title: Randomized trial comparing pegylated interferon alpha-2b versus pegylated interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients.
abstract: Although two pegylated interferons (Peg-IFN) are available to treat chronic hepatitis C virus (HCV) infection, no head-to-head comparative studies have been published. We aim to compare the efficacy and safety of PEG IFN alfa-2b (PEG 2b) versus PEG IFN alfa-2a (PEG 2a), plus ribavirin (RBV). A prospective, randomized, multi-center, open-label clinical trial including 182 human immunodeficiency virus (HIV)-hepatitis C virus (HCV) patients naïve for HCV therapy was performed. Patients were assigned to PEG 2b (80-150 mug/week; n = 96) or PEG 2a (180 mug/week; n = 86), plus RBV (800-1200 mg/day) for 48 weeks. The primary endpoint was sustained virological response (SVR: negative HCV-RNA 24 weeks after completion of treatment). At baseline, both groups were well balanced: 73% male; 63% HCV genotype 1 or [corrected] 4; 29% had fibrosis index of 3 or greater. The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P = 0.65). Among genotypes 1 or [corrected] 4, SVRs were 28% versus 32% (P = 0.67) and 62% versus 71% (P = 0.6) in genotypes 2 or [corrected] 3 for PEG 2b and PEG 2a, respectively. Early virological response (EVR; >or=2 log reduction from baseline or negative HCV-RNA at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P = 0.13), reaching a positive predictive value of SVR of 64% and a negative predictive value of 100% in both arms. Side effects were present in 96% of patients but led to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a, P = 0.47).
  
  
  CONCLUSIONS
  In patients with HIV, HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety.
authors.affiliation: Infectious Diseases Service, Hospital Clínic, Barcelona, Spain. mlaguno@clinic.ub.es
authors.forename: Montserrat
authors.initials: M
authors.lastname: Laguno
authors.forename: Carmen
authors.initials: C
authors.lastname: Cifuentes
authors.forename: Javier
authors.initials: J
authors.lastname: Murillas
authors.forename: Sergio
authors.initials: S
authors.lastname: Veloso
authors.forename: Maria
authors.initials: M
authors.lastname: Larrousse
authors.forename: Antoni
authors.initials: A
authors.lastname: Payeras
authors.forename: Lucia
authors.initials: L
authors.lastname: Bonet
authors.forename: Francese
authors.initials: F
authors.lastname: Vidal
authors.forename: Ana
authors.initials: A
authors.lastname: Milinkovic
authors.forename: Antoni
authors.initials: A
authors.lastname: Bassa
authors.forename: Concha
authors.initials: C
authors.lastname: Villalonga
authors.forename: Iñaki
authors.initials: I
authors.lastname: Pérez
authors.forename: Cristina
authors.initials: C
authors.lastname: Tural
authors.forename: Maria
authors.initials: M
authors.lastname: Martínez-Rebollar
authors.forename: Marta
authors.initials: M
authors.lastname: Calvo
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Blanco
authors.forename: Estaban
authors.initials: E
authors.lastname: Martínez
authors.forename: Jose M
authors.initials: JM
authors.lastname: Sánchez-Tapias
authors.forename: Jose M
authors.initials: JM
authors.lastname: Gatell
authors.forename: Jose
authors.initials: J
authors.lastname: Mallolas
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a