NORTH CHICAGO, Ill., Oct. 1, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that new data from its phase II hepatitis C clinical development program will be presented at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C., November 1-5, 2013. In total, eight abstracts will be presented, four of which include additional analyses from the phase IIb AVIATOR study. The data examine sustained virologic response (SVR) concordance, patient adherence to the regimen, patient reported outcomes and the impact of ribavirin dose reduction.
The Liver Meeting will precede AbbVie's reporting of initial results from the pivotal phase III clinical trials of the safety and efficacy of AbbVie's investigational triple direct-acting antiviral (DAA) regimen for the treatment of hepatitis C. Reporting of those results is expected to begin later this year.
"At AbbVie, we are committed to researching new therapies that maximize sustained virologic response with the hope of providing much needed new options for people with hepatitis C," said Barry Bernstein, M.D., vice president, infectious disease development, AbbVie. "We are very encouraged as we await top-line results from our phase III program, which we will share later this year."
Additionally, the oral presentation at AASLD will provide results from the PEARL-I study evaluating an interferon- and ribavirin-free, two-DAA investigational regimen in genotype 1b treatment-naïve patients and prior null responders. AbbVie is also investigating drug combinations for additional genotypes and next generations of DAAs as part of their ongoing commitment to the HCV community.
A brief summary of AbbVie's abstract titles is presented below.
About AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge by investigating an interferon-free, all-oral DAA regimen with the goal of producing high SVR rates in as many patients as possible, including those typically most difficult to cure. The large, multinational HCV program includes more than 2,200 patients from 30 countries.
AbbVie's hepatitis C portfolio includes investigational medicines with three different mechanisms of action targeting areas of the viral replication process including boosted protease inhibitor (ABT-450), polymerase (ABT-333) inhibitor and NS5A (ABT-267) inhibitor, currently being studied in clinical trials. ABT-450/r is co-formulated with ABT-267.
Details of AbbVie's phase III clinical programs are as follows:
Study |
Patients (n) |
Treatment Regimen |
Treatment Duration |
SAPPHIRE I |
GT1, treatment-naïve (600*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
SAPPHIRE II |
GT1, treatment-experienced (400*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
PEARL II |
GT1b, treatment-experienced (210*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
•ABT450/r +ABT267** ABT333 |
12 weeks | ||
PEARL III |
GT1b, treatment-naïve (400*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
• ABT450/r +ABT267** • ABT333 |
12 weeks | ||
PEARL IV |
GT1a, treatment-naive (300*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
• ABT450/r +ABT267** • ABT333 |
12 weeks | ||
TURQUOISE II |
GT1, treatment-naïve and treatment-experienced (with compensated cirrhosis) (300*) |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
12 weeks |
• ABT450/r +ABT267** • ABT333 • Ribavirin |
24 weeks |
*projected study population
**ABT-267 is co-formulated with ABT-450/r
In May of 2013, AbbVie's investigational DAA regimen with and without ribavirin for HCV genotype 1 was designated as a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA). This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.
AbbVie Hepatitis C Data at AASLD 2013
The list of accepted abstracts for The Liver Meeting can be accessed on www.aasld.org.
ABT-450 was discovered during the course of the ongoing collaboration between AbbVie and Enanta Pharmaceuticals 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 HCV.
About the Hepatitis C Virus
Across the world, about 160 million people are chronically infected with hepatitis C.[1] Hepatitis C is an inflammation of the liver caused by an infection with the hepatitis C virus (HCV).[2] HCV is transmitted when an infected person's blood enters the bloodstream of another person.[3]
For the hepatitis C virus, there are six major HCV genotypes (GT1-6).[4] Presently, there is no vaccine for the hepatitis C virus (HCV) infection.3 Decision to treat is dependent on a number of factors such as the amount of liver damage present, other conditions the patient may have, amount of virus in the body, and viral genotype.4 If treatment is needed, a hepatitis C infection is typically treated with a combination of antivirals.3
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. With its 125-year history, 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. In 2013, AbbVie employs approximately 21,000 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.
SOURCE AbbVie Inc.
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