GT1 chronic HCV.1,3 Patients included in the CERTAIN-1 study were further representative of the HCV-infected patient population in Japan, where the prevalence of HCV infection increases with age, by including a majority of patients over 65 years of age.4
"Due to patient characteristics and virological considerations, people living with HCV in Japan have specific treatment challenges and needs," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie's dedicated G/P registrational clinical development program in Japan reflects our continued commitment to make a real difference in the lives of Japanese patients."
The CERTAIN-1 study compared the safety and efficacy of 8 weeks of treatment with the investigational G/P regimen, to 12 weeks of 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 substudy 1 evaluating GT1 patients (treated with G/P) without cirrhosis and who are 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. Substudy 1 is randomized, open-label, active-controlled, in genotype 1 (GT1) chronic HCV-infected patients without cirrhosis and who are new to DAA treatment. Patients who tested negative for 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.
Substudy 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.
Additional data will be presented at an upcoming scientific congress.
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 Japan, AbbVie studied the G/P regimen in additional dedicated clinical trials due to patient and viral characteristics specific to the Japanese HCV patient population.
G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment with direct-acting antivirals (DAA), who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.
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 (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
G/P is an investigational product and its safety and efficacy have not been established in Japan.
*Patients with a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
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