studies

736A AASLD ABSTRACTS HEPATOLOGY, October, 2015
results must be confirmed by analysis of the SVR12. Full result
analysis will be presented at the congress. * Same contribution
for the 2 first authors
Disclosures:
Eric Nguyen-Khac - Speaking and Teaching: Gilead, Abbvie, Janssen, Roche,
MSD, BMS
Alexandre Pariente - Board Membership: Mayoli spindler; Speaking and Teaching:
Janssen, Roche, BMS, Abbvie
Thong Dao - Board Membership: Schering-Plough, Schering-Plough, Schering-Plough,
Schering-Plough; Speaking and Teaching: Roche, Gilead, Roche,
Gilead, Roche, Gilead, Roche, Gilead
Alexandre Pariente - Board Membership: Mayoli spindler; Speaking and Teaching:
Janssen, Roche, BMS, Abbvie
Patrick Delasalle - Speaking and Teaching: ROCHE, AXCAN, BMS, GILEAD,
MERCK, JANSSEN, ROCHE, AXCAN, BMS, GILEAD, MERCK, JANSSEN
Xavier Causse - Board Membership: Gilead, Janssen-Cilag; Grant/Research
Support: MSD; Speaking and Teaching: Gilead, BMS, Janssen-Cilag
Francois Bourhis - Consulting: ABBVIE, GILEAD; Speaking and Teaching: BMS
Alexandra Heurgué-Berlot - Consulting: Abbvie; Speaking and Teaching: Gilead
The following authors have nothing to disclose: Bruno Lesgourgues, Remy Andre,
Brigitte Bernard-Chabert, Isabelle Rosa, Damien Lucidarme, Christophe Renou,
Christine Silvain, Gilles Macaigne, Thierry Fontanges, Matthieu Schnee, Hortensia
Lison, Christophe Pilette, Jean Pierre Arput, Frédéric Heluwaert
1073
Safety And Efficacy Of The Combination Simeprevir-Sofosbuvir
In HCV Genotype 1- And 4-Mono-Infected
Patients From The French Observational Cohort Anrs
Co22 Hepather*
ANRS/AFEF HEPATHER CO22 study group; National Agency for
Research on AIDS and Viral Hepatitis, Paris, France
Background and aims. Real-life results of the Sofosbuvir/Simeprevir
combination have been extensively reported from USA
but there are few data from other geographical areas. In May
2015, more than 3500 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/Simeprevir
combination in Genotype 1- and 4-infected
patients. 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. 552 HCV (433 genotype 1-
and 119 genotype 4-) mono-infected patients were given a
combination of Sofosbuvir (SOF: 400 mg/d) and Simeprevir
(SMV: 150 mg/d) without Ribavirin (n=491) or with Ribavirin
(1-1.2 g/d, n=61). 54% of patients had cirrhosis (3% decompensated),
75% were previously treated with PR (n=315) or
PR + a first generation PI (n=25). Overall, the SVR12 rate was
88%. Underlying cirrhosis did not impact SVR rates. In patients
who received the 12-week combination SOF/SMV +/- RBV the
SVR12 rate differed significantly according to the genotype
(80% in GT1a, 92% in GT1b and 86% in GT4, p=0.004) and
according to the biochemical markers of liver severity -MELD
score, total and conjugated bilirubin, platelet count, Prothrombin
time, ALT, AST-, p50 gms/day), active cocaine or crack use Patient characteristics-
table to follow on the slide/poster They were divided into
2 groups; Group A (n=14): SOF 400 mg + LDV 90 mg (daily
once) - 4 weeks Group B (n=15): SOF 400 mg + SIM 150 mg
(daily once) - 8 weeks Labs: Prior to therapy- HCV RNA 0 and
3 weeks, sickle cell panel, LFT’s, CBC, SMA On therapy- HCV
RNA on day 0, 1 week, 4 week, 6 week followed by 16 th and
20 th week (SVR), LFT’s, CBC, SMA Results: Table Conclusion:
This study demonstrates a high SVR with short-course DAA’s in
acute hepatitis C with SVR (at 20 weeks) >90% in both groups.
The drugs were well tolerated.
Results
Disclosures:
The following authors have nothing to disclose: Patrick Basu, Niraj J. Shah, Nimy
John, M. Aloysius, Robert Brown