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3. NAFLD and MAFLD independently increase the risk of major adverse cardiovascular events (MACE): a 20-year longitudinal follow-up study from regional Australia

Author

Vaz, K, Kemp, W, Majeed, A, Lubel, J, Magliano, DJ, Glenister, KM, Bourke, L, Simmons, D, Roberts, SK, Vaz, K, Kemp, W, Majeed, A, Lubel, J, Magliano, DJ, Glenister, KM, Bourke, L, Simmons, D, and Roberts, SK

Abstract

BACKGROUND AND AIMS: The association between fatty liver disease (FLD) and cardiovascular disease (CVD) in an Australian context has yet to be defined. The primary aim of this study was to investigate the association between FLD and 3-point major adverse cardiovascular events (MACE). METHODS: This was a longitudinal follow-up study of a randomly sampled adult cohort from regional Australia between 2001 and 2003. Baseline covariates included demographic details, anthropometry, health and lifestyle data, and laboratory tests. Non-alcoholic fatty liver disease (NAFLD) and metabolic-(dysfunction) associated fatty liver disease (MAFLD) were diagnosed in participants with fatty liver index (FLI) ≥ 60 and meeting other standard criteria. ICD-10 codes were used to define clinical outcomes linked to hospitalisations. Three-point MACE defined as non-fatal myocardial infarction (MI) and cerebrovascular accident (CVA) and CVD death. RESULTS: In total, 1324 and 1444 participants met inclusion criteria for NAFLD and MAFLD analysis, respectively. Over 23,577 and 25,469 person-years follow-up, NAFLD and MAFLD were independent predictors for 3-point MACE, adjusting for demographic covariates and known cardiometabolic risk factors, whilst considering non-CVD death as a competing event (NAFLD: sub-hazard ratio [sHR] 1.56, 95% confidence interval [CI 1.12-2.19]; MAFLD: sHR 1.51, 95% CI 1.11-2.06). The results held true on several sensitivity analyses. CONCLUSIONS: Both forms of FLD increase the risk for CVD independent of traditional cardiometabolic risk factors.

Published
2024

4. Global multi-stakeholder endorsement of the MAFLD definition

Author

Mendez-Sanchez, N, Bugianesi, E, Gish, R, Lammert, F, Tilg, H, Nguyen, M, Sarin, S, Fabrellas, N, Zelber-Sagi, S, Fan, J, Shiha, G, Targher, G, Zheng, M, Chan, W, Vinker, S, Kawaguchi, T, Castera, L, Yilmaz, Y, Korenjak, M, Spearman, C, Ungan, M, Palmer, M, El-Shabrawi, M, Gruss, H, Dufour, J, Dhawan, A, Wedemeyer, H, George, J, Valenti, L, Fouad, Y, Romero-Gomez, M, Eslam, M, Abate, M, Abbas, B, Abbassy, A, Abd El Ghany, W, Abd Elkhalek, A, Abd ElMajeed, E, Abdalgaber, M, Abdallah, M, Abdallah, N, Abdelaleem, S, Abdelghani, Y, Abdelghany, W, Abdelhalim, S, Abdelhamid, W, Abdelhamid, N, Abdelkader, N, Abdelkreem, E, Abdelmohsen, A, Abdelrahman, A, Abd-elsalam, S, Abdeltawab, D, Abduh, A, Abdulhakam, N, Abdulla, M, Abedpoor, N, Abenavoli, L, Aberg, F, Ablack, O, Abo elftouh, M, Abo-Amer, Y, Aboubkr, A, Aboud, A, Abouelnaga, A, Aboufarrag, G, Aboutaleb, A, Abundis, L, Adali, G, Adames, E, Adams, L, Adda, D, Adel, N, Adel Sayed, M, Afaa, T, Afredj, N, Aghayeva, G, Aghemo, A, Aguilar-Salinas, C, Ahlenstiel, G, Ahmady, W, Ahmed, W, Ahmed, A, Ahmed, S, Ahmed, H, Ahmed, R, Aigner, E, Akarsu, M, Akroush, M, Akyuz, U, Al Mahtab, M, Al Qadiri, T, Al Rawahi, Y, AL rubaee, R, Al Saffar, M, Alam, S, Al-Ani, Z, Albillos, A, Alboraie, M, Al-Busafi, S, Al-Emam, M, Alharthi, J, Ali, K, Ali, B, Ali, M, Ali, R, Alisi, A, AL-Khafaji, A, Alkhatry, M, Aller, R, Almansoury, Y, Al-Naamani, K, Alnakeeb, A, Alonso, A, Alqahtani, S, Alrabadi, L, Alswat, K, Altaher, M, Altamimi, T, Altamirano, J, Alvares-da-Silva, M, Aly, E, Alzahaby, A, Alzamzamy, A, Amano, K, Amer, M, Amin, M, Amin, S, Amir, A, Ampuero, J, Anas, N, Andreone, P, Andriamandimby, S, Anees, M, Angela, P, Antonios, M, Arafat, W, Araya, J, Armendariz-Borunda, J, Armstrong, M, Ashktorab, H, Aspichueta, P, Assal, F, Atef, M, Attia, D, Atwa, H, Awad, R, Awad, M, Awny, S, Awolowo, O, Awuku, Y, Ayada, I, Aye, T, Ayman, S, Ayman, H, Ayoub, H, Azmy, H, Babaran, R, Badreldin, O, Badry, A, Bahcecioglu, I, Bahour, A, Bai, J, Balaban, Y, Balasubramanyam, M, Bamakhrama, K, Banales, J, Bangaru, B, Bao, J, Barahona, J, Barakat, S, Barbalho, S, Barbra, B, Barranco, B, Barrera, F, Baumann, U, Bazeed, S, Bech, E, Benayad, A, Benesic, A, Bernstein, D, Bessone, F, Birney, S, Bisseye, C, Blake, M, Bobat, B, Bonfrate, L, Bordin, D, Bosques-Padilla, F, Boursier, J, Boushab, B, Bowen, D, Bravo, P, Brennan, P, Bright, B, Broekaert, I, Buque, X, Burgos-Santamaria, D, Burman, J, Busetto, L, Byrne, C, Cabral-Prodigalidad, P, Cabrera-Alvarez, G, Cai, W, Cainelli, F, Caliskan, A, Canbay, A, Cano-Contreras, A, Cao, H, Cao, Z, Carrion, A, Carubbi, F, Casanovas, T, Castellanos Fernandez, M, Chai, J, Chan, S, Charatcharoenwitthaya, P, Chavez-Tapia, N, Chayama, K, Chen, J, Chen, L, Chen, Z, Chen, H, Chen, S, Chen, Q, Chen, Y, Chen, G, Chen, E, Chen, F, Chen, P, Cheng, R, Cheng, W, Chieh, J, Chokr, I, Cholongitas, E, Choudhury, A, Chowdhury, A, Chukwudike, E, Ciardullo, S, Clayton, M, Clement, K, Cloa, M, Coccia, C, Collazos, C, Colombo, M, Cosar, A, Cotrim, H, Couillerot, J, Coulibaly, A, Crespo, G, Crespo, J, Cruells, M, Cua, I, Dabbous, H, Dalekos, G, D'Alia, P, Dan, L, Dao, V, Darwish, M, Datz, C, Davalos-Moscol, M, Dawoud, H, de Careaga, B, de Knegt, R, de Ledinghen, V, de Silva, J, Debzi, N, Decraecker, M, Del Pozo, E, Delgado, T, Delgado-Blanco, M, Dembinski, L, Depina, A, Derbala, M, Desalegn, H, Desbois-Mouthon, C, Desoky, M, Dev, A, Di Ciaula, A, Diago, M, Diallo, I, Diaz, L, Dirchwolf, M, Dongiovanni, P, Dorofeyev, A, Dou, X, Douglas, M, Doulberis, M, Dovia, C, Doyle, A, Dragojevic, I, Drenth, J, Duan, X, Dulskas, A, Dumitrascu, D, Duncan, O, Dusabejambo, V, Dwawhi, R, Eiketsu, S, El Amrousy, D, El Deeb, A, El Deriny, G, El Din, H, El Kamshishy, S, El Kassas, M, El Raziky, M, Elagamy, O, Elakel, W, Elalfy, D, Elaraby, H, Elawady, H, Elbadawy, R, Eldash, H, Eldefrawy, M, Elecharri, C, Elfaramawy, A, Elfatih, M, Elfiky, M, Elgamsy, M, Elgendy, M, El-Guindi, M, Elhussieny, N, Eliwa, A, Elkabbany, Z, El-Khayat, H, El-Koofy, N, Elmetwalli, A, Elrabat, A, El-Raey, F, Elrashdy, F, Elsahhar, M, Elsaid, E, Elsayed, S, Elsayed, H, Elsayed, A, El-Serafy, M, Elsharkawy, A, Elsheemy, R, Elshemy, E, Elsherbini, S, Eltoukhy, N, Elwakil, R, Emad, O, Emad, S, Embabi, M, Ergenc, I, Ermolova, T, Esmat, G, Esmat, D, Estupinan, E, Ettair, S, Eugen, T, Ezz-Eldin, M, Falcon, L, Fan, Y, Fandari, S, Farag, M, Farahat, T, Fares, E, Fares, M, Fassio, E, Fathy, H, Fathy, D, Fathy, W, Fayed, S, Feng, D, Feng, G, Fernandez-Bermejo, M, Ferreira, C, Ferrer, J, Forbes, A, Fouad, R, Fouad, H, Frisch, T, Fujii, H, Fukunaga, S, Fukunishi, S, Fulya, H, Furuhashi, M, Gaber, Y, Galang, A, Gallardo, J, Galloso, R, Gamal, M, Gamal, R, Gamal, H, Gan, J, Ganbold, A, Gao, X, Garas, G, Garba, T, Garcia-Cortes, M, Garcia-Monzon, C, Garcia-Samaniego, J, Gastaldelli, A, Gatica, M, Gatley, E, Gegeshidze, T, Geng, B, Ghazinyan, H, Ghoneem, S, Giacomelli, L, Giannelli, G, Giannini, E, Giefer, M, Gines, P, Girala, M, Giraudi, P, Goh, G, Gomaa, A, Gong, B, Gonzales, D, Gonzalez, H, Gonzalez-Huezo, M, Graupera, I, Grgurevic, I, Gronbaek, H, Gu, X, Guan, L, Gueye, I, Guingane, A, Gul, O, Gul, C, Guo, Q, Gupta, P, Gurakar, A, Gutierrez, J, Habib, G, Hafez, A, Hagman, E, Halawa, E, Hamdy, O, Hamed, A, Hamed, D, Hamid, S, Hamoudi, W, Han, Y, Haridy, J, Haridy, H, Harris, D, Hart, M, Hasan, F, Hashim, A, Hassan, I, Hassan, A, Hassan, E, Hassan, M, Hassanin, F, Hassnine, A, Haukeland, J, Hawal, A, He, J, He, Q, He, Y, He, F, Hegazy, M, Hegazy, A, Henegil, O, Hernandez, N, Hernandez-Guerra, M, Higuera-de-la-Tijera, F, Hindy, I, Hirota, K, Ho, L, Hodge, A, Hosny, M, Hou, X, Huang, J, Huang, Y, Huang, Z, Huang, A, Huang, X, Hui-ping, S, Hunyady, B, Hussein, M, Hussein, O, Hussien, S, Ibanez-Samaniego, L, Ibdah, J, Ibrahim, L, Ibrahim, M, Ibrahim, I, Icaza-Chavez, M, Idelbi, S, Idilman, R, Ikeda, M, Indolfi, G, Invernizzi, F, Irshad, I, Isa, H, Iskandar, N, Ismaiel, A, Ismail, M, Ismail, Z, Ismail, F, Iwamoto, H, Jack, K, Jacob, R, Jafarov, F, Jafri, W, Jahshan, H, Jalal, P, Jancoriene, L, Janicko, M, Jayasena, H, Jefferies, M, Jha, V, Ji, F, Ji, Y, Jia, J, Jiang, C, Jiang, N, Jiang, Z, Jin, X, Jin, Y, Jing, X, Jingyu, Q, Jinjolava, M, Jong, F, Jucov, A, Julius, I, Kaddah, M, Kamada, Y, Kamal, A, Kamal, E, Kamel, A, Kao, J, Karin, M, Karlas, T, Kashwaa, M, Katsidzira, L, Kaya, E, Kayasseh, M, Keenan, B, Keklikkiran, C, Keml, W, Khalaf, D, Khalefa, R, Khamis, S, Khater, D, Khattab, H, Khavkin, A, Khlynova, O, Khmis, N, Kobyliak, N, Koffas, A, Koike, K, Kok, K, Koller, T, Komas, N, Korochanskaya, N, Koulla, Y, Koya, S, Kraft, C, Kraja, B, Krawczyk, M, Kuchay, M, Kulkarni, A, Kumar, A, Kumar, M, Lakoh, S, Lam, P, Lan, L, Lange, N, Lankarani, K, Lanthier, N, Lapshyna, K, Lashen, S, Laure, K, Lazebnik, L, Lebrec, D, Lee, S, Lee, W, Lee, Y, Leeming, D, Leite, N, Leon, R, Lesmana, C, Li, J, Li, Q, Li, Y, Li, L, Li, M, Liang, H, Lijuan, T, Lim, S, Lim, L, Lin, S, Lin, H, Lin, R, Lithy, R, Liu, Y, Liu, X, Liu, W, Liu, S, Liu, K, Liu, T, Lonardo, A, Lopez, M, Lopez-Benages, E, Lopez-Jaramillo, P, Lu, H, Lu, L, Lu, Y, Lubel, J, Lui, R, Lupasco, I, Luzina, E, Lv, X, Lynch, K, Ma, H, Machado, M, Maduka, N, Madzharova, K, Magdaong, R, Mahadeva, S, Mahfouz, A, Mahmood, N, Mahmoud, E, Mahrous, M, Maiwall, R, Majeed, A, Majumdar, A, Mak, L, Maklouf, M, Malekzadeh, R, Mandato, C, Mangia, A, Mann, J, Mansour, H, Mansouri, A, Mantovani, A, Mao, J, Maramag, F, Marchesini, G, Marcus, C, Marinho, R, Martinez-Chantar, M, Martins, A, Marwan, R, Mason, K, Masoud, G, Massoud, M, Matamoros, M, Mateos, R, Mawed, A, Mbanya, J, Mbendi, C, Mccolaugh, L, Mcleod, D, Medina, J, Megahed, A, Mehrez, M, Memon, I, Merat, S, Mercado, R, Mesbah, A, Meskini, T, Metwally, M, Metwaly, R, Miao, L, Micah, E, Miele, L, Milivojevic, V, Milovanovic, T, Mina, Y, Mishkovik, M, Mishriki, A, Mitchell, T, Mohamed, A, Mohamed, M, Mohamed, S, Mohammed, S, Mohammed, A, Mohan, V, Mohie, S, Mokhtar, A, Moniem, R, Montilla, M, Morales, J, Morata, M, Moreno-Planas, J, Morise, S, Mosaad, S, Moselhy, M, Mostafa, A, Mostafa, E, Mouane, N, Mousa, N, Moustafa, H, Msherif, A, Muller, K, Munoz, C, Munoz-Urribarri, A, Murillo, O, Mustapha, F, Muzurovic, E, Nabil, Y, Nafady, S, Nagamatsu, A, Nakajima, A, Nakano, D, Nan, Y, Nascimbeni, F, Naseef, M, Nashat, N, Natalia, T, Negro, F, Nersesov, A, Neuman, M, Ng'Wanasayi, M, Ni, Y, Nicoll, A, Niizeki, T, Nikolova, D, Ningning, W, Niriella, M, Nogoibaeva, K, Nordien, R, O Sullivan, C, O'Beirne, J, Obekpa, S, Ocama, P, Ochwoto, M, Ogolodom, M, Ojo, O, Okrostsvaridze, N, Oliveira, C, Omana, R, Omar, O, Omar, H, Omar, M, Omran, S, Omran, R, Osman, M, Owise, N, Owusu-Ansah, T, Padilla- Machaca, P, Palle, S, Pan, Z, Pan, X, Pan, Q, Papaefthymiou, A, Paquissi, F, Par, G, Parkash, A, Payawal, D, Peltekian, K, Peng, X, Peng, L, Peng, Y, Pengoria, R, Perez, M, Perez, J, Perez, N, Persico, M, Pessoa, M, Petta, S, Philip, M, Plaz Torres, M, Polavarapu, N, Poniachik, J, Portincasa, P, Pu, C, Purnak, T, Purwanto, E, Qi, X, Qian, Z, Qiang, Z, Qiao, Z, Qiao, L, Queiroz, A, Rabiee, A, Radwan, M, Rahetilahy, A, Ramadan, Y, Ramadan, D, Ramli, A, Ramm, G, Ran, A, Rankovic, I, Rao, H, Raouf, S, Ray, S, Reau, N, Refaat, A, Reiberger, T, Remes-Troche, J, Reyes, E, Richardson, B, Ridruejo, E, Riestra Jimenez, S, Rizk, I, Roberts, S, Roblero, J, Robles, J, Rockey, D, Rodriguez, M, Rodriguez Hernandez, H, Roman, E, Romeiro, F, Romeo, S, Rosales-Zabal, J, Roshdi, G, Rosso, N, Ruf, A, Ruiz, P, Runes, N, Ruzzenente, A, Ryan, M, Saad, A, Sabbagh, E, Sabbah, M, Saber, S, Sabrey, R, Sabry, R, Saeed, M, Said, D, Said, E, Sakr, M, Salah, Y, Salama, R, Salama, A, Saleh, H, Saleh, A, Salem, A, Salifou, A, Salih, A, Salman, A, Samouda, H, Sanai, F, Sanchez-Avila, J, Sanker, L, Sano, T, Sanz, M, Saparbu, T, Sawhney, R, Sayed, F, Sayed, S, Sayed, A, Sayed, M, Sebastiani, G, Secadas, L, Sediqi, K, Seif, S, Semida, N, Senates, E, Serban, E, Serfaty, L, Seto, W, Sghaier, I, Sha, M, Shabaan, H, Shalaby, L, Shaltout, I, Sharara, A, Sharma, V, Shawa, I, Shawkat, A, Shawky, N, Shehata, O, Sheils, S, Shewaye, A, Shi, G, Shi, J, Shimose, S, Shirono, T, Shou, L, Shrestha, A, Shui, G, Sievert, W, Sigurdardottir, S, Sira, M, Siradj, R, Sison, C, Smyth, L, Soliman, R, Sollano, J, Sombie, R, Sonderup, M, Sood, S, Soriano, G, Stedman, C, Stefanyuk, O, Stimac, D, Strasser, S, Strnad, P, Stuart, K, Su, W, Su, M, Sumida, Y, Sumie, S, Sun, D, Sun, J, Suzuki, H, Svegliati-Baroni, G, Swar, M, Taharboucht, S, Taher, Z, Takamura, S, Tan, L, Tan, S, Tanwandee, T, Tarek, S, Tatiana, G, Tavaglione, F, Tecson, G, Tee, H, Teschke, R, Tharwat, M, Thong, V, Thursz, M, Tine, T, Tiribelli, C, Tolmane, I, Tong, J, Tongo, M, Torkie, M, Torre, A, Torres, E, Trajkovska, M, Treeprasertsuk, S, Tsutsumi, T, Tu, T, Tur, J, Turan, D, Turcan, S, Turkina, S, Tutar, E, Tzeuton, C, Ugiagbe, R, Uygun, A, Vacca, M, Vajro, P, Van der Poorten, D, Van Kleef, L, Vashakidze, E, Velazquez, C, Velazquez, M, Vento, S, Verhoeven, V, Vespasiani-Gentilucci, U, Vethakkan, S, Vilaseca, J, Vitek, L, Volkanovska, A, Wallace, M, Wan, W, Wang, Y, Wang, X, Wang, C, Wang, M, Wangchuk, P, Weltman, M, White, M, Wiegand, J, Wifi, M, Wigg, A, Wilhelmi, M, William, R, Wittenburg, H, Wu, S, Wubeneh, A, Xia, H, Xiao, J, Xiao, X, Xiaofeng, W, Xiong, W, Xu, L, Xu, J, Xu, W, Xu, K, Xu, Y, Xu, S, Xu, M, Xu, A, Xu, C, Yan, H, Yang, J, Yang, R, Yang, Y, Yang, Q, Yang, N, Yao, J, Yara, J, Yaras, S, Yilmaz, N, Younes, R, Younes, H, Young, S, Youssef, F, Yu, Y, Yu, M, Yuan, J, Yue, Z, Yuen, M, Yun, W, Yurukova, N, Zakaria, S, Zaky, S, Zaldastanishvili, M, Zapata, R, Zare, N, Zerem, E, Zeriban, N, Zeshuai, X, Zhang, H, Zhang, X, Zhang, Y, Zhang, W, Zhang, Z, Zhao, J, Zhao, R, Zhao, H, Zheng, C, Zheng, Y, Zheng, R, Zheng, T, Zheng, K, Zhou, X, Zhou, Y, Zhou, H, Zhou, L, Zhu, L, Zhu, Y, Zhu, P, Ziada, E, Ziring, D, Ziyi, L, Zou, S, Zou, Z, Zou, H, Zuart Ruiz, R, Mendez-Sanchez N., Bugianesi E., Gish R. G., Lammert F., Tilg H., Nguyen M. H., Sarin S. K., Fabrellas N., Zelber-Sagi S., Fan J. -G., Shiha G., Targher G., Zheng M. -H., Chan W. -K., Vinker S., Kawaguchi T., Castera L., Yilmaz Y., Korenjak M., Spearman C. W., Ungan M., Palmer M., El-Shabrawi M., Gruss H. -J., Dufour J. -F., Dhawan A., Wedemeyer H., George J., Valenti L., Fouad Y., Romero-Gomez M., Eslam M., Abate M. L., Abbas B., Abbassy A. A., Abd El Ghany W., Abd Elkhalek A., Abd ElMajeed E., Abdalgaber M., AbdAllah M., Abdallah M., Abdallah N., Abdelaleem S., Abdelghani Y., Abdelghany W., Abdelhalim S. M., Abdelhamid W., Abdelhamid N., Abdelkader N. A., Abdelkreem E., Abdelmohsen A. M., Abdelrahman A. A., Abd-elsalam S. M., Abdeltawab D., Abduh A., Abdulhakam N., Abdulla M., Abedpoor N., Abenavoli L., Aberg F., Ablack O., Abo elftouh M., Abo-Amer Y. E. -E., Aboubkr A., Aboud A., Abouelnaga A. M., Aboufarrag G. A., Aboutaleb A., Abundis L., Adali G., Adames E., Adams L., Adda D., Adel N., Adel Sayed M., Afaa T. J., Afredj N., Aghayeva G., Aghemo A., Aguilar-Salinas C. A., Ahlenstiel G., Ahmady W., Ahmed W., Ahmed A., Ahmed S. N., Ahmed H. M., Ahmed R., Aigner E., Akarsu M., Akroush M., Akyuz U., Al Mahtab M., Al Qadiri T., Al Rawahi Y., AL rubaee R., Al Saffar M., Alam S., Al-Ani Z., Albillos A., Alboraie M., Al-Busafi S., Al-Emam M., Alharthi J., Ali K., Ali B. A., Ali M., Ali R. A. R., Alisi A., AL-Khafaji A. R., Alkhatry M., Aller R., Almansoury Y., Al-Naamani K., Alnakeeb A., Alonso A., Alqahtani S. A., Alrabadi L., Alswat K., Altaher M., Altamimi T., Altamirano J., Alvares-da-Silva M. R., Aly E. A. M., Alzahaby A., Alzamzamy A., Amano K., Amer M. A., Amin M. A., Amin S. A., Amir A. A., Ampuero J., Anas N., Andreone P., Andriamandimby S. F., Anees M., Angela P., Antonios M., Arafat W., Araya J. M., Armendariz-Borunda J., Armstrong M. J., Ashktorab H., Aspichueta P., Assal F., Atef M., Attia D., Atwa H., Awad R., Awad M. A. E., Awny S., Awolowo O., Awuku Y. A., Ayada I., Aye T. T., Ayman S., Ayman H., Ayoub H., Azmy H. M., Babaran R. P., Badreldin O., Badry A., Bahcecioglu I. H., Bahour A., Bai J., Balaban Y., Balasubramanyam M., Bamakhrama K., Banales J. M., Bangaru B., Bao J., Barahona J. S., Barakat S., Barbalho S. M., Barbra B., Barranco B., Barrera F., Baumann U., Bazeed S., Bech E., Benayad A., Benesic A., Bernstein D., Bessone F., Birney S., Bisseye C., Blake M., Bobat B., Bonfrate L., Bordin D. S., Bosques-Padilla F., Boursier J., Boushab B. M., Bowen D., Bravo P. M., Brennan P. N., Bright B., Broekaert I., Buque X., Burgos-Santamaria D., Burman J., Busetto L., Byrne C. D., Cabral-Prodigalidad P. A. I., Cabrera-Alvarez G., Cai W., Cainelli F., Caliskan A. R., Canbay A., Cano-Contreras A., Cao H. -X., Cao Z., Carrion A., Carubbi F., Casanovas T., Castellanos Fernandez M. I., Chai J., Chan S. P., Charatcharoenwitthaya P., Chavez-Tapia N., Chayama K., Chen J., Chen L., Chen Z. -W., Chen H., Chen S. -D., Chen Q., Chen Y., Chen G., Chen E. -Q., Chen F., Chen P. -J., Cheng R., Cheng W., Chieh J. T. W., Chokr I., Cholongitas E., Choudhury A., Chowdhury A., Chukwudike E. S., Ciardullo S., Clayton M., Clement K., Cloa M. M., Coccia C., Collazos C., Colombo M., Cosar A. M., Cotrim H. P., Couillerot J., Coulibaly A., Crespo G., Crespo J., Cruells M., Cua I. H. Y., Dabbous H. K., Dalekos G. N., D'Alia P., Dan L., Dao V. H., Darwish M., Datz C., Davalos-Moscol M. B., Dawoud H., de Careaga B. O., de Knegt R., de Ledinghen V., de Silva J., Debzi N., Decraecker M., Del Pozo E., Delgado T. C., Delgado-Blanco M., Dembinski L., Depina A., Derbala M., Desalegn H., Desbois-Mouthon C., Desoky M., Dev A., Di Ciaula A., Diago M., Diallo I., Diaz L. A., Dirchwolf M., Dongiovanni P., Dorofeyev A., Dou X., Douglas M. W., Doulberis M., Dovia C. K., Doyle A., Dragojevic I., Drenth J. P., Duan X., Dulskas A., Dumitrascu D. L., Duncan O., Dusabejambo V., Dwawhi R. S. N. A., Eiketsu S., El Amrousy D., El Deeb A., El Deriny G., El Din H. S., El Kamshishy S., El Kassas M., El Raziky M., Elagamy O. A., Elakel W., Elalfy D., Elaraby H., ElAwady H., Elbadawy R., Eldash H. H., Eldefrawy M. S., Elecharri C. L., Elfaramawy A., Elfatih M., Elfiky M., Elgamsy M., Elgendy M., El-Guindi M. A., Elhussieny N., Eliwa A. M., Elkabbany Z., El-Khayat H., El-Koofy N. M., Elmetwalli A., Elrabat A., El-Raey F., Elrashdy F., Elsahhar M., Elsaid E. M., Elsayed S., Elsayed H., Elsayed A., Elsayed A. M., El-Serafy M., Elsharkawy A. M., Elsheemy R. Y., Elshemy E. E., Elsherbini S., Eltoukhy N., Elwakil R., Emad O., Emad S., Embabi M., Ergenc I., Ermolova T., Esmat G., Esmat D. M., Estupinan E. C., Ettair S., Eugen T., Ezz-Eldin M., Falcon L. P. V., Fan Y. -C., Fandari S., Farag M., Farahat T. M., Fares E. M., Fares M., Fassio E., Fathy H., Fathy D., Fathy W., Fayed S., Feng D., Feng G., Fernandez-Bermejo M., Ferreira C. T., Ferrer J. D., Forbes A., Fouad R., Fouad H. M., Frisch T., Fujii H., Fukunaga S., Fukunishi S., Fulya H., Furuhashi M., Gaber Y., Galang A. J. G., Gallardo J. C., Galloso R., Gamal M., Gamal R., Gamal H., Gan J., Ganbold A., Gao X., Garas G., Garba T., Garcia-Cortes M., Garcia-Monzon C., Garcia-Samaniego J., Gastaldelli A., Gatica M., Gatley E., Gegeshidze T., Geng B., Ghazinyan H., Ghoneem S., Giacomelli L., Giannelli G., Giannini E. G., Giefer M., Gines P., Girala M., Giraudi P. J., Goh G. B. -B., Gomaa A. A., Gong B., Gonzales D. H. C., Gonzalez H. C., Gonzalez-Huezo M. S., Graupera I., Grgurevic I., Gronbaek H., Gu X., Guan L., Gueye I., Guingane A. N., Gul O. O., Gul C. B., Guo Q., Gupta P. P., Gurakar A., Gutierrez J. C. R., Habib G., Hafez A., Hagman E., Halawa E., Hamdy O., Hamed A. E., Hamed D. H., Hamid S., Hamoudi W., Han Y., Haridy J., Haridy H., Harris D. C. H. H., Hart M., Hasan F., Hashim A., Hassan I., Hassan A., Hassan E. A., Hassan A. A., Hassan M. S., Hassanin F., Hassnine A., Haukeland J. W., Hawal A. I. M., He J., He Q., He Y., He F. -P., Hegazy M., Hegazy A., Henegil O., Hernandez N., Hernandez-Guerra M., Higuera-de-la-Tijera F., Hindy I., Hirota K., Ho L. C., Hodge A., Hosny M., Hou X., Huang J. -F., Huang Y., Huang Z., Huang A., Huang X. -P., Hui-ping S., Hunyady B., Hussein M. A., Hussein O., Hussien S. M., Ibanez-Samaniego L., Ibdah J., Ibrahim L., Ibrahim M., Ibrahim I., Icaza-Chavez M. E., Idelbi S., Idilman R. I., Ikeda M., Indolfi G., Invernizzi F., Irshad I., Isa H. M. A., Iskandar N. J., Ismaiel A., Ismail M., Ismail Z., Ismail F., Iwamoto H., Jack K., Jacob R., Jafarov F., Jafri W., Jahshan H., Jalal P. K., Jancoriene L., Janicko M., Jayasena H., Jefferies M., Jha V., Ji F., Ji Y., Jia J., Jiang C., Jiang N., Jiang Z. -Z., Jin X., Jin Y., Jing X., Jingyu Q., Jinjolava M., Jong F. H. H., Jucov A., Julius I., Kaddah M., Kamada Y., kamal A., Kamal E. M., Kamel A. S., Kao J. -H., Karin M., Karlas T., Kashwaa M., Katsidzira L., Kaya E., Kayasseh M. A., Keenan B., Keklikkiran C., Keml W., Khalaf D. K., Khalefa R., Khamis S., Khater D., khattab H., Khavkin A., Khlynova O., Khmis N., Kobyliak N., Koffas A., Koike K., Kok K. Y. Y., Koller T., Komas N. P., Korochanskaya N. V., Koulla Y., Koya S., Kraft C., Kraja B., Krawczyk M., Kuchay M. S., Kulkarni A. V., Kumar A., Kumar M., Lakoh S., Lam P., Lan L., Lange N. F., Lankarani K. B., Lanthier N., Lapshyna K., Lashen S. A., Laure K. N. J., Lazebnik L., Lebrec D., Lee S. S., Lee W. S., Lee Y. Y., Leeming D. J., Leite N. C., Leon R., Lesmana C. R. A., Li J., Li Q., Li Y. -Y., Li Y., Li L., Li M., li Y., Liang H., Lijuan T., Lim S. 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M., Palle S., Pan Z., Pan X. -Y., Pan Q., Papaefthymiou A., Paquissi F. C., Par G., Parkash A., Payawal D., Peltekian K. M., Peng X., Peng L., Peng Y., Pengoria R., Perez M., Perez J. L., Perez N. M., Persico M., Pessoa M. G., Petta S., Philip M., Plaz Torres M. C., Polavarapu N., Poniachik J., Portincasa P., Pu C., Purnak T., Purwanto E., Qi X., Qian Z., Qiang Z., Qiao Z., Qiao L., Queiroz A., Rabiee A., Radwan M., Rahetilahy A. M., Ramadan Y., Ramadan D., Ramli A. S., Ramm G. A., Ran A., Rankovic I., RAO H., Raouf S., Ray S., Reau N., Refaat A., Reiberger T., Remes-Troche J. M., Reyes E. C., Richardson B., Ridruejo E., Riestra Jimenez S., Rizk I., Roberts S., Roblero J. P., Robles J. A. P., Rockey D., Rodriguez M., Rodriguez Hernandez H., Roman E., Romeiro F. G., Romeo S., Rosales-Zabal J. M., Roshdi G. R., Rosso N., Ruf A., Ruiz P. C., Runes N. R., Ruzzenente A., Ryan M., Saad A., Sabbagh E. B., Sabbah M., Saber S., Sabrey R., Sabry R., Saeed M. A., Said D., Said E. M., Sakr M. A., Salah Y., Salama R. M., Salama A., Saleh H., Saleh A., Salem A., Salem A. T., Salifou A., Salih A. F., Salman A., Samouda H., Sanai F., Sanchez-Avila J. F., Sanker L., Sano T., Sanz M., Saparbu T., Sawhney R., Sayed F., Sayed S. A., Sayed A. O., Sayed M., Sebastiani G., Secadas L., Sediqi K. Q., Seif S., Semida N., Senates E., Serban E. D., Serfaty L., Seto W. -K., Sghaier I., Sha M., Shabaan H. M., Shalaby L., Shaltout I., Sharara A. I., Sharma V., Shawa I. T., Shawkat A., Shawky N., Shehata O., Sheils S., Shewaye A. B., Shi G., Shi J., Shimose S., Shirono T., Shou L., Shrestha A., Shui G., Sievert W., Sigurdardottir S., Sira M. M., Siradj R., Sison C., Smyth L., Soliman R., Sollano J. D., Sombie R., Sonderup M., Sood S., Soriano G., Stedman C. A. M., Stefanyuk O., Stimac D., Strasser S., Strnad P., Stuart K., Su W., Su M., Sumida Y., Sumie S., Sun D. -Q., Sun J., Suzuki H., Svegliati-Baroni G., Swar M. O., TAHARBOUCHT S., Taher Z., Takamura S., Tan L., Tan S. -S., Tanwandee T., Tarek S., Tatiana G., Tavaglione F., Tecson G. Y., Tee H. -P., Teschke R., Tharwat M., Thong V. D., Thursz M., Tine T., Tiribelli C., Tolmane I., Tong J., Tongo M., Torkie M., Torre A., Torres E. A., Trajkovska M., Treeprasertsuk S., Tsutsumi T., Tu T., Tur J. A., Turan D., Turcan S., Turkina S., Tutar E., Tzeuton C., Ugiagbe R., Uygun A., Vacca M., Vajro P., Van der Poorten D., Van Kleef L. A., Vashakidze E., Velazquez C. M., Velazquez M. I., Vento S., Verhoeven V., Vespasiani-Gentilucci U., Vethakkan S. R., Vilaseca J., Vitek L., Volkanovska A., Wallace M., Wan W., Wang Y., Wang X., Wang C., Wang M., Wangchuk P., Weltman M., White M., Wiegand J., Wifi M. -N., Wigg A., Wilhelmi M., William R., Wittenburg H., Wu S., Wubeneh A. M., Xia H., Xiao J., Xiao X., Xiaofeng W., Xiong W., Xu L., Xu J., Xu W., Xu J. -H., Xu K., Xu Y., Xu S. -H., Xu M., Xu A., Xu C., Yan H., Yang J., Yang R. -X., Yang Y., Yang Q., Yang N., Yao J., Yara J., Yaras S., Yilmaz N., Younes R., younes H., Young S., Youssef F., Yu Y., Yu M. -L., Yuan J., Yue Z., Yuen M. -F., Yun W., Yurukova N., Zakaria S., Zaky S., Zaldastanishvili M., Zapata R., Zare N., Zerem E., Zeriban N., Zeshuai X., Zhang H., Zhang X., Zhang Y., Zhang W. -H., Zhang Y. -P., Zhang Z. -Q., Zhao J., Zhao R. -R., Zhao H., Zheng C., Zheng Y., Zheng R., Zheng T. -L., Zheng K., Zhou X. Q., Zhou Y., Zhou Y. -J., Zhou H., Zhou L., Zhu L. D., Zhu Y. F., Zhu Y., Zhu P. -W., Ziada E., Ziring D., Ziyi L., Zou S., Zou Z., Zou H., and Zuart Ruiz R.

Published
2022

5. Baseline serum HBV RNA is associated with the risk of hepatitis flare after stopping nucleoside analog therapy in HBeAg-negative participants

Author

Thompson, AJ, Jackson, K, Bonanzinga, S, Hall, SAL, Hume, S, Burns, GS, Sundararajan, V, Ratnam, D, Levy, MT, Lubel, J, Nicoll, AJ, Strasser, SI, Sievert, W, Desmond, PV, Ngu, MC, Sinclair, M, Meredith, C, Matthews, G, Revill, PA, Littlejohn, M, Bowden, DS, Canchola, JA, Torres, J, Siew, P, Lau, J, La Brot, B, Kuchta, A, Visvanathan, K, Thompson, AJ, Jackson, K, Bonanzinga, S, Hall, SAL, Hume, S, Burns, GS, Sundararajan, V, Ratnam, D, Levy, MT, Lubel, J, Nicoll, AJ, Strasser, SI, Sievert, W, Desmond, PV, Ngu, MC, Sinclair, M, Meredith, C, Matthews, G, Revill, PA, Littlejohn, M, Bowden, DS, Canchola, JA, Torres, J, Siew, P, Lau, J, La Brot, B, Kuchta, A, and Visvanathan, K

Abstract

BACKGROUND AND AIMS: HBV RNA in peripheral blood reflects HBV cccDNA transcriptional activity and may predict clinical outcomes. The prospective Melbourne HBV-STOP trial studied nucleot(s)ide analog discontinuation in HBeAg-negative non-cirrhotic participants with long-term virological suppression. Ninety-six weeks after stopping treatment, the proportion of participants with virological relapse (HBV DNA > 2000 IU/mL), biochemical relapse (ALT > 2 × ULN and HBV DNA > 2000 IU/mL), or hepatitis flare (ALT > 5 × ULN and HBV DNA > 2000 IU/mL) was 89%, 58%, and 38%, respectively. We evaluated the ability of serum HBV RNA levels to predict these outcomes. APPROACH RESULTS: HBV RNA levels were measured using the Roche cobas 6800/8800 HBV RNA Investigational Assay. Sixty-five participants had baseline and longitudinal off-treatment specimens available for RNA testing. HBV RNA was detectable at baseline in 25% of participants and was associated with a higher risk of biochemical relapse (81% vs. 51%, p value 0.04) and hepatitis flare (63% vs. 31%, p value 0.04). Participants who had undetectable serum HBV RNA as well as HBsAg ≤ 100 IU/mL at baseline were less likely to experience virological relapse (4 of 9, 44%) than participants with detectable HBV RNA and HBsAg level > 100 IU/mL (15/15, 100%; p value 0.0009). Off-treatment levels of HBV RNA were correlated with HBV DNA and were associated with the risk of hepatitis flare. CONCLUSIONS: Serum HBV RNA may be a useful biomarker for guiding clinical decision-making before stopping nucleot(s)ide analog therapy. Baseline HBV RNA and HBsAg levels are associated with the risk of clinical relapse, hepatitis flare, and disease remission off-treatment.

Published
2023

6. Non-alcoholic fatty liver disease prevalence in Australia has risen over 15 years in conjunction with increased prevalence of obesity and reduction in healthy lifestyle

Author

Vaz, K, Kemp, W, Majeed, A, Lubel, J, Magliano, DJ, Glenister, KM, Bourke, L, Simmons, D, Roberts, SK, Vaz, K, Kemp, W, Majeed, A, Lubel, J, Magliano, DJ, Glenister, KM, Bourke, L, Simmons, D, and Roberts, SK

Abstract

BACKGROUND AND AIM: Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver condition globally. The aim of this study was to evaluate the change in age- and sex-standardized prevalence of NAFLD in regional Victoria over a 15-year period and explore the underlying factors associated with differences over time. METHODS: Repeated comparative cross-sectional studies in four towns in regional Victoria, Australia. Individuals randomly selected from households from residential address lists from local government organizations in 2001-2003 (CrossRoads I [CR1]) and 2016-2018 (CrossRoads II [CR2]) with 1040 (99%) and 704 (94%) participants from CR1 and CR2 having complete data for analysis. Primary outcome was change in prevalence estimates of NAFLD (defined by a fatty liver index ≥ 60 in the absence of excess alcohol and viral hepatitis) between 2003 and 2018. RESULTS: Crude prevalence of NAFLD increased from 32.7% to 38.8% (P < 0.01), while age-standardized/sex-standardized prevalence increased from 32.4% to 35.4% (P < 0.01). Concurrently, prevalence of obesity defined by BMI and elevated waist circumference increased 28% and 25%, respectively. Women had a greater increase in the prevalence of NAFLD than men, in parallel with increasing prevalence of obesity. Proportion of participants consuming takeaway food greater than once weekly increased significantly over time. Up to 60% of NAFLD patients require additional tests for assessment of significant fibrosis. CONCLUSIONS: Crude and age-standardized/sex-standardized prevalence of NAFLD have both increased significantly over the last 15 years, particularly among women, in association with a parallel rise in the prevalence of obesity.

Published
2023

7. Liver stiffness (Fibroscan®) is a predictor of all-cause mortality in people with non-alcoholic fatty liver disease.

Author

Braude, M, Roberts, S, Majeed, A, Lubel, J, Prompen, J, Dev, A, Sievert, W, Bloom, S, Gow, P, Kemp, W, Braude, M, Roberts, S, Majeed, A, Lubel, J, Prompen, J, Dev, A, Sievert, W, Bloom, S, Gow, P, and Kemp, W

Abstract

BACKGROUND AND AIMS: Progressive liver fibrosis related to non-alcoholic fatty liver disease (NAFLD) is associated with all-cause and liver-related mortality. We assessed vibration-controlled transient elastography (VCTE) as a predictor of mortality. METHOD: Data from patients who underwent VCTE for NAFLD at four large health services in Victoria, Australia between the years 2008 and 2019 were linked to state-wide data registries. Cause of death (COD) and predictors of all-cause mortality were subsequently analysed using descriptive statistics and Cox-proportional regression analysis. RESULTS: Of 7079 VCTE records submitted for data linkage, 6341 were matched via data registry linkage. There were 217 deaths over a 22 653 person-year follow-up. COD included malignancies other than hepatocellular carcinoma (HCC) (18.0%, n = 39), sepsis (16.1%, n = 35), decompensated liver disease (15.2%, n = 33), cardiac disease (15.2%, n = 33) and HCC 6.0% (n = 13). Controlled attenuation parameter (CAP) was not associated with mortality in univariable analysis (HR = 1.00, CI 1.0-1.0, p = .488). Increased liver stiffness measurement (LSM) (HR 1.02 per kiloPascal, CI 1.01-1.03, p < .001), Charlson comorbidity index (CCI) (HR 1.32 for each point, CI 1.27-1.38, p < .001) and age (HR 1.05 per annum, CI 1.03-1.07, p < .001) were each associated with higher rates of all-cause mortality in multivariable analysis. LSM ≥10 kPa suggestive of compensated advanced chronic liver disease (cACLD) was associated with mortality in multivariable analysis (HR 2.31, CI 1.73-3.09, p < .001). CONCLUSION: VCTE LSM, in addition to age and CCI, is independently associated with increased all-cause mortality in a large cohort with NAFLD.

Published
2023

9. Monitoring quality of care in hepatocellular carcinoma: A modified Delphi consensus

Author

Maharaj, AD, Lubel, J, Lam, E, Clark, PJ, Duncan, O, George, J, Jeffrey, GP, Lipton, L, Liu, H, McCaughan, G, Neo, EL, Philip, J, Strasser, SI, Stuart, K, Thompson, A, Tibballs, J, Tu, T, Wallace, MC, Wigg, A, Wood, M, Zekry, A ; https://orcid.org/0000-0002-5675-1810, Greenhill, E, Ioannou, LJ, Ahlenstiel, G, Bowers, K, Clarke, SJ, Dev, A, Fink, M, Goodwin, M, Karapetis, CS, Levy, MT, Muller, K, O'Beirne, J, Pryor, D, Seow, J, Shackel, N, Tallis, C, Butler, N, Olynyk, JK, Reed-Cox, K, Zalcberg, JR, Roberts, SK, Maharaj, AD, Lubel, J, Lam, E, Clark, PJ, Duncan, O, George, J, Jeffrey, GP, Lipton, L, Liu, H, McCaughan, G, Neo, EL, Philip, J, Strasser, SI, Stuart, K, Thompson, A, Tibballs, J, Tu, T, Wallace, MC, Wigg, A, Wood, M, Zekry, A ; https://orcid.org/0000-0002-5675-1810, Greenhill, E, Ioannou, LJ, Ahlenstiel, G, Bowers, K, Clarke, SJ, Dev, A, Fink, M, Goodwin, M, Karapetis, CS, Levy, MT, Muller, K, O'Beirne, J, Pryor, D, Seow, J, Shackel, N, Tallis, C, Butler, N, Olynyk, JK, Reed-Cox, K, Zalcberg, JR, and Roberts, SK

Abstract

Although there are several established international guidelines on the management of hepatocellular carcinoma (HCC), there is limited information detailing specific indicators of good quality care. The aim of this study was to develop a core set of quality indicators (QIs) to underpin the management of HCC. We undertook a modified, two-round, Delphi consensus study comprising a working group and experts involved in the management of HCC as well as consumer representatives. QIs were derived from an extensive review of the literature. The role of the participants was to identify the most important and measurable QIs for inclusion in an HCC clinical quality registry. From an initial 94 QIs, 40 were proposed to the participants. Of these, 23 QIs ultimately met the inclusion criteria and were included in the final set. This included (a) nine related to the initial diagnosis and staging, including timing to diagnosis, required baseline clinical and laboratory assessments, prior surveillance for HCC, diagnostic imaging and pathology, tumor staging, and multidisciplinary care; (b) thirteen related to treatment and management, including role of antiviral therapy, timing to treatment, localized ablation and locoregional therapy, surgery, transplantation, systemic therapy, method of response assessment, and supportive care; and (c) one outcome assessment related to surgical mortality. Conclusion: We identified a core set of nationally agreed measurable QIs for the diagnosis, staging, and management of HCC. The adherence to these best practice QIs may lead to system-level improvement in quality of care and, ultimately, improvement in patient outcomes, including survival.

Published
2022

10. Impact of renaming NAFLD to MAFLD in an Australian regional cohort: Results from a prospective population-based study

Author

Kemp, W, Clayton-Chubb, D, Majeed, A, Glenister, KM, Magliano, DJ, Lubel, J, Bourke, L, Simmons, D, Roberts, SK, Kemp, W, Clayton-Chubb, D, Majeed, A, Glenister, KM, Magliano, DJ, Lubel, J, Bourke, L, Simmons, D, and Roberts, SK

Abstract

BACKGROUND AND AIMS: Clinical and public health implications of the recent redefining of non-alcoholic fatty liver disease (NAFLD) to metabolic-associated fatty liver disease (MAFLD) remain unclear. We sought to determine the prevalence and compare MAFLD with NAFLD in a well-defined cohort. METHODS: A cross-sectional study was conducted in regional Victoria with participants from randomly selected households. Demographic and health-related clinical and laboratory data were obtained. Fatty liver was defined as a fatty liver index ≥ 60 with MAFLD defined according to recent international expert consensus. RESULTS: A total of 722 participants were included. Mean age was 59.3 ± 16 years, and 55.3% were women with a median body mass index of 27.8 kg/m2 . Most (75.2%) participants were overweight or obese. MAFLD was present in 341 participants giving an unadjusted prevalence of 47.2% compared with a NAFLD prevalence of 38.7%. Fifty-nine (17.5%) participants met the criteria of MAFLD but not NAFLD. The increased prevalence of MAFLD in this cohort was primarily driven by dual etiology of fatty liver. All participants classified as NAFLD met the new definition of MAFLD. Compared with NAFLD subjects, participants with MAFLD had higher ALT (26.0 [14.0] U/L vs 30.0 [23] U/L, P = 0.024), but there were no differences in non-invasive markers for steatosis or fibrosis. CONCLUSION: Metabolic-associated fatty liver disease is a highly prevalent condition within this large community cohort. Application of the MAFLD definition increased prevalence of fatty liver disease by including people with dual etiologies of liver disease.

Published
2022

11. Epidemiology and outcomes of primary sclerosing cholangitis: an Australian multicentre retrospective cohort study

Author

Tan, N, Ngu, N, Worland, T, Lee, T, Abrahams, T, Pandya, K, Freeman, E, Hannah, N, Gazelakis, K, Madden, RG, Lynch, KD, Valaydon, Z, Sood, S, Dev, A, Bell, S, Thompson, A, Ding, J, Nicoll, AJ, Liu, K, Gow, P, Lubel, J, Kemp, W, Roberts, SK, Majeed, A, Tan, N, Ngu, N, Worland, T, Lee, T, Abrahams, T, Pandya, K, Freeman, E, Hannah, N, Gazelakis, K, Madden, RG, Lynch, KD, Valaydon, Z, Sood, S, Dev, A, Bell, S, Thompson, A, Ding, J, Nicoll, AJ, Liu, K, Gow, P, Lubel, J, Kemp, W, Roberts, SK, and Majeed, A

Abstract

BACKGROUND AND AIMS: Little is known regarding the epidemiology and outcomes of patients with primary sclerosing cholangitis (PSC) in Australia. We, therefore, evaluated the epidemiology and clinical outcomes of PSC in a large cohort of Australian patients and compared these to the general population. METHODS: We conducted a multicentre, retrospective cohort study of PSC patients at nine tertiary liver centers across three Australian states, including two liver transplant centers. RESULTS: A total of 413 PSC patients with 3,285 person-years of follow-up were included. Three hundred and seventy-one (90%) patients had large duct PSC and 294 (71%) had associated inflammatory bowel disease. A total of 168 (41%) patients developed cirrhosis (including 34 at the time of PSC diagnosis) after a median of 15.8 (95% CI 12.4, NA) years. The composite endpoint of death or liver transplantation occurred in 49 (12%) and 78 (19%) patients, respectively, with a median transplant-free survival of 13.4 (95% CI 12.2-15) years. Compared to the general population, PSC accounted for a 240-fold increased risk of development of cholangiocarcinoma (CCA) and CCA-related death. CCA risk was increased with older age of PSC diagnosis, presence of dominant stricture and colectomy. Compared to same-aged counterparts in the general population, PSC patients who were diagnosed at an older age or with longer disease duration had reduced relative survival. CONCLUSION: In this large retrospective cohort study of PSC patients in Australia, increased age and time from diagnosis was associated with increased mortality and morbidity particularly from CCA and development of cirrhosis, necessitating need for liver transplant.

Published
2022

39. HBV-STOP study: Large hepatitis B virus flares off nucleot(s)ide analog therapy cause large innate immune response.

Author

Bowden S., Jackson K., Locarnini S., Visvanathan K., Thompson A., Hall S., Burns G., Anagnostou D., Morris R., Mooney B., Levy M., Sievert W., Lubel J., Nicoll A., Strasser S., Desmond P., Ngu M., Angus P., Meredith C., Revill P., Bowden S., Jackson K., Locarnini S., Visvanathan K., Thompson A., Hall S., Burns G., Anagnostou D., Morris R., Mooney B., Levy M., Sievert W., Lubel J., Nicoll A., Strasser S., Desmond P., Ngu M., Angus P., Meredith C., and Revill P.

Abstract

Background and Aim: Current guidelines recommend indefinite nucleot( s)ide analog (NA) therapy for patients with HBeAg-negative chronic hepatitis B virus (HBV). However, sustained virological response (SVR) has been described in patients after discontinuation of long-term NA therapy. The HBV-STOP study is a prospective multicenter study of NA discontinuation in patients who have achieved long-term virological suppression on treatment. In addition to previously describing clinical outcomes after treatment discontinuation, we also aim to detail the immunological response in this scenario, especially that of the innate immune system. Method(s): Stimulation study: To gauge the potential innate activation of the peripheral blood cells by the flare, we stimulated peripheral blood mononuclear cell (PBMC) samples of HBV-STOP study patients by toll-like receptor (TLR)-specific ligands (TLR-2, TLR-3, TLR-4, TLR-7/8, and TLR-9) ex vivo. These patients either had a large biochemical flare (alanine aminotransferase [ALT] level > 10 x ULN) or did not have a biochemical flare (ALT < ULN). PBMCs were tested at baseline and peak ALT level time points, and matched non-flare samples were used as controls. Cytokine levels (IL-6, IL-8, IL-10, TNF, CCL-2, and CXCL-10) were measured after PBMC stimulation. Flow cytometry study: Additionally, we performed flow cytometry on PBMC samples of HBV-STOP study patients who either had a large biochemical flare (ALT > 10 x ULN) or did not have a biochemical flare. We did these studies at baseline and peak ALT level time points. Non-flare samples were matched to the closest respective week. Flow cytometry was used to isolate specific natural killer (NK) cell and monocyte populations using CD 56, CD 3, CD 16, and CD 14 cell surface markers. Expression of various immune markers was assessed in each cell population, including NKP46, NKG2D, TLR2, TLR4, and TREM1. Result(s): The stimulation study cohort consisted of 13 patients with flares and 12 patient

Published
2021

40. Low baseline HBsAg levels predict disease remission and HBsAg loss after stopping nucleot(s)ide analogs in chronic hepatitis B e-antigen-negative patients: Final results of the HBV-STOP study.

Author

Hall S., Burns G., Anagnostou D., Vogrin S., Sundararajan V., Ratnam D., Levy M., Lubel J., Nicoll A., Strasser S., Sievert W., Desmond P., Ngu M., Angus P., Sinclair M., Meredith C., Matthews G., Revill P., Jackson K., Bowden S., Locarnini S., Visvanathan K., Thompson A., Hall S., Burns G., Anagnostou D., Vogrin S., Sundararajan V., Ratnam D., Levy M., Lubel J., Nicoll A., Strasser S., Sievert W., Desmond P., Ngu M., Angus P., Sinclair M., Meredith C., Matthews G., Revill P., Jackson K., Bowden S., Locarnini S., Visvanathan K., and Thompson A.

Abstract

Background and Aim: Current guidelines recommend indefinite nucleot( s)ide analog (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB) infection. However, durable disease remission, including HBsAg loss, has been described in these patients after discontinuation of long-term NA therapy. The HBV-STOP study is a prospective multicenter study of NA discontinuation in non-cirrhotic patients who have achieved long-term virological suppression of hepatitis B virus (HBV) on treatment. We present the final results of the study, reporting clinical outcomes at Week 96 after treatment discontinuation. Method(s): Inclusion criteria were HBeAg-negative CHB infection, the absence of cirrhosis (on FibroScan), and virological suppression on NA (HBV DNA level below lower limit of quantitation) for >18 months. All patients were prospectively followed for 96 weeks after treatment withdrawal. Clinical outcomes of interest included rates of virological and biochemical relapse, disease remission, HBsAg decline, and HBsAg loss, as well as rates of NA retreatment. Criteria for recommencing NA therapy included serum HBV DNA level > 2000 IU/mL with either alanine aminotransferase (ALT) level > 5x the upper limit of normal (ULN) for >=16 weeks or ALT level > 10x ULN for >=8 weeks. ALT ULN was defined by local laboratory reference ranges. Result(s): A total of 108 participants (62% taking entecavir, 28% tenofovir, 10% other) were prospectively enrolled. Of these, 106 participants have completed 96 weeks of follow-up. At baseline, the median patient age was 55 years, 58% were male, and 83% were Asian. Median HBsAg level was 699 IU/mL (250-1819). After treatment withdrawal, virological reactivation occurred in all participants, with a median time to detection of 8 weeks (4-12), occurring earlier in tenofovir- than entecavir-treated patients (4 vs 12 weeks, P = 0.008) (Fig. 1). At Week 96, 76 patients (70%) remained off treatment, 35 (33%) were in disease remission with both DN

Published
2021

41. A prospective study of nucleot(s)ide analog discontinuation in non-cirrhotic patients with HBeAg-negative chronic hepatitis B: Interim analysis identifies different viral kinetics after stopping tenofovir versus entecavir.

Author

Hall S., Lubel J., Nicoll A., Strasser S., Desmond P., Levy M., Ngu M., Angus P., Meredith C., Revill P., Jackson K., Bowden S., Locarnini S., Visvanathan K., Thompson A., Vogrin S., Sievert W., Anagnostou D., Burns G., Hall S., Lubel J., Nicoll A., Strasser S., Desmond P., Levy M., Ngu M., Angus P., Meredith C., Revill P., Jackson K., Bowden S., Locarnini S., Visvanathan K., Thompson A., Vogrin S., Sievert W., Anagnostou D., and Burns G.

Abstract

Background and Aim: Current guidelines recommend indefinite nucleot(-s)ide analog (NA) therapy for patients with HBeAg-negative chronic hepatitis B (CHB) infection. However, sustained virological response (SVR) has been described in patients after discontinuation of long-term NA therapy, as well as HBsAg loss. The HBV-STOP study is a prospective multicenter study of NA discontinuation in patients who have achieved long-term virological suppression of hepatitis B virus (HBV) on treatment. The study describes clinical outcomes after treatment discontinuation, with the aim of identifying determinants of SVR. Method(s): We performed an interim narrative analysis of outcomes at Week 48 after NA discontinuation. Outcomes at Week 96 are the primary endpoint for the study. Inclusion criteria for the study were HBeAg-negative, non-cirrhotic, and virological suppression for > 18 months on NA therapy uninterrupted for > 2 years. Criteria for recommencing NA therapy were HBV DNA > 2000 IU/mL with either alanine aminotransferase (ALT) > 5x ULN for > 16 weeks or ALT > 10x ULN for > 8 weeks, international normalized ratio > 1.5, bilirubin level > 2x ULN, ascites, hepatic encephalopathy, and investigator discretion. Result(s): The cohort is fully enrolled, and data are currently available for 111 patients. At baseline, median patient age was 56 years, 64% were male, and 85% were Asian. The median HBsAg level was 705 IU/mL (214-2325). All patients were non-cirrhotic. Virological reactivation occurred in all, with a median time to detection of 8 weeks (4-12). Patients stopping tenofovir (TDF) experienced virological and biochemical relapse earlier than patients stopping entecavir (ETV) (Fig. 1; P < 0.001). Twenty-three patients (21%) have experienced an ALT flare > 10x ULN; there was no significant difference in the rate of ALT flare > 10x ULN after stopping TDF versus ETV. Two patterns of ALT flare were observed: beneficial flares that were associated with reductions in HBV DNA and

Published
2021

42. Community Approach Targeting Cirrhosis and Hepatocellular Carcinoma (CATCH): 4AGP, a new indirect biomarker-based algorithm that can predict risk of liver-related outcomes.

Author

Valaydon Z., Thompson A., Sood S., Lubel J., Kronborg I., Lewis D., Trezise K., Kemp W., Nicoll A., Bloom S., Ryan M., Freeman E., Vaz K., Wells R., Kodikara C., Sarraf B., Hirsch R., Satake S., Karunadasa H., Gardner S., Hartley I., Bell S., Gow P., Dev A., Roberts S., Valaydon Z., Thompson A., Sood S., Lubel J., Kronborg I., Lewis D., Trezise K., Kemp W., Nicoll A., Bloom S., Ryan M., Freeman E., Vaz K., Wells R., Kodikara C., Sarraf B., Hirsch R., Satake S., Karunadasa H., Gardner S., Hartley I., Bell S., Gow P., Dev A., and Roberts S.

Abstract

Background and Aim: Transient elastography with liver stiffness measurement (LSM) is known to correlate with liver fibrosis and liver-related outcomes. 4AGP is a new algorithm that uses indirect biomarkers to determine those who are at risk of elevated LSM (> 12.5 kPa). It is calculated using alpha-fetoprotein, albumin, aspartate aminotransferase, age, sex (gender), and platelet count. Although 4AGP correlates with elevated LSM in patients with chronic hepatitis C (CHC) virus infection, it is unknown whether it also predicts liver-related outcomes. We aimed to determine whether LSM or 4AGP, or other indirect biomarkers such as aspartate aminotransferase to platelet ratio index (APRI), Fibrosis-4 (FIB-4), or Forns index, can best predict liver-related outcomes in a cohort of patients with CHC. Method(s): The Community Approach Targeting Cirrhosis and Hepatocellular Carcinoma (CATCH) study is a prospective study that recruited patient with CHC. Baseline LSM and indirect biomarkers were assessed (all were before treatment), along with outcomes (hepatocellular carcinoma [HCC], decompensation, or liver-related death). Survival curves were analyzed using a log-rank test, along with receiver operator characteristic (ROC) curves and Cox proportional hazard ratios. Optimal cut-off points were calculated, accounting for sensitivity, specificity, false positives and negatives, as well as the area under the ROC curve (AUROC). Result(s): A total of 1049 patients with CHC were recruited between October 2014 and June 2018. Mean follow-up was 3.4 +/- 0.7 years, indicating 3631 patient-years. Patients' mean age was 45.1 years (19-82), and 31.3% were female. Seven patients developed HCC; the best predictors of HCC development were, in order, 4AGP, Forns index, FIB-4, LSM, and APRI (Fig. 1a). An LSM of 21.3 kPa was the optimal cut-off point for predicting HCC, with a sensitivity of 85.7%, specificity of 92.2%, and a hazard ratio (HR) of 30 (95% CI, 5.7-150). A 4AGP value of -2.81 had

Published
2021

43. Liver disease prevalence and severity in people with serious mental illness: a cross-sectional analysis using non-invasive diagnostic tools.

Author

Braude M.R., Con D., Lubel J., Bidwai A., Nguyen H.-T., Sharmamiglani S., Clarke D., Dev A., Sievert W., Braude M.R., Con D., Lubel J., Bidwai A., Nguyen H.-T., Sharmamiglani S., Clarke D., Dev A., and Sievert W.

Abstract

Background/purpose of the study: Little is known about all-cause liver disease in people with serious mental illness (SMI), despite heightened risk factors. We, therefore, prospectively assessed liver disease by etiology and severity in a cross-sectional cohort of people with SMI at a tertiary health service. Method(s): We recruited 255 people with SMI between August 2019 and March 2020. Liver disease data were derived from structured interview, medical records, biochemical and BBV serological analyses, and vibration-controlled transient elastography (VCTE). Steatosis was determined using a threshold of >= 248 db/m via the controlled attenuation parameter (CAP) on VCTE. Liver disease prevalence was assessed descriptively, and predictors of metabolic-dysfunction associated fatty liver disease (MAFLD) analyzed using linear regression and multivariable analysis. Best fit modeling of non-invasive screening tests for MAFLD was also assessed. Result(s): Valid VCTE was obtained for 252 (98.9%) participants. Median age was 40 years (IQR 31-49) with male predominance (65.9%). Hepatitis C Virus (HCV) seroprevalence was 14.7% (37/252), with four new viremic cases identified. Hepatic steatosis was diagnosed in 61.5% (155/252) of participants, with MAFLD criteria met in 59.9% (151/252) of cases. Clozapine and paliperidone were associated with hepatic steatosis (CAP + 23.3 db/m, p 0.013 and CAP + 25.5, p 0.037, respectively). Advanced liver disease, defined by LSM >= 8.2 kPa, was identified in 26 individuals (10.3%). MAFLD compared to no MAFLD was associated with more advanced liver disease (5.3 kPa, 4.3-6.5 versus 4.9 kPa, 3.9-5.6, p < 0.001). Conclusion(s): Liver disease is common in people with SMI and should be screened for as part of standard physical health assessment. Graphic abstract: [Figure not available: see fulltext.].Copyright © 2021, Asian Pacific Association for the Study of the Liver.

Published
2021

44. A prospective study of nucleot(s)ide analogue discontinuation in non-cirrhotic HBeAg-negative chronic hepatitis B patients: interimanalysis at week 48 demonstrates profound reductions of HBsAg associated with ALT flare.

Author

Hall S., Burns G., Levy M., Lubel J., Nicoll A., Matthews G., Desmond P., Sievert W., Bowden S., Locarnini S., Holmes J., Visvanathan K., Thompson A., Hall S., Burns G., Levy M., Lubel J., Nicoll A., Matthews G., Desmond P., Sievert W., Bowden S., Locarnini S., Holmes J., Visvanathan K., and Thompson A.

Abstract

Background and Aims: Current guidelines recommend indefinite Nucleot(s)ide Analogue (NA) therapy for patients with HBeAg-negative CHB. However, sustained virological response (SVR) has been described in patients after discontinuation of long-term NA therapy, as well as HBsAg loss. The HBV-STOP study is a prospective multi-centre study of NA discontinuation in patients who have achieved long-term virological suppression on treatment. The study describes clinical outcomes post-treatment discontinuation, with the aim of identifying determinants of SVR. Method(s): An interim narrative analysis of outcomes at week 48 post-NA discontinuation was performed. The primary endpoint for the study is outcomes at week 96. Inclusion criteria for the study were HBeAg-negative, non-cirrhotic & virological suppression for >= 18 months on NA therapy uninterrupted for >= 2 years. Criteria for recommencing NA therapy were HBV DNA >2000 IU/mL with either ALT?>5x ULN for >= 16 weeks or ALT >10x ULN for >= 8 weeks, INR >= 1.5, Bilirubin?>2x ULN, ascites, hepatic encephalopathy and investigator discretion. Result(s): The cohort is fully enrolled and data are currently available for 90/111 patients. At baseline, median age was 55 yrs, 58% were male, 83% were Asian. Median HBsAg level was 699 (250-1819) IU/mL. All patients were non-cirrhotic. Virological reactivation occurred in all, with median time to detection 8 (4-12) weeks. At week 48, four (4%) patients have experienced HBsAg loss, 42 (47%) had DNA >,000 IU/mL, 13 (14%) had DNA >2,000 and ALT?>2x ULN, and 10 (11%) had restarted treatment. Patients who achieved HBsAg loss had low baseline HBsAg levels (HBsAg loss: median baseline HBsAg level = 3.1 IU/ml in HBsAg loss vs. 776 IU/mL in patients with no HBsAg loss). The overall median reduction in HBsAg was 68 IU/mL at week 48. 21 (23%) have experienced an ALT flare >10x ULN. ALT flare was associated with reduction in HBsAg level. Median reduction of HBsAg level from the flare time-point to

Published
2021

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