Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients

Summary

The primary objective of this protocol is to study the effect of the standard of care in hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.

Timeline

Start

2010-05

Primary completion

2012-10

Completion

2013-08

Outcome

Met primary endpoint

paper 64.2% of evaluable patients achieved cEVR, compared with 30.0% in group A and 45.9% in group B (P = .0003 for group C vs A). PMID 24657484 ↗

Publications

• Di Bisceglie AM, Janczweska-Kazek E, Habersetzer F, Mazur W, Stanciu C, Carreno V, Tanasescu C, Flisiak R, Romero-Gomez M, Fich A, Bataille V, Toh ML, Hennequi M, Zerr P, Honnet G, Inchauspe G, Agathon D, Limacher JM, Wedemeyer H. Efficacy of immunotherapy with TG4040, peg-interferon, and ribavirin in a Phase 2 study of patients with chronic HCV infection. Gastroenterology. 2014 Jul;147(1):119-131.e3. doi: 10.1053/j.gastro.2014.03.007. Epub 2014 Mar 18.

Drugs

Indications