Abbott touts promising results in phase II Hep C trial
Thursday, April 5, 2012
Abbott has released promising data from two different interferon-free phase II studies for hepatitis C (HCV), suggesting that a 12-week regimen of two Abbott medicines, and no peginterferon, can achieve high cure rates for treatment-naïve, genotype 1 patients.
In the study known as “Co-Pilot,” different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 95% and 93% of treatment-naïve genotype 1 patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47% of patients who were previous non-responders to past HCV treatment.
In a separate study, known as “Pilot,” 91% of genotype 1 infected, treatment-naïve patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
“We are extremely encouraged to see this level of sustained response with only 12 weeks of therapy in patients who were new to treatment, and to see a response in patients who had failed past treatment because options to cure this population are limited,” said Fred Poordad, M.D., chief of hepatology at Cedars-Sinai Medical Center in Los Angeles, and the lead investigator for Co-Pilot and an investigator for Pilot. “These data suggest that an interferon-free, all-oral regimen of direct-acting antiviral medications could be an important new treatment option for HCV.”
This data is especially significant because current treatments for HCV remain interferon-based, despite a significant number of HCV patients unable or unwilling to take interferon due to contraindications and/or side effects. Specifically targeted antiviral therapies for HCV, such as protease inhibitors and non-nucleoside polymerase inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated.