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Page 1
Primary biliary cholangitis drug evaluation and regulatory approval: Where do we go from here?
Jones DEJ, Beuers U, Bonder A, Carbone M, Culver E, Dyson J, Gish RG, Hansen BE, Hirschfield G, Jones R, Kowdley K, Kremer AE, Lindor K, Mayo M, Mells G, Neuberger J, Prince M, Swain M, Tanaka A, Thorburn D, Trauner M, Trivedi P, Weltman M, Yeoman A, Levy C. Jones DEJ, et al. Among authors: kowdley k. Hepatology. 2024 Nov 1;80(5):1291-1300. doi: 10.1097/HEP.0000000000000864. Epub 2024 Mar 22. Hepatology. 2024. PMID: 38506926 Free PMC article.
Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials.
Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3; STELLAR-4 Investigators. Harrison SA, et al. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6. J Hepatol. 2020. PMID: 32147362 Clinical Trial.
PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis.
Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Färkkilä M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. Trauner M, et al. Among authors: kowdley kv. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2. BMC Gastroenterol. 2023. PMID: 36922785 Free PMC article. Clinical Trial.
Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival.
Murillo Perez CF, Ioannou S, Hassanally I, Trivedi PJ, Corpechot C, van der Meer AJ, Lammers WJ, Battezzati PM, Lindor KD, Nevens F, Kowdley KV, Bruns T, Cazzagon N, Floreani A, Mason AL, Gulamhusein A, Ponsioen CY, Carbone M, Lleo A, Mayo MJ, Dalekos GN, Gatselis NK, Thorburn D, Verhelst X, Parés A, Londoño MC, Janssen HLA, Invernizzi P, Vuppalanchi R, Hirschfield GM, Hansen BE, Levy C; Global PBC Study Group. Murillo Perez CF, et al. Among authors: kowdley kv. Liver Int. 2023 Jul;43(7):1497-1506. doi: 10.1111/liv.15592. Epub 2023 May 8. Liver Int. 2023. PMID: 37157905 Free article.
A multisociety Delphi consensus statement on new fatty liver disease nomenclature.
Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, Romero D, Abdelmalek MF, Anstee QM, Arab JP, Arrese M, Bataller R, Beuers U, Boursier J, Bugianesi E, Byrne CD, Castro Narro GE, Chowdhury A, Cortez-Pinto H, Cryer DR, Cusi K, El-Kassas M, Klein S, Eskridge W, Fan J, Gawrieh S, Guy CD, Harrison SA, Kim SU, Koot BG, Korenjak M, Kowdley KV, Lacaille F, Loomba R, Mitchell-Thain R, Morgan TR, Powell EE, Roden M, Romero-Gómez M, Silva M, Singh SP, Sookoian SC, Spearman CW, Tiniakos D, Valenti L, Vos MB, Wong VW, Xanthakos S, Yilmaz Y, Younossi Z, Hobbs A, Villota-Rivas M, Newsome PN; NAFLD Nomenclature consensus group. Rinella ME, et al. Among authors: kowdley kv. Hepatology. 2023 Dec 1;78(6):1966-1986. doi: 10.1097/HEP.0000000000000520. Epub 2023 Jun 24. Hepatology. 2023. PMID: 37363821 Free PMC article.
Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
Kowdley KV, Bowlus CL, Levy C, Akarca US, Alvares-da-Silva MR, Andreone P, Arrese M, Corpechot C, Francque SM, Heneghan MA, Invernizzi P, Jones D, Kruger FC, Lawitz E, Mayo MJ, Shiffman ML, Swain MG, Valera JM, Vargas V, Vierling JM, Villamil A, Addy C, Dietrich J, Germain JM, Mazain S, Rafailovic D, Taddé B, Miller B, Shu J, Zein CO, Schattenberg JM; ELATIVE Study Investigators’ Group; ELATIVE Study Investigators' Group. Kowdley KV, et al. N Engl J Med. 2024 Feb 29;390(9):795-805. doi: 10.1056/NEJMoa2306185. Epub 2023 Nov 13. N Engl J Med. 2024. PMID: 37962077 Clinical Trial.
A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis.
Hirschfield GM, Bowlus CL, Mayo MJ, Kremer AE, Vierling JM, Kowdley KV, Levy C, Villamil A, Ladrón de Guevara Cetina AL, Janczewska E, Zigmond E, Jeong SH, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londoño Hurtado MC, Bergheanu S, Yang K, Choi YJ, Crittenden DB, McWherter CA; RESPONSE Study Group. Hirschfield GM, et al. Among authors: kowdley kv. N Engl J Med. 2024 Feb 29;390(9):783-794. doi: 10.1056/NEJMoa2312100. Epub 2024 Feb 21. N Engl J Med. 2024. PMID: 38381664 Clinical Trial.
Cilofexor in Patients With Compensated Cirrhosis Due to Primary Sclerosing Cholangitis: An Open-Label Phase 1B Study.
Levy C, Caldwell S, Mantry P, Luketic V, Landis CS, Huang J, Mena E, Maheshwari R, Rank K, Xu J, Malkov VA, Billin AN, Liu X, Lu X, Barchuk WT, Watkins TR, Chung C, Myers RP, Kowdley KV. Levy C, et al. Among authors: kowdley kv. Clin Transl Gastroenterol. 2024 Aug 1;15(8):e00744. doi: 10.14309/ctg.0000000000000744. Clin Transl Gastroenterol. 2024. PMID: 38976363 Free PMC article. Clinical Trial.
541 results