title: Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3.
abstract: Albinterferon alfa-2b (albIFN) is a fusion protein of recombinant human albumin/recombinant interferon (IFN)-α-2b, with ∼200-h half-life. Safety/efficacy of albIFN q4wk was evaluated in 391 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 2/3. Patients were randomized 3:4:4:4 to one of four open-label treatment groups: pegylated IFN (Peg-IFN)-α-2a 180 μg qwk or albIFN 900, 1200 or 1500 μg q4wk, plus oral ribavirin 800 mg/day, for 24 weeks. Primary efficacy endpoint was sustained virologic response (SVR; HCV RNA <20 IU/mL 24 weeks post-treatment). SVR rates were as follows: 85%, 76%, 76% and 78% with Peg-IFNα-2a and albIFN 900, 1200 and 1500 μg, respectively (P = NS); corresponding rapid virologic response rates (HCV RNA <43 IU/mL at week 4) were as follows: 78%, 49% (P < 0.001), 60% (P = 0.01) and 71%. SVR rates were not influenced by interleukin 28B genotype, although rapid virologic response rates were greater with interleukin 28B CC (P = NS). Serious adverse event rates were as follows: 4%, 11%, 3% and 3% with Peg-IFNα-2a and albIFN 900, 1200 and 1500 μg, respectively. No increase in serious/severe respiratory events was noted with albIFN. Fewer absolute neutrophil count reductions <750/mm(3) occurred with albIFN (P = 0.03), leading to fewer IFN dose reductions. Haemoglobin reductions <10 g/dL were less frequent with albIFN 900 and 1200 μg vs 1500 μg and Peg-IFNα-2a (P = 0.02), leading to fewer ribavirin dose reductions. albIFN administered q4wk produced fewer haematologic reductions than Peg-IFNα-2a, but had numerically lower SVR rates (P = NS) in patients with chronic HCV genotype 2/3.
authors.affiliation: Monash Medical Centre and Monash University, Melbourne, Vic., Australia. spianko@geds.com.au
authors.forename: S
authors.initials: S
authors.lastname: Pianko
authors.forename: S
authors.initials: S
authors.lastname: Zeuzem
authors.forename: W-L
authors.initials: WL
authors.lastname: Chuang
authors.forename: G R
authors.initials: GR
authors.lastname: Foster
authors.forename: S K
authors.initials: SK
authors.lastname: Sarin
authors.forename: R
authors.initials: R
authors.lastname: Flisiak
authors.forename: C-M
authors.initials: CM
authors.lastname: Lee
authors.forename: P
authors.initials: P
authors.lastname: Andreone
authors.forename: T
authors.initials: T
authors.lastname: Piratvisuth
authors.forename: S
authors.initials: S
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: Sood
authors.forename: J
authors.initials: J
authors.lastname: George
authors.forename: M
authors.initials: M
authors.lastname: Gould
authors.forename: P
authors.initials: P
authors.lastname: Komolmit
authors.forename: S
authors.initials: S
authors.lastname: Thongsawat
authors.forename: T
authors.initials: T
authors.lastname: Tanwandee
authors.forename: J
authors.initials: J
authors.lastname: Rasenack
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.forename: M
authors.initials: M
authors.lastname: Pang
authors.forename: Y
authors.initials: Y
authors.lastname: Yin
authors.forename: G
authors.initials: G
authors.lastname: Feutren
authors.forename: I M
authors.initials: IM
authors.lastname: Jacobson
mesh_terms: D000328:Adult; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics* / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D007372:Interferons; D007378:Interleukins / Q000235:genetics; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome; D019562:Viral Load; D000095022:Interferon Lambda
chemical_list: D000418:Albumins; D000998:Antiviral Agents; D016898:Interferon-alpha; D007372:Interferons; D007378:Interleukins; D012367:RNA, Viral; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; C531108:albinterferon alfa-2b