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

Identity note: The chemical identifiers in this project's record (CAS 174641-44-2, CID 25078222) correspond to Gepon / HEP1 / Human Ezrin Peptide-1 (sequence TEKKRRETVEREKE, residues 324-337 of human ezrin) — a Russian antiviral immunomodulator registered for human use since 2001. This citation refers to that compound, distinct from the hepatoprotective "Hepatocyte Peptide-1" whose chemical identity is not verified in public databases.

This was a clinical study in HCV+HIV coinfected patients, conducted to evaluate the efficacy of oral HEP1 as monotherapy on HCV viral load. The peptide is typically administered orally (on buccal/gingival mucosa) or rectally, acting as an activator of innate and adaptive antiviral immunity through mechanisms involving amplification of CD8⁺ T cell response and inhibition of IL-6 and other pro-inflammatory cytokine expression.

Combined study results (pilot + second study): in 37 HCV+HIV coinfected patients, monotherapy with HEP1 produced mean HCV viral load reduction of -2 log (~100x). Sixteen of 18 pilot study patients responded well to treatment. 27% of patients (10 of 37) showed robust viral load reduction between -3 log and -7 log — clinically significant magnitude for HCV, comparable to interferon/ribavirin-based regimens of that era. No relevant adverse reactions were detected, contrasting with the toxic profile of interferon.

The authors concluded that oral HEP1 offers comparable efficacy to peginterferon/ribavirin with faster action and better tolerability. Important limitations include the open-label design, absence of randomized control group, and publication in a lower-impact journal. Gepon remains registered and clinically used in Russia for opportunistic viral infections, with over 20 years of use and a consistent safety profile. In the West, its adoption is limited by lack of regulatory approval and the development of direct-acting antivirals (DAAs) for HCV, which made other therapeutic options obsolete.