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Ther Drug Monit ; 37(6): 745-50, 2015 Dec.
Article in English | MEDLINE | ID: mdl-25811342

ABSTRACT

BACKGROUND: The aim of the study was to investigate whether patients with a previous nonresponse to standard of care treatment with ribavirin dosed according to body weight would respond to a high individualized dose of concentration-monitored ribavirin. METHODS: Previous nonresponders to standard of care treatment with peginterferon (peg-IFN) and ribavirin were included. Ribavirin was dosed aiming at a plasma concentration of >15 µmol/L. The initial ribavirin dose was calculated from a formula based on renal function and body weight. Erythropoietin treatment was started 2 weeks before antiviral therapy. RESULTS: Twenty patients (16 men and 4 women) with a mean age of 52 years were included. Sixty percent had advanced fibrosis. Eighty percent of patients achieved an early viral response, and 60% were negative for hepatitis C virus ribonucleic acid (HCV RNA) at treatment week 24. High-dose ribavirin resulted in a significantly increased HCV RNA drop at week 12 (mean: 3.13 versus 2.05 IU/mL; P < 0.001). Nine patients were negative for HCV RNA at the end of treatment, and 1 achieved sustained viral response. The final steady-state daily dose of ribavirin varied from 1400 to 4400 mg. Hemoglobin levels decreased during treatment, mean Hb 163, 134, and 110 g/L at week 0, 4, and 12, respectively. Two patients received blood transfusions. No other severe adverse events were recorded. CONCLUSIONS: An individualized high ribavirin dose resulted in a more pronounced early viral HCV RNA decline than a standard-dose ribavirin scheme. This regime is safe provided that close monitoring of anemia is undertaken and that treatment with erythropoietin is given.


Subject(s)
Antiviral Agents/therapeutic use , Hepacivirus/genetics , Hepatitis C, Chronic/drug therapy , Ribavirin/therapeutic use , Adult , Antiviral Agents/administration & dosage , Chromatography, High Pressure Liquid/methods , Cohort Studies , Coinfection , Dose-Response Relationship, Drug , Drug Therapy, Combination , Female , Genotype , HIV Infections/epidemiology , Hepacivirus/isolation & purification , Hepatitis C, Chronic/virology , Humans , Interferons/administration & dosage , Male , Middle Aged , Polyethylene Glycols/chemistry , Retrospective Studies , Ribavirin/administration & dosage , Treatment Outcome
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