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4. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials

Author

Gadano, Adrian, Martins, Marcelo, Angus, Peter, Bate, John, Danta, Mark, George, Jacob, Hodge, Alexander, Kontorinis, Nickolas, Roberts, Stuart, Sanagapalli, Santosh, Skoien, Richard, Thompson, Alexander, Zekry, Amany, Stauber, Rudolf, Trauner, Michael, Moreno, Christophe, Reynaert, Hendrik, Verbeke, Len, Silva, Mario Reis Alvares da, Parise, Edison, Oliveira, Claudia Pinto Marques Souza de, Araujo, Roberta Chaves, Martinelli, Ana de Lourdes Candolo, Borman, Meredith, Chandok, Natasha, Elkhashab, Magdy, Fraser, Hughie, Kaita, Kelly, Ma, Mang, Marotta, Paul, Ramji, Alnoor, Tam, Edward, Yoshida, Eric, Swain, Mark, Sebastiani, Giada, Petrunia, Denis, Abergel, Armando, Anty, Rodolphe, Bourlière, Marc, Boursier, Jérôme, Bureau, Christophe, Castera, Laurent, Habersetzer, François, Hézode, Christophe, Ledinghen, Victor De, Leroy, Vincent, Loustaud-Ratti, Véronique, Mathurin, Philippe, Pol, Stanislas, Zoulim, Fabien, Hinrichsen, Holger, Ingiliz, Patrick, Lammert, Frank, Manns, Michael, Schattenberg, Jörn, Schiefke, Ingolf, Trautwein, Christian, Zeuzem, Stefan, Hui, Aric, Li, King-Kong, Wong, Vincent, Acharya, Subrat, Chowdhury, Abhijit, Duseja, Ajay, Kapoor, Dharmesh, Mukewar, Shrikant, Sarin, Shiv, Shah, Samir, Shalimar, Sood, Ajit, Tantry, BV, Ben-Ari, Ziv, Katchman, Helena, Safadi, Rifaat, Veitsman, Ella, Zuckerman, Eli, Brunetto, Maurizia, Lampertico, Pietro, Mangia, Alessandra, Akahane, Takemi, Akuta, Norio, Eguchi, Yuichiro, Fujiyama, Shigetoshi, Genda, Takuya, Hiasa, Yoichi, Ido, Akio, Ikeda, Fusao, Ikegami, Tadashi, Imajo, Kento, Itoh, Yoshito, Iwasa, Motoh, Karino, Yoshiyasu, Kato, Naoya, Kawaguchi, Takumi, Kawanaka, Miwa, Kido, Masahiro, Kobayashi, Tomoo, Kurosaki, Masayuki, Matsuzaki, Yasushi, Mita, Eiji, Mizukoshi, Eishiro, Nakahara, Takashi, Nomura, Hideyuki, Notsumata, Kazuo, Okanoue, Takeshi, Saito, Satoshi, Sakugawa, Hiroshi, Suzuki, Yoshiyuki, Takaguchi, Koichi, Takaki, Akinobu, Takashima, Tomoyuki, Tanaka, Saiyu, Tsuji, Keiji, Ueno, Yoshiyuki, Umemura, Takeji, Uto, Hirofumi, Yamashita, Nobuyuki, Yanase, Mikio, Yatsuhashi, Hiroshi, Yoneda, Masashi, Chan, Wah Kheong, Tan, Soek Siam, Garza, Laura Cisneros, Ladron De Guevara Cetina, Alma, Angeles, Rocio Guadalupe Vargas, Silva, Francisca Martinez, Van Erpecum, Karel, Orr, David, Jabłkowski, Maciej, Jaroszewicz, Jerzy, Ramos, Jose, Ahmed, Taufique, Ang, Tiing, Dan, Yock young, Goh, Boon Bee, Kaliyaperumal, Kalaiyarasi, Yip, Cherng Hann, Baik, Soon Koo, Jang, Byoung Kuk, Jun, Dae Won, Kim, Won, Kim, Hyung Joon, Kim, Ji Hoon, Lee, Kwan Sik, Lee, Chun Kyon, Lim, Young-Suk, Park, Jun Yong, Tak, Won Young, Augustin, Salvador, Perez, Salvador Benlloch, Caballeria, Juan, Luis, Jose, Panero, Calleja, Rodríguez, Jose Carrión, Garcia, Javier Crespo, Samaniego, Javier Garcia, Gibert, Pere Ginès, Prieto, Martin, Gomez, Manuel Romero, Turnes, Juan, Dufour, Jean-Francois, Moriggia, Alberto, Sheen, I-Shyan, Kao, Jia-Horng, Cheng, Pin-Nan, Huang, Jee-Fu, Yang, Sheng-Shun, Su, Wei-Wen, Chen, Chi-Yi, Chien, Rong-Nan, Lo, Gin-Ho, Chu, Chi-Jen, Wang, Horng-Yuan, Hu, Jui-Ting, Huang, Yi Wen, Agarwal, Kosh, Allison, Michael, Anstee, Quentin, Austin, Andrew, Fowell, Andrew, Ch'ng, Chin Lye, Manousou, Pinelopi, Newsome, Philip, Ryder, Stephen, Shankar, Arun, Abdelmalek, Manal, Abrams, Gary, Aguilar, Humberto, Alam, Imtiaz, Alba, Laura, Alkhouri, Naim, Allen, Alina, Aqel, Bashar, Balart, Luis, Barritt, A. Sidney, IV, Behari, Jaideep, Bennett, Michael, Bernstein, David, Bhandari, Bal Raj, Bonacini, Maurizio, Borg, Brian, Brown, Kimberly, Bzowej, Natalie, Caldwell, Stephen, Chami, Tawfik, Coates, Allan, Cueli, Adolfo, Davis, Mitchell, deLemos, Andrew, Desai, Archita, Dunn, Winston, Ferreira, Nelson, Fine, Michael, Firpi-Morell, Roberto, Freedland, Curtis, Freilich, Bradley, Fuchs, Michael, Galambos, Michael, Gallegos-Orozco, Juan, Galler, Greg, Ghali, Maged, Ghalib, Reem, Gill, Satinder, Gillis, Marcum, Gilroy, Richard, Gordon, Stuart, Gunn, Nadege, Halegoua-DeMarzio, Dina, Hassan, Mohamed, Hassanein, Tarek, Herring, Robert, Jr., Hong, John, Huang, Jonathan, Kabler, Heidi, Kayali, Zeid, Knapple, Whitfield, Kolli, Geetha, Kowdley, Kris, Krause, Richard, Lawitz, Eric, Lidofsky, Steven, Lim, Joseph, Lipkis, Donald, Loomba, Rohit, Mahgoub, Amar, Malespin, Miguel, Manch, Richard, Mannis, Steven, Manos, Paul, McDonald, Thomas, McKenzie, Mark, Mena, Edward, Merriman, Raphael, Moehlen, Martin William, Montgomery, Richard, Murphy, Robert, Natarajan, Yamini, Neff, Guy, Noureddin, Mazen, Ortiz-Lasanta, Grisell, Pagadala, Mangesh, Patel, Keyur, Patton, Heather, Peyton, Adam, Pimstone, Neville, Poulos, John, Pound, David, Pyrsopoulos, Nikolaos, Rafiq, Nila, Ravendhran, Natarajan, Ravinuthala, Ravi, Reddy, K. Rajendar, Reindollar, Robert, Reynolds, Justin, Rinella, Mary, Rizvi, Syed, Rockey, Don, Rodriguez-Perez, Federico, Ruane, Peter, Rubin, Raymond, Ryan, Michael, Saeian, Kia, Sanyal, Arun, Sarkar, Souvik, Scanga, Andrew, Schiff, Eugene, Schmidt, Warren, Schneider, Jeffrey, Sepe, Thomas, Shah, Dhiren, Shaikh, Obaid, Shankar, Uday, Sheikh, Aasim, Sheikh, Muhammad, Sherman, Kenneth, Shiffman, Mitchell, Siddique, Asma, Smith, Matthew, Suarez, Rosa, Talal, Andrew, Te, Helen, Tekola, Bezawit, Tetri, Brent, Thuluvath, Paul, Toro, Doris, Torres, Dawn, Trinh, Huy, Trotter, James, Vento, Angel, Vierling, John, Vuppalanchi, Raj, Waters, Michael, Weisberg, Ilan, Wieland, Amanda, Williams, Alonzo, Younes, Ziad, Adams, Leon, Harding, Damian, Hodge, Alex, Kontorinis, Nick, Strasser, Simone, Thompson, Alex, Horsmans, Yves, Steenkiste, Christophe Van, Bailey, Robert, Giard, Jeanne-Marie, Montano-Loza, Aldo, Puglia, Marco, Tsoi, Keith, Larrey, Dominique, Nguyen-Khac, Eric, Ratziu, Vlad, Spengler, Ulrich, Wiegand, Johannes, Hui, Aric Josun, Acharya, Subrat Kumar, Sarin, Shiv Kumar, Tantry, Vishwanath, Braun, Marius, Hazzan, Rawi, Lurie, Yoav, Colombo, Massimo, Fujii, Hideki, Hashimoto, Etsuko, Kato, Masaki, Ogawa, Koji, Takehara, Tetsuo, Tokushige, Katsutoshi, Garza, Laura Esthela Cisneros, Ladrón De Guevara, Alma Laura, Schultz, Michael, Janczewska, Ewa, Toro, Doris H., Jeong, Sook-Hyang, Kim, Yoon Jun, Lee, Jin-Woo, Ang, Tiing Leong, Bee, George Goh Boon, Benlloch, Salvador, Caballería, Juan, Calleja, José Luis, Rodríguez, Jose A. Carrión, Crespo, Javier, Diago, Moises, Fernandez-Rodriguez, Conrado, García-Samaniego, Javier, Ginès, Pere, Romero, Manuel, Dufour, Jean-François, Alazawi, William, Ch'ng, Chin-Lye, Forton, Daniel, Priest, Matthew, Sheridan, David, Ankoma-Sey, Victor, Balakrishnan, Maya, Bambha, Kiran, Barritt, A. Sidney, Bhandari, Bal, Brandman, Danielle, Chang, Charissa, Corey, Kathleen, Feldman, Michael, Gholam, Pierre, Goff, John, Marzio, Dina Halegoua-De, Harrison, Stephen, Hellstern, Paul, Jr., Herring, Robert, Iyer, Rajalakshmi, Jakiche, Antoine, Kohli, Anita, Krok, Karen, Kugelmas, Marcelo, Kumar, Sonal, Lai, Michelle, Mahmoud, Mitchell, Mantry, Parvez, Marsano, Luis, Nguyen, Tuan, Park, James, Patton, Heather M., Pockros, Paul, Reddy, Rajender, Rodriguez, Miguel, Sarles, Harry, Satapathy, Sanjaya, Sedghi, Shahriar, Shah, Nikunj, Sheikh, Muhammad Yasin, Sigal, Samuel, Stanca, Carmen, Steinbook, Michael, Szabo, Gyongyi, Terrault, Norah, Tong, Myron, Victor, David, Zervos, Xaralambos, Harrison, Stephen A., Wong, Vincent Wai-Sun, Caldwell, Stephen H., Shiffman, Mitchell L., Camargo, Marianne, Li, Georgia, Kersey, Kathryn, Jia, Catherine, Zhu, Yanni, Djedjos, C. Stephen, Subramanian, G. Mani, Myers, Robert P., Anstee, Quentin M., Romero-Gomez, Manuel, Goodman, Zachary, Lawitz, Eric J., and Younossi, Zobair

Published
2020
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5. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study

Author

Lampertico, Pietro, Buti, Maria, Fung, Scott, Ahn, Sang Hoon, Chuang, Wan-Long, Tak, Won Young, Ramji, Alnoor, Chen, Chi-Yi, Tam, Edward, Bae, Ho, Ma, Xiaoli, Flaherty, John F, Gaggar, Anuj, Lau, Audrey, Liu, Yang, Wu, George, Suri, Vithika, Tan, Susanna K, Subramanian, G Mani, Trinh, Huy, Yoon, Seung-Kew, Agarwal, Kosh, Lim, Young-Suk, and Chan, Henry L Y

Published
2020
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7. The Use of Noninvasive Velacur® for Discriminating between Volunteers and Patients with Chronic Liver Disease: A Feasibility Study.

Author

Curry, Michael P., Tam, Edward, Schneider, Caitlin, Abdelgelil, Noha, Hassanien, Tarek, and Afdhal, Nezam H.

Subjects
*CHRONICALLY ill, *HEPATIC fibrosis, *NON-alcoholic fatty liver disease, *LIVER failure, *ATTENUATION coefficients
Abstract

Background and Aims. Nonalcoholic fatty liver disease is the leading cause of chronic liver disease globally and can progress to cirrhosis, liver failure, and liver cancer. Current AASLD, AGA, and ADA guidelines recommend assessment for liver fibrosis in all patients with NAFLD. Serum biomarkers for fibrosis, while widely available, have notable limitations. Imaging-based noninvasive testing for liver fibrosis/cirrhosis is more accurate and is becoming more widespread. Methods. We evaluated the feasibility of a novel shear wave absolute vibroelastography (S-WAVE) modality called Velacur® for assessing liver stiffness measurement (LSM) for fibrosis and attenuation coefficient estimation (ACE) in differentiating patients with chronic liver disease from normal healthy controls. Results. Fifty-four healthy controls and 89 patients with NAFLD or cured HCV with a prior known LSM of >8 kPa were enrolled, and all subjects were evaluated with FibroScan® and Velacur®. Velacur® was able to discriminate patients with increased liver stiffness as determined by a FibroScan® score of >8 kPa from healthy controls with an AUC of 0.938 (0.88-0.96). For assessment of steatosis in NAFLD patients only, Velacur® could identify patients with steatosis from healthy controls with an AUC of 0.831 (0.777-0.880). The Velacur® scan quality assessment was superior in healthy controls, as compared to patients, and the scan quality, as assessed by the quality factor (QF) and interquartile range (IQR)/median, was affected by BMI. Velacur® was safe and well tolerated by patients, and there were no adverse events. Conclusion. Velacur® assessment of liver stiffness measurement and liver attenuation is comparable to results obtained by FibroScan® and is an alternative technology for monitoring liver fibrosis progression in patients with chronic liver disease. This trial is registered with NCT03957070. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An Open-Label Study

Author

Feld, Jordan J., Ramji, Alnoor, Shafran, Stephen D., Willems, Bernard, Marotta, Paul, Huchet, Emmanuelle, Vachon, Marie-Louise, Svarovskaia, Evguenia S., Huang, K. C., Hyland, Robert H., Yun, Chohee, Massetto, Benedetta, Brainard, Diana M., McHutchison, John G., Tam, Edward, Bailey, Robert, Cooper, Curtis, Yoshida, Eric M., Greenbloom, Susan, Elkhashab, Magdy, Borgia, Sergio, and Swain, Mark G.

Published
2017

10. Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: pooled analysis of two phase 3 trials

Author

Jensen, Donald M., Asselah, Tarik, Dieterich, Douglas, Foster, Graham R., Sulkowski, Mark S., Zeuzem, Stefan, Mantry, Parvez, Yoshida, Eric M., Moreno, Christophe, Ouzan, Denis, Wright, Mark, Morano, Luis E., Buynak, Robert, Bourlière, Marc, Hassanein, Tarek, Nishiguchi, Shuhei, Kao, Jia-Horng, Omata, Masao, Paik, Seung W., Wong, David K., Tam, Edward, Kaita, Kelly, Feinman, S. Victor, Stern, Jerry O., Scherer, Joseph, Quinson, Anne-Marie, Voss, Florian, Gallivan, John-Paul, Böcher, Wulf O., and Ferenci, Peter

Published
2016
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12. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial

Author

Lawitz, Eric, Gane, Edward, Pearlman, Brian, Tam, Edward, Ghesquiere, Wayne, Guyader, Dominique, Alric, Laurent, Bronowicki, Jean-Pierre, Lester, Laura, Sievert, William, Ghalib, Reem, Balart, Luis, Sund, Fredrik, Lagging, Martin, Dutko, Frank, Shaughnessy, Melissa, Hwang, Peggy, Howe, Anita Y M, Wahl, Janice, Robertson, Michael, Barr, Eliav, and Haber, Barbara

Published
2015
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13. Glecaprevir–Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection

Author

Zeuzem, Stefan, Foster, Graham R., Wang, Stanley, Asatryan, Armen, Gane, Edward, Feld, Jordan J., Asselah, Tarik, Bourlière, Marc, Ruane, Peter J., Wedemeyer, Heiner, Pol, Stanislas, Flisiak, Robert, Poordad, Fred, Chuang, Wan-Long, Stedman, Catherine A., Flamm, Steven, Kwo, Paul, Dore, Gregory J., Sepulveda-Arzola, Gladys, Roberts, Stuart K., Soto-Malave, Ruth, Kaita, Kelly, Puoti, Massimo, Vierling, John, Tam, Edward, Vargas, Hugo E., Bruck, Rafi, Fuster, Francisco, Paik, Seung-Woon, Felizarta, Franco, Kort, Jens, Fu, Bo, Liu, Ran, Ng, Teresa I., Pilot-Matias, Tami, Lin, Chih-Wei, Trinh, Roger, and Mensa, Federico J.

Published
2018
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14. Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Diverse Chronic Hepatitis B Patients in Canada: A Retrospective Real-World Study of CHB in Canada (REVEAL-CANADA).

Author

Coffin, Carla S., Haylock-Jacobs, Sarah, Doucette, Karen, Ramji, Alnoor, Ko, Hin Hin, Wong, David K., Elkhashab, Magdy, Bailey, Robert, Uhanova, Julia, Minuk, Gerald, Tsoi, Keith, Wong, Alexander, Ma, Mang M., Tam, Edward, Brahmania, Mayur, Nudo, Carmine, Zhu, Julie, Lowe, Christopher F., Osiowy, Carla, and Lethebe, B. Cord

Subjects
CHRONIC hepatitis B, CELL surface antigens, HEPATITIS associated antigen, TREATMENT effectiveness, HEPATITIS B virus
Abstract

Background: Hepatitis B surface antigen (HBsAg) loss is associated with improved clinical outcomes for individuals with chronic hepatitis B (CHB); however, the effects of varying HBsAg levels on clinical outcomes in diverse cohorts are understudied. Methods: In this cross-sectional, multicentre, retrospective study, the data on adult subjects enrolled in the Canadian HBV Network with CHB seen from 1 January 2012 to 30 January 2021 with the treatment and virologic data within 1 year of HBsAg testing were analyzed. Patients were tested for HBsAg using qualitative (for HBsAg-negative samples) and/or commercial quantitative assays. Fibrosis or hepatic necroinflammation was determined by the liver stiffness measurement (LSM). The baseline data were summarized using descriptive statistics and compared by using univariable/multivariable analyses. Results: This study included 844 CHB patients, with a median age of 49.6 years (IQR 40.1–60.5), and 37% were female. In total, 751 patients (78.6%) had known ethnicity data, and 76.7% self-reported as Asian, 11.4% as Black, 6.8% as White, and 4.8% as other. Among the 844 patients, 237 (28.0%) were HBsAg (−) (1000 IU/mL. Overall, 80% (682) had known HBeAg status at the last follow-up, and the majority (87.0%) were HBeAg-negative. In addition, 54% (461/844) had prior antiviral therapy, 19.7% of which (16.3, 23.7, n = 91) were HBsAg (−). The treated patients had a lower risk of cirrhosis (16.46, 95% CI 1.89–143.39, p = 0.01) or HCC (8.23, 95% CI 1.01–67.39, p = 0.05) than the untreated patients. A lower proportion of the HBsAg-loss group had cirrhosis (5.7% vs. 10.9%, p = 0.021) and HCC (0.9% vs. 6.2%, p = 0.001). Conclusion: In this retrospective, ethnically diverse cohort study, CHB patients who received antiviral therapy and/or had HBsAg loss were less likely to develop cirrhosis and HCC, confirming the results of the studies in less diverse cohorts. No association was found between the qHBsAg level and fibrosis determined with LSM. Individuals who achieved HBsAg loss had low-level qHBsAg within 1 year of seroclearance. [ABSTRACT FROM AUTHOR]

Published
2022
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15. Randomised clinical trial: alisporivir combined with peginterferon and ribavirin in treatment-naïve patients with chronic HCV genotype 1 infection (ESSENTIAL II)

Author

Zeuzem, S., Flisiak, R., Vierling, J. M., Mazur, W., Mazzella, G., Thongsawat, S., Abdurakhmanov, D., Van Kính, N., Calistru, P., Heo, J., Stanciu, C., Gould, M., Makara, M., Hsu, S.-J., Buggisch, P., Samuel, D., Mutimer, D., Nault, B., Merz, M., Bao, W., Griffel, L. H., Brass, C., Naoumov, N. V., Tanno, Hugo, Bessone, Fernando, Terg, Ruben, Frider, Bernardo, Bertuzzi, Romina, Desmond, Paul, Zekry, Amany, Weltman, Martin, George, Jacob, Crawford, Darrell, Matthews, Gail, Moreno, Christophe, Van Vlierberghe, Hans, Reynaert, Hendrik, Gould, Michael, Lee, Samuel, Ramji, Alnoor, Tam, Edward, Marotta, Paul, Yoshida, Eric, Wong, Florence, Feld, Jordan, Samuel, Didier, Marcellin, Patrick, Alric, Laurent, Zarski, Jean-Pierre, Zoulim, Fabien, Buggisch, Peter, Hinrichsen, Holger, Goeser, Tobias, Zeuzem, Stefan, Galle, Peter, Berg, Thomas, Schott, Eckart, Rasenack, Jens, Gerken, Guido, Wedemeyer, Hans, Tsang, Owen, Yuen, Man-Fung, Chan, Henry, Hui, Aric Josun, Makara, Mihaly, Tornai, Istvan, Gervain, Judit, Szalay, Ferenc, Varga, Marta, Horvath, Gabor, Hunyady, Bela, Vincze, Aron, Mazzella, Giuseppe, Gaeta, Giovanni Battista, Alberti, Alfredo, Colombo, Massimo, Andreone, Pietro, Rizzetto, Mario, Angelico, Mario, Craxi, Antonio, Picciotto, Antonino, Sacchi, Paolo, Vinci, Maria, Invernizzi, Pietro, Bruno, Savino, Heo, Jeong, Lee, Younjae, Cho, Mong, Han, Sangyoung, Lee, Jinwoo, Ahn, Sanghoon, Lim, Youngsuk, Hwang, Seonggyu, Sanchez, Juan, Muñoz, Linda, Maldonado, Hector, Mazur, Wlodzimierz, Flisiak, Robert, Jablkowski, Maciej, Kryczka, Wieslaw, Halota, Waldemar, Calistru, Petre, Prelipcean, Cristina, Musa, Manuela, Stanciu, Carol, Manuc, Mircea, Tanasescu, Coman, Dumitrascu, Dan, Abdurakhmanov, Djamal, Chulanov, Vladimir, Nikitin, Igor, Zhdanov, Konstantin, Esaulenko, Elena, Maevskaya, Marina, Znoyko, Olga, Lamoglia, Ricard Sola, Ferret, Maria Buti, Garcia-Samaniego, Javier, Gomez, Manuel Romero, Diago, Moises, Calleja, Jose Luis, Hsu, Shih-Jer, Chuang, Wan-Long, Hu, Tsung-Hui, Peng, Cheng-Yuan, Chen, Chi-Yi, Kao, Jia-Horng, Thongsawat, Satawat, Sukeepaisarnjaroen, Wattana, Piratvisuth, Teerha, Tanwandee, Tawesak, Komolmit, Piyawat, Agarwal, Kosh, Mutimer, David, Brown, Ashley, Foster, Graham, McPherson, Stuart, Ryder, Stephen, Poulos, John, Rustgi, Vinod, Lyche, Kip, Omarro, Steven, Vierling, John, Ghalib, Reem, Karnam, Umaprasanna, Peine, Craig, Galati, Joseph, Person, John, De La Torre, Andrew, Ravendhran, Natarajan, Mushahwar, Andria, OʼLeary, Jacqueline, Lee, William, Lawitz, Eric, Ankoma-Sey, Victor, King, John, Pound, David, Scarsella, Anthony, Thuluvath, Paul, Pockros, Paul, Mailliard, Mark, Shiffman, Mitchell, Sylvestre, Diana, Heiman, David, Jacobson, Ira, Bacon, Bruce, Dimitroff, James, Reindollar, Robert, Tobias, Hillel, Godofsky, Eliot, Rodriguez-Torres, Maribel, Bennett, Michael, Ben-Zvi, Jeffrey, Van, Kinh Nguyen, Dao, Long, Huu, Hoang Bui, Minh, Yen Lam, Le Thanh, Ly, and Van Long, Dao

Published
2015
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16. Fixed-Dose Combination Therapy With Daclatasvir, Asunaprevir, and Beclabuvir for Noncirrhotic Patients With HCV Genotype 1 Infection

Author

Poordad, Fred, Sievert, William, Mollison, Lindsay, Bennett, Michael, Tse, Edmund, Bräu, Norbert, Levin, James, Sepe, Thomas, Lee, Samuel S., Angus, Peter, Conway, Brian, Pol, Stanislas, Boyer, Nathalie, Bronowicki, Jean-Pierre, Jacobson, Ira, Muir, Andrew J., Reddy, K. Rajender, Tam, Edward, Ortiz-Lasanta, Grisell, de Lédinghen, Victor, Sulkowski, Mark, Boparai, Navdeep, McPhee, Fiona, Hughes, Eric, Swenson, E. Scott, and Yin, Philip D.

Published
2015
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18. ABT-450/r–Ombitasvir and Dasabuvir with or without Ribavirin for HCV

Author

Ferenci, Peter, Bernstein, David, Lalezari, Jacob, Cohen, Daniel, Luo, Yan, Cooper, Curtis, Tam, Edward, Marinho, Rui T., Tsai, Naoky, Nyberg, Anders, Box, Terry D., Younes, Ziad, Enayati, Pedram, Green, Sinikka, Baruch, Yaacov, Bhandari, Bal Raj, Caruntu, Florin Alexandru, Sepe, Thomas, Chulanov, Vladimir, Janczewska, Ewa, Rizzardini, Giuliano, Gervain, Judit, Planas, Ramon, Moreno, Christophe, Hassanein, Tarek, Xie, Wangang, King, Martin, Podsadecki, Thomas, and Reddy, Rajender K.

Published
2014
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19. Retreatment of HCV with ABT-450/r– Ombitasvir and Dasabuvir with Ribavirin

Author

Zeuzem, Stefan, Jacobson, Ira M., Baykal, Tolga, Marinho, Rui T., Poordad, Fred, Bourlière, Marc, Sulkowski, Mark S., Wedemeyer, Heiner, Tam, Edward, Desmond, Paul, Jensen, Donald M., Di Bisceglie, Adrian M., Varunok, Peter, Hassanein, Tarek, Xiong, Junyuan, Pilot-Matias, Tami, DaSilva-Tillmann, Barbara, Larsen, Lois, Podsadecki, Thomas, and Bernstein, Barry

Published
2014
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21. Patient‐specific genetic factors predict treatment failure in sofosbuvir‐treated patients with chronic hepatitis C.

Author

Loucks, Catrina M., Lin, Jennifer J., Trueman, Jessica N., Drögemöller, Britt I., Wright, Galen E. B., Chang, Wan‐Chun, Li, Kathy H., Yoshida, Eric M., Ford, Jo‐Ann, Lee, Samuel S., Crotty, Pam, Kim, Richard B., Al‐Judaibi, Bandar, Schwarz, Ute I., Ramji, Alnoor, Farivar, Jeanette F., Tam, Edward, Walston, Lori Lee, Ross, Colin J. D., and Carleton, Bruce C.

Subjects
CHRONIC hepatitis C, TREATMENT failure, HEPATITIS C, GENETIC polymorphisms
Abstract

Background & Aims: According to pivotal clinical trials, cure rates for sofosbuvir‐based antiviral therapy exceed 96%. Treatment failure is usually assumed to be because of virological resistance‐associated substitutions or clinical risk factors, yet the role of patient‐specific genetic factors has not been well explored. We determined if patient‐specific genetic factors help predict patients likely to fail sofosbuvir treatment in real‐world treatment situations. Methods: We recruited sofosbuvir‐treated patients with chronic hepatitis C from five Canadian treatment sites, and performed a case‐control pharmacogenomics study assessing both previously published and novel genetic polymorphisms. Specifically studied were variants predicted to impair CES1‐dependent production of sofosbuvir's active metabolite, interferon‐λ signalling variants expected to impact a patient's immune response to the virus and an HLA variant associated with increased spontaneous and treatment‐induced viral clearance. Results: Three hundred and fifty‐nine sofosbuvir‐treated patients were available for analyses after exclusions, with 34 (9.5%) failing treatment. We identified CES1 variants as novel predictors for treatment failure in European patients (rs115629050 or rs4513095; odds ratio (OR): 5.43; 95% confidence interval (CI): 1.64‐18.01; P =.0057), replicated associations with IFNL4 variants predicted to increase interferon‐λ signalling (eg rs12979860; OR: 2.25; 95% CI: 1.25‐4.06; P =.0071) and discovered a novel association with a coding variant predicted to enhance the activity of IFNL4's receptor (rs2834167 in IL10RB; OR: 1.81; 95% CI: 1.01‐3.24; P =.047). Conclusions: Ultimately, this work demonstrates that patient‐specific genetic factors could be used as a tool to identify patients at higher risk of treatment failure and allow for these patients to receive effective therapy sooner. [ABSTRACT FROM AUTHOR]

Published
2022
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22. Active management of data caches by exploiting reuse information

Author

Tam, Edward S., Rivers, Jude A., Srinivasan, Vijayalakshmi, Tyson, Gary S., and Davidson, Edward S.

Subjects
Cache memory -- Management, Data communications -- Speed, Transmission speed -- Analysis, Information storage and retrieval -- Speed
Published
1999

23. Effectiveness and Renal Safety of Tenofovir Alafenamide Fumarate among Chronic Hepatitis B Patients: Real‐World Study.

Author

Farag, Mina S., Fung, Scott, Tam, Edward, Doucette, Karen, Wong, Alexander, Ramji, Alnoor, Conway, Brian, Cooper, Curtis, Tsoi, Keith, Wong, Philip, Sebastiani, Giada, Brahmania, Mayur, Haylock‐Jacobs, Sarah, Coffin, Carla S., Hansen, Bettina E., and Janssen, Harry L.A.

Subjects
CHRONIC hepatitis B, EPIDERMAL growth factor receptors, CHRONIC kidney failure, TENOFOVIR, GLOMERULAR filtration rate, PLASMA stability
Abstract

Tenofovir alafenamide fumarate (TAF) has high plasma stability resulting in fewer renal adverse events compared to tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients. We aimed to study the effectiveness and renal safety of TAF in a real‐world setting, in patients with or without compromised kidney function. CHB patients (Nucleos(t)ide Analogue [NA]‐naïve or experienced) who received TAF >1 year from 11 academic institutions as part of the Canadian Hepatitis B Network (CanHepB) were included. Kidney function was measured by estimated glomerular filtration rate (eGFR) as per Cockcroft‐Gault. Patients were followed for up to 160 weeks. Of 176 patients receiving TAF, 143 switched from NA (88% TDF), and 33(19%) were NA naïve. Majority of NA‐naïve patients (75%) achieved undetectable HBV DNA after one year of TAF treatment. Majority of patients with eGFR <60 mL/min who had renal deterioration during TDF (76%) reversed to eGFR increase after one year of TAF (p=0.009). Among patients with stage 2 chronic kidney disease (CKD) (eGFR 60–89), the estimated eGFR decline during TDF was halted after switching to TAF (p=0.09). NA‐experienced patients with abnormal ALT before TAF showed a significant decline after switching to TAF: −0.005 [−0.006 – −0.004] log10 ULN U/L/month, p<0.001). In CHB patients, TAF was safe, well‐tolerated and effective in this real‐world cohort. Switching to TAF led to improved kidney function, particularly in those with stage 2 CKD, which suggests that the indication for TAF in the guidelines could be extended to patients with an eGFR higher than 60 mL/min. [ABSTRACT FROM AUTHOR]

Published
2021
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24. The Z-Profile Study: a multicenter, retrospective cohort study to assess the real-world use and effectiveness of elbasvir/grazoprevir in Canadian adult patients with chronic hepatitis C.

Author

Tam, Edward, Tremblay, Julie, Fraser, Chris, Conway, Brian, Ramji, Alnoor, Borgia, Sergio, Tsoi, Keith, Yoshida, Eric M., Rajendran, Bahe, Macphail, Gisela, Wong, Alexander, Cooper, Curtis, Patel, Keyur, Puglia, Marco, Stewart, Kris, Trottier, Benoit, Deshaies, Lucie, Doucette, Karen, Ghali, Peter, and Lee, Samuel S.

Published
2020
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25. Burden of nonalcoholic fatty liver disease in Canada, 2019–2030: a modelling study.

Author

Swain, Mark G., Ramji, Alnoor, Patel, Keyur, Sebastiani, Giada, Shaheen, Abdel Aziz, Tam, Edward, Marotta, Paul, Elkhashab, Magdy, Bajaj, Harpreet S., Estes, Chris, and Razavi, Homie

Abstract

Background: Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) account for a growing proportion of liver disease cases, and there is a need to better understand future disease burden. We used a modelling framework to forecast the burden of disease of NAFLD and NASH for Canada. Methods: We used a Markov model to forecast fibrosis progression from stage F0 (no fibrosis) to stage F4 (compensated cirrhosis) and subsequent progression to decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and liver-related death among Canadians with NAFLD from 2019 to 2030. We used historical trends for obesity prevalence among adults to estimate longitudinal changes in the number of incident NAFLD cases. Results: The model projected that the number of NAFLD cases would increase by 20% between 2019 and 2030, from an estimated 7 757 000 cases to 9 305 000 cases. Increases in advanced fibrosis cases were relatively greater, as the number of model-estimated prevalent stage F3 cases would increase by 65%, to 357 000, and that of prevalent stage F4 cases would increase by 95%, to 195 000. Estimated incident cases of hepatocellular carcinoma and decompensated cirrhosis would increase by up to 95%, and the number of annual NAFLD-related deaths would double, to 5600. Interpretation: Increasing rates of obesity translate into increasing NAFLD-related cases of cirrhosis and hepatocellular carcinoma and related mortality. Prevention efforts should be aimed at reducing the incidence of NAFLD and slowing fibrosis progression among those already affected. [ABSTRACT FROM AUTHOR]

Published
2020
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26. Epidemiologic and clinical features of chronic hepatitis B virus infection in 8 Canadian provinces: a descriptive study by the Canadian HBV Network.

Author

Coffin, Carla S., Ramji, Alnoor, Cooper, Curtis L., Miles, David, Doucette, Karen E., Wong, Philip, Tam, Edward, Wong, David K., Wong, Alexander, Ukabam, Sylvester, Bailey, Robert J., Tsoi, Keith, Conway, Brian, Barrett, Lisa, Michalak, Tomasz I., Congly, Stephen E., Minuk, Gerald, Kaita, Kelly, Kelly, Erin, and Ko, Hin Hin

Abstract

Background: Published Canadian epidemiologic data on hepatitis B virus (HBV) infection include single-centre studies or are focused on Indigenous populations. We performed a study to characterize the demographic and clinical features, liver disease status and treatment of people with chronic hepatitis B in Canada. Methods: In this descriptive, opportunistic, cross-sectional study, available data for people known to be monoinfected with HBV were collected by the Canadian HBV Network from existing clinical databases, with support from the National Microbiology Laboratory, Public Health Agency of Canada. Data were collected in all provinces with the exception of New Brunswick and Newfoundland and Labrador. We analyzed the data using parametric and nonparametric statistical methods, with a significance level of p < 0.05. Results: In the 9380 unique patient records reviewed, the median age was 48 years, and 5193 patients (55.4%) were male. Ethnicity information was available for 7858 patients, of whom 5803 (73.8%) were Asian, 916 (11.6%) were black and 914 (11.6%) were white. Most of those tested (5556/6796 [81.8%]) were negative for HBV e-antigen, and most of those with fibrosis data (3481/4260 [81.7%]) had minimal liver fibrosis, with more advanced fibrosis noted in older people (> 40 yr). Of the 980 patients with genotype data, 521 (53.2%) had genotype B or C infection. Most of the 9241 patients with known confirmed treatment status received tenofovir disoproxil fumarate (1655 [17.9%]), lamivudine (1434 [15.5%]) or entecavir (548 [5.9%]). Interpretation: Based on available data, Canadian patients with chronic hepatitis B are predominantly Asian and negative for HBV e-antigen, and have genotype B or C infection. Interprovincial variations were noted in antiviral treatment regimen. This multicentre nationwide study provides data regarding patients with chronic hepatitis B and may inform future studies on the epidemiologic features of HBV infection in Canada. [ABSTRACT FROM AUTHOR]

Published
2019
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28. JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐Infected Patients Without Cirrhosis: OMEGA‐1.

Author

Zeuzem, Stefan, Bourgeois, Stefan, Greenbloom, Susan, Buti, Maria, Aghemo, Alessio, Lampertico, Pietro, Janczewska, Ewa, Lim, Seng Gee, Moreno, Christophe, Buggisch, Peter, Tam, Edward, Corbett, Chris, Willems, Wouter, Vijgen, Leen, Fevery, Bart, Ouwerkerk‐Mahadevan, Sivi, Ackaert, Oliver, Beumont, Maria, Kalmeijer, Ronald, and Sinha, Rekha

Published
2019
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29. Ledipasvir/sofosbuvir for treatment of hepatitis C virus in sofosbuvir‐experienced, NS5A treatment‐naïve patients: Findings from two randomized trials.

Author

Tam, Edward, Luetkemeyer, Anne F., Mantry, Parvez S., Satapathy, Sanjaya K., Ghali, Peter, Kang, Minhee, Haubrich, Richard, Shen, Xianlin, Ni, Liyun, Camus, Gregory, Copans, Amanda, Rossaro, Lorenzo, Guyer, Bill, Brown, Jr, Robert S., and the RESCUE and ACTG A5348 study investigators

Subjects
*ANTIVIRAL agents, *CHRONIC hepatitis C, *CIRRHOSIS of the liver, *GENOTYPES, SOFOSBUVIR
Abstract

Abstract: Background & Aims: We report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF‐based, non‐NS5A inhibitor‐containing regimens. Methods: The RESCUE study enrolled HCV mono‐infected adults with genotype (GT) 1 or 4. Non‐cirrhotic participants were randomized to 12 weeks of LDV/SOF or LDV/SOF + RBV. Compensated cirrhotic participants were randomized to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co‐infection to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). Both studies used SVR at 12 weeks post‐treatment (SVR12) as the primary endpoint. Results: In the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81‐100% in non‐cirrhotic participants treated with LDV/SOF or LDV/SOF + RBV for 12 weeks and 80‐92% in cirrhotic participants treated with LDV/SOF + RBV for 12 weeks or LDV/SOF for 24 weeks. Adverse events (AEs), mostly mild‐to‐moderate in severity, were experienced by 78% of participants, with headache and fatigue most frequently reported. One serious AE, not related to treatment, was observed. No premature discontinuations of study drug, or deaths occurred. In the A5348 study, seven participants were randomized (cirrhotic n = 1; GT1a n = 5) and all attained SVR12, with no serious AEs or premature discontinuations. Conclusions: In this SOF‐experienced, NS5A inhibitor‐naïve population, which included participants with cirrhosis or HCV/HIV co‐infection, high SVR12 rates were achieved. [ABSTRACT FROM AUTHOR]

Published
2018
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30. Incidence and predictors of sudden arrhythmic death or ventricular tachyarrhythmias after acute coronary syndrome: An asian perspective.

Author

Hai, Jo-Jo, Tam, Edward, Chan, Pak-Hei, Lau, Chu-Pak, Siu, Chung-Wah, and Tse, Hung-Fat

Abstract

Background: Current data on the risk of sudden arrhythmic death (SAD) and ventricular tachyarrhythmias (VTs) after acute coronary syndrome (ACS) in the Asian population are limited.Objective: The purpose of this study was to investigate the incidence and predictors of SAD or VT after ACS in a contemporary cohort of Chinese patients in the era of early revascularization.Methods: Consecutive patients admitted to our unit for ACS from 2010 to 2015 were retrospectively reviewed.Results: A total of 918 patients (74.8% male, mean age 65.9 ± 13.4 years) were included in the study. Of these patients, 864 (94.1%) survived to discharge. After a mean of 34.1 ± 21.8 months, 42 (4.9%) had SAD or VT. The event rate was 0.46% in month 1, 0.26% per month in the months 2 to 6, 0.15% per month in months 6 to 12, and 1.23% per year from the second year onward. In multivariate analysis, early VT (hazard ratio [HR] 5.78, 95% confidence interval [CI] 2.63-12.72, P < .01), left ventricular ejection fraction ≤35% (HR 1.96, 95% CI 1.03-3.73, P = .04), prior coronary artery disease (HR 2.50, 95% CI 1.29-4.82, P < .01), triple-vessel disease (HR 3.69, 95% CI 1.81-7.54, P < .01), and chronic kidney disease (HR 2.43, 95% CI 1.21-4.92, P = .01) independently predicted SAD or VT.Conclusion: This study reports the rate of SAD or VT among Asian patients after ACS in the era of early revascularization and optimal medical therapy. Aggressive preventive measures should be considered for patients with multiple risk factors for SAD or VT, especially in the initial period after ACS. [ABSTRACT FROM AUTHOR]

Published
2017
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32. Partnering for Success A Team Effort Restores a Smile.

Author

Hulac, Sandra and Tam, Edward C. L.

Subjects
FEAR of dentists, DENTAL fillings, DENTAL implants, DENTISTS, OPERATIVE dentistry
Abstract

This article describes how a dentophobic patient was able to overcome her anxieties and obtain an overdue smile restoration, thanks to the successful collaboration of an implant surgeon and a restorative dentist. The pleasing outcome was facilitated by the fact that the two practitioners work in the same office and could see the patient in fewer separate appointments, thus easing her dread of trips to the dentist. The surgeon and the restorative dentist worked side by side with optimal communication on the case design and execution. [ABSTRACT FROM AUTHOR]

Published
2014

36. Is it Possible to Make Everyone Talk in the Same Language?

Author

Maggie Lau, Fung, Vicky, Cheung, N. T., Wong, Austen, Tam, Edward, and Wai, Andy

Subjects
HOSPITAL patients, ORAL communication, FOSTER home care, DATA analysis
Abstract

Speaking the same language is a vital pre-requisite in verbal communication. The same applies in sharing health information among medical professionals in rendering care to patients. The Hospital Authority of Hong Kong developed its own clinical vocabulary table (HACVT) for clinicians to document diagnoses and procedures directly in the Clinical Management System (CMS) since 1996. HACVT is referenced to international classifications and reference terminologies, with local terms added and is built according to the principles of terminology management [1]. This poster describes the process of data standardisation within the organisation in the past years to achieve data interoperability through different adoption methods of HACVT. [ABSTRACT FROM AUTHOR]

Published
2015
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37. Is it Possible to Make Everyone Talk in the Same Language?

Author

Lau, Maggie, Fung, Vicky, Cheung, N. T., Wong, Austen, Tam, Edward, and Wai, Andy

Abstract

Speaking the same language is a vital pre-requisite in verbal communication. The same applies in sharing health information among medical professionals in rendering care to patients. The Hospital Authority of Hong Kong developed its own clinical vocabulary table (HACVT) for clinicians to document diagnoses and procedures directly in the Clinical Management System (CMS) since 1996. HACVT is referenced to international classifications and reference terminologies, with local terms added and is built according to the principles of terminology management [1]. This poster describes the process of data standardisation within the organisation in the past years to achieve data interoperability through different adoption methods of HACVT. [ABSTRACT FROM AUTHOR]

Published
2015
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38. Su1049 Faldaprevir Plus Pegylated Interferon Alfa-2A and Ribavirin in Treatment-Naïve Patients With Chronic Hepatitis C Genotype-1 Infection: A Pooled Analysis of Two Randomized, Double-Blind Placebo-Controlled Phase III Trials (Startverso1&2).

Author

Jensen, Donald M., Foster, Graham, Ferenci, Peter, Cooper, Curtis, Dieterich, Douglas T., Sulkowski, Mark, Mantry, Parvez S., Buynak, Robert, Hassanein, Tarek, Lee, William M., Wright, David, Tam, Edward, Kaita, Kelly, Feinman, S. Victor, Scherer, Joseph, Olson, Stephen, and Quinson, Anne-Marie

Published
2014
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39. Su1058 Early Stopping Rules for Faldaprevir Plus Pegylated Interferon α-2A and Ribavirin in Treatment-Naïve Patients: Exploratory Study of Pooled Data From Phase III Trials.

Author

Ferenci, Peter, Dieterich, Douglas T., Zeuzem, Stefan, Mantry, Parvez S., Sarrazin, Christoph, Crespo, Javier, Tam, Edward, Dufour, Jean-Francois, Yoshida, Eric M., Nishiguchi, Shuhei, Bourliere, Marc, Omata, Masao, Abergel, Armando, Kuboki, Makoto, Carvalho, Armando, Peng, Cheng-Yuan, Romero-Gomez, Manuel, Wright, David, Stern, Jerry O., and Böcher, Wulf

Published
2014
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40. Su1062 Comparisons of Populations in Faldaprevir Phase III Studies Based on Pegylated Interferon α-2A and Ribavirin-Predicted Responsiveness and Impact on Achieving Svr12.

Author

Ferenci, Peter, Jensen, Donald M., Dieterich, Douglas T., Jacobson, Ira M., Romero-Gomez, Manuel, Foster, Graham, Asselah, Tarik, Cooper, Curtis, Tural, Cristina, Streinu-Cercel, Adrian, Ryder, Stephen D., Puoti, Massimo, Tam, Edward, Calleja, Jose Luis, Núñez, Marina, Quinson, Anne-Marie, Böcher, Wulf, Voss, Florian, and Scherer, Joseph

Published
2014
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42. 235 SAPPHIRE II: Phase 3 Placebo-Controlled Study of Interferon-Free, 12-Week Regimen of ABT-450/r/ABT-267, ABT-333, and Ribavirin in 394 Treatment-Experienced Adults With Hepatitis C Virus Genotype 1.

Author

Jacobson, Ira M., Zeuzem, Stefan, Baykal, Tolga, Marinho, Rui T., Poordad, Fred, Bourliere, Marc, Sulkowski, Mark, Wedemeyer, Heiner, Tam, Edward, Desmond, Paul V., Jensen, Donald M., Di Bisceglie, Adrian M., Varunok, Peter, Hassanein, Tarek, Xiong, Junyuan, DaSilva-Tillmann, Barbara, Larsen, Lois, and Podsadecki, Thomas

Published
2014
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44. Randomized study of danoprevir/ritonavir-based therapy for HCV genotype 1 patients with prior partial or null responses to peginterferon/ribavirin.

Author

Feld, Jordan J., Jacobson, Ira M., Jensen, Donald M., Foster, Graham R., Pol, Stanislas, Tam, Edward, Jablkowski, Maciej, Berak, Hanna, Vierling, John M., Yoshida, Eric M., Perez-Gomez, Héctor R., Scalori, Astrid, Hooper, Gregory J., Tavel, Jorge A., Navarro, Mercidita T., Shahdad, Saba, Kulkarni, Rohit, Pogam, Sophie Le, Nájera, Isabel, and Eng, Simon

Subjects
*RANDOMIZED controlled trials, *RITONAVIR, *HEPATITIS C treatment, *HEPATITIS C, *RIBAVIRIN, *DISEASE relapse, *PATIENTS, *THERAPEUTICS
Abstract

Background & Aims Chronic hepatitis C treatment for prior non-responders to peginterferon (PegIFN)/ribavirin remains suboptimal. The MATTERHORN study evaluated regimens containing ritonavir-boosted danoprevir (danoprevir/r) in prior PegIFN alfa/ribavirin non-responders. Methods Prior partial responders (N = 152) were randomized to 24 weeks of twice-daily danoprevir/r 100/100 mg, mericitabine 1000 mg and ribavirin 1000/1200 mg (IFN-free); danoprevir/r plus PegIFN alfa-2a/ribavirin (triple); or danoprevir/r, mericitabine and PegIFN alfa-2a/ribavirin (Quad). Prior null responders (N = 229) were randomized to 24 weeks of IFN-free therapy, or quad alone (Quad 24) or quad plus 24-weeks of PegIFN alfa-2a/ribavirin (Quad 48). The primary endpoint was sustained virological response (HCV RNA <25 IU/ml) 24 weeks after end-of-treatment (SVR24). Due to high relapse rates, genotype (G) 1a patients in IFN-free arms were offered additional PegIFN alfa-2a/ribavirin. Results Among prior partial responders, SVR24 rates were 46.2%, 51.0%, and 86.0%, in the IFN-free, Triple and Quad arms, respectively; among prior null responders, SVR24 rates were 45.5%, 80.5%, and 83.8% respectively. Relapse rates were lower and SVR24 rates higher in G1b-infected than G1a-infected patients. SVR24 rates in G1a and G1b patients randomized to Quad were 75.0% and 96.2%, respectively, in the partial Quad arm, and 68.1% and 100%, respectively, in the null Quad 24 arm. Treatment failure was associated with resistance to danoprevir, but not to mericitabine, and was more common in G1a infected patients. Treatment was well-tolerated. Conclusions Danoprevir/r, mericitabine plus PegIFN alfa-2a/ribavirin was well-tolerated and produced high overall SVR24 rates in prior partial and null responders to PegIFN alfa/ribavirin. In contrast, IFN-free regimens were associated with unacceptably high relapse rates. [ABSTRACT FROM AUTHOR]

Published
2015
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45. A multiparametric volumetric quantitative ultrasound imaging technique for soft tissue characterization.

Author

Deeba, Farah, Schneider, Caitlin, Mohammed, Shahed, Honarvar, Mohammad, Lobo, Julio, Tam, Edward, Salcudean, Septimiu, and Rohling, Robert

Subjects
*ULTRASONIC imaging, *FATTY liver, *ATTENUATION coefficients, *SPATIAL ability, *TISSUES
Abstract

• 3D QUS reconstructs multiple quantitative ultrasound parameters. • 3D weighted total variation regularization improves reconstruction quality. • Validation on in-vivo liver shows promise for detection of hepatic steatosis. [Display omitted] Quantitative ultrasound (QUS) offers a non-invasive and objective way to quantify tissue health. We recently presented a spatially adaptive regularization method for reconstruction of a single QUS parameter, limited to a two dimensional region. That proof-of-concept study showed that regularization using homogeneity prior improves the fundamental precision-resolution trade-off in QUS estimation. Based on the weighted regularization scheme, we now present a multiparametric 3D weighted QUS (3D QUS) method, involving the reconstruction of three QUS parameters: attenuation coefficient estimate (ACE), integrated backscatter coefficient (IBC) and effective scatterer diameter (ESD). With the phantom studies, we demonstrate that our proposed method accurately reconstructs QUS parameters, resulting in high reconstruction contrast and therefore improved diagnostic utility. Additionally, the proposed method offers the ability to analyze the spatial distribution of QUS parameters in 3D, which allows for superior tissue characterization. We apply a three-dimensional total variation regularization method for the volumetric QUS reconstruction. The 3D regularization involving N planes results in a high QUS estimation precision, with an improvement of standard deviation over the theoretical 1 / N rate achievable by compounding N independent realizations. In the in vivo liver study, we demonstrate the advantage of adopting a multiparametric approach over the single parametric counterpart, where a simple quadratic discriminant classifier using feature combination of three QUS parameters was able to attain a perfect classification performance to distinguish between normal and fatty liver cases. [ABSTRACT FROM AUTHOR]

Published
2021
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46. THU448 - Efficacy of sofosbuvir/velpatasvir (s/v): impact of treatment adherence.

Author

Magel, Tianna, Fraser, Chris, Borgia, Sergio, Smyth, Daniel, Cooper, Curtis, Webster, Duncan, Barrett, Lisa, Stewart, Kristoffer, Wong, Alexander, Vachon, Marie-Louise, Ramji, Alnoor, Macphail, Gisela, Hamour, Abu Obeida, Bulinckx, Leeanna, Tam, Edward, Feld, Jordan, Lee, Samuel, and Conway, Brian

Subjects
*PATIENT compliance, *VIRAL hepatitis, *HEPATITIS C
Published
2020
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47. AS091 - A phase 3 study comparing switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) with continued TDF treatment in virologically-suppressed patients with chronic hepatitis B (CHB): final week 96 efficacy and safety results

Author

Lampertico, Pietro, Buti, Maria, Ramji, Alnoor, Fung, Scott, Ahn, Sang Hoon, Chuang, Wan-Long, Yoon, Seung Kew, Kao, Jia-Horng, Chen, Chi-Yi, Tam, Edward, Khalili, Mandana, Bae, Ho, Ma, Xiaoli, Tak, Won Young, Flaherty, John F., Gaggar, Anuj, Suri, Vithika, Tan, Susanna, Liu, Yang, and Wu, George

Subjects
*CHRONIC hepatitis B
Published
2020
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48. FRI-183-A phase 3 study comparing switching from tenofovir disoproxil fumarate to tenofovir alafenamide with continued TDF treatment in virologically-suppressed patients with chronic hepatitis B (CHB): week 48 efficacy and safety results.

Author

Lampertico, Pietro, Buti, Maria, Fung, Scott, Ahn, Sang Hoon, Chuang, Wan-Long, Ramji, Alnoor, Tak, Won Young, Chen, Chiyi, Tam, Edward, Bae, Ho, Ma, Xiaoli, Flaherty, John F., Gaggar, Anuj, Lau, Audrey, Feierbach, Becket, Wu, George, Suri, Vithika, Subramanian, Mani, Trinh, Huy N., and Yoon, Seung Kew

Subjects
*CHRONIC hepatitis B, *THERAPEUTICS, *BISOPROLOL, *BONE density
Published
2019
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