 |
|
|
| |
<400,000 is New HCV RNA Cutoff In genotype 1 with Pegasys/RBV
|
| |
| |
Reported by Jules Levin
AASLD, Oct 27-31, 2006, Boston, MA
"Improving the clinical relevance of pretreatment viral load as a predictor of sustained virological response in patients infected with hepatitis C genotype 1 treated with peginterferon alfa-2a (40KD) plus ribavirin"
Stefan Zeuzem
Saarland University Hospital, Homburg/Saar
Germany
AUTHOR CONCLUSIONS
A baseline HCV RNA cut-off of 400,000 IU/mL best discriminates between LVL and HVL in HCV genotype 1 patients based on the probability of achieving an SVR
--An HCV RNA cut-off of 400,000 IU/mL resulted in the greatest delta in SVR rate between patients with a LVL and a HVL
HVL remains a poor prognostic factor, but an increasing pre-treatment HCV RNA level above 400,000 IU/mL is likely to have little influence on SVR
In patients with a pre-treatment HCV RNA level below 400,000 IU/mL, the chance of achieving an SVR increases with decreasing HCV RNA
BACKGROUND
A cut-off point of 2,000,000 copies/mL was established to define a low / high baseline viral load (LVL / HVL) in the context of monotherapy trials
In the process of standardization of the HCV assays:
-- Roche Assay: 2,000,000 copies/mL - 800,000 IU/mL
-- Assay used by SP: 2,000,000 copies/mL - 600,000 IU/mL
The SVR data presented in the PI / SPC for LVL / HVL for the two pegylated interferons are based on these cut-offs
Patients in these two categories have different probabilities of achieving an SVR, particularly those with HCV genotype 1 infection
AIM OF STUDY:
To determine the optimal cut-off point that separates LVL versus HVL based on the probability of achieving an SVR in patients with chronic hepatitis C
(HCV genotype 1) treated with pegylated interferon plus ribavirin
METHODS
568 treatment-naive patients with HCV genotype 1 infection from two international phase III trials1,2
Treatment with peginterferon alfa-2a (40KD) 180 mg/week plus ribavirin 1000/1200 mg/day for 48 weeks
All patients with a pre-treatment HCV RNA measurement who received ≥1 dose of treatment were included in the analysis
A generalized additive multiple logistic regression model (GAM) and a receiver operating characteristic (ROC) curve was used to determine an appropriate cut-off point
Support for an optimized HCV RNA
cut-off of 400,000 IU/mL at AASLD 2006
An optimized viral load cut-off value of 400,000 IU/mL is supported by two other presentations at AASLD 2006
Berg T, et al. Cut-off defined for optimized prediction of treatment outcome in HCV genotype 1 patients receiving 48 or 72 weeks of PEGASYS plus COPEGUS
(ID# 350, Exhibit Hall C, Sat, Oct 28)
Zehnter, et al. Improving differentiation between LVL and HVL for better prediction of SVR in HCV genotype 1
patients receiving PEGASYS plus COPEGUS
(ID# 368, Exhibit Hall C, Sat, Oct 28)
|
| |
|
|
|
|
|
