In this way, the efficacy, safety and immunotherapeutic properties of TG4040 are determined in combination with interferon-pegylated (PEG) and ribavirin (R). The results of the study have been published in the journal Gastroeneterology.
We included patients with genotype 1, not previously treated and assigned to the following groups: PEG + R for 48 weeks (Group A, N = 31 patients); PEG + R for 4 weeks followed by PEG + R 44 weeks and 6 injections of TG4040 (Group B, N = 63); and TG4040 for 12 weeks (7 injections) followed by PEG + R for 48 weeks together with 6 more injections of TG4040 (Group C, N = 59). In group C, 64% of patients had a response at the end of treatment, compared to 30% in Group A and 45.9% in Group B. Also, the sustained response in Group C was greater than in A and B (58.2%, 48.4% and 50.8%, respectively). Significant marrow toxicity (decrease in platelets) occurred in 3 patients ..
In summary, from this study in which the Foundation participated, it can be deduced that the therapeutic vaccine TG4040 is effective in the treatment of hepatitis C. However, given the significant haematological toxicity that it produces, it will no longer be used in the treatment.