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Abbott Presents Promising Phase 2b Interferon-free Hepatitis C Results at 2012 Liver Meeting®
By: PR Newswire
Nov. 10, 2012 09:00 AM
- Investigational Triple-DAA Regimen plus Ribavirin Treatment for 12 Weeks Demonstrated High SVR(12) Rates in Intent-to-Treat Analysis
- Phase 3 Registrational Program Currently Enrolling
ABBOTT PARK, Illinois, Nov. 10, 2012 /PRNewswire/ -- Results from Abbott's phase 2b clinical trial, "Aviator," demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR(12)) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). Results will be presented at the President's Press Conference and the latebreaking clinical trials session at the Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD) in Boston.
Based on promising results from Aviator, Abbott has selected triple-DAA regimens, with and without ribavirin, to move forward into phase 3 clinical trials. Topline intent-to-treat results for the 12-week, triple-DAA regimen with ribavirin are as follows:
In addition, results from the 12-week triple-DAA regimen without RBV in treatment naïve patients showed:
"Based on the high SVR(12) results with Abbott's triple-direct acting antiviral regimen in GT1 patients, it appears we are moving closer to potential oral treatment regimens that do not require interferon to treat HCV," said Kris Kowdley, M.D., director of the Liver Center of Excellence in the Digestive Disease Institute at Virginia Mason Medical Center, and Clinical Professor of Medicine at the University of Washington in Seattle. "This is encouraging news for the many patients who are unable or unwilling to take interferon."
About Study M11-652 (Aviator)
 ITT (Intent-to-treat) population: includes all patients who received at least one dose of study drug
 OD (Observed data): Excludes patients with values missing for reasons other than virologic failure or discontinuation due to AEs
"The 93.3 percent SVR(12) seen with triple-DAA therapy with ribavirin in previous null responder patients in Aviator is noteworthy given the limited treatment options with interferon-based therapies for this patient population," said Scott Brun, M.D., divisional vice president, Infectious Disease Development, Abbott. "As the data from the Aviator study have matured, we are encouraged that we have continued to see high SVR(12) rates. Results from Aviator have allowed Abbott to confidently move into larger, confirmatory Phase 3 trials with the goal of being the first company to bring an interferon-free treatment regimen to genotype 1 patients."
Aviator Safety Results
About the Hepatitis C Virus
Of the six main genotypes of hepatitis C, genotypes 1, 2 and 3 are the most widespread. Genotype 1 is the most common genotype in the U.S. and the most difficult to treat with interferon based therapies. Patients with genotypes 2 and 3 are more likely than individuals with genotype 1 to respond to therapy with peg-interferon or the combination of peg-interferon and ribavirin.
About Abbott's HCV Development Programs
ABT-450 was discovered during the course of a collaboration between Abbott and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by Abbott for use in combination with Abbott's other investigational medicines for the treatment of HCV. Abbott is well-positioned to explore combinations and co-formulations of these medicines.
On Monday, November 12 at 5:30 p.m. EST, Abbott will host an investor webcast to discuss the phase 2b Aviator data, as well as our recently initiated phase 3 registrational program. The webcast can be accessed on Abbott's investor relations website at abbottinvestor.com.
Ritonavir Use in Treatment of HIV
Ritonavir does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others. People taking ritonavir may still get opportunistic infections or other conditions that happen with HIV infection. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
Ritonavir Safety in Treatment of HIV
Patients may develop large increases in triglycerides and cholesterol, diabetes, high blood sugar, changes in body fat, increased bleeding in people with hemophilia, allergic reactions, and/or changes in heart rhythm. Patients may develop signs and symptoms of infections that they already have after starting anti-HIV medicines. For more information, please see Important Safety Information and Full Prescribing Information.
Abbott's news releases and other information are available on the company's website at www.abbott.com.
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