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2. Review article: Recommendations for detection, assessment and management of suspected drug‐induced liver injury during clinical trials in oncology patients.

Author

Fettiplace, Anna, Marcinak, John, Merz, Michael, Zhang, Hui‐Talia, Kikuchi, Luciana, Regev, Arie, Palmer, Melissa, Rockey, Don, Fontana, Robert, Hayashi, Paul H., Tillmann, Hans L., Di Bisceglie, Adrian M., and Lewis, James H.

Subjects
*LITERATURE reviews, *CANCER patients, *ANTINEOPLASTIC agents, *CONSORTIA, *CLINICAL trials
Abstract

Summary: Background: Drug‐induced liver injury (DILI) is a major concern for oncology drugs in clinical practice and under development. Monitoring cancer patients for hepatotoxicity is challenging as these patients may have abnormal liver tests pre‐treatment or on‐study for many reasons including liver injury due to past oncology treatments, hepatic metastases, medical co‐morbidities such as heart failure, and concomitant medications. At present, there are no regulatory guidelines or position papers that systematically address best practices pertaining to DILI detection, assessment and management in oncology patients. Aims: The goals of this review are (1) to examine and interpret the available evidence and (2) to make recommendations for detection, monitoring, adjudication, and management of suspected hepatocellular DILI during oncology clinical trials. Methods: This manuscript was developed by the IQ Consortium (International Consortium for Innovation and Quality in pharmaceutical development) DILI Initiative that consists of members from 17 pharmaceutical companies, in collaboration with academic and regulatory DILI experts. The manuscript is based on extensive literature review, expert interpretation of the literature, and several rounds of consensus discussions. Results: This review highlights recommendations for patient eligibility for clinical trials with or without primary/metastatic liver involvement, as well as changes in liver tests that should trigger increased monitoring and/or discontinuation of study drug. Guidance regarding causality assessment for suspected DILI events, rechallenge and dose‐modification is provided. Conclusions: This review brings together evidence‐based recommendations and expert opinion to provide the first dedicated consensus for best practices in detection, assessment, and management of DILI in oncology clinical trials. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cassetti, Lidia, David, Daniel, Figueras, Laura, Losso, Marcelo, Lopardo, Gustavo, Lupo, Sergio, Porteiro, Norma, Sánchez, Marisa, Bloch, Mark, Cooper, David, Finlayson, Robert, Kelleher, Anthony, Koh, Kenneth, Lewis, David, McMahon, James, Moore, Richard, Roth, Norman, Shields, Matthew, De Wit, Stephane, Florence, Eric, Goffard, Jean-Christophe, Demeester, Remy, Lacor, Patrick, Vandercam, Bernard, Vandekerckhove, Linos, Angel, Jonathan, Baril, Jean-Guy, Conway, Brian, De Pokomandy, Alexandra, Szabo, Jason, Walmsley, Sharon, Bouchaud, Olivier, Chidiac, Christian, Delobel, Pierre, Goujard, Cecile, Katlama, Christine, Molina, Jean-Michel, Pialoux, Gilles, Philibert, Patrick, Bogner, Johannes, Esser, Stefan, Krznaric, Ivanka, Lehmann, Clara, Spinner, Christoph, Stellbrink, Hans-Jurgen, Stephan, Christoph, Stoehr, Albrecht, Barchi, Enrico, Caramello, Pietro, Castelli, Francesco, Cattelan, Anna Maria, D'Arminio Monforte, Antonella, Di Biagio, Antonio, Di Perri, Giovanni, Gori, Andrea, Maggiolo, Franco, Menzaghi, Barbara, Migliorino, Guglielmo, Mussini, Cristina, Penco, Giovanni, Puoti, Massimo, Rizzardini, Giuliano, Gulminetti, Roberto, Lazzarin, Adriano, Quirino, Tiziano, Sighinolfi, Laura, Viale, Pierluigi, Amaya Tapia, Gerardo, Andrade Villanueva, Jaime, Granados Reyes, Enrique R, Perez Rios, Alma, Santoscoy Gomez, Mario, Den Hollander, Jan, Rijnders, Bart, Hidalgo, José A, Hercilla Vasquez, Luis, Illescas, Luis, Olczak, Anita, Mansinho, Kamal, Correia Pacheco, Patricia Paula, Teófilo, Eugénio, Saraiva da Cunha, Jose, Sarmento e Castro, Rui, Serrão, Rosário, Arbune, Manuela, Jianu, Cristian, Oprea, Anca, Preotescu, Liliana, Prisacariu, Liviu-Jany, Belonosova, Elena, Borodkina, Olga, Chernova, Oxana, Gankina, Natalia, Kizhlo, Svetlana, Kulagin, Valeriy, Kurina, Nadezhda, Nagimova, Firaya, Pokrovsky, Vadim, Ryamova, Elena, Voronin, Evgeny, Yakovlev, Alexey, Kaplan, Richard, Lee, Sun Hee, Kim, Shin-Woo, Kim, Sang-Il, Kim, Woo Joo, Antela Lopez, Antonio, Casado Osorio, Jose L, Castaño Carracedo, Manuel A, De Los Santos Gil, Ignacio, Estrada Perez, Vicente, Falco Ferrer, Vicenç, Force, Luis, Galinda Puerto, Maria Jose, Garcia Deltoro, Miguel, Gatell, Josep M, Goenaga Sanchez, Miguel A, González Cordón, Ana, Knobel, Hernando, Lopez Bernaldo de Quiros, Juan Carlos, Losa Garcia, Juan E, Masia, Mar, Montero-Alsonso, Marta, Ocampo Hermida, Antonio, Pasquau Liaño, Juan, Portilla Sogorb, Joaquin, Pulido Ortega, Federico, Rivera Roman, Antonio, Santos Fernandez, Jose Ramon, Torres Perea, Rafael, Troya Garcia, Jesus, Viciana Fernandez, Pompeyo, Calmy, Alexandra, Hauser, Christoph, Fehr, Jan, Cheng, Shu-Hsing, Ko, Wen-Chien, Lin, Hsi-Hsun, Lu, Po-Liang, Tseng, Yu-Ting, Wang, Ning-Chi, Wong, Wing-Wai, Yang, Chia-Jui, Arduino, Roberto, Benson, Paul, Berhe, Mezgebe, Bredeek, Fritz, Brinson, Cynthia, Campbell, Thomas, Crofoot, Gordon, Cunningham, Douglas, DeJesus, Edwin, Dretler, Robin, Eron, Joseph, Fife, Kenneth, Fichtenbaum, Carl, Flamm, Jason, Goldstein, Deborah, Gupta, Samir, Hagins, Debbie, Hoffman-Terry, Margaret, Jayaweera, Dushyantha, Kinder, Clifford, Klein, Daniel, McDonald, Cheryl, Mills, Anthony, Nahass, Ronald, Osiyemi, Olayemi, Overton, Edgar, Parks, David, Prelutsky, David, Ramgopal, Moti, Schrader, Shannon, Sha, Beverly, Simon, Gary, Sims, James, Skiest, Daniel, Slim, Jihad, Tashima, Karen, Thedinger, Blair, Gazzard, Brian, Fox, Julie, Johnson, Margaret, Kegg, Stephen, Khoo, Saye, Mazhude, Charles, Orkin, Chloe, Schembri, Gabriel, Ustianowski, Andrew, Cahn, Pedro, Madero, Juan Sierra, Arribas, José Ramón, Antinori, Andrea, Ortiz, Roberto, Clarke, Amanda E, Hung, Chien-Ching, Rockstroh, Jürgen K, Girard, Pierre-Marie, Sievers, Jörg, Man, Choy, Currie, Alexander, Underwood, Mark, Tenorio, Allan R, Pappa, Keith, Wynne, Brian, Fettiplace, Anna, Gartland, Martin, Aboud, Michael, and Smith, Kimberly

Published
2019
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6. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials

Author

Cahn, Pedro, primary, Madero, Juan Sierra, additional, Arribas, José Ramón, additional, Antinori, Andrea, additional, Ortiz, Roberto, additional, Clarke, Amanda E, additional, Hung, Chien-Ching, additional, Rockstroh, Jürgen K, additional, Girard, Pierre-Marie, additional, Sievers, Jörg, additional, Man, Choy, additional, Currie, Alexander, additional, Underwood, Mark, additional, Tenorio, Allan R, additional, Pappa, Keith, additional, Wynne, Brian, additional, Fettiplace, Anna, additional, Gartland, Martin, additional, Aboud, Michael, additional, Smith, Kimberly, additional, Cassetti, Lidia, additional, David, Daniel, additional, Figueras, Laura, additional, Losso, Marcelo, additional, Lopardo, Gustavo, additional, Lupo, Sergio, additional, Porteiro, Norma, additional, Sánchez, Marisa, additional, Bloch, Mark, additional, Cooper, David, additional, Finlayson, Robert, additional, Kelleher, Anthony, additional, Koh, Kenneth, additional, Lewis, David, additional, McMahon, James, additional, Moore, Richard, additional, Roth, Norman, additional, Shields, Matthew, additional, De Wit, Stephane, additional, Florence, Eric, additional, Goffard, Jean-Christophe, additional, Demeester, Remy, additional, Lacor, Patrick, additional, Vandercam, Bernard, additional, Vandekerckhove, Linos, additional, Angel, Jonathan, additional, Baril, Jean-Guy, additional, Conway, Brian, additional, De Pokomandy, Alexandra, additional, Szabo, Jason, additional, Walmsley, Sharon, additional, Bouchaud, Olivier, additional, Chidiac, Christian, additional, Delobel, Pierre, additional, Goujard, Cecile, additional, Katlama, Christine, additional, Molina, Jean-Michel, additional, Pialoux, Gilles, additional, Philibert, Patrick, additional, Bogner, Johannes, additional, Esser, Stefan, additional, Krznaric, Ivanka, additional, Lehmann, Clara, additional, Spinner, Christoph, additional, Stellbrink, Hans-Jurgen, additional, Stephan, Christoph, additional, Stoehr, Albrecht, additional, Barchi, Enrico, additional, Caramello, Pietro, additional, Castelli, Francesco, additional, Cattelan, Anna Maria, additional, D'Arminio Monforte, Antonella, additional, Di Biagio, Antonio, additional, Di Perri, Giovanni, additional, Gori, Andrea, additional, Maggiolo, Franco, additional, Menzaghi, Barbara, additional, Migliorino, Guglielmo, additional, Mussini, Cristina, additional, Penco, Giovanni, additional, Puoti, Massimo, additional, Rizzardini, Giuliano, additional, Gulminetti, Roberto, additional, Lazzarin, Adriano, additional, Quirino, Tiziano, additional, Sighinolfi, Laura, additional, Viale, Pierluigi, additional, Amaya Tapia, Gerardo, additional, Andrade Villanueva, Jaime, additional, Granados Reyes, Enrique R, additional, Perez Rios, Alma, additional, Santoscoy Gomez, Mario, additional, Den Hollander, Jan, additional, Rijnders, Bart, additional, Hidalgo, José A, additional, Hercilla Vasquez, Luis, additional, Illescas, Luis, additional, Olczak, Anita, additional, Mansinho, Kamal, additional, Correia Pacheco, Patricia Paula, additional, Teófilo, Eugénio, additional, Saraiva da Cunha, Jose, additional, Sarmento e Castro, Rui, additional, Serrão, Rosário, additional, Arbune, Manuela, additional, Jianu, Cristian, additional, Oprea, Anca, additional, Preotescu, Liliana, additional, Prisacariu, Liviu-Jany, additional, Belonosova, Elena, additional, Borodkina, Olga, additional, Chernova, Oxana, additional, Gankina, Natalia, additional, Kizhlo, Svetlana, additional, Kulagin, Valeriy, additional, Kurina, Nadezhda, additional, Nagimova, Firaya, additional, Pokrovsky, Vadim, additional, Ryamova, Elena, additional, Voronin, Evgeny, additional, Yakovlev, Alexey, additional, Kaplan, Richard, additional, Lee, Sun Hee, additional, Kim, Shin-Woo, additional, Kim, Sang-Il, additional, Kim, Woo Joo, additional, Antela Lopez, Antonio, additional, Casado Osorio, Jose L, additional, Castaño Carracedo, Manuel A, additional, De Los Santos Gil, Ignacio, additional, Estrada Perez, Vicente, additional, Falco Ferrer, Vicenç, additional, Force, Luis, additional, Galinda Puerto, Maria Jose, additional, Garcia Deltoro, Miguel, additional, Gatell, Josep M, additional, Goenaga Sanchez, Miguel A, additional, González Cordón, Ana, additional, Knobel, Hernando, additional, Lopez Bernaldo de Quiros, Juan Carlos, additional, Losa Garcia, Juan E, additional, Masia, Mar, additional, Montero-Alsonso, Marta, additional, Ocampo Hermida, Antonio, additional, Pasquau Liaño, Juan, additional, Portilla Sogorb, Joaquin, additional, Pulido Ortega, Federico, additional, Rivera Roman, Antonio, additional, Santos Fernandez, Jose Ramon, additional, Torres Perea, Rafael, additional, Troya Garcia, Jesus, additional, Viciana Fernandez, Pompeyo, additional, Calmy, Alexandra, additional, Hauser, Christoph, additional, Fehr, Jan, additional, Cheng, Shu-Hsing, additional, Ko, Wen-Chien, additional, Lin, Hsi-Hsun, additional, Lu, Po-Liang, additional, Tseng, Yu-Ting, additional, Wang, Ning-Chi, additional, Wong, Wing-Wai, additional, Yang, Chia-Jui, additional, Arduino, Roberto, additional, Benson, Paul, additional, Berhe, Mezgebe, additional, Bredeek, Fritz, additional, Brinson, Cynthia, additional, Campbell, Thomas, additional, Crofoot, Gordon, additional, Cunningham, Douglas, additional, DeJesus, Edwin, additional, Dretler, Robin, additional, Eron, Joseph, additional, Fife, Kenneth, additional, Fichtenbaum, Carl, additional, Flamm, Jason, additional, Goldstein, Deborah, additional, Gupta, Samir, additional, Hagins, Debbie, additional, Hoffman-Terry, Margaret, additional, Jayaweera, Dushyantha, additional, Kinder, Clifford, additional, Klein, Daniel, additional, McDonald, Cheryl, additional, Mills, Anthony, additional, Nahass, Ronald, additional, Osiyemi, Olayemi, additional, Overton, Edgar, additional, Parks, David, additional, Prelutsky, David, additional, Ramgopal, Moti, additional, Schrader, Shannon, additional, Sha, Beverly, additional, Simon, Gary, additional, Sims, James, additional, Skiest, Daniel, additional, Slim, Jihad, additional, Tashima, Karen, additional, Thedinger, Blair, additional, Gazzard, Brian, additional, Fox, Julie, additional, Johnson, Margaret, additional, Kegg, Stephen, additional, Khoo, Saye, additional, Mazhude, Charles, additional, Orkin, Chloe, additional, Schembri, Gabriel, additional, and Ustianowski, Andrew, additional

Published
2019
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7. Psychiatric Symptoms in Patients Receiving Dolutegravir

Author

Fettiplace, Anna, primary, Stainsby, Chris, additional, Winston, Alan, additional, Givens, Naomi, additional, Puccini, Sarah, additional, Vannappagari, Vani, additional, Hsu, Ricky, additional, Fusco, Jennifer, additional, Quercia, Romina, additional, Aboud, Michael, additional, and Curtis, Lloyd, additional

Published
2017
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