title: Weight-based combination therapy with peginterferon alpha-2b and ribavirin for naïve, relapser and non-responder patients with chronic hepatitis C.
abstract: Combination therapy with pegylated interferon and ribavirin is considered the new standard therapy for naïve patients with chronic hepatitis C. We evaluated the efficacy and safety of treatment with weight-based peginterferon alpha-2b (1.5 mg/kg per week) plus ribavirin (800-1,200 mg/day) for 48 weeks in naïve, relapser and non-responder (to previous treatment with interferon plus ribavirin) patients with chronic hepatitis C. Sixty-seven naïve, 26 relapser and 40 non-responder patients were enrolled. The overall sustained virological response (SVR) for the intention-to-treat population was 54% for naïve, 62% for relapser and 38% for non-responder patients. In the naïve subgroup, SVR was significantly higher in patients with the non-1 genotype (67%) compared to those with genotype 1 (45%). In relapsers and non-responders, SVR was, respectively, 69% and 24% in patients with genotype 1 and 43% and 73% in those with genotype non-1. There were no significant differences in SVR rates among the three body weight ranges (<65 kg, 65-85 kg and >85 kg) in any of the subgroups. Early virological response (EVR) was reached by 78%, 81% and 58% of naïve, relapser and non-responder patients, respectively, and among those with EVR, 63%, 67% and 61%, respectively, subsequently achieved SVR. All of the non-responder patients who did not have EVR reached SVR. Treatment was discontinued in 13% of the patients, due to loss to follow-up, hematological abnormalities or depression.
authors.affiliation: Faculty of Medical Sciences of Campinas, Campinas, SP, Brazil.
authors.forename: Fernando Lopes
authors.initials: FL
authors.lastname: Gonçales
authors.forename: Aline
authors.initials: A
authors.lastname: Vigani
authors.forename: Neiva
authors.initials: N
authors.lastname: Gonçales
authors.forename: Antonio Alci
authors.initials: AA
authors.lastname: Barone
authors.forename: Evaldo
authors.initials: E
authors.lastname: Araújo
authors.forename: Roberto
authors.initials: R
authors.lastname: Focaccia
authors.forename: Umbeliana
authors.initials: U
authors.lastname: Oliveira
authors.forename: Henrique Sérgio Morais
authors.initials: HS
authors.lastname: Coelho
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Paixao
authors.forename: Renata
authors.initials: R
authors.lastname: Perez
authors.forename: Cirley
authors.initials: C
authors.lastname: Lobato
authors.forename: Judith
authors.initials: J
authors.lastname: Weirich
authors.forename: Heitor
authors.initials: H
authors.lastname: Rosa
authors.forename: Andrelina
authors.initials: A
authors.lastname: Borges
authors.forename: Ricardo
authors.initials: R
authors.lastname: Vila
authors.forename: Maria Lúcia
authors.initials: ML
authors.lastname: Corrêa-Giannella
authors.forename: Maria Lúcia Gomes
authors.initials: ML
authors.lastname: Ferraz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D001835:Body Weight; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b