The DOI matches its Crossref record; 39 of the 39 references it cites were found in a registry or an index.
Hepatic Failure and Lactic Acidosis Due to Fialuridine (FIAU), an Investigational Nucleoside Analogue for Chronic Hepatitis B
Open accessAbstract
BACKGROUND: We describe severe and unexpected multisystem toxicity that occurred during a study of the antiviral nucleoside analogue fialuridine (1-(2-deoxy-2-fluoro-beta-D-arabinofuranosyl)-5-iodouracil, or FIAU) as therapy for chronic hepatitis B virus infection. METHODS: Fifteen patients with chronic hepatitis B were randomly assigned to receive fialuridine at a dose of either 0.10 or 0.25 mg per kilogram of body weight per day for 24 weeks and were monitored every 1 to 2 weeks by means of a physical examination, blood tests, and testing for hepatitis B virus markers. RESULTS: During the 13th week lactic acidosis and liver failure suddenly developed in one patient. The study was terminated on an emergency basis, and all treatment with fialuridine was discontinued. Seven patients were found to have severe hepatotoxicity, with progressive lactic acidosis, worsening jaundice, and deteriorating hepatic synthetic function despite the discontinuation of fialuridine. Three other patients had mild hepatotoxicity. Several patients also had pancreatitis, neuropathy, or myopathy. Of the seven patients with severe hepatotoxicity, five died and two survived after liver transplantation. Histologic analysis of liver tissue revealed marked accumulation of microvesicular and macrovesicular fat, with minimal necrosis of hepatocytes or architectural changes. Electron microscopy showed abnormal mitochondria and the accumulation of fat in hepatocytes. CONCLUSIONS: In patients with chronic hepatitis B, treatment with fialuridine induced a severe toxic reaction characterized by hepatic failure, lactic acidosis, pancreatitis, neuropathy, and myopathy. This toxic reaction was probably caused by widespread mitochondrial damage and may occur infrequently with other nucleoside analogues.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Fialuridine (Section 7.1) and troglitazone (Section 7.4) are intrinsic toxicodynamic failures, driven by human-relevant mitochondrial injury and reactive-metabolite formation, respectively.”
From Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions (2026) · cites this paper as [69]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Fialuridine, an antiviral nucleoside analogue, caused catastrophic hepatic failure and lactic acidosis in a 1993 clinical trial, resulting in five deaths and two liver transplantations.”
From Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions (2026) · cites this paper as [69]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Preclinical studies across multiple species showed no indication of the severe mitochondrial toxicity observed in humans, because fialuridine’s incorporation into mitochondrial DNA is mediated by a human-specific mitochondrial transporter [69,70].”
From Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions (2026) · cites this paper as [69]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Fourth, idiosyncratic toxicities, such as those underlying the fialuridine and troglitazone failures, are by definition not captured by any pharmacokinetic scaling framework, and even sophisticated PBPK or PBPK–PD models cannot reliably anticipate them without orthogonal mechanistic assays [69,70,75,76].”
From Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions (2026) · cites this paper as [69]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“even sophisticated PBPK or PBPK–PD models cannot reliably anticipate them without orthogonal mechanistic assays [69,70,75,76]”
From Beyond Body Weight: A Comprehensive Review of Allometric Scaling in Drug Development for Human Dose Predictions (2026) · cites this paper as [69]
Experimental — accuracy not yet measured
The cited source says what the claim attributes to it.
In the citing paper
“Even a pilot study on 43 patients treated for 2 and 4 weeks duration with Fialuridine did not reveal any signs of hepatic toxicity on initial examination.[17]”
From TGN1412: From Discovery to Disaster (2010) · cites this paper as [17]
The cited source says what the claim attributes to it.
In the citing paper
“During 13th week of phase II studies, one of the patients suddenly developed hepatic toxicity and lactic acidosis. At this point, trial was stopped for all other patients.”
From TGN1412: From Discovery to Disaster (2010) · cites this paper as [17]
The cited source says what the claim attributes to it.
In the citing paper
“Even after discontinuation of Fialuridine administration, seven other patients showed signs of severe hepatic toxicity five of which could not survive and other two could survive only after liver transplantation.[17]”
From TGN1412: From Discovery to Disaster (2010) · cites this paper as [17]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Wong, D., Cheung, A. M., O'Rourke, K., Naylor, C. D., Detsky, A. S., & Heathcote, J. (1993) · Annals of Internal Medicine · doi:10.7326/0003-4819-119-4-199308150-00011 · Cited by 974
Perrillo, R. P., Schiff, E. R., Davis, G. L., Bodenheimer, H. C., Lindsay, K. L., Payne, J., Dienstag, J. L., O'Brien, C., Tamburro, C. H., Jacobson, I. M., et al. (1990) · New England Journal of Medicine · doi:10.1056/nejm199008023230503 · Cited by 838
Mitochondrial Myopathy Caused by Long-Term Zidovudine Therapy
Dalakas, M. C., Illa, I., Pezeshkpour, G. H., Laukaitis, J. P., Cohen, B. H., & Griffin, J. L. (1990) · New England Journal of Medicine · doi:10.1056/nejm199004193221602 · Cited by 837
Doong, S.-L., Tsai, C. H., Schinazi, R. F., Liotta, D. C., & Cheng, Y. C. (1991) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.88.19.8495 · Cited by 513
Depletion of muscle mitochondrial DNA in AIDS patients with zidovudine-induced myopathy
Arnaudo, E., Shanske, S., DiMauro, S., Schon, E. A., Moraes, C. T., Schon, E. A., & Dalakas, M. C. (1991) · The Lancet · doi:10.1016/0140-6736(91)91294-5 · Cited by 504
Randomized, controlled trial of recombinant human α-interferon in patients with chronic hepatitis B
Hoofnagle, J. H., Peters, M. G., Mullen, K. D., Jones, D. B., Rustgi, V. K., Bisceglie, A. M. D., Hallahan, C. W., Park, Y., Meschievitz, C., & Jones, E. A. (1988) · Gastroenterology · doi:10.1016/0016-5085(88)90367-8 · Cited by 420
Self-citationReversal of Fulminant Hepatic Failure Using An Extracorporeal Liver Assist Device
Sussman, N., Chong, M. G., Koussayer, T., He, D.-E., Shang, T. A., Whisennand, H. H., & Kelly, J. H. (1992) · Hepatology · doi:10.1002/hep.1840160112 · Cited by 341
Chen, C., Vazquez-Padua, M. A., & Cheng, Y. C. (1991) · Molecular Pharmacology · doi:10.1016/s0026-895x(25)11067-5 · Cited by 296
A controlled trial of interferon with or without prednisone priming for chronic hepatitis B
Lok, A. S.-F., Wu, P., Lai, C., Lau, J. Y. N., Leung, E. K. Y., Wong, L. S. K., Ma, O. C. K., Lauder, I. J., Ng, C. P. L., & Chung, H.-T. (1992) · Gastroenterology · doi:10.1016/0016-5085(92)90337-x · Cited by 239
Hodge, R. A. V., Sutton, D., Boyd, M. R., Harnden, M. R., & Jarvest, R. L. (1989) · Antimicrobial Agents and Chemotherapy · doi:10.1128/aac.33.10.1765 · Cited by 207
Research works printed but not linked: 7
- Dusheiko G, Hoofnagle JH. Hepatitis B. In: McIntyre N, Benhamou JP, Bircher J, Rizzetto M, Rodes J, eds. Oxford textbook of clinical hepatology. New York: Oxford University Press, 1991:571-92.
- Paar DP, Hooten TM, Smiles KA, et al. The effect of FIAU on chronic hepatitis B virus (HBV) infection in HIV-infected subjects (ACTG 122b). In: Program and abstracts of the 32nd Interscience Conference on Antimicrobial Agents and Chemotherapy, Anaheim, Calif., October 10–14, 1992. Washington, D.C.: American Society for Microbiology, 1992:264. abstract.
- 10.1002/hep.1840160402 · DOI
- Stevenson W, 1995, Transplant Proc, 27, 1219
- Chen CH, 1991, Mol Pharmacol, 39, 625
- Klecker RW, 1994, Mol Pharmacol, 46, 1204
- Maxson CJ, 1992, Am J Gastroenterol, 87, 708
Cited by
Sorted by citations
Items 401–500 of 614
Remdesivir increases mtDNA copy number causing mild alterations to oxidative phosphorylation
DeFoor, N., Paul, S., Li, S., Basso, E. K. G., Stevenson, V. B., Browning, J. L., Prater, A. K., Brindley, S., Tao, G., & Pickrell, A. M. (2023) · Scientific Reports · doi:10.1038/s41598-023-42704-y · Cited by 9
Lin, C., Sloan, D. D., Dang, C. H., Wagner, T. A., Cabrera, A. J. E., Tobin, N. H., Frenkel, L. M., & Jerome, K. R. (2008) · Cytometry Part B Clinical Cytometry · doi:10.1002/cyto.b.20458 · Cited by 9
Equilibrative and Concentrative Transport Mechanisms
Preusch, P. C. (2007) · Elsevier eBooks · doi:10.1016/b978-012369417-1/50054-7 · Cited by 9
Drug-Induced Mitochondrial Toxicity
Massart, J., Borgne‐Sanchez, A., & Fromenty, B. (2018) · Springer eBooks · doi:10.1007/978-3-319-73344-9_13 · Cited by 9
Niu, X., Lin, M., & Lee, B. H. (2022) · Gels · doi:10.3390/gels8070404 · Cited by 9
Colacino, J. M., Horn, J. W., Horn, D. M., & Richardson, F. C. (1996) · Toxicology in Vitro · doi:10.1016/0887-2333(96)00016-1 · Cited by 9
Gill, M. W., Horn, K., Hennan, J. K., White, R., Bounous, D. I., Clark, S., Megill, J. R., Janovitz, E. B., Davies, M. H., Sanderson, T. P., et al. (2016) · Toxicological Sciences · doi:10.1093/toxsci/kfw211 · Cited by 9
Clercq, E. D., & Field, H. J. (2008) · Antiviral chemistry & chemotherapy · doi:10.1177/095632020801900205 · Cited by 9
Neuschwander‐Tetri, B. A. (1998) · Clinics in Liver Disease · doi:10.1016/s1089-3261(05)70369-x · Cited by 9
Expanding spectrum of mitochondrial disorders
Sokol, R. J. (1996) · The Journal of Pediatrics · doi:10.1016/s0022-3476(96)80121-1 · Cited by 9
Treatment of chronic hepatitis B: New antiviral therapies
Yao, F. Y., & Gish, R. G. (1999) · Current Gastroenterology Reports · doi:10.1007/s11894-999-0082-7 · Cited by 9
Müller, F. A., Stamou, M., Englert, F. H., Frenzel, O., Diedrich, S., Suter‐Dick, L., Wambaugh, J. F., & Sturla, S. J. (2023) · Archives of Toxicology · doi:10.1007/s00204-023-03490-8 · Cited by 8
Innovative therapeutic strategies to overcome radioresistance in breast cancer
Arnold, C. R., Mangesius, J., Portnaia, I., Ganswindt, U., & Wolff, H. A. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1379986 · Cited by 8
Complications graves des traitements antirétroviraux
LECLERCQ, P., Roudière, L., & Viard, J. (2004) · Réanimation · doi:10.1016/j.reaurg.2004.02.010 · Cited by 8
Ware, B. R., Brown, G. E., Soldatow, V. Y., LeCluyse, E. L., & Khetani, S. R. (2019) · Gene Expression · doi:10.3727/105221619x15638857793317 · Cited by 8
Cell Death in Drug-Induced Liver Injury
Dara, L., & Kaplowitz, N. (2017) · Springer eBooks · doi:10.1007/978-3-319-53774-0_1 · Cited by 8
Pharmacogenomics, Toxicogenomics, and DNA Polymerase γ
Lewis, W. (2007) · The Journal of Infectious Diseases · doi:10.1086/513879 · Cited by 9
Hepatic Adverse Drug Reactions
Aithal, G. P., & Larrey, D. G. (2014) · Wiley eBooks · doi:10.1002/9781118820186.ch35 · Cited by 8
Yahagi, K., Ueno, Y., Mano, Y., & Shimosegawa, T. (2002) · Liver Transplantation · doi:10.1053/jlts.2002.36734 · Cited by 8
Cutaia, M. V. (1996) · CHEST Journal · doi:10.1378/chest.109.4.866 · Cited by 8
Advances in the treatment of chronic hepatitis B virus infection
Marques, A. R., & Straus, S. E. (1998) · Reviews in Medical Virology · doi:10.1002/(sici)1099-1654(1998100)8:4 · Cited by 8
Self-citationKenna, J. G. (2017) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2017.1290082 · Cited by 7
Neural organoids as advanced tools for neurotoxicity modeling
Majumder, J., & Murphy, W. L. (2025) · Current Research in Toxicology · doi:10.1016/j.crtox.2025.100249 · Cited by 7
Gaudriault, P., Fassini, D., & Homs-Corbera, A. (2019) · Elsevier eBooks · doi:10.1016/b978-0-12-817202-5.00008-5 · Cited by 7
Toxic and Drug-Induced Disorders of the Liver
Bioulac‐Sage, P., & Balabaud, C. P. (2009) · Elsevier eBooks · doi:10.1016/b978-141604059-0.50043-6 · Cited by 7
Recent Progress in Prediction Systems for Drug-induced Liver Injury Using In vitro Cell Culture
Ozawa, S., Miura, T., Terashima, J., Habano, W., & Ishida, S. (2020) · Drug Metabolism Letters · doi:10.2174/1872312814666201202112610 · Cited by 8
Assessing Toxicity in Drug Trials in Liver Disease
Sherman, M. (2021) · Seminars in Liver Disease · doi:10.1055/s-0041-1723030 · Cited by 7
Deoxynucleoside Kinases and Their Potential Role in Deoxynucleoside Cytotoxicity
Munch‐Petersen, B., & Piškur, J. (2007) · Humana Press eBooks · doi:10.1007/978-1-59745-148-2_3 · Cited by 7
Progress in Hepatitis B: A 30-Year Journey Through Three Continents
Lok, A. S.-F. (2014) · Hepatology · doi:10.1002/hep.27120 · Cited by 7
Hepatic Mitochondrial Toxicity From Nucleoside Analog Therapy
Finkle, H. I. (1999) · Archives of Pathology & Laboratory Medicine · doi:10.5858/1999-123-0189-hmtfna · Cited by 7
Unusual Indications for Liver Transplantation
Thiel, D. H. V., MINDIKOGLU, A. L., ABHINANDANA, A., BALUCH, M., DHILLON, S., GEORGE, M. M., BREMS, J., LI, S. D., & HAMDANI, R. (2005) · Elsevier eBooks · doi:10.1016/b978-0-7216-0118-2.50025-2 · Cited by 7
Meinert, C. L. (2014) · Wiley eBooks · doi:10.1002/9781118445112.stat05003 · Cited by 7
Staschke, K. A., & Colacino, J. M. (2001) · Birkhäuser Basel eBooks · doi:10.1007/978-3-0348-7784-8_4 · Cited by 7
Hepatitis B Virus and Hepatitis Delta Virus
Sherlock, F. S., & BSc, J. D. (2001) · Wiley eBooks · doi:10.1002/9780470986820.ch17 · Cited by 7
Mitochondrial Dysfunction in Drug‐Induced Liver Injury
Borgne‐Sanchez, A., & Fromenty, B. (2018) · Wiley eBooks · doi:10.1002/9781119329725.ch5 · Cited by 7
Wong, X. K., Ng, C. S., & Yeong, K. Y. (2024) · Bioorganic Chemistry · doi:10.1016/j.bioorg.2024.107150 · Cited by 6
Negi, C. K., Sakolish, C., Tsai, H.-H. D., Nitsche, K. S., Gang, H., Bajaj, P., Ferguson, S., Stanko, J. P., Hewitt, P. G., Kukla, D. A., et al. (2025) · ACS Pharmacology & Translational Science · doi:10.1021/acsptsci.5c00554 · Cited by 6
A transient kinetic approach to investigate nucleoside inhibitors of mitochondrial DNA polymerase γ
Anderson, K. S. (2010) · Methods · doi:10.1016/j.ymeth.2010.05.001 · Cited by 6
Bergasa, N. V. (2021) · Springer eBooks · doi:10.1007/978-1-4471-4715-2_14 · Cited by 6
Human Immunodeficiency Virus Infection-Associated Cardiomyopathy and Heart Failure
Papamanoli, A., Muncan, B., Yoo, J., Psevdos, G., & Kalogeropoulos, A. P. (2022) · Journal of Personalized Medicine · doi:10.3390/jpm12111760 · Cited by 6
Szewczyk, E., Kasuga, T., & Fan, Z. (2014) · Journal of Microbiological Methods · doi:10.1016/j.mimet.2014.02.007 · Cited by 6
Next-Generation Therapeutics: mRNA as a Novel Therapeutic Option for Single-Gene Disorders
Michel, T., Wendel, H.-P., & Krajewski, S. (2016) · InTech eBooks · doi:10.5772/62243 · Cited by 7
Alsunaid, S. R., Ashraf, H., & Soubani, A. O. (2018) · Transplant Infectious Disease · doi:10.1111/tid.12960 · Cited by 6
Biomarkers for Drug-Induced Liver Injury
Watkins, P. B. (2013) · Elsevier eBooks · doi:10.1016/b978-0-12-387817-5.00017-0 · Cited by 6
Lamivudine Therapy of Chronic Hepatitis B
Hunt, C. M., Brown, N. A., & Rubin, M. (1999) · Advances in experimental medicine and biology · doi:10.1007/978-1-4615-4743-3_2 · Cited by 6
Side Effects of Suicide Gene Therapy
van der Eb, M. M., de Leeuw, B., van der Eb, A. J., & Hoeben, R. C. (2004) · Humana Press eBooks · doi:10.1385/1-59259-429-8:479 · Cited by 6
CHEN, J., Lin, C., SHEU, M., KUO, H., SUN, C., TANG, L., WANG, S., & TSAI, S. (2005) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2006.02718.x · Cited by 6
Klincewicz, S. L., Clark, J. A., & LaFrance, N. D. (2001) · Drug Information Journal · doi:10.1177/009286150103500204 · Cited by 6
Computational Toxicology and the Generation of Mechanistic Hypotheses: γ-Butyrolactone
Rosenkranz, H. S. (2001) · SAR and QSAR in environmental research · doi:10.1080/10629360108035383 · Cited by 6
Role of the Adaptive Immune System in Idiosyncratic Drug-Induced Liver Injury
Uetrecht, J. (2013) · Elsevier eBooks · doi:10.1016/b978-0-12-387817-5.00011-x · Cited by 6
Goldring, C. E., Norris, A. M., Kitteringham, N. R., Aleo, M. D., Antoine, D. J., Heslop, J. A., Howell, B. A., Ingelman‐Sundberg, M., Kia, R., Kamalian, L., et al. (2015) · Applied In Vitro Toxicology · doi:10.1089/aivt.2015.0001 · Cited by 5
Impaired mitochondrial energy metabolism
Das, B. B., Ray, P., & Raut, S. (2020) · Elsevier eBooks · doi:10.1016/b978-0-12-819621-2.00004-8 · Cited by 6
Tonsekar, P., Tonsekar, V., Jiang, S. S., & Yue, G. (2024) · International Journal of Translational Medicine · doi:10.3390/ijtm4010005 · Cited by 5
Fernández‐Solà, J., Campistol, J. M., Miró, Ò., Garcés, N., Soy, D., & Grau, J. M. (1996) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/11.9.1850 · Cited by 5
Sallie, R. (2007) · Virology Journal · doi:10.1186/1743-422x-4-29 · Cited by 5
Self-citationLack of Predictivity of the Rat Lethality (LD50) Test for Ecological and Human Health Effects
Rosenkranz, H. S., & Cunningham, A. R. (2005) · Alternatives to Laboratory Animals · doi:10.1177/026119290503300104 · Cited by 5
Human Liver Slices to Investigate Injury and Repair
Vickers, A. E. M., & Fisher, R. L. (2018) · Applied In Vitro Toxicology · doi:10.1089/aivt.2018.0017 · Cited by 5
Antiviral β-L-nucleosides specific for hepatitis B virus infection
Bryant, M. L., Bridges, E. G., Placidi, L., Faraj, A., Loi, A.-G., Pierra, C., Benzaria, S., Dukhan, D., Gosselin, G., Imbach, J., et al. (2003) · Elsevier eBooks · doi:10.1016/b978-044450986-4/50072-2 · Cited by 5
The chemistry of L-nucleosides
Agrofoglio, L. A., & Challand, S. R. (1998) · Springer eBooks · doi:10.1007/978-94-007-0816-7_6 · Cited by 5
NRTI-associated mitochondrial toxicity.
Landovitz, R. J., & Sax, P. E. (2001) · PubMed · Cited by 5
Interferon and Other Therapies for Hepatitis B and Hepatitis C Infections
Rothstein, K. D., & Muñoz, S. J. (1996) · Clinics in Laboratory Medicine · doi:10.1016/s0272-2712(18)30280-4 · Cited by 5
Aslamkhan, A. G., Michna, L., Podtelezhnikov, A. A., Vlasáková, K., Suemizu, H., Ohnishi, Y., Liu, L., Lane, P., Xu, Q., Kuhls, M. C., et al. (2024) · Toxicology Research · doi:10.1093/toxres/tfad120 · Cited by 4
Recognizing Mitochondrial Hepatopathy in Acute Fatty Liver of Pregnancy
Goel, A., Ramakrishna, B., Beck, M. M., Alex, T., Zachariah, U., & Eapen, C. (2022) · Gastroenterology Hepatology and Endoscopy Practice · doi:10.4103/ghep.ghep_35_22 · Cited by 4
Bajaj, P., Brennan, R., Laurent, S., Sauzeat, S., Dufault, M. R., Richards, B., & Adkins, K. (2025) · Toxicological Sciences · doi:10.1093/toxsci/kfaf012 · Cited by 4
Kiy, R. T., Khoo, S., & Chadwick, A. E. (2024) · Toxicology Research · doi:10.1093/toxres/tfae012 · Cited by 4
Javid, M., Nandave, M., & Kumar, A. (2024) · Springer eBooks · doi:10.1007/978-981-99-8949-2_2 · Cited by 4
Davies, S. E., & Craig, C. (2007) · Cambridge University Press eBooks · doi:10.1017/cbo9780511545955.012 · Cited by 4
Oker, N., Kapetanakis, N.-I., & Busson, P. (2016) · InTech eBooks · doi:10.5772/64738 · Cited by 4
Viral Hepatitis: Expanding the Alphabet
Hochman, J. A., & Balistreri, W. F. (1999) · Advances in Pediatrics · doi:10.1016/s0065-3101(24)00032-x · Cited by 4
Painter, G. R., Trost, L. C., Blum, M. R., Szczech, G. M., & Furman, P. A. (2003) · Elsevier eBooks · doi:10.1016/b978-044450986-4/50075-8 · Cited by 4
Features and Mechanisms of Drug‐Induced Liver Injury
Pessayre, D., Berson, A., & Fromenty, B. (2008) · Wiley eBooks · doi:10.1002/9780470372531.ch5 · Cited by 4
Ahluwalia, G. S., Driscoll, J. S., Ford, H., & Johns, D. G. (1996) · Journal of Pharmaceutical Sciences · doi:10.1021/js950494b · Cited by 4
Assay of mtDNA Polymerase γ from Human Tissues
Naviaux, R. K. (2003) · Humana Press eBooks · doi:10.1385/1-59259-284-8:259 · Cited by 4
Why Drugs Fail – A Study on Side Effects in New Chemical Entities
Schuster, D., Laggner, C., & Langer, T. (2008) · Methods and principles in medicinal chemistry · doi:10.1002/9783527621460.ch1 · Cited by 4
Bruckner, D. M., Connerney, J., & Dordick, J. S. (2018) · AIChE Journal · doi:10.1002/aic.16442 · Cited by 3
Liver Injury Due to Drugs and Herbal Agents
Kleiner, D. E. (2011) · Elsevier eBooks · doi:10.1016/b978-0-443-06803-4.00024-1 · Cited by 3
Self-citationKim, B. K., Young, S., Young, S., Park, E., & Han, J. H. (2013) · Hepatitis Monthly · doi:10.5812/hepatmon.6056 · Cited by 3
Pharmacologic Considerations for Antiviral Drug Development
Fletcher, C. V. (1996) · Annals of Pharmacotherapy · doi:10.1177/106002809603000912 · Cited by 3
Unanticipated Risk in Clinical Research
Straus, S. E. (2007) · Elsevier eBooks · doi:10.1016/b978-012369440-9/50010-4 · Cited by 3
Self-citationFurther investigation of 3D culture spheroid models of human hepatocytes
Ogihara, T., Hosono, M., & Kojima, H. (2019) · Folia Pharmacologica Japonica · doi:10.1254/fpj.153.235 · Cited by 3
Aithal, G. P. (2010) · Alternatives to Laboratory Animals · doi:10.1177/026119291003801s01 · Cited by 3
Desmet, V. J., & Rosaí, J. (2011) · Elsevier eBooks · doi:10.1016/b978-0-323-06969-4.00001-5 · Cited by 3
Chang, J. H., Sangaraju, D., Liu, N., Jaochico, A., & Plise, E. G. (2019) · Molecular Pharmaceutics · doi:10.1021/acs.molpharmaceut.9b00562 · Cited by 3
(2009) · CRC Press eBooks · doi:10.1201/9781420080124.ch3 · Cited by 3
In Vitro Safety Pharmacology Profiling: An Important Tool to Decrease Attrition
Hamon, J., & Whitebread, S. (2009) · Methods and principles in medicinal chemistry · doi:10.1002/9783527627448.ch12 · Cited by 3
Holý, A., & Clercq, E. D. (2010) · Burger's Medicinal Chemistry and Drug Discovery · doi:10.1002/0471266949.bmc237 · Cited by 3
The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species
Green, M. D., & Hartsough, M. T. (2010) · Pharmaceutical Sciences Encyclopedia · doi:10.1002/9780470571224.pse171 · Cited by 3
Implementation of a Data and Safety Monitoring Program in a General Clinical Research Center
Brass, E. P. (2001) · Journal of Investigative Medicine · doi:10.2310/6650.2001.33623 · Cited by 3
Focus on Pneumocystis carinii pneumonia AIDS in the intensive care unit
Forrest, D. M., Russell, J. A., & Montaner, J. S. G. (1999) · Current Opinion in Critical Care · doi:10.1097/00075198-199910000-00006 · Cited by 3
New treatments for chronic viral hepatitis B and C
Dusheiko, G. M. (1996) · Baillière s Clinical Gastroenterology · doi:10.1016/s0950-3528(96)90009-3 · Cited by 3
Adverse Drug Reactions: The Great Masqueraders
Routledge, P., Bialas, M. C., Houghton, J. E., & Woods, F. J. (1998) · Drug Information Journal · doi:10.1177/009286159803200111 · Cited by 3
Fromenty, B. (2019) · Chemical Research in Toxicology · doi:10.1021/acs.chemrestox.9b00416 · Cited by 3
The Woodchuck Model of Hepatitis B Virus Infection
Tennant, B. C. (1999) · Elsevier eBooks · doi:10.1016/b978-012775390-4/50263-3 · Cited by 3
Hepatitis C and HIV Co-Infection
Poles, M. A., & Dieterich, D. T. (2002) · Humana Press eBooks · doi:10.1007/978-1-59259-104-6_5 · Cited by 3
DiMauro, S., & Tanji, K. (1997) · The Japanese Journal of Human Genetics · doi:10.1007/bf02767024 · Cited by 3
Mallillin, M. C., Silva, D. A., Miller, N. A., Zhao, S., Salami, M., Löbenberg, R., & Davies, N. M. (2026) · Pharmaceutics · doi:10.3390/pharmaceutics18070824 · Cited by 2
“…idiosyncratic toxicities, such as those underlying the fialuridine and troglitazone failures, are by definition not captured by any pharmacokinetic scaling framework, and even sophisticated PBPK or PBPK–PD models cannot reliably anticipate them without orthogonal mechanistic assays [69,70,75,76].”
Leading-Edge Approaches for In Vitro Hepatotoxicity Evaluation
LeCluyse, E. L., Norona, L. M., Akingbasote, J. A., Howell, L. S., Woodhead, J. L., Cross, M. J., Roth, A. B., & Goldring, C. E. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-801238-3.64267-8 · Cited by 2
Cardiotoxicity and HIV/AIDS Therapy
Koczor, C. A., & Lewis, W. (2017) · Elsevier eBooks · doi:10.1016/b978-0-12-801238-3.65236-4 · Cited by 2
Triantos, C. K., Kalafateli, M., Aggeletopoulou, I., Mandellou, M., Assimakopoulos, S. F., Tselekouni, P., Taprantzi, D., Tsiaoussis, G. I., Vourli, G., Anastassiou, E. D., et al. (2017) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000000924 · Cited by 2
Radiation induced cardiovascular disease: An odyssey of bedside-bench-bedside approach
Rikhi, R. R., Samra, G. S., Arustamyan, M., Patel, J., Zhou, L., Bungo, B., & Moudgil, R. (2020) · Life Sciences in Space Research · doi:10.1016/j.lssr.2020.07.005 · Cited by 2
Metadata
- Authors
- McKenzie, R., Fried, M. W., Sallie, R., Conjeevaram, H., Di Bisceglie, A. M., Park, Y., Savarese, B., Kleiner, D., Tsokos, M., Luciano, C., Pruett, T., Stotka, J. L., Straus, S. E., & Hoofnagle, J. H.
- Affiliations
- National Institutes of Health (US)
- National Institute of Diabetes and Digestive and Kidney Diseases (US)
- National Institute of Allergy and Infectious Diseases (US)
- National Cancer Institute (UA)
- University of Virginia Hospital (US)
- Eli Lilly (United States) (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1995-10-26
- Volume
- 333
- Issue
- 17
- Pages
- 1099-1105
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2327070670
- Cited by
- 616
- References
- 39
- Citations by year
- 2026: 14 · 2025: 11 · 2024: 17 · 2023: 13 · 2022: 11 · 2021: 19 · 2020: 13 · 2019: 26 · 2018: 32 · 2017: 23 · 2016: 27 · 2015: 16 · 2014: 12 · 2013: 16 · 2012: 10
- FWCI
- 28.57
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health
- NIH Clinical Center
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Keywords
- FIAU, lactic acidosis, liver failure, hepatotoxicity, chronic hepatitis B, nucleoside analogues, drug toxicity, mitochondrial damage, pancreatitis, neuropathy, myopathy, liver transplantation, drug-induced liver injury
- MeSH terms
- Acidosis, Lactic, Adult, Alanine Transaminase, Antiviral Agents, Arabinofuranosyluracil, Chronic Disease, DNA, Mitochondrial, DNA, Viral, Female, Hepatitis B, Humans, Jaundice, Liver, Male, Middle Aged, Pancreatitis, Peripheral Nervous System Diseases, Drugs, Investigational, Liver Transplantation, Liver Failure
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
