AbbVie to Present Results from Phase 2 PEARL-I Study in Genotype 4 Chronic Hepatitis C Patients at The Liver Meeting® 2014
- Results demonstrated high response rates in adult chronic hepatitis C genotype 4 patients without cirrhosis
- Data underscore AbbVie's commitment to evaluating treatments across a range of patients with chronic hepatitis C virus infection
BOSTON, Nov. 11, 2014 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced detailed results from its open-label Phase 2b study, PEARL-I, which demonstrated that 100 percent of genotype 4 (GT4) patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie's investigational treatment with ribavirin (RBV). Additionally, 90.9 percent of patients who were new to therapy achieved SVR12 (n=40/44) after taking the treatment without RBV. These data will be presented today during a poster session at The Liver Meeting® 2014.
"As many as 34 million people around the world are living with genotype 4 chronic hepatitis C, a population that is common in the Middle East and Africa, where it accounts for more than 80 percent of all hepatitis C cases,[i]" said Barry Bernstein, M.D., vice president, infectious disease development, AbbVie. "The data from PEARL-I represent another important step forward in realizing our commitment to advancing scientific knowledge in hepatitis C with the ultimate goal of providing treatment options to as many patients as possible."
PEARL-I studied AbbVie's all-oral, interferon-free investigational treatment combining two direct-acting antivirals (ABT-450/ritonavir and ombitasvir) with and without RBV for 12 weeks in non-cirrhotic adult patients with chronic genotype 1b (GT1b) and GT4 hepatitis C virus (HCV) infection.
There were no discontinuations due to adverse events in PEARL-I. The most commonly reported treatment-emergent adverse events (greater than 15 percent in any group) were headache (29-33 percent), asthenia (weakness) (24-33 percent), fatigue (7-18 percent), nausea (9-17 percent) and insomnia (5-16 percent). One patient had a grade 3 liver function test elevation (AST> five times the upper limit of normal), which was asymptomatic and resolved during continued dosing. Four patients with hemoglobin decreases (anemia) required RBV dose reductions; however, none of these patients required blood transfusions or medication to boost their red blood cell production. In the treatment-naïve group without RBV, on-treatment virologic breakthrough was reported in one patient (2 percent) and two patients (5 percent) experienced post-treatment relapse. There were no virologic failures in the other treatment arms.
About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment
AbbVie's proposed all-oral antiviral treatment consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (25mg) dosed once daily, co-administered with weight-based ribavirin (1000mg or 1200mg in divided doses twice daily). The combination of two direct-acting antivirals, each with distinct mechanisms of action, targets and inhibits specific HCV proteins in the viral replication process.
About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of achieving high sustained virologic response rates in as many patients as possible. AbbVie's development programs combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational use discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score =6.
Showing posts with label ABT-450/ritonavir and ombitasvir with or without RBV. Show all posts
Showing posts with label ABT-450/ritonavir and ombitasvir with or without RBV. Show all posts
Tuesday, November 11, 2014
Wednesday, October 1, 2014
AASLD: AbbVie HCV Drug Data (ABT-450/ritonavir, ombitasvir and dasabuvir) To Be Presented
AbbVie Demonstrates Commitment to Continued Research in Hepatitis C with Investigational Data from Clinical Program Being Presented at The Liver Meeting®
Data from 25 accepted abstracts include results from:
-- AbbVie's investigational treatment in liver transplant recipients with recurrent genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and in GT1 HCV patients with human immunodeficiency virus type 1 co-infection
-- AbbVie's investigational treatment in liver transplant recipients with recurrent genotype 1 (GT1) chronic hepatitis C virus (HCV) infection and in GT1 HCV patients with human immunodeficiency virus type 1 co-infection
-- Abstracts evaluating AbbVie's investigational treatment combining two direct-acting antivirals with or without ribavirin (RBV) in patients with genotype 4 chronic HCV infection
-- Trials of other pipeline compounds ABT-493 and ABT-530 in GT1 chronic HCV infection
NORTH CHICAGO, Ill., Oct. 1, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that data from its ongoing Phase 1 through Phase 3 hepatitis C clinical development programs will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014.
Abstracts will be presented highlighting results from AbbVie's investigational treatment combining three direct-acting antivirals (ABT-450/ritonavir, ombitasvir and dasabuvir) with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection. These abstracts include a Phase 2/3 study in patients co-infected with human immunodeficiency virus type 1 (HIV-1) (TURQUOISE-I) and a Phase 2 study in liver transplant recipients without cirrhosis (CORAL-I).
Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.
Key AbbVie HCV Data at AASLD 2014 includes:
About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible. AbbVie's multinational Phase 3 program using an investigational treatment combining three direct-acting antivirals includes more than 2,300 patients in over 25 countries. The program is designed to identify ways to maximize response rates in a broad spectrum of GT1 patient populations, including those with compensated cirrhosis, liver transplant recipients and those with human immunodeficiency virus type 1 co-infection. AbbVie's development programs using all-oral investigational treatments combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.
AbbVie's pipeline of multiple direct-acting antiviral compounds for the treatment of hepatitis C aims to investigate interferon-free treatments that target multiple HCV genotypes.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational uses discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score >6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Additionally, Phase 2 data will be presented from investigational studies evaluating the combination of ABT-450/ritonavir and ombitasvir with or without RBV in genotype 4 (GT4) patients (PEARL-I). AbbVie will also be presenting data from its two additional pipeline HCV compounds, ABT-493 and ABT-530.
Key AbbVie HCV Data at AASLD 2014 includes:
- TURQUOISE-I: SVR12 data in HCV/HIV-1 Co-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and RibavirinPoster # 1939
November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
This study evaluates a treatment of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in treatment-naïve and peginterferon/RBV-experienced adults co-infected with GT1 HCV and HIV-1, with and without cirrhosis (Child-Pugh A). - Sustained Virologic Response Rates in Liver Transplant Recipients with Recurrent HCV Genotype 1 Infection Receiving ABT-450/r/Ombitasvir + Dasabuvir Plus RibavirinOral Presentation at the Hepatitis Plenary Session
November 11, 2014, 9:15 a.m. – 9:30 a.m. EST
This ongoing Phase 2 study examines safety and efficacy of ABT-450/ritonavir, ombitasvir and dasabuvir plus RBV in non-cirrhotic HCV treatment-naïve since liver transplant recipients with recurrent GT1 HCV infection. - Interferon-Free Regimens of Ombitasvir and ABT-450/r with or without Ribavirin in Patients with HCV Genotype 4 Infection: PEARL-I Study ResultsPoster # 1928
November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
The PEARL-I study assesses safety and efficacy of an all-oral regimen of ABT-450/ritonavir and ombitasvir with or without RBV in treatment-naïve and peginterferon/RBV-experienced non-cirrhotic patients with GT1b and GT4 HCV infection.
- Antiviral Activity of ABT-493 and ABT-530 with 3-Day Monotherapy in Patients with and without Compensated Cirrhosis with Hepatitis C Virus (HCV) Genotype 1 InfectionPoster # 1956
November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
This study evaluates antiviral activity, safety, and tolerability of ABT-493 and ABT-530 administered as monotherapy for three days in treatment-naive adults with chronic GT1 HCV infection with and without compensated cirrhosis.
- Pharmacokinetics and Safety of Pan-Genotypic, Direct Acting Protease Inhibitor, ABT-493, and NS5A Inhibitor, ABT-530, Following 3-Day Monotherapy in HCV Genotype-1 Infected Subjects with or without Compensated CirrhosisPoster # 1986
November 11, 2014, 8:00 a.m. – 12:00 p.m. EST, Poster Hall
This study explores the safety, pharmacokinetics and antiviral activity of ABT-493 and ABT-530 administered as monotherapy for three days in GT1 HCV infected patients with or without compensated cirrhosis.
About AbbVie's HCV Clinical Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating interferon-free, all-oral treatments with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible. AbbVie's multinational Phase 3 program using an investigational treatment combining three direct-acting antivirals includes more than 2,300 patients in over 25 countries. The program is designed to identify ways to maximize response rates in a broad spectrum of GT1 patient populations, including those with compensated cirrhosis, liver transplant recipients and those with human immunodeficiency virus type 1 co-infection. AbbVie's development programs using all-oral investigational treatments combining two direct-acting antivirals are studying additional hepatitis C virus (HCV) genotypes.
AbbVie's pipeline of multiple direct-acting antiviral compounds for the treatment of hepatitis C aims to investigate interferon-free treatments that target multiple HCV genotypes.
ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.
Safety Information for Ribavirin and Ritonavir
Ribavirin and ritonavir are not approved for the investigational uses discussed above, and no conclusions can or should be drawn regarding the safety or efficacy of these products for this use.
There are special safety considerations when prescribing these drugs in approved populations.
Ritonavir must not be used with certain medications due to significant drug-drug interactions and in patients with known hypersensitivity to ritonavir or any of its excipients.
Ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus and must not be used alone for this use. Ribavirin causes significant teratogenic effects and must not be used in women who are pregnant or breast-feeding and in men whose female partners are pregnant. Ribavirin must not be used in patients with a history of severe pre-existing cardiac disease, severe hepatic dysfunction or decompensated cirrhosis of the liver, autoimmune hepatitis, hemoglobinopathies, or in combination with peginterferon alfa-2a in HIV/HCV co-infected patients with cirrhosis and Child-Pugh score >6.
See approved product labels for more information.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
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