Obeticholic Acid Among Chronic HBV Patients with Hepatic Steatosis : Clinical and Portal Doppler Outcomes

Summary

In this study, the investigators aimed to evaluate the hepatoprotective effect of OCA against HBV-induced liver injury by comparing patients demographic , laboratory date ( liver function , viremia ) , degree of hepatic steatosis and fibrosis and portal doppler at the beginning and after six months .

Timeline

Start

2024-11-15

Primary completion

2026-01-01

Completion

2026-03-01

Publications

• Background Zhang L, Duan YY, Li JM, Yin JK. Hemodynamic features of Doppler ultrasonography in patients with portal hypertension: intraoperative direct measurement of portal pressure in the portal venous system. J Ultrasound Med. 2007 Dec;26(12):1689-96. doi: 10.7863/jum.2007.26.12.1689.
• Background Piscaglia F, Donati G, Serra C, Muratori R, Solmi L, Gaiani S, Gramantieri L, Bolondi L. Value of splanchnic Doppler ultrasound in the diagnosis of portal hypertension. Ultrasound Med Biol. 2001 Jul;27(7):893-9. doi: 10.1016/s0301-5629(01)00390-8.
• Background Sacerdoti D, Gaiani S, Buonamico P, Merkel C, Zoli M, Bolondi L, Sabba C. Interobserver and interequipment variability of hepatic, splenic, and renal arterial Doppler resistance indices in normal subjects and patients with cirrhosis. J Hepatol. 1997 Dec;27(6):986-92. doi: 10.1016/s0168-8278(97)80141-9.
• Background Bolognesi M, Sacerdoti D, Merkel C, Gerunda G, Maffei-Faccioli A, Angeli P, Jemmolo RM, Bombonato G, Gatta A. Splenic Doppler impedance indices: influence of different portal hemodynamic conditions. Hepatology. 1996 May;23(5):1035-40. doi: 10.1002/hep.510230515.
• Background McNaughton DA, Abu-Yousef MM. Doppler US of the liver made simple. Radiographics. 2011 Jan-Feb;31(1):161-88. doi: 10.1148/rg.311105093.
• Background Scheinfeld MH, Bilali A, Koenigsberg M. Understanding the spectral Doppler waveform of the hepatic veins in health and disease. Radiographics. 2009 Nov;29(7):2081-98. doi: 10.1148/rg.297095715.
• Background Sasso M, Miette V, Sandrin L, Beaugrand M. The controlled attenuation parameter (CAP): a novel tool for the non-invasive evaluation of steatosis using Fibroscan. Clin Res Hepatol Gastroenterol. 2012 Feb;36(1):13-20. doi: 10.1016/j.clinre.2011.08.001. Epub 2011 Sep 15.
• Background Friedrich-Rust M, Nierhoff J, Lupsor M, Sporea I, Fierbinteanu-Braticevici C, Strobel D, Takahashi H, Yoneda M, Suda T, Zeuzem S, Herrmann E. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. 2012 Feb;19(2):e212-9. doi: 10.1111/j.1365-2893.2011.01537.x. Epub 2011 Oct 30.
• Background Castera L, Forns X, Alberti A. Non-invasive evaluation of liver fibrosis using transient elastography. J Hepatol. 2008 May;48(5):835-47. doi: 10.1016/j.jhep.2008.02.008. Epub 2008 Feb 26.
• Background Verbeke L, Farre R, Trebicka J, Komuta M, Roskams T, Klein S, Elst IV, Windmolders P, Vanuytsel T, Nevens F, Laleman W. Obeticholic acid, a farnesoid X receptor agonist, improves portal hypertension by two distinct pathways in cirrhotic rats. Hepatology. 2014 Jun;59(6):2286-98. doi: 10.1002/hep.26939. Epub 2014 Apr 14.
• Background Erken R, Andre P, Roy E, Kootstra N, Barzic N, Girma H, Laveille C, Radreau-Pierini P, Darteil R, Vonderscher J, Scalfaro P, Tangkijvanich P, Flisiak R, Reesink H. Farnesoid X receptor agonist for the treatment of chronic hepatitis B: A safety study. J Viral Hepat. 2021 Dec;28(12):1690-1698. doi: 10.1111/jvh.13608. Epub 2021 Sep 29.
• Background GBD 2019 Hepatitis B Collaborators. Global, regional, and national burden of hepatitis B, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Gastroenterol Hepatol. 2022 Sep;7(9):796-829. doi: 10.1016/S2468-1253(22)00124-8. Epub 2022 Jun 21.
• Background Fiorucci S, Di Giorgio C, Distrutti E. Obeticholic Acid: An Update of Its Pharmacological Activities in Liver Disorders. Handb Exp Pharmacol. 2019;256:283-295. doi: 10.1007/164_2019_227.
• Background Chapman RW, Lynch KD. Obeticholic acid-a new therapy in PBC and NASH. Br Med Bull. 2020 May 15;133(1):95-104. doi: 10.1093/bmb/ldaa006.
• Background Nevens F, Andreone P, Mazzella G, Strasser SI, Bowlus C, Invernizzi P, Drenth JP, Pockros PJ, Regula J, Beuers U, Trauner M, Jones DE, Floreani A, Hohenester S, Luketic V, Shiffman M, van Erpecum KJ, Vargas V, Vincent C, Hirschfield GM, Shah H, Hansen B, Lindor KD, Marschall HU, Kowdley KV, Hooshmand-Rad R, Marmon T, Sheeron S, Pencek R, MacConell L, Pruzanski M, Shapiro D; POISE Study Group. A Placebo-Controlled Trial of Obeticholic Acid in Primary Biliary Cholangitis. N Engl J Med. 2016 Aug 18;375(7):631-43. doi: 10.1056/NEJMoa1509840.
• Background Cao P, Gan J, Wu S, Hu Y, Xia B, Li X, Zeng H, Cheng B, Yu H, Li F, Si L, Huang J. Molecular mechanisms of hepatoprotective effect of tectorigenin against ANIT-induced cholestatic liver injury: Role of FXR and Nrf2 pathways. Food Chem Toxicol. 2023 Aug;178:113914. doi: 10.1016/j.fct.2023.113914. Epub 2023 Jun 20.

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