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Title: Peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) in retreatment of chronic hepatitis C patients, nonresponders and relapsers to previous conventional interferon plus ribavirin therapy
Authors: Parise, Edison Roberto [UNIFESP]
Cheinquer, H.
Crespo, D.
Meirelles, A.
Martinelli, A.
Sette Junior, Hoel
Gallizi, J.
Silva, R.
Lacet, C.
Correa, E.
Cotrim, H.
Fonseca, J.
Paraná, Raymundo
Spinelli, V.
Amorim, W.
Tatsch, F.
Pessoa, M.
Universidade Federal de São Paulo (UNIFESP)
Santa Casa de Misericórdia Gastroenterology Service
Federal University of Pará
Federal University of Juiz de Fora
São Paulo University Medical School of Ribeirão Preto
Emílio Ribas Institute
Federal University of Minas Gerais
Medical School of São José do Rio Preto
Federal University of Alagoas
Federal University of Santa Catarina
Federal University of Bahia
Tropical Medicine Fundation
Oswaldo Cruz Hospital
Federal University of Paraíba
Keywords: Peginterferon alfa
hepatitis C
Issue Date: 1-Feb-2006
Publisher: Brazilian Society of Infectious Diseases
Citation: Brazilian Journal of Infectious Diseases. Brazilian Society of Infectious Diseases, v. 10, n. 1, p. 11-16, 2006.
Abstract: Peginterferon alfa plus ribavirin is currently the treatment of choice for chronic hepatitis C. Peginterferon alfa-2a (40KD) plus ribavirin has given an overall sustained virological response of 18% in F3/F4 previous nonresponder US patients. We evaluated the effectiveness of peginterferon alfa-2a (40KD) plus ribavirin in Brazilian patients who were relapsers or nonresponders to previous interferon-based therapy. One-hundred-thirty-four patients with biopsy-proven chronic hepatitis C, HCV RNA positive, elevated ALT and who were either relapsers (n=37) or nonresponders (n=97) to at least 24 weeks of conventional interferon/ribavirin therapy were retreated with peginterferon alfa-2a (40KD) 180mg/qw and ribavirin 800mg bid for 48 weeks. Efficacy was assessed as virological response (defined as undetectable HCV RNA) at the end of treatment (EoT) and at the end of follow-up (SVR - Sustained Virological Response). Safety assessments consisted of clinical and laboratory evaluations. In the patient sample, 72% were genotype 1 and 34% were cirrhotic. In an intention-to-treat analysis, relapser patients showed 78% EoT response and 51% SVR. Nonresponders showed 57% EoT response and 26% SVR. Positive predictive factors of SVR were non-1 genotype and relapser state. Six percent of the patients interrupted treatment because of adverse events and 45% had dose reduction (mainly associated with leucopenia and anemia). Brazilian patient relapsers and nonresponders to conventional interferon and ribavirin treatment can achieve a sustained virological response when retreated with peginterferon alfa-2a (40KD) and ribavirin. The safety profile is similar to that of naive patients.
ISSN: 1413-8670
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