Regulatory Science and Drug Approval for Alcoholic and Nonalcoholic Steatohepatitis

Gastroenterology

Volumn 150, Issue 8, 2016, Pages 1723-1727

  Sanyal, Arun J ^a   Miller, Veronica ^b  

^a VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Alcoholic Hepatitis; Clinical Trials; Drug Approval; Drug Development; End Points; Nonalcoholic Steatohepatitis; Regulatory Science; Trial Design

Indexed keywords

ALCOHOL LIVER DISEASE; COMORBIDITY; DISEASE COURSE; DISEASE SEVERITY; DRINKING BEHAVIOR; DRUG APPROVAL; HUMAN; LIVER HISTOLOGY; NONALCOHOLIC FATTY LIVER; NOTE; PRIORITY JOURNAL; ALCOHOLIC FATTY LIVER; ANIMAL; BIOASSAY; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; LEGISLATION AND JURISPRUDENCE; MANAGEMENT; METHODOLOGY; PROCEDURES; TREATMENT OUTCOME;

ANIMALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; ENDPOINT DETERMINATION; FATTY LIVER, ALCOHOLIC; HUMANS; NON-ALCOHOLIC FATTY LIVER DISEASE; POLICY MAKING; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 84971298358     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2016.02.044     Document Type: Article

References (19)

1. M.R. Charlton, J.M. Burns, R.A. Pedersen, and et al. Frequency and outcomes of liver transplantation for nonalcoholic steatohepatitis in the United States Gastroenterology 141 2011 1249 1253
2. A. Sanyal, A. Poklepovic, E. Moyneur, and et al. Population-based risk factors and resource utilization for HCC: US perspective Curr Med Res Opin 26 2010 2183 2191
3. A.J. Sanyal, S.L. Friedman, A.J. McCullough, and et al. Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration Joint Workshop Hepatology 61 2015 1392 1405
4. US Food and Drug Administration. Guidance for industry-expedited programs for serious conditions-drugs and biologics. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed April 28, 2016.
5. The Liver Forum: facilitating drug development for the treatment of liver disease. Forum for Collaborative HIV Research website. Available at: http://www.hivforum.org/projects/drug-development/liver-forum. Accessed April 28, 2016.
6. J.T. Galambos Natural history of alcoholic hepatitis. 3. Histological changes Gastroenterology 63 1972 1026 1035
7. M.W. Lischner, J.F. Alexander, and J.T. Galambos Natural history of alcoholic hepatitis. I. The acute disease Am J Dig Dis 16 1971 481 494
8. J. Casanova, and R. Bataller Alcoholic hepatitis: Prognosis and treatment Gastroenterol Hepatol 37 2014 262 268
9. A.J. Sanyal, B. Gao, and G. Szabo Gaps in knowledge and research priorities for alcoholic hepatitis Gastroenterology 149 2015 4 9
10. A.K. Singal, P.S. Kamath, G.J. Gores, and et al. Alcoholic hepatitis: current challenges and future directions Clin Gastroenterol Hepatol 12 2014 555 564 quiz e31-e32
11. J. Altamirano, R. Miquel, A. Katoonizadeh, and et al. A histologic scoring system for prognosis of patients with alcoholic hepatitis Gastroenterology 146 2014 1231 1239 e1-e6
12. W. Dunn, L.H. Jamil, L.S. Brown, and et al. MELD accurately predicts mortality in patients with alcoholic hepatitis Hepatology 41 2005 353 358
13. A. Louvet, F. Wartel, H. Castel, and et al. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor Gastroenterology 137 2009 541 548
14. T. Damgaard Sandahl Alcoholic hepatitis Dan Med J 61 2014 B4755
15. A.J. Sanyal, C. Banas, C. Sargeant, and et al. Similarities and differences in outcomes of cirrhosis due to nonalcoholic steatohepatitis and hepatitis C Hepatology 43 2006 682 689
16. C. Ripoll, R. Groszmann, G. Garcia-Tsao, and et al. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis Gastroenterology 133 2007 481 488
17. C. Ripoll, P. Lastra, D. Rincon, and et al. Comparison of MELD, HVPG, and their changes to predict clinically relevant endpoints in cirrhosis Scand J Gastroenterol 47 2012 204 211
18. M.S. Ascha, I.A. Hanouneh, R. Lopez, and et al. The incidence and risk factors of hepatocellular carcinoma in patients with nonalcoholic steatohepatitis Hepatology 51 2010 1972 1978
19. P. Angulo, D.E. Kleiner, S. Dam-Larsen, and et al. Liver fibrosis, but no other histologic features, is associated with long-term outcomes of patients with nonalcoholic fatty liver disease Gastroenterology 149 2015 389 397 e10