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SVR Rates: predictors/liver disease stage(cirrhosis) - Abbvie 3D, Gilead's LDV/SOF, JNJ's SIM/SOF, BMS's Daclatasvir+Sofosbuvir
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Jules Levin, NATAP
This report takes a look at cirrhosis as a predictor of SVR response, considering 12 vs 24 weeks, addition or not of Rbv in the SOF/LDV studies, or in SIM/SOF studies although the numbers of patients in the SIM/SOF studies is small. All the reports referred to in this report, the full slide presentations & the accompanying publication pdfs are posted at this link:
EASL: New DAA Phase 3 Studies for genotype 1 at EASL - in both Treatment-naives, treatment-experienced; simultaneous publications - (04/21/14)
ION-3 compared 8 to 12 weeks in naive non-cirrhotics.....
http://www.natap.org/2014/EASL/EASL_10.htm
at EASL/2014 there was discussion after the presentation of ION-2 for treat-exp where there was at least a numerical difference between 24 vs 12 weeks & 12 weeks of LDV/SOF as seen in slide immediately below:
http://www.natap.org/2014/EASL/EASL_32.htm and of course for cirrhotics 12 weeks was 82-86% vs 99-100% for 24 weeks where the failures were all relapsers.
In ION-1/naives, 12 vs 24 weeks was 97-99% vs 99%, not much difference.
In ION-1, for naive cirrhotics without Rbv SVR was at least numerically lower lower for both 12 & 24 weeks
http://www.natap.org/2014/EASL/EASL_28.htm
Abbvie 3D TURQUOISE-2, 12 or 24 weeks in 1a & 1b naives & treat-exp with compensated cirrhosis, SVR was 88.6% for Gt1a with 12 weeks & 94.2% with 24 weeks overall, but the 88.6% appears mostly due to the null responders who got 12 weeks & had 86.7% SVR who pulled down SVR, as the partial prior responders had 94.4% SVR & the relapsers had 96.6% SVR rate, table below, but null responders with 24 weeks had 92.9% SVR rate with 24 weeks which was as good as the 1a naives with 12 weeks in this study (these SVR rates are taken from the publication linked to here along with oral slide presentation at EASL/2014:....
http://www.natap.org/2014/EASL/EASL_27.htm........
http://www.natap.org/2014/EASL/nejmoa1402869_appendix.pdf
With Abbvie 3D, in SAPPHIRE-1 a study in treatment-naives, GT1a naives had 95.3% SVR overall while Gt1b had 98% overall SVR, with <800k RNA 98% SVR vs 95.7% for >800k, with F0-F1 97% SVR vs 94.3% for F2 & 92.5% for F3, 97% for BMI<30 vs 91.5% for BMI>30....http://www.natap.org/2014/EASL/EASL_11.htm.....failures were mostly relapsers-
SAPPHIRE-2 was 12 weeks in treat-exp stratified by prior response with no cirrhosis with 68% having F0/F1
COSMOS 2 was in naives & null responders with F3/F4 for 12 & 24 weeks: with 24 weeks 100% (N=28) achieved SVR with either SIM/SOD-Rbv or SIM/SOF; with 12 weeks of SIM/SOF-Rbv 94% (n=16) & 91% (n=11) with F3 & F4, respectively had SVR, with SIM/SOF 12 weeks 7/7 100%with F4 had SVR & 6/7 86% had SVR. Patients with F4 with 24 weeks 100% had SVR with either SIM/SOF+Rbv or SIM/SOF; with 12 weeks SIM/SOF+RBV F4 null responders 4/4 80% had SVR & naives 6/6 100% had SVR, with 12 weeks SIM/SOF 4/4 100% F4 null responders had SVR & 2/3 67% naives had SVR......http://www.natap.org/2014/EASL/EASL_26.htm
COSMOS-1 null responders with F0-F2, 40-80% had F2.....
http://www.natap.org/2014/EASL/EASL_46.htm......
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)
Phase 3 studies of this combination are ongoing
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