Public Release: 

Sofosbuvir/daclatasvir combination effective treatment for difficult-to-treat hep C patients

Study looks into further treatment option amongst hepatitis C virus genotype-1 mono-infected patients

European Association for the Study of the Liver

April 25, 2015, Vienna, Austria: Results presented today at The International Liver Congress™ 2015 show that the sofosbuvir (SOF)/daclatasvir (DCV) treatment combination is effective amongst hepatitis C virus (HCV) genotype-1 mono-infected patients. These results are significant because whilst other combinations have been widely reported on, there have been few data until now regarding the use of SOF/DCV combination in real world situations.

Overall, the sustained virologic response rate at 4 weeks (SVR4) for SOF/DCV was 81.6% after 12 weeks of treatment and 93.9% following 24 weeks of treatment. The SVR4 rate for SOF/DCV with ribavirin (RBV) was 100% and 96.6% after 12 and 24 weeks, respectively. The 12-week combination of SOF/DCV/RBV achieved a 100% SVR4 rate in cirrhotic patients without the additive effect of extension of the treatment to 24 weeks with or without RBV (95.7% and 92.5%, respectively), and this was also true in experienced patients. All non-cirrhotic patients achieved 100% SVR4 at 12 weeks, demonstrating that the 12-week combination of SOF/DCV is a proven therapeutic option. Importantly, the SVR12 rate was 100% for SOF/DCV/RBV after both 12 and 24 weeks.

"The cohort study has found that the sofosbuvir/daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by genotype-1 hepatitis C. We also found that the combination with ribavirin increases the SVR rate in cirrhotic or experienced patients without the additive effect of the extension of the treatment from 12 to 24 weeks. We hope that this helps support further treatment options for difficult-to-treat patients," said Professor Stanislas Pol, Hôpital Cochin, Paris, France, principal investigator of the French ANRS CO-22 Hepather cohort.

409 HCV genotype-1 mono-infected patients were given a combination of SOF (400 mg/d) and DCV (60 mg/d) without ribavirin (n=318) or with ribavirin (1-1.2 g/d, n=91). 318 patients had cirrhosis and 306 were previously treated with peginterferon-ribavirin (PR) (n=134) or PR + a first generation protease inhibitor (PI) (n=172).

"This study shows very positive results for hepatitis C genotype-1 mono-infected patients. This is one of the first real-life studies looking into sofosbuvir/daclatasvir combinations and has demonstrated that this is a good therapeutic option for these patients. It represents another treatment option to help patients beat hepatitis C," said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver.

Serious adverse events were reported in 9% of patients and treatment discontinuation related to adverse events in 3.1%.

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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: 16:30-16:45
Presenter: Stanislas Pol (France)
Abstract LB3: SAFETY AND EFFICACY OF THE COMBINATION DACLATASVIR-SOFOSBUVIR IN HCV GENOTYPE 1-MONO-INFECTED PATIENTS FROM THE FRENCH OBSERVATIONAL COHORT ANRS CO22 HEPATHER*

SAFETY AND EFFICACY OF THE COMBINATION DACLATASVIR-SOFOSBUVIR IN HCV GENOTYPE 1-MONO-INFECTED PATIENTS FROM THE FRENCH OBSERVATIONAL COHORT ANRS CO22 HEPATHER*

Stanislas Pol* 1, 2, Marc Bourliere3, Sandy Lucier4, Victor De Ledinghen5, 6, Fabien Zoulim7, 8, Céline Dorival-Mouly9, Sophie Métivier10, Dominique Larrey11, 12, Albert Tran13, 14, Christophe Hezode15, 16, Jean-Pierre Bronowicki17, 18, Didier Samuel19, 20, 21, Patrick Marcellin22, 23, Jean-Pierre Zarski24, 25, Anne Minello26, Laurent Alric27, 28, Jean-Claude Trinchet29, Pierre Nahon29, Dominique Guyader30, 31, Olivier Chazouillères32, 33, Ghassan Riachi34, Véronique Loustaud-Ratti35, 36, Xavier Causse37, Philippe Mathurin38, Isabelle Hubert-Fouchard39, Isabelle Rosa40, Yves Benhamou41, 42, Jérôme Gournay43, Jean-Jacques Raabe44, François Raffi45, Ventzislava Petrov-Sanchez46, Alpha Diallo47, Hélène Fontaine48, 49, Fabrice Carrat4 on behalf of Hepather Study Group

1Department of Hepatology, Cochin Hopital, 2INSERM USM20, Pasteur Institute and René Descartes University, 3Department of Hepatology and Gastroenterology, Hôpital Saint Joseph, 4INSERM UMR-S 1136, Université Pierre et Marie Curie Paris 6, Paris, 5Department of Hepatology and Gastroenterology, Hôpital Haut-Lévêque, Pessac, 6INSERM U1053, Université Bordeaux Segalen, Bordeaux, 7Department of Hepatology, Hospices Civils de Lyon, 8INSERM U1052, Université de Lyon, Lyon, 9INSERM UMR-S 1136, Université Pierre et Marie Curie Paris 6, Paris, 10Department of Hepatology and Gastroenterology, CHU Purpan, Toulouse, 11Liver unit, Hôpital Saint Eloi, 12INSERM1040, Université de Montpellier, Montpellier, 13Digestive Center, Centre Hospitalier Universitaire de Nice, 14U1065-8, INSERM, Nice, 15Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, AP-HP, 16INSERM U955, Université Paris-Est, Créteil, 17Department of Hepatology and Gastroenterology, Centre Hospitalier Universitaire de Nancy, Nancy, 18 INSERM U954, Université de Lorraine, Vandoeuvre-les-Nancy, 19Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, Villejuif, 20UMR-S785, Université Paris-Sud, Vilejuif, 21U785, INSERM, Villejuif, 22Department of Hepatology, Hôpital Beaujon, AP-HP, 23INSERM CRB3, Université Paris-Diderot, Clichy, 24Department of Hepatology and Gastroenterology, Centre Hospitalo-Universitaire, 25U823, INSERM, Grenoble, 26Department of Hepatology and Gastroenterology, CHU de Dijon, Université de Bourgogne, Dijon, 27Department of Internal Medicine and Digestive Diseases, Purpan Hospital, 28UMR-152, Toulouse III University, Toulouse, 29Department of Hepatology and Gastroenterology, Hôpital Jean Verdier, AP-HP, Bondy, 30Liver disease unit, CHU Rennes, 31U991, INSERM, Rennes, 32Department of Hepatology, Hôpital Saint-Antoine, AP-HP, 33Université Pierre et Marie Curie, Paris 6, Paris, 34Department of Hepatology and Gastroenterology, CHU Charles Nicolle, Rouen, 35Department of Hepatology and Gastroenterology, CHU Dupuytren, 36 U1092, UMR INSERM, Limoges, 37Department of Hepatology and Gastroenterology and Digestive Oncology, CHR La Source, Orléans, 38Department of Hepatology and Gastroenterology, Centre Hospitalier Régional et Universitaire Claude Huriez, Lille, 39Liver-Gastroenterology Department, CHU Angers, Angers, 40Department of Hepatology and Gastroenterology, Centre Hospitalier Intercommunal, Créteil, 41Department of Hepatology and Gastroenterology, Groupe Hospitalier Pitié-Salpétrière, AP-HP, 42INSERM , Université Pierre et Marie Curie Paris 6, Paris, 43Department of Hepatology and Gastroenterology, Hôpital Hôtel-Dieu, Nantes, 44Department of Hepatology and Gastroenterology, Centre Hospitalier Régional, Metz, 45Division of Infectious Diseases, University Hospital of Nantes, Nantes, 46Unit for Basic and Clinical research on viral hepatitis, 47 Service de recherches cliniques et thérapeutique, French National Agency for research on Aids and viral Hepatiti, 48Department of Hepatology, Hôpital Cochin, APHP, 49INSERM USM20, Pasteur Institute and René Descartes University, Paris, France

Introduction: Real-life results of the Sofosbuvir/Simeprevir combination have been extensively reported but there are few data regarding the Sofosbuvir/Daclatasvir combination. In January 2015, 3003 patients of the French observational cohort ANRS CO22 HEPATHER were given the new oral antivirals in 32 centers: we report the preliminary results of the Sofosbuvir/Daclatasvir combination in Genotype 1-infected patients.

Material and Methods: Demographics, history of liver disease were collected at entry in the cohort. Clinical, adverse events, and virological data were collected throughout treatment and post-treatment follow-up.

Results: 409 HCV Genotype 1 mono-infected patients were given a combination of Sofosbuvir (SOF: 400 mg/d) and Daclatasvir (DCV: 60 mg/d) without ribavirin (n=318) or with ribavirin (1-1.2 g/d, n=91). 318 patients had cirrhosis and 306 were previously treated with PR (n =134) or PR + a first generation PI (n =172).

The overall SVR4 rate was 81.6, 93.9,100 and 96.6% in those who were given for 12 and 24 weeks SOF/DCV and SOF/DCV/RBV, respectively. The overall SVR4 rate differed according to the prior history and fibrosis (Table). The 12-week combination SOF/DCV/RBV achieved a 100% SVR4 rate in cirrhotics without additive effect of extension of the treatment to 24 weeks with or without RBV (95.7 and 92.5, respectively) and this was also true in experienced patients; all non-cirrhotic patients achieved 100% SVR4 at 12 weeks and, thus, the 12-week combination of SOF/DCV is a good therapeutic option. Serious adverse events were only reported in 9% and treatment discontinuation related to adverse events in 3.1%.

Conclusions: The Sofosbuvir/Daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by Genotype 1. The combination of Ribavirin increases the SVR rate in cirrhotic or experienced patients without additive effect of the extension of the treatment from 12 to 24 weeks.

*The ANRS CO22 Hepather cohort is supported by MSD, Janssen, Gilead, BMS, Roche, Abbvie and conducted in collaboration with AFEF.

Disclosure of Interest: S. Pol: Grant: Conflict with: Bristol-Myers Squibb, Gilead, Roche and MSD, Consultant: Conflict with: Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Vertex, Gilead, Roche, MSD, Novartis, Abbvie, Sanofi and Glaxo Smith Kline, Sponsored Lectures (National and International): Conflict with: Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Vertex, Gilead, Roche, MSD, Novartis, Abbvie, Sanofi and Glaxo Smith Kline, M. Bourliere: : None Declared, S. Lucier: : None Declared, V. De Ledinghen: Consultant: Conflict with: Abbvie, Gilead, Janssen, MSD, BMS, Sponsored Lectures (National and International): Conflict with: Gilead, BMS, MSD, Abbvie, F. Zoulim: Consultant: Conflict with: BMS, Abbvie, Gilead, Merck, Janssen, C. Dorival-Mouly: : None Declared, S. Métivier: Consultant: Conflict with: Gilead, BMS, Janssen, Abbvie, D. Larrey: : None Declared, A. Tran: Consultant: Conflict with: BMS, Gilead, Abbvie, Janssen, MSD, Sponsored Lectures (National and International): Conflict with: BMS, Gilead, Abbvie, JanSSen, MSD, C. Hezode: Consultant: Conflict with: Abbvie, BMS, Gilead, Janssen, Merck, Sponsored Lectures (National and International): Conflict with: Abbvie, BMS, Gilead, Janssen, Merck, J.-P. Bronowicki: Consultant: Conflict with: BMS, MSD, Gilead, Boehringer, Novartis, Sponsored Lectures (National and International): Conflict with: BMS, MSD, Gilead, Boehringer, Roche, D. Samuel: Consultant: Conflict with: Gilead Sciences, Abbvie, BMS, MSD, Astellas, Novartis, LFB, Biotest, P. Marcellin: : None Declared, J.-P. Zarski: Consultant: Conflict with: Abbvie, BMS, Gilead, Janssen, A. Minello: : None Declared, L. Alric: Consultant: Conflict with: BMS, MSD, Roche, Jansen, Gilead, Sponsored Lectures (National and International): Conflict with: BMS, MSD, Roche, Jansen, Gilead, J.-C. Trinchet: : None Declared, P. Nahon: : None Declared, D. Guyader: : None Declared, O. Chazouillères: : None Declared, G. Riachi: : None Declared, V. Loustaud-Ratti: Grant: Conflict with: BMS, Consultant: Conflict with: Gilead, Abbvie, BMS, Sponsored Lectures (National and International): Conflict with: Roche; Merck/Schering Plough; Janssen; BMS ; Gilead, X. Causse: Consultant: Conflict with: Gilead, Janssen, Sponsored Lectures (National and International): Conflict with: BMS, Gilead, Janssen, P. Mathurin: : None Declared, I. Hubert-Fouchard: : None Declared, I. Rosa: : None Declared, Y. Benhamou: : None Declared, J. Gournay: : None Declared, J.-J. Raabe: : None Declared, F. Raffi: Grant: Conflict with: Janssen, Gilead, MSD, Consultant: Conflict with: Gilead, Janssen, MSD, ViiV Healthcare , V. Petrov-Sanchez: : None Declared, A. Diallo: : None Declared, H. Fontaine: Consultant: Conflict with: Abbvie, BMS, Sponsored Lectures (National and International): Conflict with: Gilead, BMS, Abbvie, Janssen, , F. Carrat: : None Declared

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