Clinical Investigation of Erlotinib as an HCV Entry Inhibitor
Status:
Unknown status
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and
hepatocellular carcinoma world-wide. Current combination therapy of pegylated
interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial
side effects.
The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV
infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM)
broadly inhibits HCV infection of all major genotypes including viral escape variants
resistant to host immune responses.
Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems
demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral
approach for prevention and treatment of HCV infection (European patent application EP 08 305
604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature
Medicine 2011).
Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a
well characterized safety profile in humans, the aim of the study is to investigate the
safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for
treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in
patients chronically infected with HCV. Following completion, this trial will set the stage
for a further investigation of entry inhibitors as antivirals in combination with standard of
care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical
trial will be an important step in the development of novel urgently needed antiviral
therapies overcoming resistance.