April 25, 2015, Vienna, Austria: 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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About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.
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Late breakers, Hall D Presentation time: 17:00-17:15 Presenter: Graham Foster (United Kingdom) Abstract L05: 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
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
Graham R. Foster* 1, Stephen Pianko2, Curtis Cooper3, Ashley Brown4, Daniel Forton5, Ronald G. Nahass6, Jacob George7, Ellie Barnes8, Diana M. Brainard9, Benedetta Massetto9, Ming Lin9, John G. McHutchison9, G. Mani Subramanian9, Kosh Agarwal10 1Queen Mary's University of London, Barts Health, London, United Kingdom, 2Monash Medical Centre, Melbourne, Australia, 3The Ottawa Hospital, University of Ottawa, Ottawa, Canada, 4Imperial College Healthcare National Health Service Trust, 5St George's University of London, London, United Kingdom, 6ID Care, Hillsborough, United States, 7Westmead Millennium Institute, University of Sydney, and Westmead Hospital, Sydney, Australia, 8Nuffield Department of Medicine, Oxford and representing STOP-HCV, London, United Kingdom, 9Gilead Sciences, Inc., Foster City, United States, 10Institute of Liver Studies, King's College Hospital, London, United Kingdom
Introduction: Sofosbuvir (SOF) in combination with ribavirin with or without peginterferon (PEG) has demonstrated high efficacy in genotype 2 or 3 HCV-infected patients. However, these regimens have not been directly compared. The phase 3 BOSON study 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 (GT2) HCV-infected patients with cirrhosis, and in treatment-naïve and -experienced genotype 3 (GT3) HCV-infected patients with and without cirrhosis.
Material and Methods: Patients were randomized 1:1:1 to receive either SOF+RBV for 16 or 24 weeks or SOF+PEG/RBV for 12 weeks and stratified by HCV genotype and cirrhosis status. All patients received SOF 400mg daily and RBV 1000-1200mg in a divided daily dose. PEG was administered as 180µg weekly injection. The primary end point was sustained virologic response 12 weeks after treatment (SVR12).
Results: Of 592 patients randomized and treated, 92% had GT3 HCV, 67% were male, 84% white, 53% treatment experienced, 62% had non-CC IL28B genotypes, and 37% had cirrhosis. GT2 treatment-experienced patients with cirrhosis had high SVR12 rates in all treatment groups: 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. Among GT3 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) (Table). The most common adverse events in all arms were fatigue, headache, insomnia, and nausea. Overall, 6 (1%) patients discontinued treatment due to adverse events; one of them was treated with SOF+PEG/RBV.
Conclusions: GT2 treatment-experienced patients with cirrhosis had high SVR12 rates in all treatment arms. In GT3 patients, including a large proportion of treatment-experienced patients with cirrhosis, SOF+PEG/RBV for 12 weeks resulted in the highest SVR12 rates observed to date in a Phase 3 study. Overall and in all subgroups, GT3 patients receiving 24 weeks of SOF+RBV had higher SVR12 rates than those receiving 16 weeks of treatment, confirming that 24 weeks is the optimal duration for this combination in GT3 patients. SOF+PEG/RBV for 12 weeks was well tolerated with a high rate of treatment completion. These data suggest SOF+PEG/RBV treatment should still be considered for IFN-eligible GT3 patients, particularly for those with cirrhosis and/or prior treatment failure.
Disclosure of Interest: G. Foster: Consultant: Conflict with: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis, Roche, Sponsored Lectures (National and International): Conflict with: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Idenix, Merck, Novartis, Roche, S. Pianko: Grant: Conflict with: Merck, Consultant: Conflict with: Gilead, Roche, Other: Conflict with: Gilead, Roche, Janssen, Merck, C. Cooper: Grant: Conflict with: Merck, Roche, Sponsored Lectures (National and International): Conflict with: Roche, Merck, Other: Conflict with: Vertex, Merck, Roche, A. Brown: Sponsored Lectures (National and International): Conflict with: MSD, Roche, Bristol-Myers Squibb, Gilead, Janssen, Abbvie, Other: Conflict with: MSD, Roche, Bristol-Myers-Squibb, Gilead, Janssen, Abbvie, Achillion, D. Forton: Grant: Conflict with: Roche, Boehringer Ingelheim, Gilead, Sponsored Lectures (National and International): Conflict with: BMS, Other: Conflict with: Merck, Janssen, Abbvie, R. Nahass: Grant: Conflict with: Gilead, Merck, Janssen, BMS, Sponsored Lectures (National and International): Conflict with: Gilead, Merck, Janssen, Other: Conflict with: Gilead, Merck, Janssen, BMS, J. George: Other: Conflict with: Roche, BMS, MSD, Gilead, Janssen, E. Barnes: : None Declared, D. Brainard: Stockholder: Conflict with: Gilead Sciences, Inc., Employee: Conflict with: Gilead Sciences, Inc., B. Massetto: Stockholder: Conflict with: Gilead Sciences, Inc., Employee: Conflict with: Gilead Sciences, Inc., M. Lin: Stockholder: Conflict with: Gilead Sciences, Inc., Employee: Conflict with: Gilead Sciences, Inc., J. McHutchison: Stockholder: Conflict with: Gilead Sciences, Inc., Employee: Conflict with: Gilead Sciences, Inc., G. M. Subramanian: Stockholder: Conflict with: Gilead Sciences, Inc., Employee: Conflict with: Gilead Sciences, Inc., K. Agarwal: Grant: Conflict with: Roche, MSD, Sponsored Lectures (National and International): Conflict with: BMS, Astellas, Janssen, Other: Conflict with: Gilead, Novartis, Abbott