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

Transcription

1 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, Marc Bourliere, Sandy Lucier, Victor De Ledinghen, Fabien Zoulim, Céline Dorival-Mouly, Sophie Metivier, Dominique Larrey, Albert Tran, Christophe Hezode, Jean-Pierre BronowickI, Didier Samuel, Patrick Marcellin, Jean-Pierre Zarski, Anne Minello, Laurent Alric, Jean-Claude Trinchet, Pierre Nahon, Dominique Guyader, Olivier Chazouilleres, Ghassan Riachi, Véronique Loustaud-ratti, Xavier Causse, Philippe Mathurin, Isabelle Hubert-Fouchard, Isabelle Rosa, Yves Benhamou, Jérôme Gournay, Jean-Jacques Raabe, François Raffi, Ventzislava Petrov-sanchez, Alpha Diallo, Hélène Fontaine, Fabrice Carrat on the behalf of the Anrs/Afef HEPATHER study group The ANRS CO22 Hepather cohort is conducted in collaboration with AFEF and supported by MSD, Janssen, Gilead, BMS, Roche, Abbvie.

2 CohortANRS CO22 HEPATHER Inclusion Follow up D ( HBV & HCV) Patients Clinical follow-up by interval: 1 to 2 yearly visits according to the status «A la carte» clinical follow-up: Treatment initiation Clinical event Follow-up by individual matching on medico-administrative database: SNIIRAM CEPI-DC

3 Background and aims Real-life results of the sofosbuvir/simeprevir combination have been extensively reported but there are few data regarding the sofosbuvir/daclatasvir combination in GT1 or 4 patients. 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- & 4-infected patients

4 SOF+DCV+/-RBV in Genotype 1 All patients with HCV Genotype 1 infection who initiated a combination of sofosbuvir (400 mg/d) and daclatasvir (60 mg/d) before July 1st 2014 were included (n=409): With ribavirin (1-1.2 g/d) (n=92) or without (n=317) 319 (78%) patients had cirrhosis 307 (75%) were previously treated with: Pegylated interferon and ribavirin (n =134, 43.6%) Pegylated interferon, ribavirin and a 1 st generation PI (n =173, 56,3%)

5 SOF+DCV+/-RBV in Genotype 1 SOF/DCV/RBV (n = SOF/DCV (n= 317) 92) 12 w. 24 w. 12 w. 24 w. % SVR % SVR % SVR4 cirrhotic % SVR4 non cirrhotic % SVR4 naïve % SVR4 experienced

6 SOF+DCV or SIM+/-RBV in Genotype 4 On July 1st, 2014, 82 Genotype 4 mono-infected patients had initiated a combination of: 1. Sofosbuvir (400 mg/d) and daclatasvir (60 mg/d) (n=48) With ribavirin (1-1.2 g/d) (n=15) or without (n=33) For 12 (n = 11) or 24 weeks (n = 36); 2. Sofosbuvir (400 mg/d) + simeprevir (150 mg/d) (n=34) (including 64 cirrhotic) With ribavirin (1-1.2 g/d, n=7) or without (n=27) For 12 (n = 23) or 24 weeks (n = 11);

7 SOF+DCV or SIM+/-RBV in Genotype 4 SOF/DCV SOF/DCV/RBV SOF/SIM SOF/SIM /RBV (n = 33) (n = 15) (n = 27) (n = 7) Tx duration (weeks) 12 w. 24 w. 12 w. 24 w. 12 w. 24 w. 12 w. 24 w. % SVR % SVR % SVR4 cirrhotic %SVR4 non-cirrhotic %SVR4 naïve %SVR4 experienced Conclusion: The 12 week combination of sofosbuvir-daclatasvir or sofosbuvir-simeprevir is associated with a high rate of SVR4 in genotype 4- infected patients. The addition of ribavirin increases the SVR rate in cirrhotic or experienced patients at 12 weeks without additive effect of the treatment extension to 24 weeks

8 SOF+DCV in Genotype 1 & 4 1. The sofosbuvir/daclatasvir combination is associated with a high rate of SVR4 in difficult-to-treat patients infected by Genotype 1 (or 4) 2. The combination of ribavirin increases the SVR rate in both cirrhotic or experienced patients without additive effect of the extension of the treatment from 12 to 24 weeks. GT1 or 4 Non cirrhotic naïve patients : SOF+DCV 12w. Cirrhotic or experienced patients : SOF+DCV + RBV 12w. *The ANRS CO22 Hepather cohort is supported by MSD, Janssen, Gilead, BMS, Roche, Abbvie and conducted in collaboration with AFEF.

9 CohortANRS CO22 HEPATHER April 2, ,116 included patients 3,432 HCV-infected patients treated by DAAs Combination Number ATU/AMM Sofosbuvir + RBV 378 Sofosbuvir + PegIFN + RBV 247 Sofosbuvir + Daclatasvir 1260 Sofosbuvir + Daclatasvir + RBV 359 Sofosbuvir + Simeprevir 680 Sofosbuvir + Simeprevir + RBV 75 Others 433