Extended Peginterferon Alfa-2a/Ribavirin Therapy Beyond 48 Weeks

Identifying Patients Infected With HCV Genotype 1 Who May Benefit From Extended Peginterferon Alfa-2a/Ribavirin Therapy Beyond 48 Weeks-- see attached full poster report

EASL April 23-26 2009 Copenhagen Reported by Jules Levin

Donald M. Jensen, MD1; Fayez M. Hamzeh, MD, PhD2; Ellen Lentz, PhD2; Nancy Reau, MD1 1University of Chicago Medical Center, Chicago, IL; 2Roche, Nutley, NJ

INTRODUCTION

Treatment for 48 weeks with peginterferon alfa-2a plus ribavirin produces sustained virologic response (SVR) in 46% to 52% of patients infected with hepatitis C virus (HCV) genotype 1.1,2

This suggests that approximately 50% of patients:

– Fail to respond to treatment

– Having become HCV RNA undetectable, subsequently become HCV RNA detectable while on treatment (breakthrough)

– Having become HCV RNA undetectable, relapse during the 24 weeks after the end of treatment (EOT)

– Discontinue treatment early.

Studies have shown that treatment for >48 weeks with peginterferon alfa-2a plus ribavirin may reduce relapse in HCV genotype-1 infected patients who did not achieve rapid virologic response (RVR) at 4 weeks.3,4

The objective of this analysis was to develop a model that can be used to identify non-RVR patients who may be candidates for extended treatment duration.

Author CONCLUSIONS

The practice of treating all patients without cEVR but undetectable HCV RNA at Weeks 13–24 was less accurate, but may be the most practical, when compared with the optimal model.

Week 4 HCV <2 log10 reduction was the earliest marker of candidates for extended treatment duration but the least accurate.

However, prospective clinical trials are necessary to confirm the benefit of extended treatment duration.

Author DISCUSSION

The optimal model provided acceptable sensitivity and specificity to identify patients who will relapse and therefore may benefit from extended treatment duration.

Age, ethnicity, time to first HCV RNA undetectable, baseline ALT level, baseline HCV RNA level, cirrhosis, and HCV RNA reduction at Weeks 4 and 12 were included in the optimal model to predict relapse among patients who were non-RVR and HCV RNA undetectable at EOT.