Intravenous Ribavirin for Hantavirus Pulmonary Syndrome: Safety and Tolerance during 1 Year of Open-Label Experience
Louisa E. Chapman(Centers for Disease Control and Prevention), Grégory Mertz(University of New Mexico), C. J. Peters(Centers for Disease Control and Prevention), Heidi M. Jolson(United States Food and Drug Administration), Ali S. Khan(Centers for Disease Control and Prevention), Thomas G. Ksiazek(Centers for Disease Control and Prevention), Frederick Koster(University of New Mexico), Kenneth F. Baum(University of Colorado Denver), Pierre E. Rollin(Centers for Disease Control and Prevention), Andrew T. Pavia(University of Utah), Robert C. Holman(Centers for Disease Control and Prevention), John C. Christenson(University of Utah), Phillip J. Rubin(Infectious Disease Consultants), Rachel E. Behrman(United States Food and Drug Administration), Linda Bell(Centers for Disease Control and Prevention), Gary L. Simpson(New Mexico Department of Health), Ramses Sadek(Centers for Disease Control and Prevention), The Ribavirin Study Group(Indian Health Service), Benjamin H Armstrong(Indian Health Service), BT Atterbury(New Mexico Department of Health), G Baacke(Indian Health Service), Debora Bellardi(Indian Health Service), M. J. Carroll(Indian Health Service), James E. Cheek(Indian Health Service), Alexander Craig(Indian Health Service), David Daniels(Indian Health Service), William L. Freeman(Indian Health Service), Fabian Held(Indian Health Service), David Keßler(Indian Health Service), S Konicck(Indian Health Service), Amy Light(Indian Health Service), Jennifer McGee(Indian Health Service), Joshua Savage(Indian Health Service), Matthew E. Sloan(Indian Health Service), Bruce Tempest(Indian Health Service), Kathleen Vaughan(Indian Health Service), D Waite(Indian Health Service), J‐C Becher(Hyattsville Community Development Corporation), R Brieman(Hyattsville Community Development Corporation), Javed Bulter(United States Food and Drug Administration), MJ Schmidt-Dalton(Hyattsville Community Development Corporation), D McKay Hart(Hyattsville Community Development Corporation), J.L.M. Hawk(Hyattsville Community Development Corporation), Rima Khabbaz(Hyattsville Community Development Corporation), Elisabeth A. Lloyd(Hyattsville Community Development Corporation), M Sortir(Hyattsville Community Development Corporation), Suzy Stokes(Hyattsville Community Development Corporation), TJ Torok(United States Food and Drug Administration), Charles Vitek(Hyattsville Community Development Corporation), S. Harding(Arizona Department of Health Services), Roger England(Arizona Department of Health Services), Clare M. Kioski(Arizona Department of Health Services), D. G. Mosley(Arizona Department of Health Services), L Sands(Arizona Department of Health Services), T Johnson-Baach(Flagstaff Medical Center), KJ Ronnau(Flagstaff Medical Center), DD Mast(Phoenix (United States)), Ronald J. Servi(Phoenix (United States)), Ralph D. Levinson(Vitalant), FS Yeager(Vitalant), R. Adam, Boris Friedman(New Mexico Department of Health), Lynette Lincoln, EA Petersen, Elizabeth E. Wack(Coronado Unified School District), Rogelio Moncada(Coronado Unified School District), Simona Bassi(Seton Medical Center), JS Rumack(Seton Medical Center), Sei Kuriyama, Jacqui McGovern(United States Food and Drug Administration), Daniel J. Olson(New Mexico Department of Health), Paul Garst(Oakland University), ML Butera, Kim S. Erlich(University of Santa Monica), Mariadaniela Dinolfo(United States Food and Drug Administration), Craig Dalton(Colorado Department of Public Health and Environment), Richard E. Hoffman(Colorado Department of Public Health and Environment), Daniel R. Kuritzkes(University of Colorado Health), Nancy Madinger(University of Colorado Health), Robert T. Schooley(American Society for Parenteral and Enteral Nutrition), Alon Mass(American Society for Parenteral and Enteral Nutrition), JM Hofflin(The Recovery Center), K. E. Britton(The Recovery Center), Ronald H. Blum(New Mexico Department of Health), Gary R. Cott(Denver School of Nursing), Barry Golub(Denver School of Nursing), Karen J. Greenberg(Denver School of Nursing), K Lichtenstien(Denver School of Nursing), Rebecca L. O’Brien(Montrose Center), RF Motley(Montrose Center), M Culliman(New Mexico Department of Health), N Fujeta(Southern Nursing Research Society), Sarah Mason(Stamford Hospital), GX McLeod(Stamford Hospital), Miguel Mateos-Mora, D Demers(United States Food and Drug Administration), Celia Jackson(Evanston Hospital), B Zar(Evanston Hospital), Banumathi Ramakrishna(Indianapolis Zoo), CL Jones(Indianapolis Zoo), William D. Lucht(Louisiana State University in Shreveport), Steven A. Conrad(Louisiana State University in Shreveport), LR Grier(Louisiana State University in Shreveport), JW King(Louisiana State University in Shreveport), J Adelso, M Kim-Karpe(Milford Hospital), M. Bergman(Milford Hospital), Ronald Schut(University of Utah), Timothy R. Sterling(Biloxi Public Schools), J. Mason Brewer(Great Falls Clinic), Anderson De(University of Nebraska at Omaha), Juliano A. Roehrs(University of Nebraska at Omaha), JE Dietrich, Dan Jones(United States Food and Drug Administration), Christopher Ward, JF Stockfish(University of New Mexico), Sarah E. Allen(University of New Mexico), R. Crowell(University of New Mexico), Angela Cushing(University of New Mexico), D. Goade(University of New Mexico), Lourdes Irizarry(University of New Mexico), Steven Jenison(United States Food and Drug Administration), Howard Levy(University of New Mexico), Gary D. Overturf(University of New Mexico), Dennis L. Palmer(University of New Mexico), Ronald W. Quenzer(University of New Mexico), William P. Reed(University of New Mexico), Steve Simpson(University of New Mexico), Jason D. Williams(University of New Mexico), BJ Berger(New York Hospital Queens), Faheem Hussain(New York Hospital Queens), Benjamin Berger(New York Hospital Queens), F. A. Sepe(Grand Forks Air Force Base), J.A. Hargreaves(Colorado Springs School District 11), L.M. Baddour(Oak Ridge Associated Universities), Rudolph S. Parrish(Oak Ridge Associated Universities), R. M. Plemmons, Justin D. Radolf(New Mexico Department of Health), G Szeyko(Fort Worth Library), K.E. Elkind(University of Utah), Vernon Knight, MS Badger, Julio C. Furlan, Matthew P. Gillum, AD Tice, J Bárány
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Abstract
Intravenous ribavirin was provided non-selectively for investigational open-label use among persons with suspected hantavirus pulmonary syndrome (HPS) in the United States between 4 June 1993 and 1 September 1994. Therapy was initiated prior to laboratory confirmation of hantavirus infection because most deaths from HPS occur within 48 h of hospitalization. Thirty patients with confirmed HPS, 105 patients without HPS and 5 patients without adequate diagnostic testing for HPS were enrolled. This observational study arguably provides the most complete information available on ribavirin-associated adverse effects. Although ribavirin was generally well tolerated, 71% of recipients became anaemic and 19% underwent transfusion. An apparent excess of hyperamylasaemia/pancreatitis was either therapy-associated or due to enrollment bias. The 30 enrolled HPS patients had a case-fatality rate of 47% (14/30). It is not possible to assess efficacy with this study design. However, comparison of survival curves for the 30 enrolled HPS patients and 34 patients who developed HPS during the same time period but were not enrolled did not suggest an appreciable drug effect. A randomized, placebo-controlled trial that enrolls patients during the prodrome phase would be necessary to assess the efficacy and further define the safety of intravenous ribavirin for HPS.
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