PMID- 20600013 OWN - NLM STAT- MEDLINE DCOM- 20101022 LR - 20240109 IS - 1528-0012 (Electronic) IS - 0016-5085 (Linking) VI - 139 IP - 4 DP - 2010 Oct TI - Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 1. PG - 1257-66 LID - 10.1053/j.gastro.2010.06.066 [doi] AB - BACKGROUND & AIMS: The current standard of care for patients with chronic hepatitis C virus (HCV) genotype 1 is once-weekly pegylated interferon-alpha (Peg-IFNalpha) plus daily ribavirin for 48 weeks. We evaluated the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of albumin and IFNalpha-2b. METHODS: In the phase 3 ACHIEVE-1 trial, 1331 patients were assigned equally to 3 open-label, 48-week treatment groups: Peg-IFNalpha-2a 180 mug every week, or albIFN 900 or 1200 mug every 2 weeks administered subcutaneously, with weight-based oral ribavirin 1000-1200 mg/day. During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 mug to 900 mug because of increased pulmonary adverse events (AEs) in the 1200-mug arms of both ACHIEVE studies. Main outcome measure was sustained virologic response (SVR; undetectable serum HCV RNA at week 72). RESULTS: Intention-to-treat SVR rates were 51.0% (225/441), 48.2% (213/442), and 47.3% (208/440) with Peg-IFNalpha-2a, and albIFN 900 and 1200 mug, respectively. The primary objective of showing noninferiority of albIFN 900 mug (P < .001) and 1200 mug (P = .003) vs Peg-IFNalpha-2a for SVR was achieved. Multivariate modeling indicated consistency of treatment effect across subgroups. Serious/severe AE rates were 23.1%, 24.0%, 28.2%; treatment discontinuation rates because of AEs were 4.1%, 10.4%, 10.0%; discontinuation rates because of respiratory AEs were 0%, 0.9%, 1.6%; with Peg-IFNalpha-2a, and albIFN 900 and 1200 mug, respectively. Hematologic abnormality rates were comparable across the Peg-IFNalpha-2a and albIFN 900-mug groups. CONCLUSIONS: albIFN 900 mug every 2 weeks showed comparable efficacy, with similar serious/severe AE rates, although with a higher discontinuation rate, vs Peg-IFNalpha-2a in patients with chronic HCV genotype 1. CI - Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved. FAU - Zeuzem, Stefan AU - Zeuzem S AD - JW Goethe University Hospital, Frankfurt, Germany. zeuzem@em.uni-frankfurt.de FAU - Sulkowski, Mark S AU - Sulkowski MS FAU - Lawitz, Eric J AU - Lawitz EJ FAU - Rustgi, Vinod K AU - Rustgi VK FAU - Rodriguez-Torres, Maribel AU - Rodriguez-Torres M FAU - Bacon, Bruce R AU - Bacon BR FAU - Grigorescu, Mircea AU - Grigorescu M FAU - Tice, Alan D AU - Tice AD FAU - Lurie, Yoav AU - Lurie Y FAU - Cianciara, Janusz AU - Cianciara J FAU - Muir, Andrew J AU - Muir AJ FAU - Cronin, Patrick W AU - Cronin PW FAU - Pulkstenis, Erik AU - Pulkstenis E FAU - Subramanian, G Mani AU - Subramanian GM FAU - McHutchison, John G AU - McHutchison JG CN - ACHIEVE-1 Study Team LA - eng SI - ClinicalTrials.gov/NCT00402428 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20100627 PL - United States TA - Gastroenterology JT - Gastroenterology JID - 0374630 RN - 0 (Albumins) RN - 0 (Antiviral Agents) RN - 0 (Interferon alpha-2) RN - 0 (Interferon-alpha) RN - 0 (Recombinant Proteins) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 49717AWG6K (Ribavirin) RN - 4DVS4AG4DF (albinterferon alfa-2b) RN - Q46947FE7K (peginterferon alfa-2a) SB - IM CIN - Gastroenterology. 2010 Oct;139(4):1084-6. PMID: 20800652 MH - Adult MH - Albumins/administration & dosage/adverse effects/*therapeutic use MH - Antiviral Agents/*therapeutic use MH - Drug Therapy, Combination MH - Female MH - Hepatitis C, Chronic/*drug therapy/virology MH - Humans MH - Interferon alpha-2 MH - Interferon-alpha/administration & dosage/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Polyethylene Glycols/administration & dosage/adverse effects/*therapeutic use MH - Recombinant Proteins MH - Ribavirin/administration & dosage FIR - Angus, P IR - Angus P FIR - Bell, S IR - Bell S FIR - Cheng, W IR - Cheng W FIR - Crawford, D IR - Crawford D FIR - George, J IR - George J FIR - Harley, H IR - Harley H FIR - Hughes, B IR - Hughes B FIR - Kronborg, I IR - Kronborg I FIR - Lee, A IR - Lee A FIR - Leggett, B IR - Leggett B FIR - Mollison, L IR - Mollison L FIR - Pianko, S IR - Pianko S FIR - Roberts, S IR - Roberts S FIR - Sasadeusz, J IR - Sasadeusz J FIR - Strasser, S IR - Strasser S FIR - Zekry, A IR - Zekry A FIR - Ferenci, P IR - Ferenci P FIR - Stauber, R IR - Stauber R FIR - Vogel, W IR - Vogel W FIR - Bailey, R IR - Bailey R FIR - Bain, V IR - Bain V FIR - Cooper, C IR - Cooper C FIR - Heathcote, J IR - Heathcote J FIR - Kaita, K IR - Kaita K FIR - Marotta, P IR - Marotta P FIR - Peltekian, K IR - Peltekian K FIR - Sherman, M IR - Sherman M FIR - Swain, M IR - Swain M FIR - Wong, P IR - Wong P FIR - Yoshida, E IR - Yoshida E FIR - Dlouhy, P IR - Dlouhy P FIR - Galsky, J IR - Galsky J FIR - Husa, P IR - Husa P FIR - Kumpel, P IR - Kumpel P FIR - Plisek, S IR - Plisek S FIR - Rehak, V IR - Rehak V FIR - Urbanek, P IR - Urbanek P FIR - Benhamou, Y IR - Benhamou Y FIR - Bourliere, M IR - Bourliere M FIR - Causse, X IR - Causse X FIR - Couzigou, P IR - Couzigou P FIR - Marcellin, P IR - Marcellin P FIR - Pawlotsky, J M IR - Pawlotsky JM FIR - Poupon, R IR - Poupon R FIR - Trepo, C IR - Trepo C FIR - Berg, T IR - Berg T FIR - Eisenbach, K C A IR - Eisenbach KC FIR - Galle, P R IR - Galle PR FIR - Gerken, G IR - Gerken G FIR - Haussinger, D IR - Haussinger D FIR - Manns, M IR - Manns M FIR - Mauss, S IR - Mauss S FIR - Rasenack, J F W IR - Rasenack JF FIR - Reiser, M IR - Reiser M FIR - Wiegand, J IR - Wiegand J FIR - Zeuzem, S IR - Zeuzem S FIR - Baruch, Y IR - Baruch Y FIR - Lurie, Y IR - Lurie Y FIR - Safadi, R IR - Safadi R FIR - Shouval, D IR - Shouval D FIR - Tur Kaspar, R IR - Tur Kaspar R FIR - Cianciara, J IR - Cianciara J FIR - Flisiak, R IR - Flisiak R FIR - Gladysz, A IR - Gladysz A FIR - Horban, A IR - Horban A FIR - Jablkowski, M IR - Jablkowski M FIR - Kryczka, W IR - Kryczka W FIR - Mach, T IR - Mach T FIR - Calistru, P IR - Calistru P FIR - Grigorescu, M IR - Grigorescu M FIR - Manuc, M IR - Manuc M FIR - Stanciu, C IR - Stanciu C FIR - Tanasescu, C IR - Tanasescu C FIR - Diago, M IR - Diago M FIR - Esteban Mur, R IR - Esteban Mur R FIR - Forns, X IR - Forns X FIR - Moreno, R IR - Moreno R FIR - Planas, R IR - Planas R FIR - Cramp, M IR - Cramp M FIR - Foster, G IR - Foster G FIR - Main, J IR - Main J FIR - Mutimer, D IR - Mutimer D FIR - Afdhal, N IR - Afdhal N FIR - Arora, S IR - Arora S FIR - Bacon, B IR - Bacon B FIR - Bennett, M IR - Bennett M FIR - Bernstein, D IR - Bernstein D FIR - Brady, C IR - Brady C FIR - Bzowej, N IR - Bzowej N FIR - Carp, M IR - Carp M FIR - Chasen, R IR - Chasen R FIR - Davis, G IR - Davis G FIR - Dickson, R IR - Dickson R FIR - Dieterich, D IR - Dieterich D FIR - Everson, G IR - Everson G FIR - Fallon, M IR - Fallon M FIR - Flamm, S IR - Flamm S FIR - Franco, J IR - Franco J FIR - Fried, M IR - Fried M FIR - Galati, J IR - Galati J FIR - Ghalib, R IR - Ghalib R FIR - Gibas, A IR - Gibas A FIR - Gitlin, N IR - Gitlin N FIR - Godofsky, E IR - Godofsky E FIR - Gordon, S IR - Gordon S FIR - Han, S IR - Han S FIR - Harrison, S IR - Harrison S FIR - Hassanein, T IR - Hassanein T FIR - Herrine, S IR - Herrine S FIR - Herring, R IR - Herring R FIR - Ho, S IR - Ho S FIR - Jacobson, I IR - Jacobson I FIR - Jeffers, L IR - Jeffers L FIR - Joshi, S IR - Joshi S FIR - Kugelmas, M IR - Kugelmas M FIR - Kwo, P IR - Kwo P FIR - Lambiase, L IR - Lambiase L FIR - Lawitz, E IR - Lawitz E FIR - Lee, W IR - Lee W FIR - Lindsay, K IR - Lindsay K FIR - Liou, I IR - Liou I FIR - Lucey, M IR - Lucey M FIR - Monsour, H IR - Monsour H FIR - Nelson, D IR - Nelson D FIR - Nyberg, L IR - Nyberg L FIR - Phillips, J IR - Phillips J FIR - Pockros, P IR - Pockros P FIR - Poordad, F IR - Poordad F FIR - Pruitt, R IR - Pruitt R FIR - Reau, N IR - Reau N FIR - Reddy, K R IR - Reddy KR FIR - Rodriquez-Torres, M IR - Rodriquez-Torres M FIR - Rubin, R IR - Rubin R FIR - Rustgi, V IR - Rustgi V FIR - Schiff, E IR - Schiff E FIR - Schmidt, W IR - Schmidt W FIR - Sheikh, A IR - Sheikh A FIR - Sheikh, M IR - Sheikh M FIR - Sherman, K IR - Sherman K FIR - Shiffman, M IR - Shiffman M FIR - Sjogren, M IR - Sjogren M FIR - Sulkowski, M IR - Sulkowski M FIR - Terrault, N IR - Terrault N FIR - Tice, A IR - Tice A FIR - Tong, M IR - Tong M FIR - Vargas, H IR - Vargas H FIR - Wiesner, R IR - Wiesner R FIR - Wruble, L IR - Wruble L FIR - Younossi, Z IR - Younossi Z EDAT- 2010/07/06 06:00 MHDA- 2010/10/23 06:00 CRDT- 2010/07/06 06:00 PHST- 2010/03/19 00:00 [received] PHST- 2010/06/03 00:00 [revised] PHST- 2010/06/23 00:00 [accepted] PHST- 2010/07/06 06:00 [entrez] PHST- 2010/07/06 06:00 [pubmed] PHST- 2010/10/23 06:00 [medline] AID - S0016-5085(10)01009-7 [pii] AID - 10.1053/j.gastro.2010.06.066 [doi] PST - ppublish SO - Gastroenterology. 2010 Oct;139(4):1257-66. doi: 10.1053/j.gastro.2010.06.066. Epub 2010 Jun 27.