PHASE III TOP-LINE RESULTS EXPECTED BEGINNING LATER IN 2013
Oct 1, 2013
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
- Trends in Liver-Related Healthcare Resource Utilization for HCV-Infected Individuals in the US: 2002-2010
Poster #367
November 2nd, 2:00PM ET; Poster Hall
This study analyzed years 2002-2010 of the National Inpatient Sample (NIS) data set of hospital admissions from the Healthcare Cost and Utilization Project (HCUP) to determine the number of adult (age 20+ years) liver-related hospital admissions occurring in HCV-infected patients (identified by ICD-9 codes).
- Interferon- and Ribavirin-free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-Naïve Patients and Prior Null Responders
Oral Presentation: Parallel Session 75
November 3rd, 5:15PM ET; Hall E
This oral presentation includes data from the phase IIb PEARL-I study, which examines an interferon-free, ribavirin-free investigational regimen of ABT-450/r plus ABT-267 in 82 patients with HCV genotype 1b.
- Low Relapse Rate Leads to High Concordance of SVR4 and SVR12 with SVR24 After Treatment with ABT-450/r, ABT-267, ABT-333 + Ribavirin in Patients with Chronic HCV Genotype 1 Infection in the AVIATOR Study
Poster #1089
November 3rd, 8:00AM ET; Poster Hall
This study evaluated the concordance of SVR24 with rapid virologic response (RVR), SVR4 and SVR12 in treatment groups from the phase IIb AVIATOR study in 247 patients.
- High Medication Adherence in HCV-Infected Patients Taking a Triple-DAA Regimen for 12 Weeks
Poster #1096
November 3rd, 8:00AM ET; Poster Hall
This study presents medication adherence data based on electronic compilation of drug dosing history among 327 patients receiving the investigational triple-DAA regimen plus ribavirin for 8, 12 or 24 weeks.
- Health-Related Quality of Life (HRQoL), Health State, Function and Wellbeing of Chronic HCV Patients Treated with Interferon-Free, Oral DAA Regimens: Patient Reported Outcome (PRO) Results from the AVIATOR Study
Poster #1113
November 3rd, 8:00AM ET; Poster Hall
This intent-to-treat analysis from the phase IIb AVIATOR study includes patient reported outcomes (PRO) in patients receiving 12-week, ribavirin-containing investigational triple-DAA regimen.
- Safety of Ribavirin-containing Regimens of ABT-450/r, ABT-333, and ABT-267 for the Treatment of HCV Genotype 1 Infection and Efficacy in Subjects with Ribavirin Dose Reductions
Poster #1118
November 3rd, 8:00AM ET; Poster Hall
This study examined the safety of a ribavirin-containing, investigational triple-DAA, interferon-free regimen and the effects of ribavirin dose reductions on treatment response.
- HCV RNA "Target Detected" after "Target Not Detected" During IFN-Free Treatment: Time to Worry or Not?
Poster #1125
November 3rd, 8:00AM ET; Poster Hall
This study examined the frequency of TDANs (Target Detected After Not Detected) and the likelihood of subsequent virologic failure in subjects from the phase IIb AVIATOR study treated with ABT- 450/r plus ABT-267 plus ABT-333 plus ribavirin for 12 or 24 weeks in treatment naïve and null responders.
- Adherence to Interferon-containing Therapy Among Veteran Affairs Hepatitis C Patients
Poster #1909
November 5th, 8:00AM ET; Poster Hall
Data from the United States Veterans Health Administration (VHA) Medical SAS Dataset (years 2008 to 2011) were used in this analysis.
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.
- Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
- World Health Organization. Global Alert and Response (GAR): Hepatitis C. 2003. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index1.html. Accessed April 9, 2013.
- World Health Organization. Hepatitis C Fact Sheet 2012. http://www.who.int/mediacentre/factsheets/fs164/en/ Accessed April 9, 2013.
- European Association for the Study of the Liver. Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011; 55: 245–264.
SOURCE AbbVie Inc.
For further information: Media: Elizabeth Hoff, +1 (847) 935-4236; Javier Boix, +1 (847) 937-6113; Or Investor Relations: Elizabeth Shea, +1 (847) 935-2211
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