Direct-acting antivirals now ready for prime time
Studies show encouraging data in a wide range of HCV patient populations
Amsterdam, The Netherlands, Wednesday 24 April 2013: New data from a number of clinical trials presented for the first time at the International Liver Congress™ 2013 demonstrate encouraging results in the use of new direct-acting antiviral agents (DAAs) for the treatment of hepatitis C.
The following covers key results from the much anticipated Phase III trials conducted among HCV patients with a range of genotypes (GT 1 to 6) on DAA treatment.
POSITRON A study of interferon (IFN)-ineligible, IFN-intolerant, or IFN-unwilling cirrhotic and non-cirrhotic GT 2 and 3 HCV-infected patients treated with a combination of sofosbuvir and ribavirin for 12 weeks achieved a high SVR12 rate without evidence of resistance. In the POSITRON Phase III trial, the SVR12 rate of 78% for sofosbuvir and ribavirin (161/207) was superior to placebo (0%, p< 0.001) and all 278 patients became HCV RNA negative on treatment. In terms of adverse events only 2% of patients discontinued treatment in the sofosbuvir + ribavirin group due to adverse events vs. 4% in the placebo group.
NEUTRINO Treatment with a combination of sofosbuvir, peginterferon alfa-2a and ribavirin for 12 weeks achieved 90% SVR12 in treatment naïve genotype 1, 4, 5, or 6 HCV-infected patients with no viral resistance detected in failures, according to the results of the Phase III NEUTRINO study. The regimen was well tolerated and is a short, simple and effective treatment option for patients with these genotypes. A total of 327 patients (292 genotype 1, 28 genotype 4, 7 genotype 5/6) were enrolled and received the study drug.
EASL Secretary General Prof. Mark Thursz commented on the studies: "Unlike the US, in Europe and Asia genotype 3 is quite common. As such for European audiences the interferon-free results in genotype 3 are not as impressive as expected; however the side effect profile and lack of viral resistance means that longer treatment durations will be evaluated in the near future. In the meantime, we feel it's not time to bury pegylated interferon just yet."
"Many patients can tolerate 12 weeks of an interferon based regime particularly when it produces SVR rates of more than 90%; so clearly the results of the NEUTRINO study will be welcomed by clinicians and patients" added Prof. Thursz.
STARTVerso™1 Faldaprevir, an oral once-daily protease inhibitor, in combination with peginterferon alfa-2a and ribavirin (PegIFN/RBV) significantly increased SVR12 rates in treatment-naïve HCV GT-1 patients in Europe and Japan compared with PegIFN/RBV alone and was well tolerated. In total 652 patients were treated and 88% of patients treated with faldaprevir were eligible to stop all treatment at week 24.
QUEST-1 and -2 QUEST-1: Simeprevir, an oral once-daily protease inhibitor, in combination with peginterferon alfa-2a and ribavirin (PegIFN/RBV) achieved SVR12 rates of 80% compared to placebo, 50% (p END
The following covers key results from the much anticipated Phase III trials conducted among HCV patients with a range of genotypes (GT 1 to 6) on DAA treatment.
POSITRON A study of interferon (IFN)-ineligible, IFN-intolerant, or IFN-unwilling cirrhotic and non-cirrhotic GT 2 and 3 HCV-infected patients treated with a combination of sofosbuvir and ribavirin for 12 weeks achieved a high SVR12 rate without evidence of resistance. In the POSITRON Phase III trial, the SVR12 rate of 78% for sofosbuvir and ribavirin (161/207) was superior to placebo (0%, p< 0.001) and all 278 patients became HCV RNA negative on treatment. In terms of adverse events only 2% of patients discontinued treatment in the sofosbuvir + ribavirin group due to adverse events vs. 4% in the placebo group.
NEUTRINO Treatment with a combination of sofosbuvir, peginterferon alfa-2a and ribavirin for 12 weeks achieved 90% SVR12 in treatment naïve genotype 1, 4, 5, or 6 HCV-infected patients with no viral resistance detected in failures, according to the results of the Phase III NEUTRINO study. The regimen was well tolerated and is a short, simple and effective treatment option for patients with these genotypes. A total of 327 patients (292 genotype 1, 28 genotype 4, 7 genotype 5/6) were enrolled and received the study drug.
EASL Secretary General Prof. Mark Thursz commented on the studies: "Unlike the US, in Europe and Asia genotype 3 is quite common. As such for European audiences the interferon-free results in genotype 3 are not as impressive as expected; however the side effect profile and lack of viral resistance means that longer treatment durations will be evaluated in the near future. In the meantime, we feel it's not time to bury pegylated interferon just yet."
"Many patients can tolerate 12 weeks of an interferon based regime particularly when it produces SVR rates of more than 90%; so clearly the results of the NEUTRINO study will be welcomed by clinicians and patients" added Prof. Thursz.
STARTVerso™1 Faldaprevir, an oral once-daily protease inhibitor, in combination with peginterferon alfa-2a and ribavirin (PegIFN/RBV) significantly increased SVR12 rates in treatment-naïve HCV GT-1 patients in Europe and Japan compared with PegIFN/RBV alone and was well tolerated. In total 652 patients were treated and 88% of patients treated with faldaprevir were eligible to stop all treatment at week 24.
QUEST-1 and -2 QUEST-1: Simeprevir, an oral once-daily protease inhibitor, in combination with peginterferon alfa-2a and ribavirin (PegIFN/RBV) achieved SVR12 rates of 80% compared to placebo, 50% (p END