Treatment of hepatitis C virus infection with human ezrin peptide one (HEP1) in HIV infected patients.

This report shows the therapeutic benefit of HEP1 (human ezrin peptide 324-337; TEKKRRETVEREKE) monotherapy of hepatitis C virus (HCV) infection in HIV infected patients in two clinical studies. In the Pilot Study I, 16 of 18 patients responded well to the treatment with significant reductions of HCV viral load and a normalization of serum liver enzymes. In 8 of 18 patients, HCV RNA became undetectable, and 3 of 8 interferon/ribavirin treatment failure patients showed undetectable HCV load following HEP1 treatment. In the second study, 8 of 10 patients responded well to the treatment with a pronounced reduction of the HCV viral load and a normalization of serum liver enzymes. Three of 15 patients (20%) showed an undetectable viral load 30 days after the end of a 30-day course of HEP1 treatment. In both studies, all genotypes of HCV were sensitive to HEP1 treatment. Analysis of the combined data from both studies showed the overall efficacy of HEP1 therapy: in 37 HCV+HIV patients, HEP1 therapy gave the following results: 10 of 37 (27%) HCV+HIV patients showed a reduction of viral load between -7 log (-10,000,000x) and -3 log (-1000x); 4 of 37 (11%) a reduction of -3 log (-1000x); 6 of 37 (16%) a reduction of -2 log (-100x); 11 of 37 (30%) a reduction of -1 log (-10x); 6 of 37 (16%) a reduction of less than -1 log (-10x); 0 of 37 (0%) had an increase in viral load, and the average reduction in viral load for all 37 patients was -2 log (-100x). No adverse reactions or side effects were detected and the improving CD4/CD8 ratio showed that the therapy had no negative impact on the immunological status. Thus, oral HEP1 therapy matches the efficacy results for injectable peginterferon/oral ribavirin therapy with the advantages of more rapid action and less side effects. HEP1 therapy should be used in patients where either peginterferon/ribavirin therapy fails or is contraindicated.

RCT Entities:   Population Interventions Outcomes