AbbVie recently announced encouraging results from the SURVEYOR clinical trials of its investigational HCV drug regimen, ABT-493 and ABT-530, in non-cirrhotic patients who are positive for chronic hepatitis C virus (HCV) infection.
Specifically, ABT-493, an inhibitor of the NS3/4A protease, and ABT-530, an inhibitor of NS5A, revealed high rates of continuous virologic response —meaning HCV was not detected — at 12 weeks after treatment (SVR12) in these patients. The study was presented during The Liver Meeting 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), recently held in San Francisco.
Hepatitis C is divided globally into six distinct genotypes with multiple subtypes in each genotype class (a classification of a virus based on the genetic material in the RNA strands of the virus). Generally, patients are only infected with one genotype, but each genotype is actually a mixture of closely related viruses, called quasi-species, that have the ability to quickly mutate and become immune to current treatments, explaining why chronic hepatitis C is so difficult to treat. Genotype 1 is the most common hepatitis C genotype in the United States and the most difficult to treat.
Trial results revealed that following 12 weeks of treatment, patients infected with HCV genotype 1 (GT1), HCV genotype 2 (GT2) and HCV genotype 3 (GT3) achieved SVR12 rates of 97-100%, 96-100% and 83-94%, respectively. Complementary results from a late-breaking presentation of the SURVEYOR-I trial revealed that non-cirrhotic GT1 chronic HCV patients who received treatment with ABT-493 and ABT-530 for eight weeks achieved a SVR12 rate of 97%.
“These results are encouraging and contribute to scientific knowledge about the potential for pan-genotypic options for treating chronic hepatitis C,” Fred Poordad, M.D., vice president of Academic and Clinical Affairs at The Texas Liver Institute in San Antonio, said in a recent press release. “These data mark another important step in the continued research to help address the unmet needs of patients and the medical community.”
SURVEYOR-I and SURVEYOR-II are ongoing Phase 2 trials assessing the efficacy and of ABT-493 and ABT-530, with or without ribavirin (RBV), for a period ranging from eight to 12 weeks. The results presented during the 2015 AASLD were from non-cirrhotic patients infected with the GT1, GT2 and GT3 chronic HCV virus. At future meetings, the company plans to present data from patients with genotypes 1 through 6. “The SURVEYOR trials offer important new information about the potential to treat patients with chronic hepatitis C across multiple genotypes with our two direct-acting antiviral investigational regimen,” said Michael Severino, MD, AbbVie’s Executive Vice President, Research and Development, and Chief Scientific Officer. “AbbVie’s ongoing hepatitis C research program demonstrates our commitment to make a remarkable impact on the lives of HCV patients.”