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174 results on '"Lubel J."'

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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

34. Increasing prevalence of primary biliary cholangitis in Victoria, Australia.

Author

Gow P.J., French J., Dev A., van der Mei I., Simpson S., Ng J., Angus P., Lubel J., Nicoll A., Sood S., Roberts S.K., Kemp W., Arachchi N., Thompson A., Gow P.J., French J., Dev A., van der Mei I., Simpson S., Ng J., Angus P., Lubel J., Nicoll A., Sood S., Roberts S.K., Kemp W., Arachchi N., and Thompson A.

Abstract

Background and Aim: The prevalence of primary biliary cholangitis (PBC) reported in different countries varies significantly and in some parts of the world appears to be increasing. The aim of this study was to determine the 2013 prevalence of PBC in Victoria, Australia, and to determine the time trend by comparing it with previous studies undertaken in 1991 and 2002. Method(s): Four case-finding methods were used to identify cases of PBC in Victoria: (1) physicians' survey; (2) tertiary hospital search; (3) liver transplant database search; and (4) private pathology antimitochondrial antibody search. Result(s): The prevalence of PBC in Victoria, Australia, is 189.0 per million using all four methods. The average annual increase in prevalence from 1991 to 2013 was 7.7 per million per year. Using the same case-finding methods as the 1991 Victorian prevalence study (methods 1 and 2), the prevalence of PBC increased from 19.1 per million in 1991 to 49.4 per million in 2002 (P < 0.001) and to 80.7 per million in 2013 (P < 0.001). Conclusion(s): The current prevalence of PBC in Victoria is significantly higher than previously reported. The use of private pathology-based case-finding methods is important in identifying the maximum number of PBC cases.Copyright © 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd

Published
2020

35. Prognostic role of alpha-fetoprotein in patients with hepatocellular carcinoma treated with repeat transarterial chemoembolisation.

Author

Bell S., Nicoll A., Roberts S.K., Kemp W., Majeed A., Mishra G., Dev A., Paul E., Cheung W., Koukounaras J., Jhamb A., Marginson B., Lim B.G., Simkin P., Borsaru A., Burnes J., Goodwin M., Ramachandra V., Spanger M., Lubel J., Gow P., Sood S., Thompson A., Ryan M., Bell S., Nicoll A., Roberts S.K., Kemp W., Majeed A., Mishra G., Dev A., Paul E., Cheung W., Koukounaras J., Jhamb A., Marginson B., Lim B.G., Simkin P., Borsaru A., Burnes J., Goodwin M., Ramachandra V., Spanger M., Lubel J., Gow P., Sood S., Thompson A., and Ryan M.

Abstract

Background: Repeat transarterial chemoembolisation (rTACE) is often required for hepatocellular carcinoma (HCC) to achieve disease control, however, current practice guidelines regarding treatment allocation vary significantly. This study aims to identify key factors associated with patient survival following rTACE to facilitate treatment allocation and prognostic discussion. Method(s): Patients with HCC undergoing rTACE at six Australian tertiary centers from 2009 to 2014 were included. Variables encompassing clinical, tumour, treatment type and response factors were analysed against the primary outcome of overall survival. Univariate analysis and multivariate Cox regression modelling were used to identify factors pre- and post-TACE therapy significantly associated with survival. Result(s): Total of 292 consecutive patients underwent rTACE with mainly Child Pugh A cirrhosis (61%) and BCLC stage A (57%) disease. Median overall survival (OS) was 30 months (IQR 15.2-50.2) from initial TACE. On multivariate analysis greater tumour number (p = 0.02), higher serum bilirubin (p = 0.007) post initial TACE, and hepatic decompensation (p = 0.001) post second TACE were associated with reduced survival. Patients with serum AFP >= 200 ng/ml following initial TACE had lower survival (p = 0.001), compared to patients with serum AFP level that remained < 200 ng/ml post-initial TACE, with an overall survival of 19.4 months versus 34.7 months (p = 0.0001) respectively. Conclusion(s): Serum AFP level following initial treatment in patients undergoing repeat TACE for HCC is a simple and useful clinical prognostic marker. Moreover, it has the potential to facilitate appropriate patient selection for rTACE particularly when used in conjunction with baseline tumour burden and severity of hepatic dysfunction post-initial TACE.Copyright © 2020 The Author(s).

Published
2020

36. SIRT Compared with DEB-TACE for Hepatocellular Carcinoma: a Real-world Study (the SITAR Study).

Author

Mishra G., Nicoll A.J., Gow P., Roberts S.K., Lubel J., Kemp W., Dev A., Hirsch R.D., Mills C., Sawhney R., Sood S., Bird V., Mishra G., Nicoll A.J., Gow P., Roberts S.K., Lubel J., Kemp W., Dev A., Hirsch R.D., Mills C., Sawhney R., Sood S., and Bird V.

Abstract

Background: Hepatocellular carcinoma (HCC) is responsible for 1% of deaths worldwide, and the incidence continues to increase. Despite surveillance programs, 70% of HCC patients are not suitable for curative options at diagnosis, and therefore, non-curative treatments are essential to modern clinical practice. There are many novel treatments, though their roles are not well defined. This study aimed to contrast Selective Internal Radiation Therapy (SIRT) and Drug Eluting Bead Transarterial Chemoembolisation (DEB-TACE) to further define their roles. Method(s): This was a retrospective multicentre cohort study. Factors included for analysis were type of HCC treatment, number of lesions, lesion size, multiple disease severity scores, cirrhosis and vascular invasion. The primary endpoint was transplant-free survival. Result(s): Transplant-free survival was similar between the two cohorts (p = 0.654), despite a variation in median lesion size, SIRT: 54.5 mm, DEB-TACE: 34 mm (p <= 0.001). A univariate Cox proportional hazard model utilising treatment modality as the covariate showed no significant difference in survival (DEB-TACE HR 1.4 (95%CI 0.85-2.15 p = 0.207). The size of the largest lesion was the best predictor of 3-year survival (p = 0.035). Lesion size was inversely associated with survival (HR 1.01 (95%CI 1-1.02, p = 0.025)) on multivariate analysis. Conclusion(s): This study is the first to catalogue the experience of using SIRT in HCC in a real-world Australian population. It has demonstrated no difference in survival outcomes between DEB-TACE and SIRT. Further, it has shown SIRT to be a reasonable alternative to DEB-TACE especially in larger lesions and has demonstrated that DEB-TACE has a role in select patients with advanced disease.Copyright © 2020, Springer Science+Business Media, LLC, part of Springer Nature.

Published
2020

39. Increasing prevalence of primary biliary cholangitis in Victoria, Australia

Author

French, J, van der Mei, I, Simpson, S, Ng, J, Angus, P, Lubel, J, Nicoll, A, Sood, S, Roberts, SK, Kemp, W, Arachchi, N, Dev, A, Thompson, A, Gow, PJ, French, J, van der Mei, I, Simpson, S, Ng, J, Angus, P, Lubel, J, Nicoll, A, Sood, S, Roberts, SK, Kemp, W, Arachchi, N, Dev, A, Thompson, A, and Gow, PJ

Abstract

BACKGROUND AND AIM: The prevalence of primary biliary cholangitis (PBC) reported in different countries varies significantly and in some parts of the world appears to be increasing. The aim of this study was to determine the 2013 prevalence of PBC in Victoria, Australia, and to determine the time trend by comparing it with previous studies undertaken in 1991 and 2002. METHODS: Four case-finding methods were used to identify cases of PBC in Victoria: (1) physicians' survey; (2) tertiary hospital search; (3) liver transplant database search; and (4) private pathology antimitochondrial antibody search. RESULTS: The prevalence of PBC in Victoria, Australia, is 189.0 per million using all four methods. The average annual increase in prevalence from 1991 to 2013 was 7.7 per million per year. Using the same case-finding methods as the 1991 Victorian prevalence study (methods 1 and 2), the prevalence of PBC increased from 19.1 per million in 1991 to 49.4 per million in 2002 (P < 0.001) and to 80.7 per million in 2013 (P < 0.001). CONCLUSIONS: The current prevalence of PBC in Victoria is significantly higher than previously reported. The use of private pathology-based case-finding methods is important in identifying the maximum number of PBC cases.

Published
2020

40. Prognostic role of alpha-fetoprotein in patients with hepatocellular carcinoma treated with repeat transarterial chemoembolisation

Author

Mishra, G, Dev, A, Paul, E, Cheung, W, Koukounaras, J, Jhamb, A, Marginson, B, Lim, BG, Simkin, P, Borsaru, A, Burnes, J, Goodwin, M, Ramachandra, V, Spanger, M, Lubel, J, Gow, P, Sood, S, Thompson, A, Ryan, M, Nicoll, A, Bell, S, Majeed, A, Kemp, W, Roberts, SK, Mishra, G, Dev, A, Paul, E, Cheung, W, Koukounaras, J, Jhamb, A, Marginson, B, Lim, BG, Simkin, P, Borsaru, A, Burnes, J, Goodwin, M, Ramachandra, V, Spanger, M, Lubel, J, Gow, P, Sood, S, Thompson, A, Ryan, M, Nicoll, A, Bell, S, Majeed, A, Kemp, W, and Roberts, SK

Abstract

BACKGROUND: Repeat transarterial chemoembolisation (rTACE) is often required for hepatocellular carcinoma (HCC) to achieve disease control, however, current practice guidelines regarding treatment allocation vary significantly. This study aims to identify key factors associated with patient survival following rTACE to facilitate treatment allocation and prognostic discussion. METHOD: Patients with HCC undergoing rTACE at six Australian tertiary centers from 2009 to 2014 were included. Variables encompassing clinical, tumour, treatment type and response factors were analysed against the primary outcome of overall survival. Univariate analysis and multivariate Cox regression modelling were used to identify factors pre- and post-TACE therapy significantly associated with survival. RESULTS: Total of 292 consecutive patients underwent rTACE with mainly Child Pugh A cirrhosis (61%) and BCLC stage A (57%) disease. Median overall survival (OS) was 30 months (IQR 15.2-50.2) from initial TACE. On multivariate analysis greater tumour number (p = 0.02), higher serum bilirubin (p = 0.007) post initial TACE, and hepatic decompensation (p = 0.001) post second TACE were associated with reduced survival. Patients with serum AFP ≥ 200 ng/ml following initial TACE had lower survival (p = 0.001), compared to patients with serum AFP level that remained < 200 ng/ml post-initial TACE, with an overall survival of 19.4 months versus 34.7 months (p = 0.0001) respectively. CONCLUSION: Serum AFP level following initial treatment in patients undergoing repeat TACE for HCC is a simple and useful clinical prognostic marker. Moreover, it has the potential to facilitate appropriate patient selection for rTACE particularly when used in conjunction with baseline tumour burden and severity of hepatic dysfunction post-initial TACE.

Published
2020

41. Community approach targeting cirrhosis and hepatocellular carcinoma (CATCH) study: Medium-term results.

Author

Roberts S., Kronborg I., Knight V., Valaydon Z., Lubel J., Bell S., Lewis D., Bloom S., Kemp W., Nicoll A., Dev A., Gow P., Sood S., Roberts S., Kronborg I., Knight V., Valaydon Z., Lubel J., Bell S., Lewis D., Bloom S., Kemp W., Nicoll A., Dev A., Gow P., and Sood S.

Abstract

Background and Aim: The Community Approach Targeting Cirrhosis and Hepatocellular Carcinoma (CATCH) study is a large prospective community-based cohort of patients with viral hepatitis B and C (HBV/ HCV). The study aimed to detect patients with unrecognized cirrhosis using transient elastography liver stiffness measurement (LSM). The hypothesis was that this screening program could identify asymptomatic individuals with cirrhosis and identify those at risk of liver-related events and hepatocellular carcinoma (HCC). Method(s): Participants with either HBV or HCV were prospectively recruited from 23 primary care practices in Victoria. A hospital cohort of patients was also recruited and acted as a comparator group. All patients underwent clinical assessment, transient elastography LSM, and biochemical evaluation. Patients with LSM of >= 12.5 kPa or other features of advanced fibrosis were referred for non-general practitioner specialist care. Before December 2015, when direct-acting antivirals (DAAs) became available in Australia through Medicare, all patients with HCV and an LSM of > 8 kPa were also referred. All patients were invited for annual re-evaluation. Result(s): Between October 2014 and June 2018, a total of 1431 patients were recruited. There were 1049 patients with HCV (776 from the community and 273 from hospital) and 382 patients with HBV (294 from the community and 88 from hospital). Of the community HCV patients, 31.6% (245/776) were referred to specialist care due to an elevated LSM or other features of advanced fibrosis (93.5%, 229/245) or dual infection with HBV (6.5%, 16/245). Of the remaining 531 community patients with HCV, 75.3% (400/531) received DAA therapy via their GP, and 374 patients completed therapy as prescribed. Overall, 59% (237/400) had a confirmed sustained virological response (SVR), 4.3% (17/400) are known to have failed DAA therapy, and the remaining 36.5% have no documented SVR (146/400). At the last contact, there were 18.8% (1

Published
2019

42. Community approach targeting cirrhosis and hepatocellular carcinoma (CATCH) study: Hepatitis B virus infection, screening patterns for hepatocellular carcinoma between general practitioners and non-GP specialists.

Author

Lewis D., Kemp W., Roberts S., Gow P., Dev A., Bell S., Sood S., Nicoll A., Kronborg I., Knight V., Valaydon Z., Lubel J., Bloom S., Lewis D., Kemp W., Roberts S., Gow P., Dev A., Bell S., Sood S., Nicoll A., Kronborg I., Knight V., Valaydon Z., Lubel J., and Bloom S.

Abstract

Background and Aim: The aim of the Community Approach Targeting Cirrhosis and Hepatocellular Carcinoma (CATCH) study is to detect cirrhosis using transient elastography liver stiffness measurement (LSM) in a large community-based, prospective cohort of patients with hepatitis B virus (HBV) infection to identify asymptomatic individuals with cirrhosis and ensure appropriate hepatocellular carcinoma (HCC) screening. The aim of this substudy was to compare HCC screening patterns between general practitioners and non-GP specialists for patients without cirrhosis based on age, sex, ethnicity, and family history criteria and whether treatment plans for GPs change screening practices over time. Method(s): Participants with HBV infection were prospectively recruited from 23 primary care practices in Victoria. A hospital cohort of patients was also prospectively recruited and used as the comparator. All patients underwent clinical assessment, transient elastography LSM, and biochemical evaluation. Liver radiological evaluation using ultrasound (US) within the previous 12 months was recorded. Patients with LSM of > 8 kPa or other features of advanced fibrosis were referred for non-GP specialist care. All patients were invited for annual re-evaluation. For those patients with HBV who remained in GP care, a treatment plan was provided, with instructions regarding HCC screening requirements based on age, sex, ethnicity, and family history. Follow-up data included US use within the 12 months before their last follow up; only patients without cirrhosis or known liver lesions were included to ensure that the GP and non-GP specialist groups were similar. The HCC screening practices were then compared between GP management and non-GP specialist management. Result(s): Between October 2014 and June 2018, a total of 382 patients with HBV were recruited (294 from the community and 88 from a tertiary center). Of these, 54.2% (207/382) qualified for HCC screening: 26.6% (55/ 207) based on

Published
2019

43. Treatment choice for early-stage hepatocellular carcinoma in real-world practice: impact of treatment stage migration to transarterial chemoembolization and treatment response on survival.

Author

Paul E., Mishra G., Majeed A., Kemp W., Dev A., Bell S., Roberts S.K., Gazzola A., Lubel J., Gow P., Nicoll A., Fink M.A., Sood S., Knight V., Hong T., Paul E., Mishra G., Majeed A., Kemp W., Dev A., Bell S., Roberts S.K., Gazzola A., Lubel J., Gow P., Nicoll A., Fink M.A., Sood S., Knight V., and Hong T.

Abstract

Objective: The objectives of our study were firstly to characterize the treatment stage migration phenomenon in early (Barcelona Clinic Liver Cancer [BCLC]-0/A) stage hepatocellular carcinoma (HCC) by comparing the efficacy of curative therapies with trans-arterial chemoembolization [TACE] and secondly, determining baseline and on-treatment predictors of survival. Method(s): All patients within BCLC-0/A stage from six tertiary hospitals who received curative therapy with either resection, transplantation, or ablation or TACE as first-line treatment were included in the analyses. The primary endpoint was overall survival; secondary end-points were transplant-free survival and recurrence-free survival. Result(s): Between January 2000 and December 2013, we identified 253 BCLC-0/A HCC patients of whom 148 (58.5%) received curative therapy and 105 (41.5%) migrated to TACE. Patients undergoing TACE had lower median survival (2.7 vs. 6.7 years; p <.0001), transplant-free survival (2.6 vs. 4.8 years; p <.0001) and recurrence-free survival (1.3 vs. 2.7 years; p <.001). On multivariate analysis treatment allocation to TACE was an independent prognostic predictor for both lower overall survival (HR 1.70, p =.04) and for HCC recurrence (HR 2.25, p <.001). The main prognostic determinant for each target outcome was Child-Pugh score. Conclusion(s): Our study confirms that curative treatments should always be preferred when applicable in early-stage HCC, but that in cases where this is not possible, TACE is a reasonable albeit inferior treatment option. In addition, it provides unique prognostic information on a significant proportion of patients with early-stage disease in whom curative therapy is not applicable.Copyright © 2018, © 2018 Informa UK Limited, trading as Taylor & Francis Group.

Published
2019

44. Real-world efficacy of long-term entecavir and tenofovir in patients with chronic hepatitis B.

Author

Ratnam D., Sood S., Arachchi N., Gow P., Lubel J., Ryan M., Howell J., Majeed A., Dev A., Nicoll A., Roberts S., Kemp W., Van Leest R., Bell S., Le S., Ratnam D., Sood S., Arachchi N., Gow P., Lubel J., Ryan M., Howell J., Majeed A., Dev A., Nicoll A., Roberts S., Kemp W., Van Leest R., Bell S., and Le S.

Abstract

Background and Aim: Entecavir (ETV) and tenofovir (TDF) are potent antiviral therapies for chronic hepatitis B (CHB). Data remain limited on the long-term (> 48 weeks) efficacy and safety of ETV and TDF in patients with CHB managed in a tertiary care setting, particularly treatmentexperienced and cirrhotic patients. We evaluated the long-term safety and efficacy of ETV and TDF in a large heterogeneous cohort of initial and treatment-experienced patients with CHB. Method(s): We conducted a multicenter retrospective cohort study of patients with CHB aged >= 18 years who received either ETV or TDF for >= 6 months. Patients were treated at seven tertiary health care networks across Melbourne, Australia, between January 2007 and January 2017. The primary end-points were undetectable hepatitis B virus (HBV)-DNA suppression (viral load [VL] of < 15 IU/mL) and alanine aminotransferase (ALT) normalization (American Association for the Study of Liver Diseases criteria). The rate of HBeAg and HBsAg loss/seroconversion, adverse events (AEs), and clinical outcomes, such as hepatocellular carcinoma and hepatic decompensation, were also evaluated. Result(s): Of the 1093 patients in the cohort, 68.89% were male, and the mean age was 48.28 +/- 13.18 years. At baseline, 28.73% were cirrhotic, and 30.28% were treatment-experienced. Baseline mean HBV-DNA VL was 4.63 +/- 2.14 log10 IU/mL. A total of 779 patients (71.27%) received ETV and 314 (28.73%) received TDF, with median treatment durations of 37 (IQR, 20-56) and 24.5 (IQR, 15-31) months, respectively. In the ETV group, 34% were HBeAg seropositive, and in the TDF group, 42.52% were. The Kaplan-Meier curve estimated probability of complete HBV-DNA suppression on ETV or TDF was 42.82% at 10 months, 69.57% at 20 months, and 83.31% at 30 months. Multivariate Cox regression analysis of the entire cohort identified baseline cirrhosis (hazard ratio [HR], 0.54; 95% CI, 0.32-0.91; P = 0.02) as an independent negative predictor for HBV-DNA s

Published
2019

45. Real-world Australian data reflect very high sustained virologic response at 12 weeks with direct acting antiviral therapy for hepatitis C and suggests highly achievable even in those without an end-of-treatment response.

Author

Williams, J, Lucarelli, N, Nicoll, A, Lubel, J, Williams, J, Lucarelli, N, Nicoll, A, and Lubel, J

Abstract

There are limited real-world data on the efficacy of direct acting antiviral (DAA) therapy for hepatitis C (HCV) in Australia. In this study, the efficacy of DAA therapy for HCV was compared between cirrhotic and non-cirrhotic cohorts. Patients without end-of-treatment response (EoTR) were observed to ascertain likelihood of achieving sustained virological response at 12 weeks post-treatment (SVR12). A total of 334 patients with HCV was included. Overall SVR12 was 96.7% with minimal differences in SVR12 between the cirrhosis and non-cirrhosis groups (95.7 and 97.3%). There were 20 patients (5.99%) that failed to achieve an EoTR of which 80.0% (n = 16) went on to achieve SVR12. These results suggest DAA therapy is effective with high rates of SVR12 even in patients that do not achieve an EoTR.

Published
2019

46. Sustained virologic response (SVR) to direct-acting antiviral (DAA) therapy in patients with chronic hepatitis C virus (HCV) infection and hepatocellular carcinoma (HCC): a systematic review and meta-analysis

Author

Ji, F., primary, Wei, M.T., additional, Yeo, Y.H., additional, Wei, B., additional, Ogawa, E., additional, Lee, D.H., additional, Enomoto, M., additional, Toyoda, H., additional, Bass, M.B., additional, Lubel, J., additional, Ide, T., additional, Preda, C.M., additional, Iio, E., additional, Conti, F., additional, Minami, T., additional, Bielen, R., additional, Sezaki, H., additional, Barone, M., additional, Chu, P.-S., additional, Virlogeux, V., additional, Eurich, D., additional, Kanai, T., additional, Dang, S., additional, Li, Z., additional, Furusyo, N., additional, Zoulim, F., additional, Andreone, P., additional, Cheung, R.C., additional, Tanaka, Y., additional, Tamori, A., additional, and Nguyen, M., additional

Published
2018
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48. Liver stiffness measurement in the primary care setting detects high rates of advanced fibrosis and predicts liver-related events in hepatitis C.

Author

Kronborg I., Lewis D., Lubel J., Kemp W., Nicoll A., Roberts S.K., Gow P., Dev A., Bell S., Sood S., Knight V., Bloom S., Kronborg I., Lewis D., Lubel J., Kemp W., Nicoll A., Roberts S.K., Gow P., Dev A., Bell S., Sood S., Knight V., and Bloom S.

Abstract

Background & Aims: As many as 70% of individuals with chronic hepatitis C (CHC) are managed solely in primary care. The aims of this study were to determine the prevalence of elevated liver stiffness measurement (LSM) in a cohort of community managed patients with CHC and to evaluate predictors of advanced liver disease and liver-related events. Method(s): A prospective cohort of adult patients with CHC were recruited from 21 primary care practices throughout Victoria, Australia. Inclusion criteria included the presence of CHC for >6 months, no recent (<18 months) specialist input and no history of hepatocellular carcinoma. Clinical assessment, LSM and phlebotomy were carried out in primary care. A hospital cohort was recruited for comparison. Participants were followed longitudinally and monitored for liver-related events. Result(s): Over 26 months, 780 community patients were recruited and included in the analysis. The median LSM was 6.9 kPa in the community, with 16.5% of patients at risk of advanced fibrosis (LSM >=12.5 kPa); of these 8.5% had no laboratory features of advanced liver disease. The proportion at risk of cirrhosis was no different between the community and hospital cohorts (p = 0.169). At-risk alcohol consumption, advancing age, elevated body mass index and alanine aminotransferase were independent predictors of elevated LSM. Over a median follow-up of 15.2 months, liver-related events occurred in 9.3% of those with an LSM >=12.5 kPa. An LSM of 24 kPa had the highest predictive power for liver-related events (hazard ratio 152; p <0.001). Conclusion(s): The prevalence of advanced fibrosis, as determined by LSM, in primary care managed CHC is significant and comparable to a hospital cohort. Furthermore, this study supports the use of LSM as a community screening tool in a CHC population and indicates a possible role in predicting liver-related events. Lay summary: The prevalence of advanced liver disease in primary care managed hepatitis C is unknown

Published
2018

49. Community Approach Targeting Cirrhosis and Hepatocellular carcinoma (CATCH): Community prevalence of advanced fibrosis in viral hepatitis.

Author

Bell S., Kronborg I., Knight V., Sood S., Lewis D., Lubel J., Dev A., Bloom S., Kemp W., Gow P., Nicoll A., Roberts S., Bell S., Kronborg I., Knight V., Sood S., Lewis D., Lubel J., Dev A., Bloom S., Kemp W., Gow P., Nicoll A., and Roberts S.

Abstract

Background and Aims: The majority of chronic hepatitis C (CHC) and chronic hepatitis B (CHB) is managed within primary care and the prevalence of advanced fibrosis in this group is unknown. This study aims to estimate the prevalence of significant fibrosis and cirrhosis as assessed by LSM in an at-risk population and explore the role of this investigation in facilitating the detection of hepatocellular carcinoma (HCC). Method(s): Participants were recruited from 21 primary care practices across Melbourne, Australia. Inclusion criteria included age >=18 yrs, CHB or CHC duration >=6 months, no prior or recent (<18 mths) specialist input and no history of HCC. Clinical assessment, LSM (Fibroscan 402) and blood analysis were performed in the primary care setting. Scans were considered reliable if the success rate was >=60% and IQR/median stiffness <0.3. LSMs of 8.0 kPa and 12.5 kPa were taken as cut-offs to represent significant fibrosis (>=F2) and cirrhosis (F4) respectively. Referral bias was assessed using a consecutively recruited hospital control group (h) undergoing identical assessment to the community group (c). Result(s): Over 24months, 1,523 were invited to participate of which 1,043 participants were assessed (753 cCHC/290 cCHB). LSM failure occurred in two (0.2%) subjects and phlebotomy failure in seven (0.7%). The M probe was used in 95.4% and the XL probe in 4.6%. The mean LSM was 9.9 kPa in cCHC and 5.0 kPa in cCHB with no difference in mean LSM between the cohorts (CHC p = 0.92/CHB p = 0.17). An LSM >= 8kPawas observed in 31.2% (cCHC 40.6%/cCHB 7.2% p < 0.01) and a LSM >=12.5 kPa in 11.6% (cCHC 15.9%/cCHB 0.6% p < 0.01). Three additional cCHB patients were diagnosed as cirrhotic on clinical grounds (all LSM >= 11.0), with a final prevalence of 2.8%. (vs. 5.0% hCHB p = 0.04). The prevalence of LSM >= 12.5 kPa was no different between cCHC and hCHC (15.9% vs. 21.2% p = 0.06). On multivariate analysis; advanced age (OR1.048 p < 0.01), waist circumference (O

Published
2018

50. Real-world efficacy and safety of ritonavir-boosted paritaprevir, ombitasvir, dasabuvir +/- ribavirin for hepatitis C genotype 1 - final results of the REV1TAL study.

Author

Strasser S., Stuart K.A., Dore G., Thompson A., Pianko S., Gazzola A., Cheng W., Nazareth S., Galhenage S., Wade A., Weltman M., Wigg A., MacQuillan G., Sasadeusz J., George J., Zekry A., Roberts S.K., Lubel J., Bollipo S., Mitchell J.L., Fragomeli V., Jones T., Chivers S., Gow P., Iser D., Levy M., Tse E., Strasser S., Stuart K.A., Dore G., Thompson A., Pianko S., Gazzola A., Cheng W., Nazareth S., Galhenage S., Wade A., Weltman M., Wigg A., MacQuillan G., Sasadeusz J., George J., Zekry A., Roberts S.K., Lubel J., Bollipo S., Mitchell J.L., Fragomeli V., Jones T., Chivers S., Gow P., Iser D., Levy M., and Tse E.

Abstract

Background: Limited data exist on the outcomes of ritonavir-boosted paritaprevir with ombitasvir and dasabuvir (PrOD) +/- ribavirin in a real-world setting. The aim of this study was to compare the efficacy and safety of PrOD-based therapy in hepatitis C genotype 1 patients with and without cirrhosis, and to explore pretreatment factors predictive of sustained viral response (SVR) and serious adverse events (SAEs) on treatment. Method(s): 451 patients with hepatitis C genotype 1 treated in 20 centres across Australia were included. Baseline demographic, clinical and laboratory information, on-treatment biochemical, virological and haematological indices and details on serious adverse events were collected locally. Result(s): Cirrhosis was present in 340 patients (75.4%). Overall SVR was 95.1% with no differences in SVR between the cirrhosis and non-cirrhosis groups (94.7% versus 96.4%). SVR in subgenotypes 1a and 1b was 93.1% and 99.2%, respectively. On multivariate analysis, baseline bilirubin level and early treatment cessation predicted SVR. SAEs occurred in 10.9% of patients including hepatic decompensation (2.7%) and hepatocellular carcinoma (1.8%). On multivariate analysis of factors predictive of SAEs in the overall group, Child-Turcotte-Pugh (CTP) B was the only significant factor, while in those with cirrhosis, baseline albumin and creatinine levels were significant. Conclusion(s): In this large real-world cohort of HCV genotype 1 subjects, treatment with PrOD was highly effective and similar to clinical trials. Important determinants of reduced SVR include early cessation of therapy and baseline bilirubin concentration. SAEs were not infrequent with CTP B patients being at greatest risk.Copyright © 2017 International Medical Press.

Published
2018

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