COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Re-treatment of patients with hepatitis C who failed to respond (nonresponders) to previous treatment.

The aim of four-year follow up study was evaluation of re-treatment efficacy of antiviral therapy in patients with hepatitis C who failed to respond (non responders) to previous therapy. Study enrolled 29 patients, aged 21-59 with HCV infection (15 had HCV genotype 1, and 14 had HCV non-genotype1), who previously were treated with unmodified interferon alfa (conventional interferon) 2a or 2b 5 MIU TIW plus ribavirin (1000-1200 mg/day) and who failed under this therapy. Study subjects were randomized into two groups: in group I were included 17 patients--relapsers (patient in whom HCV RNA becomes undetectable on treatment and is undetectable at the end of therapy, but is detected again after discontinuation of treatment). Group II was composed of 12 patients: 4 were non responders (patient in whom HCV RNA levels remain stable on treatment), 4--partial responders (HCV RNA levels decline by >2 logs, but never become undetectable during treatment) and 4--breakthrough non responders (HCV RNA become undetectable during treatment, but before-treatment termination again become detectable). The diagnosis of HCV infection was made based on detection of HCV antibodies by ELISA and confirmed by RIBA. Detection of HCV RNA (qualitative) and HCV RNA Viral load--by Real time PCR technique (COBAS TaqMan Test). HCV genotypes were detected by INNO-Lipa method. In group I--rapid virological response (RVR) was observed in 10 (58%) patients, early viral response (EVR) in 12 patients (70%). Among them 9 (52%) patients remained HCV RNA undetectable by the end of treatment. After 6 months sustained viral response (SVR) was received in 7 (41%) patients from group I. In group II--RVR was observed in 5 (41%), EVR in 6 (50%) patients. Among them 5 (41%) patients remained HCV RNA undetectable by the end of treatment. After 6 months Sustained Viral Response was received in 3 (25%) patients. Re-treatment with pegylated interferon and ribavirin in patients with hepatitis C who failed to responds to previous treatment was effective in relapsers. Re-treatment in non responders, partial responders and breakthrough non responders was less effective (especially in non responders). Re-treatment effectiveness was higher in HCV genotype non 1 patients in comparison with HCV genotype 1. Thus re-treatment will be considered for relapsers. For making decision on re-treatment for other nonresponders, severity of disease (advance disease) should be considered.

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