SAN ANTONIO, April 27, 2017 /PRNewswire/ -- Dr. Fred Poordad, internationally recognized for his research in the field of liver diseases, presented a retreatment study of patients who have failed to be cured with current hepatitis C therapy, achieving over 90% response rates in the most commonly found treatment failure patients. Dr. Poordad spoke on the study findings at The International Liver Congress™ 2017, presented by the European Association for the Study of Liver (EASL). The study was performed at the American Research Corp at the Texas Liver Institute, a world-renowned facility for liver research and the prevention and treatment of liver disease.
Dr. Poordad presented data on 91 patients who had failed to be cured by currently approved therapies. In some cases, the patients had failed numerous HCV therapies over multiple years.
The MAGELLAN-1, Part 2 study evaluated AbbVie's investigational, pan-genotypic, once-daily, ribavirin-free regimen of glecaprevir/pibrentasvir (G/P) for 12 or 16 weeks in patients with chronic HCV genotype 1 or 4 and prior direct-acting antiviral (DAA) treatment failure to NS5A and/or NS3/4A protease inhibitors, including those with or without compensated cirrhosis. In this registrational Phase 2 study, 89 percent (n=39/44) of patients achieved sustained virologic response (SVR12) with 12 weeks of treatment and 91 percent (n=43/47) of patients achieved SVR12 with 16 weeks of treatment.
"The currently approved treatments for hepatitis C are curing the majority, but not all patients," says Dr. Poordad. "This therapy, G/P, is a major advance for the field and will allow us to essentially cure almost everyone with hepatitis C. Our main challenge now is screening all of those Americans that are still not diagnosed, as well as offering these new therapies to those who failed treatments in the past."
Treatment emergent NS5A resistance-associated substitutions can persist for several years, and currently there are no approved treatments for NS5A inhibitor-experienced patients1. In patients with prior failure to NS5A inhibitors who were NS3/4A PI-naïve, 88 percent (n=14/16) and 94 percent (n=17/18) of patients achieved SVR12 with 12 and 16 weeks of treatment respectively. The majority of adverse events (AEs) were mild, with no serious AEs related to treatment. The most common AE (≥10%) was headache.
The hepatitis C virus affects approximately 3.5 million people in the United States, alone. Chronic forms of the condition, developing in about seventy-five to eighty-five percent of those who contract the virus, can lead to liver cancer or cirrhosis.
About the MAGELLAN-1 Study
The MAGELLAN-1 is an ongoing Phase 2, randomized, open-label multicenter study to evaluate the efficacy, safety and pharmacokinetics of glecaprevir/pibrentasvir (G/P), with and without ribavirin, in adults with GT1 and genotypes 4-6 chronic HCV infection who failed a prior DAA-containing therapy.
About Texas Liver Institute
The Texas Liver Institute (TLI) is a one-of-a-kind facility, and one of the very few dedicated and freestanding clinical care and research facilities in the world. The most advanced research in viral hepatitis, fatty liver disorders, liver cancer and cirrhosis is being conducted in this facility, which has been recognized internationally for its contributions to the field of liver diseases.
The Texas Liver Institute continues to push the boundaries of new discoveries and advance the field of liver disease into the future through research and education.
About Dr. Fred Poordad
Dr. Fred Poordad is Vice President of Academic and Clinical Affairs at the Texas Liver Institute and Clinical Professor of Medicine at the University of Texas Health, San Antonio. He is recognized as a leading clinician and researcher, and has conducted extensive research in liver disease, authored hundreds of publications, and has presented his work at both national and international medical meetings.
Phone: (775) 544-5131
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SOURCE Texas Liver Institute