AbbVie announces high sustained virologic response rates in Phase II studies

AbbVie, a global biopharmaceutical company, announced data from the SURVEYOR studies of its investigational regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR12) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. After 12 weeks of treatment, SVR12 rates achieved were 97–100% in genotype 1 (GT1), 96–100% in genotype 2 (GT2) and 83–94% in genotype 3 (GT3) patients. (1,2,3) These data are being presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

Separately, in a late-breaking presentation of the SURVEYOR-I study, data shows non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for eight weeks with ABT-493 and ABT-530 achieved a SVR12 rate of 97% (4)

“These results are encouraging and contribute to scientific knowledge about the potential for pan-genotypic options for treating chronic hepatitis C,” said Fred Poordad MD, vice president of Academic and Clinical Affairs at The Texas Liver Institute in San Antonio. “These data mark another important step in the continued research to help address the unmet needs of patients and the medical community.”

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SURVEYOR-I and SURVEYOR-II are ongoing Phase II clinical studies that evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks. These data presented at AASLD include non-cirrhotic patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional patient populations (genotypes 4–6) will be presented at future meetings.

“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, executive vice president, research and development and chief scientific officer, AbbVie. “AbbVie’s ongoing hepatitis C research programme demonstrates our commitment to make a remarkable impact on the lives of HCV patients.”

Reference:

1. Poordad F et al. SURVEYOR-I: 98% – 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null-Responders with the Combination of the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530; Oral presentation #41; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13–17, 2015.
2. Wyles D et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection; Oral presentation #250; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13–17, 2015.
3. Kwo P et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection; Oral presentation #248; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13–17, 2015.
4. Poordad F et al. 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the Combination of ABT-493 and ABT-530 for 8 Weeks (SURVEYOR-I); Poster presentation #LB-14; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13–17, 2015.