AIMS:
The aim of this clinical study was to assess virological response at end-of -treatment (ETR), sustained virological (SVR) and biochemical response in former drug users with chronic hepatitis C treated with PEG-IFN-alpha and R.
PATIENTS:
Ninety two former drug users (21 F, 71 M) average age 27 years (18 to 41 years) and previously not treated with IFN-alpha and R (naive patients, pts) were evaluated for their virological and biochemical response. Standard treatment regimen of either 24 or 48 weeks was applied in patients with genotype 3 or genotype 1, respectively. SVR was considered if viral tests (HCV RNA) were negative 24 weeks after the end of treatment.
RESULTS:
Overall SVR was attained in 87 (95%) of 92 treated patients, and therapy failed in 5 pts with genotype 1. In genotype 1 patients ETR and SVR were 81% and 86%, respectively (p < 0.001). In genotype 3 patients ETR and SVR were 98% and 100%, respectively (p < 0.001). ALT levels decreased significantly after 12 weeks of therapy (ALT 1.61 vs 0.64 micro/kat/l, p < 0.001) and were at normal levels during follow-up.
CONCLUSIONS:
Crucial predictive factors resulting in high SVR were the younger age in combination with low stage of liver fibrosis, relatively short duration of viral infection, high proportion of genotype 3 and excellent adherence of patients to treatment regimen than previously not treated with IFN-alpha and R (naive patients). High proportion of SVR in former drug users has been achieved in patients with genotype 3 (100%) and genotype 1 (86%). The most decisive prognostic factor which favors high therapeutic efficacy appears to be young age and early onset of anti-HCV treatment (Tab. 3, Fig. 1, Ref. 33). Full Text (Free, PDF) www.bmj.sk.