Results presented today at The International Liver Congress 2015 demonstrate that hepatitis C (HCV)-infected genotype-3 (GT-3) patients, with and without cirrhosis, receiving 24 weeks of sofosbuvir (SOF) in combination with ribavirin (RBV) and peginterferon (PEG) achieved the highest sustained virologic response rates at 12 weeks (SVR12), observed in a Phase 3 study, to date.
Among GT-3 patients, SVR12 rates were highest in those receiving SOF+PEG/RBV for 12 weeks (93%) as compared to SOF+RBV for 24 (84%, p = 0.008) or 16 weeks (71%, p <0.001).
"Sofosbuvir in combination with ribavirin and with and without peginterferon have never been directly compared before to determine sustained virologic response 12 weeks after treatment. This study highlights that sofosbuvir with ribavirin and peginterferon should be considered for interferon-eligible GT-3 patients, particularly for those with cirrhosis and/or prior treatment failure," said Graham Foster, Professor of Hepatology, Queen Marys University of London, UK.
Of 592 patients randomised and treated, 92% had GT-3 HCV, 67% were male, 84% white, 53% treatment experienced, 62% had non-CC IL28B genotypes and 37% had cirrhosis.
The study also evaluated the safety and efficacy of SOF+PEG/RBV for 12 weeks vs SOF+RBV for 16 or 24 weeks in treatment-experienced genotype-2 (GT-2) HCV-infected patients with cirrhosis. GT-2 treatment-experienced patients with cirrhosis had high SVR12 rates in all treatment arms; 87% of those receiving SOF+RBV for 16 weeks, 100% of those receiving SOF+RBV for 24 weeks and 94% of those receiving SOF+PEG/RBV for 12 weeks.
"BOSON is a ground-breaking new study that provides information about how we can ensure the best outcomes for both GT-2 and GT-3 hepatitis C-infected patients. It has confirmed that 24 weeks is the optimal duration for a sofosbuvir and ribavirin combination in GT-3 patients, whilst also finding that sofosbuvir and ribavirin with peginterferon for 12 weeks resulted in the highest SVR12 rates observed to date in a Phase 3 study," said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver (EASL).
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SOFOSBUVIR + PEGINTERFERON/RIBAVIRIN FOR 12 WEEKS VS SOFOSBUVIR + RIBAVIRIN FOR 16 OR 24 WEEKS IN GENOTYPE 3 HCV INFECTED PATIENTS AND TREATMENT-EXPERIENCED CIRRHOTIC PATIENTS WITH GENOTYPE 2 HCV: THE BOSON STUDY, The International Liver Congress 2015.