PMID- 23081753 OWN - NLM STAT- MEDLINE DCOM- 20130423 LR - 20220408 IS - 1527-3350 (Electronic) IS - 0270-9139 (Linking) VI - 57 IP - 3 DP - 2013 Mar TI - Anemia during treatment with peginterferon Alfa-2b/ribavirin and boceprevir: Analysis from the serine protease inhibitor therapy 2 (SPRINT-2) trial. PG - 974-84 LID - 10.1002/hep.26096 [doi] AB - Boceprevir (BOC) added to peginterferon alfa-2b (PegIFN) and ribavirin (RBV) significantly increases sustained virologic response (SVR) rates over PegIFN/RBV alone in previously untreated adults with chronic hepatitis C genotype 1. We evaluate the relationship of incident anemia with triple therapy. A total of 1,097 patients received a 4-week lead-in of PegIFN/RBV followed by: (1) placebo plus PegIFN/RBV for 44 weeks (PR48); (2) BOC plus PegIFN/RBV using response-guided therapy (BOC/RGT); and (3) BOC plus PegIFN/RBV for 44 weeks (BOC/PR48). The management of anemia (hemoglobin [Hb]<10 g/dL) included RBV dose reduction and/or erythropoietin (EPO) use. A total of 1,080 patients had >/=1 Hb measurement during treatment. The incidence of anemia was 50% in the BOC arms combined (363/726) and 31% in the PR48 arm (108/354, P<0.001). Among BOC recipients, lower baseline Hb and creatinine clearance were associated with incident anemia. In the BOC-containing arms, anemia was managed by the site investigators as follows: EPO without RBV dose reduction, 38%; RBV dose reduction without EPO, 8%; EPO with RBV dose reduction, 40%; and neither RBV dose reduction nor EPO, 14%. SVR rates were not significantly affected by management strategy (70%-74%), and overall patients with anemia had higher rates of SVR than those who did not develop anemia (58%). Serious and life-threatening adverse events (AEs) and discontinuations due to AEs among BOC-treated patients did not differ by EPO use. CONCLUSION: With BOC/PR therapy, SVR rates in patients with incident anemia were higher than nonanemic patients and did not vary significantly according to the investigator-selected approach for anemia management. Prospective studies are needed to confirm this observation. CI - Copyright (c) 2012 American Association for the Study of Liver Diseases. FAU - Sulkowski, Mark S AU - Sulkowski MS AD - Johns Hopkins University School of Medicine, Baltimore, MD 21287-0003, USA. msulkowski@jhmi.edu FAU - Poordad, Fred AU - Poordad F FAU - Manns, Michael P AU - Manns MP FAU - Bronowicki, Jean-Pierre AU - Bronowicki JP FAU - Rajender Reddy, K AU - Rajender Reddy K FAU - Harrison, Stephen A AU - Harrison SA FAU - Afdhal, Nezam H AU - Afdhal NH FAU - Sings, Heather L AU - Sings HL FAU - Pedicone, Lisa D AU - Pedicone LD FAU - Koury, Kenneth J AU - Koury KJ FAU - Sniukiene, Vilma AU - Sniukiene V FAU - Burroughs, Margaret H AU - Burroughs MH FAU - Albrecht, Janice K AU - Albrecht JK FAU - Brass, Clifford A AU - Brass CA FAU - Jacobson, Ira M AU - Jacobson IM CN - SPRINT-2 Trial Investigators LA - eng GR - K24 DA034621/DA/NIDA NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130211 PL - United States TA - Hepatology JT - Hepatology (Baltimore, Md.) JID - 8302946 RN - 0 (Antiviral Agents) RN - 0 (Hematinics) RN - 0 (Hemoglobins) RN - 0 (Interferon alpha-2) RN - 0 (Interferon-alpha) RN - 0 (Placebos) RN - 0 (Recombinant Proteins) RN - 0 (Serine Proteinase Inhibitors) RN - 11096-26-7 (Erythropoietin) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 49717AWG6K (Ribavirin) RN - 89BT58KELH (N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide) RN - 9DLQ4CIU6V (Proline) RN - G8RGG88B68 (peginterferon alfa-2b) SB - IM MH - Adult MH - Anemia/*chemically induced/drug therapy MH - Antiviral Agents/administration & dosage/adverse effects MH - Drug Therapy, Combination/adverse effects MH - Erythropoietin/administration & dosage/adverse effects MH - Female MH - Hematinics/administration & dosage/adverse effects MH - Hemoglobins/metabolism MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Interferon alpha-2 MH - Interferon-alpha/administration & dosage/*adverse effects MH - Male MH - Placebos MH - Polyethylene Glycols/administration & dosage/*adverse effects MH - Proline/administration & dosage/adverse effects/*analogs & derivatives MH - Recombinant Proteins/administration & dosage/adverse effects MH - Ribavirin/administration & dosage/*adverse effects MH - Serine Proteinase Inhibitors/administration & dosage/*adverse effects MH - Treatment Outcome FIR - Colombato, L IR - Colombato L FIR - Curciarello, J IR - Curciarello J FIR - Silva, M IR - Silva M FIR - Tanno, H IR - Tanno H FIR - Terg, R IR - Terg R FIR - Adler, M IR - Adler M FIR - Langlet, P IR - Langlet P FIR - Lasser, L IR - Lasser L FIR - Nevens, F IR - Nevens F FIR - Anderson, F IR - Anderson F FIR - Bailey, R IR - Bailey R FIR - Bilodeau, M IR - Bilodeau M FIR - Cooper, C IR - Cooper C FIR - Feinman, S V IR - Feinman SV FIR - Heathcote, J IR - Heathcote J FIR - Levstik, M IR - Levstik M FIR - Ramji, A IR - Ramji A FIR - Sherman, M IR - Sherman M FIR - Shafran, S IR - Shafran S FIR - Yoshida, E IR - Yoshida E FIR - Achim, A IR - Achim A FIR - Ben Ali, S IR - Ben Ali S FIR - Bigard, M-A IR - Bigard MA FIR - Bonny, C IR - Bonny C FIR - Bourliere, M IR - Bourliere M FIR - Boyer-Darrigrand, N IR - Boyer-Darrigrand N FIR - Bronowicki, J-P IR - Bronowicki JP FIR - Canva, V IR - Canva V FIR - Couzigou, P IR - Couzigou P FIR - De Ledinghen, V IR - De Ledinghen V FIR - Guyader, D IR - Guyader D FIR - Hezode, C IR - Hezode C FIR - Larrey, D IR - Larrey D FIR - Latournerie, M IR - Latournerie M FIR - Marcellin, P IR - Marcellin P FIR - Mathurin, P IR - Mathurin P FIR - Maynard-Muet, M IR - Maynard-Muet M FIR - Moussalli, J IR - Moussalli J FIR - Poupon, R IR - Poupon R FIR - Poynard, T IR - Poynard T FIR - Serfaty, L IR - Serfaty L FIR - Tran, A IR - Tran A FIR - Trepo, C IR - Trepo C FIR - Truchi, R IR - Truchi R FIR - Zarski, J-P IR - Zarski JP FIR - Berg, T IR - Berg T FIR - Dikopoulos, N IR - Dikopoulos N FIR - Eisenbach, C IR - Eisenbach C FIR - Galle, P R IR - Galle PR FIR - Gerken, G IR - Gerken G FIR - Goeser, T IR - Goeser T FIR - Gregor, M IR - Gregor M FIR - Klass, D IR - Klass D FIR - Kraus, M R IR - Kraus MR FIR - Niederau, C IR - Niederau C FIR - Schlaak, J F IR - Schlaak JF FIR - Schmid, R IR - Schmid R FIR - Thies, P IR - Thies P FIR - Schmidt, K IR - Schmidt K FIR - Thimme, R IR - Thimme R FIR - Weidenbach, H IR - Weidenbach H FIR - Zeuzem, S IR - Zeuzem S FIR - Angelico, M IR - Angelico M FIR - Bruno, S IR - Bruno S FIR - Carosi, G IR - Carosi G FIR - Craxi, A IR - Craxi A FIR - Mangia, A IR - Mangia A FIR - Pirisi, M IR - Pirisi M FIR - Rizzetto, M IR - Rizzetto M FIR - Taliani, G IR - Taliani G FIR - Zignego, A L IR - Zignego AL FIR - Reesink, H W IR - Reesink HW FIR - Serejo, F IR - Serejo F FIR - Reymunde, A IR - Reymunde A FIR - Rosado, B IR - Rosado B FIR - Torres, E IR - Torres E FIR - Barcena Marugan, R IR - Barcena Marugan R FIR - De La Mata, M IR - De La Mata M FIR - Calleja, J L IR - Calleja JL FIR - Castellano, G IR - Castellano G FIR - Diago, M IR - Diago M FIR - Esteban, R IR - Esteban R FIR - Fernandez, C IR - Fernandez C FIR - Sanchez Tapias, J IR - Sanchez Tapias J FIR - Serra Desfilis, M A IR - Serra Desfilis MA FIR - Afdhal, N IR - Afdhal N FIR - Al-Osaimi, A IR - Al-Osaimi A FIR - Bacon, B IR - Bacon B FIR - Balart, L IR - Balart L FIR - Bennett, M IR - Bennett M FIR - Bernstein, D IR - Bernstein D FIR - Black, M IR - Black M FIR - Bowlus, C IR - Bowlus C FIR - Boyer, T IR - Boyer T FIR - Dalke, D IR - Dalke D FIR - Davis, C IR - Davis C FIR - Davis, G IR - Davis G FIR - Davis, M IR - Davis M FIR - Everson, G IR - Everson G FIR - Felizarta, F IR - Felizarta F FIR - Flamm, S IR - Flamm S FIR - Freilich, B IR - Freilich B FIR - Galati, J IR - Galati J FIR - Galler, G IR - Galler G FIR - Ghalib, R IR - Ghalib R FIR - Gibas, A IR - Gibas A FIR - Godofsky, E IR - Godofsky E FIR - Gordon, F IR - Gordon F FIR - Gordon, S IR - Gordon S FIR - Gross, J IR - Gross J FIR - Harrison, S IR - Harrison S FIR - Herrera, J IR - Herrera J FIR - Herrine, S IR - Herrine S FIR - Hu, K-Q IR - Hu KQ FIR - Imperial, J IR - Imperial J FIR - Jacobson, I IR - Jacobson I FIR - Jones, D IR - Jones D FIR - Kilby, A IR - Kilby A FIR - King, J IR - King J FIR - Koch, A IR - Koch A FIR - Kowdley, K IR - Kowdley K FIR - Krawitt, E IR - Krawitt E 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 - Levin, J IR - Levin J FIR - Levine, R IR - Levine R FIR - Li, X IR - Li X FIR - Lok, A IR - Lok A FIR - Luketic, V IR - Luketic V FIR - Mailliard, M IR - Mailliard M FIR - McCone, J IR - McCone J FIR - McHutchison, J IR - McHutchison J FIR - Mikolich, D IR - Mikolich D FIR - Morgan, T IR - Morgan T FIR - Muir, A IR - Muir A FIR - Nelson, D IR - Nelson D FIR - Nunes, F IR - Nunes F FIR - Nyberg, A IR - Nyberg A FIR - Nyberg, L IR - Nyberg L FIR - Pandya, P IR - Pandya P FIR - Pauly, M P IR - Pauly MP FIR - Peine, C IR - Peine C FIR - Poleynard, G IR - Poleynard G FIR - Poordad, F IR - Poordad F FIR - Pound, D IR - Pound D FIR - Poulos, J IR - Poulos J FIR - Rabinovitz, M IR - Rabinovitz M FIR - Ravendhran, N IR - Ravendhran N FIR - Ready, J IR - Ready J FIR - Reddy, K IR - Reddy K FIR - Reindollar, R IR - Reindollar R FIR - Reuben, A IR - Reuben A FIR - Riley, T IR - Riley T FIR - Rossaro, L IR - Rossaro L FIR - Rubin, R IR - Rubin R FIR - Ryan, M IR - Ryan M FIR - Santoro, J IR - Santoro J FIR - Schiff, E IR - Schiff E FIR - Sepe, T IR - Sepe T FIR - Sherman, K IR - Sherman K FIR - Shiffman, M IR - Shiffman M FIR - Sjogren, M IR - Sjogren M FIR - Sjogren, R IR - Sjogren R FIR - Smith, C IR - Smith C FIR - Stein, L IR - Stein L FIR - Strauss, R IR - Strauss R FIR - Sulkowski, M IR - Sulkowski M FIR - Szyjkowski, R IR - Szyjkowski R FIR - Vargas, H IR - Vargas H FIR - Vierling, J IR - Vierling J FIR - Witt, D IR - Witt D FIR - Yapp, R IR - Yapp R FIR - Younes, Z IR - Younes Z FIR - Goodman, Zachary IR - Goodman Z EDAT- 2012/10/20 06:00 MHDA- 2013/04/24 06:00 CRDT- 2012/10/20 06:00 PHST- 2012/05/17 00:00 [received] PHST- 2012/09/27 00:00 [accepted] PHST- 2012/10/20 06:00 [entrez] PHST- 2012/10/20 06:00 [pubmed] PHST- 2013/04/24 06:00 [medline] AID - 10.1002/hep.26096 [doi] PST - ppublish SO - Hepatology. 2013 Mar;57(3):974-84. doi: 10.1002/hep.26096. Epub 2013 Feb 11.