Individualized treatment duration for hepatitis C genotype 1 patients: a randomized controlled trial
| Autor: | Giuseppe Cristofaro, Giuseppe Montalto, D. Bacca, Francesco Vinelli, Raffaele Cozzolongo, G.L. Ricci, Angelo Andriulli, Leonardo Mottola, Mario R. Romano, Nicola Minerva, Fulvio Spirito, Gaetano Scotto, Vito Carretta, Alessandra Mangia |
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| Přispěvatelé: | MANGIA A, MINERVA N, BACCA D, COZZOLONGO R, RICCI GL, CARRETTA V, VINELLI F, SCOTTO G, MONTALTO G, ROMANO M, CRISTOFARO G, MOTTOLE L, SPIRITO F, ANDRIULLI A |
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Genotype Hepatitis C virus Alpha interferon Hepacivirus Interferon alpha-2 medicine.disease_cause Antiviral Agents Gastroenterology Drug Administration Schedule Polyethylene Glycols law.invention chemistry.chemical_compound Randomized controlled trial law Internal medicine Ribavirin medicine Humans Prospective Studies Rapid Virologic Response genotype 1 Hepatology business.industry Standard treatment Interferon-alpha virus diseases Hepatitis C Middle Aged medicine.disease Recombinant Proteins digestive system diseases Confidence interval Surgery Treatment Outcome chemistry RNA Viral Drug Therapy Combination Female hepatitis C business |
| Popis: | It was hypothesized that in hepatitis C virus (HCV) genotype 1 patients, variable treatment duration individualized by first undetectable HCV RNA is as effective as standard 48-week treatment. Patients (n_696) received peginterferon alfa-2a, 180 mg/week, or peginterferon alfa-2b, 1.5 mg/kg/week, plus ribavirin, 1000-1200 mg/day, for 48 weeks (standard, n _237) or for 24, 48, or 72 weeks if HCV-RNA–negative at weeks 4, 8, or 12, respectively (variable, n _ 459). Sustained virologic response (SVR) was achieved in 45.1% [95% confidence interval (CI) 38.8-51.4] of the patients in the standard group and in 48.8% (CI 44.2-53.3) of the patients in the variable group (P _ 0.37). The percentages of patients who first achieved undetectable HCV RNA at weeks 4, 8, or 12 were 26.7%, 27.8%, and 11.3%, respectively. In the standard treatment group, 87.1%, 70.3%, and 38.1% of patients who first achieved undetectable HCV RNA at 4, 8, or 12 weeks attained SVRs, respectively. In the variable group, corresponding SVR rates were 77.2%, 71.9%, and 63.5%. Low viremia levels and young age were independent predictors of response at week 4 [rapid virologic response (RVR)]. RVR patients with baseline viremia >400,000 IU/mL achieved higher SVR rates when treated for 48 weeks rather than 24 weeks (86.8% versus 73.1%, P _ 0.14). The only predictive factor of SVR in RVR patients was advanced fibrosis. Conclusion: Variable treatment duration ensures SVR rates similar to those of standard treatment duration, sparing unnecessary side effects and costs. (HEPATOLOGY 2008;47:43-50.) |
| Databáze: | OpenAIRE |
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