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AbbVie presenterar hepatit C-data p? ?rlig leverkongress

AbbVie presenterar hepatit C-data p? ?rlig leverkongress
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Resultat fr?n AbbVies p?g?ende studieprogram inom hepatit C kommer att presenteras p? AASLDs (American Association for the Study of Liver Diseases) levermöte i Boston den 7-11 november.
Data fr?n 25 accepterade presentationer inkluderar resultat fr?n:
? AbbVies behandling för tidigare levertransplanterade hepatit C-patienter med genotyp 1 (CORAL-I) samt för hepatit C-patienter med genotyp 1 som även är HIV-infekterade (TURQUOISE-I).
? Behandling med tv? av AbbVies direktverkande antivirala läkemedel
med eller utan ribavirin för hepatit C-patienter med genotyp 4 (PEARL-I).
? Studier med nästa generation hepatit C-substanser fr?n AbbVie; ABT-493 och ABT-530 för patienter med genotyp 1.
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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
– 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., October 1, 2014 ? 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:
– TURQUOISE-I: SVR12 data in HCV/HIV-1 Co-infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir and Ribavirin
Poster # 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-na?ve 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 Ribavirin
Oral 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-naive 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 Results
Poster # 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-na?ve and peginterferon/RBV-experienced non-cirrhotic patients with GT1b and GT4 HCV infection.
Additional HCV Data Highlights
– 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 Infection
Poster # 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-na?ve 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 Cirrhosis
Poster # 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.
The full list of accepted abstracts for The Liver Meeting can be accessed on www.aasld.org.
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.
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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AbbVie är ett globalt, forskningsbaserat biopharmaföretag som bildades ?r 2013 efter delningen av Abbott. Med hjälp av kunniga, engagerade medarbetare och en unik innovationsstrategi utvecklar AbbVie behandlingar för n?gra av världens mest allvarliga sjukdomar. Företaget har cirka 25 000 medarbetare och marknadsför läkemedel i fler än 170 länder. AbbVie Sverige har omkring 130 anställda och kontor i Solna, Stockholm. För mer information om företaget besök www.abbvie.se och www.abbvie.com. Följ @abbvie p? Twitter eller se karriärmöjligheter p? v?r Facebook- eller LinkedIn-sida.

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