icon-folder.gif   Conference Reports for NATAP  
 
  59th Annual Meeting of the American Association
for the Study of Liver Diseases
(AASLD)
Oct 31-Nov 1 2008
San Francisco, CA
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SVR in African American Patients: Results of the IDEAL Study (Individualized Dosing Efficacy vs Flat Dosing to Assess OptimaL Pegylated Interferon Therapy)
 
 
  Reported by Jules Levin
American Association for the Study of Liver Diseases
The Liver Meeting 2008
San Francisco, California
October 31 - November 4, 2008
 
J McCone, K-Q Hu, JG McHutchison, ML Shiffman, J King, SK Herrine, GW Galler, MS Sulkowski, J Bloomer, FA Nunes, KA Brown, SC Gordon, KD Mullen, N Ravendhran, W Cassidy, R Ghalib, W Deng, S Noviello, JK Albrecht, AJ Muir on Behalf of the IDEAL Study Team
 
Author Conclusions
As in previous studies, African American patients had lower SVR rates than non-African American patients
 
SVR rates:
-- Low baseline viral load > high baseline viral load
-- Fasting glucose <100 mg/dl
-- Baseline Hemoglobin
-- PEG-IFN alfa-2a + RBV > low-dose PEG-IFN alfa-2b 1.0 + RBV
-- PEG-IFN alfa-2b 1.5 + RBV = PEG-IFN alfa-2a + RBV
(from Jules: low baseline VL, baseline fasting glucose <100 mg/dl, and baseline hemoglobin were predictive of SVR rate for AAs).
 
Early response in African American patients was an important factor in predicting SVR in each of the 3 treatment arms (from Jules: also of interest is that AAs had relatively high undetectable viral load rates compared to non-AAs at weeks 2 and 4 which fell off relative to non-AAs by end-of-treatment; see comments and slides below)
 
Safety and tolerability were similar among African American patients and non-African American patients in the 3 treatment groups

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from Jules: you'll notice in the following slides SVR was higher by 3 percentage points with PEG-IFN alfa-a for AAs (26 vs 23%), but at the end of 24 weeks in 2nd slide below PEG-IFN alfa-2b had higher rates of undetectable HCV RNA 54% in PEG-IFN alfa-2b 1.5/RBV, 47% with PEG-IFN alfa 2b 1.0/RBV, and 40% with PEG-IFN alfa-2b/RBV. But, end of treatment responses for AAs were different: 32% for Peg-2b 1.5/RBV, 21% for Peg-2b 1.0/RBV, and 45% for Peg-2a/RBV. And, relapse rate was higher in Peg-2a group: 37% in Peg-2a, 25% for Peg-2b 1,5, and 16% for Peg-2b 1.0.
 
Also noteworthy is although SVR rates for non-AAs are similar for all 3 Peg/RBV treatment groups, at week 24 Peg-2a rates of undetectable are lower compared to the 2 Peg2b arms, but at the end of treatment Peg-2a SVR rate appears higher for Peg-2a than for the 2 Peg-2b arms, despite that relapse rate is higher. So what happened between weeks 24 to 48?
 

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from Jules: you will note that AAs had high rates of viral response (undetectable) at weeks 2 and 4 and relatively performed well also at weeks 12 and 24. But by the end-of-treatment rates of response fell off for AAs and their relapse rate appeared to be higher compared to non-AAs in the Peg-2a group (37% vs 31%).
 
In the multivariate anaysis baseline viral load, baseline fasting glucose, and baseline hemoglobin predict SVR in AAs.

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from Jules: of interest in this slide is - in patients with low baseline viral load (<600,000 IU/ml) Peg-2a had a higher SVR rate compared to Peg-2b 1.5 (60% vs 41%), but in high baseline viral loads SVR rates were the same 18% for Peg-2b 1.5 vs 17% for Peg-2a. Similar results is seen for BMI: for patients with low baseline BMI (<30 kg/m2) SVR rates is 26% for Peg-2a and 18% for Peg 2b 1.5, but for high baseline BMI (>30 kg/m2) SVR rates were 29% for Peg-2b 1.5 and 26% for Peg-2a. Similarly or patients regarding METAVIR fibrosis score, patients with fibrosis scores of 0, 1, or 2 SVR rate for Peg-2b 1.5 was 22% and for Peg-2a it was 28%, but for patients with fibrosis scores of 3 or 4 SVR rate was 17% for Peg-2b 1,5 and 10% for Peg-2a. The numbers of patients get small in the latter group. Below is the multivariate analysis.

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