Telaprevir for Retreatment of HCV Infection: Review of the REALIZE Trial

Abstract

An estimated 170 million people are chronically infected with HCV, which is a leading cause of cirrhosis, hepatocellular carcinoma and liver transplantation in North America. However, in patients infected with HCV genotype 1, 48 weeks of pegylated IFN-α and ribavirin treatment results in a sustained virologic response of only 40–50%. Therefore, development of effective regimens to eradicate HCV has been an urgent priority, especially in those patients who have a predicted low treatment response, partial responders and nonresponders. Telaprevir is a reversible, selective, orally bioavailable inhibitor of the HCV NS3/4A serine protease, and resembles the HCV polypeptide that is cleaved by the viral protease, a necessary step in replication. The REALIZE trial was a Phase III, randomized, double-blind, placebo-controlled study of patients who were previously treated with pegylated IFN-α and ribavirin unsuccessfully for chronic genotype 1 HCV infection, with the aim to compare the efficacy, safety and tolerability of telaprevir. This article reviews the background, study design and results of the REALIZE trial, and discusses the significance of these findings in the rapidly evolving treatment regimens for genotype 1 chronic HCV.

Keywords:

• hepatitis C
• null
• partial
• peginterferon
• relapse
• response
• ribavirin
• telaprevir
• treatment failure

Financial & competing interests disclosure

EM Yoshida has been/is an investigator of clinical trials sponsored by: Vertex Inc., Merck Inc., Hoffman LaRoche Inc., Boeringer Ingleheim Inc., Pfizer Inc., Norvartis Inc., Gilead Sciences Inc., Astellas Inc. and Human Genome Sciences Inc. EM Yoshida has received honoraria for Continuing Medical Education lectures sponsored by Merck Canada Inc., and has received honoraria for physician forum lectures/advisory board lectures sponsored by Vertex Inc. and Merck Inc. EM Yoshida has received an honorarium for preparing educational materials sponsored by an educational grant from Merck Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

EM Yoshida has been/is an investigator of clinical trials sponsored by: Vertex Inc., Merck Inc., Hoffman LaRoche Inc., Boeringer Ingleheim Inc., Pfizer Inc., Norvartis Inc., Gilead Sciences Inc., Astellas Inc. and Human Genome Sciences Inc. EM Yoshida has received honoraria for Continuing Medical Education lectures sponsored by Merck Canada Inc., and has received honoraria for physician forum lectures/advisory board lectures sponsored by Vertex Inc. and Merck Inc. EM Yoshida has received an honorarium for preparing educational materials sponsored by an educational grant from Merck Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.