28 results on '"Rumi, Mariagrazia"'
Search Results
2. Concomitant therapy with direct-acting antivirals and chemoimmunotherapy in HCV-associated diffuse large B-cell lymphoma
- Author
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Occhipinti, Vincenzo, Farina, Lucia, Viganò, Mauro, Capecchi, Marco, Labanca, Sara, Fanetti, Ilaria, Corradini, Paolo, and Rumi, Mariagrazia
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- 2019
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3. Lamivudine prophylaxis prevents hepatitis B virus reactivation in anti-HBc positive patients under rituximab for non-Hodgkin lymphoma
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Loglio, Alessandro, Viganò, Mauro, Grossi, Glenda, Labanca, Sara, Goldaniga, Maria, Pompa, Alessandra, Farina, Lucia, Rumi, Mariagrazia, Corradini, Paolo, Facchetti, Floriana, Lunghi, Giovanna, Baldini, Luca, and Lampertico, Pietro
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- 2019
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4. A 28-Year Study of the Course of Hepatitis Δ Infection: A Risk Factor for Cirrhosis and Hepatocellular Carcinoma
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Romeo, Raffaella, Del Ninno, Ersilio, Rumi, Mariagrazia, Russo, Antonio, Sangiovanni, Angelo, de Franchis, Roberto, Ronchi, Guido, and Colombo, Massimo
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- 2009
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5. Case Report: A Challenging Localization of a Pulmonary Ectopic ACTH-Secreting Tumor in a Patient With Severe Cushing’s Syndrome
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Serban, Andreea Liliana, primary, Rosso, Lorenzo, additional, Mendogni, Paolo, additional, Cremaschi, Arianna, additional, Indirli, Rita, additional, Mantovani, Beatrice, additional, Rumi, Mariagrazia, additional, Castellani, Massimo, additional, Chiti, Arturo, additional, Croci, Giorgio Alberto, additional, Mantovani, Giovanna, additional, Nosotti, Mario, additional, Ferrante, Emanuele, additional, and Arosio, Maura, additional
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- 2021
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6. Patatin-Like Phospholipase Domain-Containing 3 I148M Polymorphism, Steatosis, and Liver Damage in Chronic Hepatitis Cσ
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Valenti, Luca, Rumi, MariaGrazia, Galmozzi, Enrico, Aghemo, Alessio, Del Menico, Benedetta, De Nicola, Stella, Dongiovanni, Paola, Maggioni, Marco, Fracanzani, Anna Ludovica, Rametta, Raffaela, Colombo, Massimo, and Fargion, Silvia
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- 2011
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7. Undefined/non-malignant hepatic nodules are associated with early occurrence of HCC in DAA-treated patients with HCV-related cirrhosis
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Sangiovanni, Angelo, primary, Alimenti, Eleonora, additional, Gattai, Riccardo, additional, Filomia, Roberto, additional, Parente, Elisabetta, additional, Valenti, Luca, additional, Marzi, Luca, additional, Pellegatta, Gaia, additional, Borgia, Guglielmo, additional, Gambato, Martina, additional, Terreni, Natalia, additional, Serio, Ilaria, additional, Belli, Luca, additional, Oliveri, Filippo, additional, Maimone, Sergio, additional, Brunacci, Matteo, additional, D'Ambrosio, Roberta, additional, Forzenigo, Laura Virginia, additional, Russo, Francesco Paolo, additional, Rumi, Mariagrazia, additional, Barone, Michele, additional, Fracanzani, Anna Ludovica, additional, Raimondo, Giovanni, additional, Giannini, Edoardo Giovanni, additional, Brunetto, Maurizia Rossana, additional, Villa, Erica, additional, Biganzoli, Elia, additional, Colombo, Massimo, additional, and Lampertico, Pietro, additional
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- 2020
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8. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial
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Younossi, Zobair M, primary, Ratziu, Vlad, additional, Loomba, Rohit, additional, Rinella, Mary, additional, Anstee, Quentin M, additional, Goodman, Zachary, additional, Bedossa, Pierre, additional, Geier, Andreas, additional, Beckebaum, Susanne, additional, Newsome, Philip N, additional, Sheridan, David, additional, Sheikh, Muhammad Y, additional, Trotter, James, additional, Knapple, Whitfield, additional, Lawitz, Eric, additional, Abdelmalek, Manal F, additional, Kowdley, Kris V, additional, Montano-Loza, Aldo J, additional, Boursier, Jerome, additional, Mathurin, Philippe, additional, Bugianesi, Elisabetta, additional, Mazzella, Giuseppe, additional, Olveira, Antonio, additional, Cortez-Pinto, Helena, additional, Graupera, Isabel, additional, Orr, David, additional, Gluud, Lise Lotte, additional, Dufour, Jean-Francois, additional, Shapiro, David, additional, Campagna, Jason, additional, Zaru, Luna, additional, MacConell, Leigh, additional, Shringarpure, Reshma, additional, Harrison, Stephen, additional, Sanyal, Arun J, additional, Abdelmalek, Manal, additional, Abrams, Gary, additional, Aguilar, Humberto, additional, Ahmed, Aijaz, additional, Aigner, Elmar, additional, Aithal, Guruprasad, additional, Ala, Aftab, additional, Alazawi, William, additional, Albillos, Agustin, additional, Allison, Michael, additional, Al-Shamma, Sfa, additional, Andrade, Raul, additional, Andreone, Pietro, additional, Angelico, Mario, additional, Ankoma-Sey, Victor, additional, Anstee, Quentin, additional, Anty, Rodolphe, additional, Araya, Victor, additional, Arenas Ruiz, Juan Ignacio, additional, Arkkila, Perttu, additional, Arora, Marty, additional, Asselah, Tarik, additional, Au, Jennifer, additional, Ayonrinde, Oyekoya, additional, Bailey, Robert James, additional, Balakrishnan, Maya, additional, Bambha, Kiran, additional, Bansal, Meena, additional, Barritt, Sidney, additional, Bate, John, additional, Beato, Jorge, additional, Behari, Jaideep, additional, Bellot, Pablo, additional, Ben Ari, Ziv, additional, Bennett, Michael, additional, Berenguer, Marina, additional, Beretta-Piccoli, Benedetta Terziroli, additional, Berg, Thomas, additional, Bonacini, Maurizio, additional, Bonet, Lucia, additional, Borg, Brian, additional, Bourliere, Marc, additional, Bowman, William, additional, Bradley, David, additional, Brankovic, Marija, additional, Braun, Marius, additional, Bronowicki, Jean-Pierre, additional, Bruno, Savino, additional, Cai, Cindy, additional, Calderon, Amy, additional, Calleja Panero, José Luis, additional, Carey, Elizabeth, additional, Carmiel, Michal, additional, Carrión, Jose Antonio, additional, Cave, Matthew, additional, Chagas, Cristina, additional, Chami, Tawfik, additional, Chang, Alan, additional, Coates, Allan, additional, Cobbold, Jeremy, additional, Costentin, Charlote, additional, Corey, Kathleen, additional, Corless, Lynsey, additional, Crespo, Javier, additional, Cruz Pereira, Oscar, additional, de Ledinghen, Victor, additional, deLemos, Andrew, additional, Diago, Moises, additional, Dong, Mamie, additional, Dufour, Jean-François, additional, Dugalic, Predrag, additional, Dunn, Winston, additional, Elkhashab, Magby, additional, Epstein, Michael, additional, Escudero-Garcia, Maria Desamparados, additional, Etzion, Ohad, additional, Evans, Larry, additional, Falcone, Robert, additional, Fernandez, Conrado, additional, Ferreira, Jose, additional, Fink, Scott, additional, Finnegan, Kevin, additional, Firpi-Morell, Roberto, additional, Floreani, Annarosa, additional, Fontanges, Thierry, additional, Ford, Ryan, additional, Forrest, Ewan, additional, Fowell, Andrew, additional, Fracanzani, Anna Ludovica, additional, Francque, Sven, additional, Freilich, Bradley, additional, Frias, Juan, additional, Fuchs, Michael, additional, Fuentes, Javier, additional, Galambos, Michael, additional, Gallegos, Juan, additional, Geerts, Anja, additional, George, Jacob, additional, Ghali, Maged, additional, Ghalib, Reem, additional, Gholam, Pierre, additional, Gines, Pere, additional, Gitlin, Norman, additional, Goeser, Tobias, additional, Goff, John, additional, Gordon, Stuart, additional, Gordon, Frederic, additional, Goria, Odile, additional, Greer, Shaun, additional, Grigorian, Alla, additional, Gronbaek, Henning, additional, Guillaume, Maeva, additional, Gunaratnam, Naresh, additional, Halegoua-De Marzio, Dina, additional, Hameed, Bilal, additional, Hametner, Stephanie, additional, Hamilton, James, additional, Hartleb, Marek, additional, Hassanein, Tarek, additional, Häussinger, Dieter, additional, Hellstern, Paul, additional, Herring, Robert, additional, Heurich, Eva, additional, Hezode, Christophe, additional, Hinrichsen, Holger, additional, Holland Fischer, Peter, additional, Horsmans, Yves, additional, Huang, Jonathan, additional, Hussaini, Hyder, additional, Jakiche, Antoine, additional, Jeffers, Lennox, additional, Jones, Blake, additional, Jorge, Rosa, additional, Jorquera, Francisco, additional, Joshi, Shoba, additional, Kahraman, Alisan, additional, Kaita, Kelly, additional, Karyotakis, Nicholas, additional, Kayali, Zeid, additional, Kechagias, Stergios, additional, Kepczyk, Thomas, additional, Khalili, Mandana, additional, Khallafi, Hicham, additional, Kluwe, Johannes, additional, Kohli, Anita, additional, Korenblat, Kevin, additional, Kowdley, Kris, additional, Krag, Aleksander, additional, Krause, Richard, additional, Kremer, Andreas, additional, Krok, Karen, additional, Krstic, Miodrag, additional, Kugelmas, Marcelo, additional, Kumar, Sonal, additional, Kuwada, Scott, additional, Labarriere, Damien, additional, Lai, Michelle, additional, Laleman, Wim, additional, Lampertico, Pietro, additional, Lee, Alice, additional, Leroy, Vincent, additional, Lidofsky, Steven, additional, Lim, Tina Huey, additional, Lim, Joseph, additional, Lipkis, Donald, additional, Little, Ester, additional, Lonardo, Amadeo, additional, Long, Michelle, additional, Luketic, Velimir Anthony Christopher, additional, Lurie, Yoav, additional, Macedo, Guilherme, additional, Magalhaes, Joana, additional, Makara, Mihály, additional, Maliakkal, Benedict, additional, Manns, Michael, additional, Manousou, Pinelopi, additional, Mantry, Parvez, additional, Marchesini, Giulio, additional, Marinho, Carla, additional, Marotta, Paul, additional, Marschall, Hanns-Ulrich, additional, Martinez, Linda, additional, Mayo, Marlyn, additional, McCullen, Mark, additional, McLaughlin, William, additional, Merle, Uta, additional, Merriman, Raphael, additional, Modi, Apurva, additional, Molina, Esther, additional, Montano-Loza, Aldo, additional, Monteverde, Carlos, additional, Morales Cardona, Amilcar, additional, Moreea, Sulleman, additional, Moreno, Christophe, additional, Morisco, Filomena, additional, Mubarak, Abdullah, additional, Muellhaupt, Beat, additional, Mukherjee, Sandeep, additional, Müller, Tobias, additional, Nagorni, Aleksandar, additional, Naik, Jahnavi, additional, Neff, Guy, additional, Nevah, Moises, additional, Newsome, Philip, additional, Nguyen-Khac, Eric, additional, Noureddin, Mazen, additional, Oben, Jude, additional, Orlent, Hans, additional, Orr, James, additional, Ortiz-Lasanta, Grisell, additional, Ozenne, Violaine, additional, Pandya, Prashant, additional, Paredes, Angelo, additional, Park, James, additional, Patel, Joykumar, additional, Patel, Keyur, additional, Paul, Sonali, additional, Patton, Heather, additional, Peck-Radosavljevic, Markus, additional, Petta, Salvatore, additional, Pianko, Stephen, additional, Piekarska, Anna, additional, Pimstone, Neville, additional, Pisegna, Joseph, additional, Pockros, Paul, additional, Pol, Stanislas, additional, Porayko, Michael, additional, Poulos, John, additional, Pound, David, additional, Pouzar, Joe, additional, Presa Ramos, Jose, additional, Pyrsopoulos, Nikolaos, additional, Rafiq, Nila, additional, Muller, Kate, additional, Ramji, Alnoor, additional, Ravinuthala, Ravi, additional, Reddy, Chakradhar, additional, Reddy K G, Gautham, additional, Reddy K R, K. Rajender, additional, Regenstein, Frederic, additional, Reindollar, Robert, additional, Reynolds, Justin, additional, Riera, Andres, additional, Rivera Acosta, Jose, additional, Robaeys, Geert, additional, Roberts, Stuart, additional, Rodriguez-Perez, Federico, additional, Romero, Sandor, additional, Romero-Gomez, Manuel, additional, Rubin, Raymond, additional, Rumi, Mariagrazia, additional, Rushbrook, Simon, additional, Rust, Christian, additional, Ryan, Michael, additional, Safadi, Rifaat, additional, Said, Adnan, additional, Salminen, Kimmo, additional, Samuel, Didier, additional, Santoro, John, additional, Sanyal, Arun, additional, Sarkar, Souvik, additional, Schaeffer, Cynthia, additional, Schattenberg, Jörn, additional, Schiefke, Ingolf, additional, Schiff, Eugene, additional, Schmidt, Wolfgang, additional, Schneider, Jeffrey, additional, Schouten, Jeoffrey, additional, Schultz, Michael, additional, Sebastiani, Giada, additional, Semela, David, additional, Sepe, Thomas, additional, Sheikh, Aasim, additional, Sheikh, Muhammad, additional, Sherman, Kenneth, additional, Shibolet, Oren, additional, Shiffman, Mitchell, additional, Siddique, Asma, additional, Sieberhagen, Cyril, additional, Sigal, Samuel, additional, Sikorska, Katarzyna, additional, Simon, Krzysztof, additional, Sinclair, Marie, additional, Skoien, Richard, additional, Solis, Joel, additional, Sood, Siddharth, additional, Souder, Bob, additional, Spivey, James, additional, Stal, Per, additional, Stinton, Laura, additional, Strasser, Simone, additional, Svorcan, Petar, additional, Szabo, Gyongzi, additional, Talal, Andrew, additional, Tam, Edward, additional, Tetri, Brent, additional, Thuluvath, Paul, additional, Tobias, Hillel, additional, Tomasiewicz, Krzysztof, additional, Torres, Dawn, additional, Tran, Albert, additional, Trauner, Michael, additional, Trautwein, Christian, additional, Tsochatzis, Emanuel, additional, Unitt, Esther, additional, Vargas, Victor, additional, Varkonyi, Istvan, additional, Veitsman, Ella, additional, Vespasiani Gentilucci, Umberto, additional, Victor, David, additional, Vierling, John, additional, Vincent, Catherine, additional, Vincze, Aron, additional, von der Ohe, Manfred, additional, Von Roenn, Natasha, additional, Vuppalanchi, Raj, additional, Waters, Michael, additional, Watt, Kymberly, additional, Wattacheril, Julia, additional, Weltman, Martin, additional, Wieland, Amanda, additional, Wiener, Gregory, additional, Williams A, Alonzo, additional, Williams J, Jeffrey, additional, Wilson, Jason, additional, Yataco, Maria, additional, Yoshida, Eric, additional, Younes, Ziad, additional, Yuan, Liyun, additional, Zivony, Adam, additional, Zogg, Donald, additional, Zoller, Heinz, additional, Zoulim, Fabien, additional, Zuckerman, Eli, additional, and Zuin, Massimo, additional
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- 2019
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9. Peginterferon alfa-2b plus ribavirin for naïve patients with genotype 1 chronic hepatitis C: a randomized controlled trial
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Bruno, Savino, Cammà, Calogero, Di Marco, Vito, Rumi, Mariagrazia, Vinci, Maria, Camozzi, Mario, Rebucci, Chiara, Di Bona, Danilo, Colombo, Massimo, Craxì, Antonio, Mondelli, Mario U., and Pinzello, Giovanbattista
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- 2004
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10. Minimal increases of serum alpha‐foetoprotein herald HCC detection in Caucasian HBV cirrhotic patients under long‐term oral therapy
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Loglio, Alessandro, primary, Iavarone, Massimo, additional, Viganò, Mauro, additional, Orenti, Annalisa, additional, Facchetti, Floriana, additional, Cortinovis, Ivan, additional, Lunghi, Giovanna, additional, Ceriotti, Ferruccio, additional, Occhipinti, Vincenzo, additional, Rumi, Mariagrazia, additional, Sangiovanni, Angelo, additional, Colombo, Massimo, additional, and Lampertico, Pietro, additional
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- 2019
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11. Effectiveness and safety of switching to entecavir hepatitis B patients developing kidney dysfunction during tenofovir
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Viganò, Mauro, primary, Loglio, Alessandro, additional, Labanca, Sara, additional, Zaltron, Serena, additional, Castelli, Francesco, additional, Andreone, Pietro, additional, Messina, Vincenzo, additional, Ganga, Roberto, additional, Coppola, Nicola, additional, Marrone, Aldo, additional, Russello, Maurizio, additional, Marzano, Alfredo, additional, Tucci, Alessandra, additional, Taliani, Gloria, additional, Fasano, Massimo, additional, Fagiuoli, Stefano, additional, Villa, Erica, additional, Bronte, Fabrizio, additional, Santantonio, Teresa, additional, Brancaccio, Giuseppina, additional, Occhipinti, Vincenzo, additional, Facchetti, Floriana, additional, Grossi, Glenda, additional, Rumi, Mariagrazia, additional, and Lampertico, Pietro, additional
- Published
- 2019
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12. High rates of sustained virological response despite premature discontinuation of directly acting antivirals in HCV‐infected patients treated in a real‐life setting.
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Fabbiani, Massimiliano, Lombardi, Andrea, Colaneri, Marta, Del Poggio, Paolo, Perini, Paolo, D'Ambrosio, Roberta, Degasperi, Elisabetta, Dibenedetto, Clara, Giorgini, Alessia, Pasulo, Luisa, Maggiolo, Franco, Castelli, Francesco, Brambilla, Paola, Spinelli, Ombretta, Re, Tiziana, Lleo, Ana, Rumi, Mariagrazia, Uberti‐Foppa, Caterina, Soria, Alessandro, and Aghemo, Alessio
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SOFOSBUVIR ,RIBAVIRIN ,CLINICAL trials ,CIRRHOSIS of the liver ,CHRONIC hepatitis B ,ANTIVIRAL agents ,CHRONIC hepatitis C - Abstract
In routine clinical practice, hepatitis C virus‐infected patients can prematurely discontinue the prescribed regimen for several reasons. The aim of our study was to investigate sustained virological response (SVR12) rates in patients who prematurely discontinued directly acting antiviral (DAA) regimens and to assess the shortest effective duration of DAA able to lead to SVR12. We retrospectively collected the SVR rates of patients, registered in the NAVIGATORE‐Lombardia Network database from January 2015, who discontinued DAAs before the predefined end of treatment. Overall, we included 365 patients, males were the majority (213, 58.4%), mean age was 60.5 years, and 53 (14.5%) patients were HIV‐co‐infected. Liver cirrhosis was observed in 251 (68.8%) subjects, and the most represented genotypes were 1b (n = 168, 46%) and 3 (n = 59, 16.2%). DAA was discontinued a median of 1 (IQR 1–4) weeks before the predefined EOT, with 164 (44.9%) patients stopping DAAs at least 2 weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for <4 weeks: 50% (n = 2/4) vs. 99.1% (n = 109/110) for ≥4 weeks, p = 0.003. In patients with liver cirrhosis, lower rates of SVR12 were observed in patients treated <8 weeks: 83.3% (n = 25/30) vs. 94.6% (n = 209/221) for ≥8 weeks, p = 0.038. Despite premature discontinuation of DAA, high SVR12 rates were observed in a real‐life setting for treatment lasting at least 4 weeks in patients with liver fibrosis F0–F3 and 8 weeks in those with liver cirrhosis. On this basis, feasibility of reducing DAA treatment duration should be explored in randomized clinical trials. [ABSTRACT FROM AUTHOR]
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- 2021
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13. Suboptimal response to hepatitis B vaccine in drug users
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Rumi, Mariagrazia, Colombo, Massimo, Romeo, Raffaella, Boschini, Antonio, Zanetti, Alessandro, Gringeri, Alessandro, and Mannucci, Pier Mannuccio
- Subjects
Drug addicts -- Health aspects ,Intravenous drug abuse -- Health aspects ,Hepatitis B -- Prevention ,Hepatitis B vaccine -- Evaluation ,Health - Abstract
Intravenous (IV) drug users are at risk of acquiring hepatitis B infection, which affects the liver. A vaccine against hepatitis B has recently been developed, and it may be the only means of protecting IV drug users. This is especially true since many IV drug users are infected with human immunodeficiency virus (HIV, the virus that causes AIDS). This can make them even more susceptible to hepatitis B, since HIV weakens the immune system. Fifty-five IV drug users enrolled in a drug detoxification program were vaccinated with the hepatitis B vaccine known as Engerix B. Forty-one healthy individuals from the community were also vaccinated and served as controls. Seventeen of the drug users had no evidence of previous hepatitis B, while 15 had evidence of a past infection, and 23 had evidence of a recent infection. Each group received three injections, one at the beginning of the study, one a month later, and one six months later. One month after the third vaccination, 76 percent of the drug users with no history of hepatitis B had responded to the vaccine (by producing antibodies), 6 percent with past infection had responded, and 69 percent with recent infection had responded. In contrast, 97 percent of the healthy individuals had responded. The drug users had lower levels of protective antibodies against hepatitis B virus. Two years after the first vaccination, only 43 percent of drug users with no history of hepatitis B infection had protective antibodies, compared with 86 percent of the controls. Among the IV drug users who had a prior infection with hepatitis B, none of those with past a infection had protective antibodies, and only 31 percent of those with a recent infection had them. Drug users who exhibited anergy (a decreased immune response to foreign substances) were less likely to respond to the vaccine. The vaccine used in this study may not be able to stimulate the immune system to produce protective antibodies as well as other forms of hepatitis B vaccine; other studies of hepatitis vaccination in IV drug users have shown response rates of 90 to 100 percent. The fact that many nonresponders were anergic indicates that their immune systems might be weakened. However, since many of the drug users responded to the vaccine, vaccination of IV drug users against hepatitis B may still be effective. (Consumer Summary produced by Reliance Medical Information, Inc.)
- Published
- 1991
14. HCV-RNA kinetics on-treatment do not predict sustained virologic response in HCV genotype 3 patients receiving sofosbuvir and ribavirin
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Degasperi, Elisabetta, primary, De Nicola, Stella, additional, Rumi, Mariagrazia, additional, and D’Ambrosio, Roberta, additional
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- 2016
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15. Interleukin 28B genotype and insulin resistance in chronic hepatitis C patients
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Degasperi, Elisabetta, primary, Valenti, Luca, additional, Aghemo, Alessio, additional, De Francesco, Raffaele, additional, Rumi, Mariagrazia, additional, Soffredini, Roberta, additional, Donnici, Lorena, additional, Cheroni, Cristina, additional, Fargion, Silvia, additional, Zanoni, Valeria, additional, Orsi, Emanuela, additional, and Colombo, Massimo, additional
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- 2014
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16. Etiology-related determinants of liver stiffness values in chronic viral hepatitis B or C
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Fraquelli, Mirella, primary, Rigamonti, Cristina, additional, Casazza, Giovanni, additional, Donato, Maria Francesca, additional, Ronchi, Guido, additional, Conte, Dario, additional, Rumi, Mariagrazia, additional, Lampertico, Pietro, additional, and Colombo, Massimo, additional
- Published
- 2011
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17. Transient Elastography (Fibroscan®) In Adult Patients with Inherited Bleeding Disorders and Chronic Hepatitis C.
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Mancuso, Maria Elisa, primary, Aghemo, Alessio, additional, Bucciarelli, Paolo, additional, Santagostino, Elena, additional, Rumi, Mariagrazia, additional, Colombo, Massimo, additional, and Mannucci, Pier M., additional
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- 2010
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18. Insulin resistance is associated with steatosis in nondiabetic patients with genotype 1 chronic hepatitis C
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Cammà, Calogero, primary, Bruno, Savino, additional, Di Marco, Vito, additional, Di Bona, Danilo, additional, Rumi, Mariagrazia, additional, Vinci, Maria, additional, Rebucci, Chiara, additional, Cividini, Agostino, additional, Pizzolanti, Giuseppe, additional, Minola, Ernesto, additional, Mondelli, Mario U., additional, Colombo, Massimo, additional, Pinzello, Giovanbattista, additional, and Craxfì, Antonio, additional
- Published
- 2005
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19. The Impact of the First Exposure to Different Blood Products on the Prevalence and Natural History of Hepatitis C Virus Infection in Von Willebrand Disease (VWD): Results from a Large Cohort Study Comparing VWD and Hemophilia Patients.
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Federici, Augusto B., primary, Rumi, Mariagrazia, primary, Santagostino, Elena, primary, Russo, Antonio, primary, Colombo, Massimo, primary, and Mannucci, Pier M., primary
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- 2004
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20. Quantitation of HCV viremia in patients with chronic hepatitis assessed by second and third generation branched DNA
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Soffredini, Roberta, primary, Rumi, MariaGrazia, additional, Russo, Antonio, additional, and Colombo, Massimo, additional
- Published
- 2002
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21. Interferon alfa treatment of HCV RNA carriers with persistently normal transaminase levels: A pilot randomized controlled study
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Sangiovanni, Angelo, primary, Morales, Rino, additional, Spinzi, GianCarlo, additional, Rumi, MariaGrazia, additional, Casiraghi, Antonietta, additional, Ceriani, Roberto, additional, Colombo, Enrico, additional, Fossati, Maurizio, additional, Prada, Alberto, additional, Tavani, Enrico, additional, and Minoli, Giorgio, additional
- Published
- 1998
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22. Increased detection of antibody to hepatitis C virus in renal transplant patients by third-generation assays
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Soffredini, Roberta, primary, Rumi, Mariagrazia, additional, Lampertico, Pietro, additional, Aroldi, Adriana, additional, Tarantino, Antonio, additional, Ponticelli, Claudio, additional, and Colombo, Massimo, additional
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- 1996
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23. A multicenter randomized controlled trial of recombinant interferon-α2b in patients with acute transfusion-associated hepatitis C
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Lampertico, Pietro, primary, Rumi, Mariagrazia, additional, Romeo, Raffaella, additional, Craxi, Antonio, additional, Soffredini, Roberta, additional, Biassoni, Daniela, additional, and Colombo, Massimo, additional
- Published
- 1994
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24. Insulin resistance is associated with steatosis in nondiabetic patients with genotype 1 chronic hepatitis C.
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Cammà, Calogero, Bruno, Savino, Di Marco, Vito, Di Bona, Danilo, Rumi, Mariagrazia, Vinci, Maria, Rebucci, Chiara, Cividini, Agostino, Pizzolanti, Giuseppe, Minola, Ernesto, Mondelli, Mario U., Colombo, Massimo, Pinzello, Giovanbattista, and Craxfì, Antonio
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- 2006
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25. A multicenter randomized controlled trial of recombinant interferon-α2b in patients with acute transfusion-associated hepatitis C.
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Lampertico, Pietro, Rumi, Mariagrazia, Romeo, Raffaella, Craxi, Antonio, Soffredini, Roberta, Biassoni, Daniela, and Colombo, Massimo
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- 1994
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26. 983 Steatosis is a cofactor for fibrosis and response to therapy in genotype 1B chronic hepatitis C (CHC)
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Cammà, Calogero, Di Marco, Vito, Camozzi, Mario, Bruno, Savino, Di Bona, Danilo, Rumi, Mariagrazia, Vinci, Maria, Mondelli, Mario U., Infettive, Malattie, Colombo, Massimo, Pinzello, Giovanbattista, and Craxì, Antonio
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- 2003
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27. High rates of sustained virological response despite premature discontinuation of directly acting antivirals in HCV-infected patients treated in a real-life setting
- Author
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Fabbiani M., Lombardi A., Colaneri M., Del Poggio P., Perini P., D'Ambrosio R., Degasperi E., Dibenedetto C., Giorgini A., Pasulo L., Maggiolo F., Castelli F., Brambilla P., Spinelli O., Re T., Lleo A., Rumi M., Uberti-Foppa C., Soria A., Aghemo A., Lampertico P., Baiguera C., Schiavini M., Fagiuoli S., Bruno R., Borghi M., Soffredini R., Perbellini R., Gori A., Ferroni V., Colpani M., Manini M., Cologni G., Lazzaroni S., Vinci M., De Nicola S., Mazzarelli C., Angelini Zucchetti T., Picciotto V., Puoti M., Rossotti R., Landonio S., Magni C. F., Rizzardini G., Colella E., Columpsi P., Gambaro A., Spolti A., Magnani C., Vigano P., Mena M., Villa M., Caramma I., Basilico C., Capelli F., Biagiotti S., Mazzone A., Saladino V., Baldacci M. P., Gatti F., Varalli L., Morini L., Menzaghi B., Farinazzo M., Meli R., Plaz Torres M. C., Fanetti I., Orellana D., Zermiani P., Zuin M., De Bona A., D'Arminio Monforte A., Capretti A., Taddei M. T., Soncini M., Spinetti A., Zaltron S., Pigozzi M. G., Rossini A., Pan A., Dal Zoppo S., Zoncada A., Memoli M., Salpietro S., Hamid H., Messina E., Colombo A. E., Giglio O., Bonfanti P., Molteni C., Terreni N., Spinzi G., Conforti S., Clerici E., Menozzi F., Buscarini E., Centenaro R., Corbellini A., Noventa F., Gritti S., Giani P., Fabbiani, Massimiliano, Lombardi, Andrea, Colaneri, Marta, Del Poggio, Paolo, Perini, Paolo, D'Ambrosio, Roberta, Degasperi, Elisabetta, Dibenedetto, Clara, Giorgini, Alessia, Pasulo, Luisa, Maggiolo, Franco, Castelli, Francesco, Brambilla, Paola, Spinelli, Ombretta, Tiziana, Re, Lleo, Ana, Rumi, Mariagrazia, Uberti-Foppa, Caterina, Soria, Alessandro, Aghemo, Alessio, Lampertico, Pietro, Baiguera, Chiara, Schiavini, Monica, Fagiuoli, Stefano, Bruno, Raffaele, Fabbiani, M, Lombardi, A, Colaneri, M, Del Poggio, P, Perini, P, D'Ambrosio, R, Degasperi, E, Dibenedetto, C, Giorgini, A, Pasulo, L, Maggiolo, F, Castelli, F, Brambilla, P, Spinelli, O, Re, T, Lleo, A, Rumi, M, Uberti-Foppa, C, Soria, A, Aghemo, A, Lampertico, P, Baiguera, C, Schiavini, M, Fagiuoli, S, Bruno, R, Borghi, M, Soffredini, R, Perbellini, R, Gori, A, Ferroni, V, Colpani, M, Manini, M, Cologni, G, Lazzaroni, S, Vinci, M, De Nicola, S, Mazzarelli, C, Angelini Zucchetti, T, Picciotto, V, Puoti, M, Rossotti, R, Landonio, S, Magni, C, Rizzardini, G, Colella, E, Columpsi, P, Gambaro, A, Spolti, A, Magnani, C, Vigano, P, Mena, M, Villa, M, Caramma, I, Basilico, C, Capelli, F, Biagiotti, S, Mazzone, A, Saladino, V, Baldacci, M, Gatti, F, Varalli, L, Morini, L, Menzaghi, B, Farinazzo, M, Meli, R, Plaz Torres, M, Fanetti, I, Orellana, D, Zermiani, P, Zuin, M, De Bona, A, D'Arminio Monforte, A, Capretti, A, Taddei, M, Soncini, M, Spinetti, A, Zaltron, S, Pigozzi, M, Rossini, A, Pan, A, Dal Zoppo, S, Zoncada, A, Memoli, M, Salpietro, S, Hamid, H, Messina, E, Colombo, A, Giglio, O, Bonfanti, P, Molteni, C, Terreni, N, Spinzi, G, Conforti, S, Clerici, E, Menozzi, F, Buscarini, E, Centenaro, R, Corbellini, A, Noventa, F, Gritti, S, and Giani, P
- Subjects
Simeprevir ,Male ,medicine.medical_specialty ,Cirrhosis ,SVR ,Sofosbuvir ,Sustained Virologic Response ,liver cirrhosis ,antiviral treatment ,Hepacivirus ,Antiviral Agents ,law.invention ,Randomized controlled trial ,law ,Virology ,Internal medicine ,Medicine ,Humans ,chronic hepatitis C ,Prospective cohort study ,DAA ,Retrospective Studies ,Hepatology ,liver cirrhosi ,business.industry ,Hepatitis C ,Hepatitis C, Chronic ,Middle Aged ,medicine.disease ,Discontinuation ,Regimen ,Infectious Diseases ,Treatment Outcome ,business ,medicine.drug - Abstract
In routine clinical practice, hepatitis C virus-infected patients can prematurely discontinue the prescribed regimen for several reasons. The aim of our study was to investigate sustained virological response (SVR12) rates in patients who prematurely discontinued directly acting antiviral (DAA) regimens and to assess the shortest effective duration of DAA able to lead to SVR12. We retrospectively collected the SVR rates of patients, registered in the NAVIGATORE-Lombardia Network database from January 2015, who discontinued DAAs before the predefined end of treatment. Overall, we included 365 patients, males were the majority (213, 58.4%), mean age was 60.5years, and 53 (14.5%) patients were HIV-co-infected. Liver cirrhosis was observed in 251 (68.8%) subjects, and the most represented genotypes were 1b (n=168, 46%) and 3 (n=59, 16.2%). DAA was discontinued a median of 1 (IQR 1–4) weeks before the predefined EOT, with 164 (44.9%) patients stopping DAAs at least 2weeks before the planned schedule. In patients with F0–F3 liver fibrosis, lower rates of SVR12 were observed in patients treated for
- Published
- 2021
28. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial
- Author
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Zobair M Younossi, Vlad Ratziu, Rohit Loomba, Mary Rinella, Quentin M Anstee, Zachary Goodman, Pierre Bedossa, Andreas Geier, Susanne Beckebaum, Philip N Newsome, David Sheridan, Muhammad Y Sheikh, James Trotter, Whitfield Knapple, Eric Lawitz, Manal F Abdelmalek, Kris V Kowdley, Aldo J Montano-Loza, Jerome Boursier, Philippe Mathurin, Elisabetta Bugianesi, Giuseppe Mazzella, Antonio Olveira, Helena Cortez-Pinto, Isabel Graupera, David Orr, Lise Lotte Gluud, Jean-Francois Dufour, David Shapiro, Jason Campagna, Luna Zaru, Leigh MacConell, Reshma Shringarpure, Stephen Harrison, Arun J Sanyal, Manal Abdelmalek, Gary Abrams, Humberto Aguilar, Aijaz Ahmed, Elmar Aigner, Guruprasad Aithal, Aftab Ala, William Alazawi, Agustin Albillos, Michael Allison, Sfa Al-Shamma, Raul Andrade, Pietro Andreone, Mario Angelico, Victor Ankoma-Sey, Quentin Anstee, Rodolphe Anty, Victor Araya, Juan Ignacio Arenas Ruiz, Perttu Arkkila, Marty Arora, Tarik Asselah, Jennifer Au, Oyekoya Ayonrinde, Robert James Bailey, Maya Balakrishnan, Kiran Bambha, Meena Bansal, Sidney Barritt, John Bate, Jorge Beato, Jaideep Behari, Pablo Bellot, Ziv Ben Ari, Michael Bennett, Marina Berenguer, Benedetta Terziroli Beretta-Piccoli, Thomas Berg, Maurizio Bonacini, Lucia Bonet, Brian Borg, Marc Bourliere, William Bowman, David Bradley, Marija Brankovic, Marius Braun, Jean-Pierre Bronowicki, Savino Bruno, Cindy Cai, Amy Calderon, José Luis Calleja Panero, Elizabeth Carey, Michal Carmiel, Jose Antonio Carrión, Matthew Cave, Cristina Chagas, Tawfik Chami, Alan Chang, Allan Coates, Jeremy Cobbold, Charlote Costentin, Kathleen Corey, Lynsey Corless, Javier Crespo, Oscar Cruz Pereira, Victor de Ledinghen, Andrew deLemos, Moises Diago, Mamie Dong, Jean-François Dufour, Predrag Dugalic, Winston Dunn, Magby Elkhashab, Michael Epstein, Maria Desamparados Escudero-Garcia, Ohad Etzion, Larry Evans, Robert Falcone, Conrado Fernandez, Jose Ferreira, Scott Fink, Kevin Finnegan, Roberto Firpi-Morell, Annarosa Floreani, Thierry Fontanges, Ryan Ford, Ewan Forrest, Andrew Fowell, Anna Ludovica Fracanzani, Sven Francque, Bradley Freilich, Juan Frias, Michael Fuchs, Javier Fuentes, Michael Galambos, Juan Gallegos, Anja Geerts, Jacob George, Maged Ghali, Reem Ghalib, Pierre Gholam, Pere Gines, Norman Gitlin, Tobias Goeser, John Goff, Stuart Gordon, Frederic Gordon, Odile Goria, Shaun Greer, Alla Grigorian, Henning Gronbaek, Maeva Guillaume, Naresh Gunaratnam, Dina Halegoua-De Marzio, Bilal Hameed, Stephanie Hametner, James Hamilton, Marek Hartleb, Tarek Hassanein, Dieter Häussinger, Paul Hellstern, Robert Herring, Eva Heurich, Christophe Hezode, Holger Hinrichsen, Peter Holland Fischer, Yves Horsmans, Jonathan Huang, Hyder Hussaini, Antoine Jakiche, Lennox Jeffers, Blake Jones, Rosa Jorge, Francisco Jorquera, Shoba Joshi, Alisan Kahraman, Kelly Kaita, Nicholas Karyotakis, Zeid Kayali, Stergios Kechagias, Thomas Kepczyk, Mandana Khalili, Hicham Khallafi, Johannes Kluwe, Anita Kohli, Kevin Korenblat, Kris Kowdley, Aleksander Krag, Richard Krause, Andreas Kremer, Karen Krok, Miodrag Krstic, Marcelo Kugelmas, Sonal Kumar, Scott Kuwada, Damien Labarriere, Michelle Lai, Wim Laleman, Pietro Lampertico, Alice Lee, Vincent Leroy, Steven Lidofsky, Tina Huey Lim, Joseph Lim, Donald Lipkis, Ester Little, Amadeo Lonardo, Michelle Long, Velimir Anthony Christopher Luketic, Yoav Lurie, Guilherme Macedo, Joana Magalhaes, Mihály Makara, Benedict Maliakkal, Michael Manns, Pinelopi Manousou, Parvez Mantry, Giulio Marchesini, Carla Marinho, Paul Marotta, Hanns-Ulrich Marschall, Linda Martinez, Marlyn Mayo, Mark McCullen, William McLaughlin, Uta Merle, Raphael Merriman, Apurva Modi, Esther Molina, Aldo Montano-Loza, Carlos Monteverde, Amilcar Morales Cardona, Sulleman Moreea, Christophe Moreno, Filomena Morisco, Abdullah Mubarak, Beat Muellhaupt, Sandeep Mukherjee, Tobias Müller, Aleksandar Nagorni, Jahnavi Naik, Guy Neff, Moises Nevah, Philip Newsome, Eric Nguyen-Khac, Mazen Noureddin, Jude Oben, Hans Orlent, James Orr, Grisell Ortiz-Lasanta, Violaine Ozenne, Prashant Pandya, Angelo Paredes, James Park, Joykumar Patel, Keyur Patel, Sonali Paul, Heather Patton, Markus Peck-Radosavljevic, Salvatore Petta, Stephen Pianko, Anna Piekarska, Neville Pimstone, Joseph Pisegna, Paul Pockros, Stanislas Pol, Michael Porayko, John Poulos, David Pound, Joe Pouzar, Jose Presa Ramos, Nikolaos Pyrsopoulos, Nila Rafiq, Kate Muller, Alnoor Ramji, Ravi Ravinuthala, Chakradhar Reddy, Gautham Reddy K G, K. Rajender Reddy K R, Frederic Regenstein, Robert Reindollar, Justin Reynolds, Andres Riera, Jose Rivera Acosta, Geert Robaeys, Stuart Roberts, Federico Rodriguez-Perez, Sandor Romero, Manuel Romero-Gomez, Raymond Rubin, Mariagrazia Rumi, Simon Rushbrook, Christian Rust, Michael Ryan, Rifaat Safadi, Adnan Said, Kimmo Salminen, Didier Samuel, John Santoro, Arun Sanyal, Souvik Sarkar, Cynthia Schaeffer, Jörn Schattenberg, Ingolf Schiefke, Eugene Schiff, Wolfgang Schmidt, Jeffrey Schneider, Jeoffrey Schouten, Michael Schultz, Giada Sebastiani, David Semela, Thomas Sepe, Aasim Sheikh, Muhammad Sheikh, Kenneth Sherman, Oren Shibolet, Mitchell Shiffman, Asma Siddique, Cyril Sieberhagen, Samuel Sigal, Katarzyna Sikorska, Krzysztof Simon, Marie Sinclair, Richard Skoien, Joel Solis, Siddharth Sood, Bob Souder, James Spivey, Per Stal, Laura Stinton, Simone Strasser, Petar Svorcan, Gyongzi Szabo, Andrew Talal, Edward Tam, Brent Tetri, Paul Thuluvath, Hillel Tobias, Krzysztof Tomasiewicz, Dawn Torres, Albert Tran, Michael Trauner, Christian Trautwein, Emanuel Tsochatzis, Esther Unitt, Victor Vargas, Istvan Varkonyi, Ella Veitsman, Umberto Vespasiani Gentilucci, David Victor, John Vierling, Catherine Vincent, Aron Vincze, Manfred von der Ohe, Natasha Von Roenn, Raj Vuppalanchi, Michael Waters, Kymberly Watt, Julia Wattacheril, Martin Weltman, Amanda Wieland, Gregory Wiener, Alonzo Williams A, Jeffrey Williams J, Jason Wilson, Maria Yataco, Eric Yoshida, Ziad Younes, Liyun Yuan, Adam Zivony, Donald Zogg, Heinz Zoller, Fabien Zoulim, Eli Zuckerman, Massimo Zuin, Younossi Z.M., Ratziu V., Loomba R., Rinella M., Anstee Q.M., Goodman Z., Bedossa P., Geier A., Beckebaum S., Newsome P.N., Sheridan D., Sheikh M.Y., Trotter J., Knapple W., Lawitz E., Abdelmalek M.F., Kowdley K.V., Montano-Loza A.J., Boursier J., Mathurin P., Bugianesi E., Mazzella G., Olveira A., Cortez-Pinto H., Graupera I., Orr D., Gluud L.L., Dufour J.-F., Shapiro D., Campagna J., Zaru L., MacConell L., Shringarpure R., Harrison S., Sanyal A.J., Abdelmalek M., Abrams G., Aguilar H., Ahmed A., Aigner E., Aithal G., Ala A., Alazawi W., Albillos A., Allison M., Al-Shamma S., Andrade R., Andreone P., Angelico M., Ankoma-Sey V., Anstee Q., Anty R., Araya V., Arenas Ruiz J.I., Arkkila P., Arora M., Asselah T., Au J., Ayonrinde O., Bailey R.J., Balakrishnan M., Bambha K., Bansal M., Barritt S., Bate J., Beato J., Behari J., Bellot P., Ben Ari Z., Bennett M., Berenguer M., Beretta-Piccoli B.T., Berg T., Bonacini M., Bonet L., Borg B., Bourliere M., Bowman W., Bradley D., Brankovic M., Braun M., Bronowicki J.-P., Bruno S., Cai C., Calleja Panero J.L., Carey E., Carmiel M., Carrion J.A., Cave M., Chagas C., Chami T., Chang A., Coates A., Cobbold J., Corey K., Corless L., Crespo J., Cruz Pereira O., de Ledinghen V., deLemos A., Diago M., Dugalic P., Dunn W., Elkhashab M., Epstein M., Escudero-Garcia M.D., Etzion O., Evans L., Falcone R., Fernandez C., Ferreira J., Fink S., Finnegan K., Firpi-Morell R., Floreani A., Fontanges T., Ford R., Forrest E., Fowell A., Fracanzani A.L., Francque S., Freilich B., Frias J., Fuchs M., Fuentes J., Galambos M., Gallegos J., Geerts A., George J., Ghali M., Ghalib R., Gholam P., Gines P., Gitlin N., Goeser T., Goff J., Gordon S., Gordon F., Goria O., Greer S., Grigorian A., Gronbaek H., Guillaume M., Gunaratnam N., Halegoua-De Marzio D., Hameed B., Hametner S., Hamilton J., Hartleb M., Hassanein T., Haussinger D., Hellstern P., Herring R., Heurich E., Hezode C., Hinrichsen H., Holland Fischer P., Horsmans Y., Huang J., Jakiche A., Jeffers L., Jones B., Jorge R., Jorquera F., Kahraman A., Kaita K., Karyotakis N., Kayali Z., Kechagias S., Kepczyk T., Khalili M., Khallafi H., Kluwe J., Kohli A., Korenblat K., Kowdley K., Krag A., Krause R., Kremer A., Krok K., Krstic M., Kugelmas M., Kumar S., Labarriere D., Lai M., Lampertico P., Lee A., Leroy V., Lidofsky S., Lim T.H., Lim J., Lipkis D., Little E., Lonardo A., Long M., Lurie Y., Macedo G., Makara M., Maliakkal B., Manns M., Manousou P., Mantry P., Marchesini G., Marinho C., Marotta P., Marschall H.-U., Mayo M., McCullen M., McLaughlin W., Merriman R., Modi A., Molina E., Montano-Loza A., Monteverde C., Moreea S., Moreno C., Morisco F., Mubarak A., Muellhaupt B., Mukherjee S., Muller T., Nagorni A., Naik J., Neff G., Nevah M., Newsome P., Nguyen-Khac E., Noureddin M., Oben J., Orlent H., Orr J., Ortiz-Lasanta G., Ozenne V., Pandya P., Paredes A., Park J., Patel J., Patel K., Uta M., Patton H., Peck-Radosavljevic M., Petta S., Pianko S., Piekarska A., Pimstone N., Pockros P., Pol S., Porayko M., Poulos J., Pound D., Pouzar J., Presa Ramos J., Pyrsopoulos N., Rafiq N., Muller K., Ramji A., Ravinuthala R., Reddy C., Reddy K G G., Reddy K R K.R., Regenstein F., Reindollar R., Riera A., Rivera Acosta J., Robaeys G., Roberts S., Rodriguez-Perez F., Romero-Gomez M., Rubin R., Rumi M., Rushbrook S., Rust C., Ryan M., Safadi R., Said A., Salminen K., Samuel D., Santoro J., Sanyal A., Sarkar S., Schaeffer C., Schattenberg J., Schiefke I., Schiff E., Schmidt W., Schneider J., Schouten J., Schultz M., Sebastiani G., Semela D., Sepe T., Sheikh A., Sheikh M., Sherman K., Shibolet O., Shiffman M., Siddique A., Sieberhagen C., Sigal S., Sikorska K., Simon K., Sinclair M., Skoien R., Solis J., Sood S., Souder B., Spivey J., Stal P., Stinton L., Strasser S., Svorcan P., Szabo G., Talal A., Tam E., Tetri B., Thuluvath P., Tobias H., Tomasiewicz K., Torres D., Trauner M., Trautwein C., Tsochatzis E., Unitt E., Vargas V., Varkonyi I., Veitsman E., Vespasiani Gentilucci U., Victor D., Vierling J., Vincent C., Vincze A., von der Ohe M., Von Roenn N., Vuppalanchi R., Waters M., Watt K., Weltman M., Wieland A., Wiener G., Williams A A., Williams J J., Wilson J., Yataco M., Yoshida E., Younes Z., Yuan L., Zivony A., Zogg D., Zoller H., Zoulim F., Zuckerman E., Zuin M., Repositório da Universidade de Lisboa, Younossi, Z. M., Ratziu, V., Loomba, R., Rinella, M., Anstee, Q. M., Goodman, Z., Bedossa, P., Geier, A., Beckebaum, S., Newsome, P. N., Sheridan, D., Sheikh, M. Y., Trotter, J., Knapple, W., Lawitz, E., Abdelmalek, M. F., Kowdley, K. V., Montano-Loza, A. J., Boursier, J., Mathurin, P., Bugianesi, E., Mazzella, G., Olveira, A., Cortez-Pinto, H., Graupera, I., Orr, D., Gluud, L. L., Dufour, J. -F., Shapiro, D., Campagna, J., Zaru, L., Macconell, L., Shringarpure, R., Harrison, S., Sanyal, A. J., Abdelmalek, M., Abrams, G., Aguilar, H., Ahmed, A., Aigner, E., Aithal, G., Ala, A., Alazawi, W., Albillos, A., Allison, M., Al-Shamma, S., Andrade, R., Andreone, P., Angelico, M., Ankoma-Sey, V., Anstee, Q., Anty, R., Araya, V., Arenas Ruiz, J. I., Arkkila, P., Arora, M., Asselah, T., Au, J., Ayonrinde, O., Bailey, R. J., Balakrishnan, M., Bambha, K., Bansal, M., Barritt, S., Bate, J., Beato, J., Behari, J., Bellot, P., Ben Ari, Z., Bennett, M., Berenguer, M., Beretta-Piccoli, B. T., Berg, T., Bonacini, M., Bonet, L., Borg, B., Bourliere, M., Bowman, W., Bradley, D., Brankovic, M., Braun, M., Bronowicki, J. -P., Bruno, S., Cai, C., Calleja Panero, J. L., Carey, E., Carmiel, M., Carrion, J. A., Cave, M., Chagas, C., Chami, T., Chang, A., Coates, A., Cobbold, J., Corey, K., Corless, L., Crespo, J., Cruz Pereira, O., de Ledinghen, V., Delemos, A., Diago, M., Dugalic, P., Dunn, W., Elkhashab, M., Epstein, M., Escudero-Garcia, M. D., Etzion, O., Evans, L., Falcone, R., Fernandez, C., Ferreira, J., Fink, S., Finnegan, K., Firpi-Morell, R., Floreani, A., Fontanges, T., Ford, R., Forrest, E., Fowell, A., Fracanzani, A. L., Francque, S., Freilich, B., Frias, J., Fuchs, M., Fuentes, J., Galambos, M., Gallegos, J., Geerts, A., George, J., Ghali, M., Ghalib, R., Gholam, P., Gines, P., Gitlin, N., Goeser, T., Goff, J., Gordon, S., Gordon, F., Goria, O., Greer, S., Grigorian, A., Gronbaek, H., Guillaume, M., Gunaratnam, N., Halegoua-De Marzio, D., Hameed, B., Hametner, S., Hamilton, J., Hartleb, M., Hassanein, T., Haussinger, D., Hellstern, P., Herring, R., Heurich, E., Hezode, C., Hinrichsen, H., Holland Fischer, P., Horsmans, Y., Huang, J., Jakiche, A., Jeffers, L., Jones, B., Jorge, R., Jorquera, F., Kahraman, A., Kaita, K., Karyotakis, N., Kayali, Z., Kechagias, S., Kepczyk, T., Khalili, M., Khallafi, H., Kluwe, J., Kohli, A., Korenblat, K., Kowdley, K., Krag, A., Krause, R., Kremer, A., Krok, K., Krstic, M., Kugelmas, M., Kumar, S., Labarriere, D., Lai, M., Lampertico, P., Lee, A., Leroy, V., Lidofsky, S., Lim, T. H., Lim, J., Lipkis, D., Little, E., Lonardo, A., Long, M., Lurie, Y., Macedo, G., Makara, M., Maliakkal, B., Manns, M., Manousou, P., Mantry, P., Marchesini, G., Marinho, C., Marotta, P., Marschall, H. -U., Mayo, M., Mccullen, M., Mclaughlin, W., Merriman, R., Modi, A., Molina, E., Montano-Loza, A., Monteverde, C., Moreea, S., Moreno, C., Morisco, F., Mubarak, A., Muellhaupt, B., Mukherjee, S., Muller, T., Nagorni, A., Naik, J., Neff, G., Nevah, M., Newsome, P., Nguyen-Khac, E., Noureddin, M., Oben, J., Orlent, H., Orr, J., Ortiz-Lasanta, G., Ozenne, V., Pandya, P., Paredes, A., Park, J., Patel, J., Patel, K., Uta, M., Patton, H., Peck-Radosavljevic, M., Petta, S., Pianko, S., Piekarska, A., Pimstone, N., Pockros, P., Pol, S., Porayko, M., Poulos, J., Pound, D., Pouzar, J., Presa Ramos, J., Pyrsopoulos, N., Rafiq, N., Muller, K., Ramji, A., Ravinuthala, R., Reddy, C., Reddy K G, G., Reddy K R, K. R., Regenstein, F., Reindollar, R., Riera, A., Rivera Acosta, J., Robaeys, G., Roberts, S., Rodriguez-Perez, F., Romero-Gomez, M., Rubin, R., Rumi, M., Rushbrook, S., Rust, C., Ryan, M., Safadi, R., Said, A., Salminen, K., Samuel, D., Santoro, J., Sanyal, A., Sarkar, S., Schaeffer, C., Schattenberg, J., Schiefke, I., Schiff, E., Schmidt, W., Schneider, J., Schouten, J., Schultz, M., Sebastiani, G., Semela, D., Sepe, T., Sheikh, A., Sheikh, M., Sherman, K., Shibolet, O., Shiffman, M., Siddique, A., Sieberhagen, C., Sigal, S., Sikorska, K., Simon, K., Sinclair, M., Skoien, R., Solis, J., Sood, S., Souder, B., Spivey, J., Stal, P., Stinton, L., Strasser, S., Svorcan, P., Szabo, G., Talal, A., Tam, E., Tetri, B., Thuluvath, P., Tobias, H., Tomasiewicz, K., Torres, D., Trauner, M., Trautwein, C., Tsochatzis, E., Unitt, E., Vargas, V., Varkonyi, I., Veitsman, E., Vespasiani Gentilucci, U., Victor, D., Vierling, J., Vincent, C., Vincze, A., von der Ohe, M., Von Roenn, N., Vuppalanchi, R., Waters, M., Watt, K., Weltman, M., Wieland, A., Wiener, G., Williams A, A., Williams J, J., Wilson, J., Yataco, M., Yoshida, E., Younes, Z., Yuan, L., Zivony, A., Zogg, D., Zoller, H., Zoulim, F., Zuckerman, E., Zuin, M., Younossi, Zobair M, Ratziu, Vlad, Loomba, Rohit, Rinella, Mary, Anstee, Quentin M, Goodman, Zachary, Bedossa, Pierre, Geier, Andrea, Beckebaum, Susanne, Newsome, Philip N, Sheridan, David, Sheikh, Muhammad Y, Trotter, Jame, Knapple, Whitfield, Lawitz, Eric, Abdelmalek, Manal F, Kowdley, Kris V, Montano-Loza, Aldo J, Boursier, Jerome, Mathurin, Philippe, Bugianesi, Elisabetta, Mazzella, Giuseppe, Olveira, Antonio, Cortez-Pinto, Helena, Graupera, Isabel, Orr, David, Gluud, Lise Lotte, Dufour, Jean-Francoi, Shapiro, David, Campagna, Jason, Zaru, Luna, MacConell, Leigh, Shringarpure, Reshma, Harrison, Stephen, Sanyal, Arun J, Abdelmalek, Manal, Abrams, Gary, Aguilar, Humberto, Ahmed, Aijaz, Aigner, Elmar, Aithal, Guruprasad, Ala, Aftab, Alazawi, William, Albillos, Agustin, Allison, Michael, Al-Shamma, Sfa, Andrade, Raul, Andreone, Pietro, Angelico, Mario, Ankoma-Sey, Victor, Anstee, Quentin, Anty, Rodolphe, Araya, Victor, Arenas Ruiz, Juan Ignacio, Arkkila, Perttu, Arora, Marty, Asselah, Tarik, Au, Jennifer, Ayonrinde, Oyekoya, Bailey, Robert Jame, Balakrishnan, Maya, Bambha, Kiran, Bansal, Meena, Barritt, Sidney, Bate, John, Beato, Jorge, Behari, Jaideep, Bellot, Pablo, Ben Ari, Ziv, Bennett, Michael, Berenguer, Marina, Beretta-Piccoli, Benedetta Terziroli, Berg, Thoma, Bonacini, Maurizio, Bonet, Lucia, Borg, Brian, Bourliere, Marc, Bowman, William, Bradley, David, Brankovic, Marija, Braun, Mariu, Bronowicki, Jean-Pierre, Bruno, Savino, Cai, Cindy, Calleja Panero, José Lui, Carey, Elizabeth, Carmiel, Michal, Carrión, Jose Antonio, Cave, Matthew, Chagas, Cristina, Chami, Tawfik, Chang, Alan, Coates, Allan, Cobbold, Jeremy, Corey, Kathleen, Corless, Lynsey, Crespo, Javier, Cruz Pereira, Oscar, de Ledinghen, Victor, deLemos, Andrew, Diago, Moise, Dufour, Jean-Françoi, Dugalic, Predrag, Dunn, Winston, Elkhashab, Magby, Epstein, Michael, Escudero-Garcia, Maria Desamparado, Etzion, Ohad, Evans, Larry, Falcone, Robert, Fernandez, Conrado, Ferreira, Jose, Fink, Scott, Finnegan, Kevin, Firpi-Morell, Roberto, Floreani, Annarosa, Fontanges, Thierry, Ford, Ryan, Forrest, Ewan, Fowell, Andrew, Fracanzani, Anna Ludovica, Francque, Sven, Freilich, Bradley, Frias, Juan, Fuchs, Michael, Fuentes, Javier, Galambos, Michael, Gallegos, Juan, Geerts, Anja, George, Jacob, Ghali, Maged, Ghalib, Reem, Gholam, Pierre, Gines, Pere, Gitlin, Norman, Goeser, Tobia, Goff, John, Gordon, Stuart, Gordon, Frederic, Goria, Odile, Greer, Shaun, Grigorian, Alla, Gronbaek, Henning, Guillaume, Maeva, Gunaratnam, Naresh, Halegoua-De Marzio, Dina, Hameed, Bilal, Hametner, Stephanie, Hamilton, Jame, Hartleb, Marek, Hassanein, Tarek, Häussinger, Dieter, Hellstern, Paul, Herring, Robert, Heurich, Eva, Hezode, Christophe, Hinrichsen, Holger, Holland Fischer, Peter, Horsmans, Yve, Huang, Jonathan, Jakiche, Antoine, Jeffers, Lennox, Jones, Blake, Jorge, Rosa, Jorquera, Francisco, Kahraman, Alisan, Kaita, Kelly, Karyotakis, Nichola, Kayali, Zeid, Kechagias, Stergio, Kepczyk, Thoma, Khalili, Mandana, Khallafi, Hicham, Kluwe, Johanne, Kohli, Anita, Korenblat, Kevin, Kowdley, Kri, Krag, Aleksander, Krause, Richard, Kremer, Andrea, Krok, Karen, Krstic, Miodrag, Kugelmas, Marcelo, Kumar, Sonal, Labarriere, Damien, Lai, Michelle, Lampertico, Pietro, Lee, Alice, Leroy, Vincent, Lidofsky, Steven, Lim, Tina Huey, Lim, Joseph, Lipkis, Donald, Little, Ester, Lonardo, Amadeo, Long, Michelle, Lurie, Yoav, Macedo, Guilherme, Makara, Mihály, Maliakkal, Benedict, Manns, Michael, Manousou, Pinelopi, Mantry, Parvez, Marchesini, Giulio, Marinho, Carla, Marotta, Paul, Marschall, Hanns-Ulrich, Mayo, Marlyn, McCullen, Mark, McLaughlin, William, Merriman, Raphael, Modi, Apurva, Molina, Esther, Montano-Loza, Aldo, Monteverde, Carlo, Moreea, Sulleman, Moreno, Christophe, Morisco, Filomena, Mubarak, Abdullah, Muellhaupt, Beat, Mukherjee, Sandeep, Müller, Tobia, Nagorni, Aleksandar, Naik, Jahnavi, Neff, Guy, Nevah, Moise, Newsome, Philip, Nguyen-Khac, Eric, Noureddin, Mazen, Oben, Jude, Orlent, Han, Orr, Jame, Ortiz-Lasanta, Grisell, Ozenne, Violaine, Pandya, Prashant, Paredes, Angelo, Park, Jame, Patel, Joykumar, Patel, Keyur, Uta, Merle, Patton, Heather, Peck-Radosavljevic, Marku, Petta, Salvatore, Pianko, Stephen, Piekarska, Anna, Pimstone, Neville, Pockros, Paul, Pol, Stanisla, Porayko, Michael, Poulos, John, Pound, David, Pouzar, Joe, Presa Ramos, Jose, Pyrsopoulos, Nikolao, Rafiq, Nila, Muller, Kate, Ramji, Alnoor, Ravinuthala, Ravi, Reddy, Chakradhar, Reddy K G, Gautham, Reddy K R, K. Rajender, Regenstein, Frederic, Reindollar, Robert, Riera, Andre, Rivera Acosta, Jose, Robaeys, Geert, Roberts, Stuart, Rodriguez-Perez, Federico, Romero-Gomez, Manuel, Rubin, Raymond, Rumi, Mariagrazia, Rushbrook, Simon, Rust, Christian, Ryan, Michael, Safadi, Rifaat, Said, Adnan, Salminen, Kimmo, Samuel, Didier, Santoro, John, Sanyal, Arun, Sarkar, Souvik, Schaeffer, Cynthia, Schattenberg, Jörn, Schiefke, Ingolf, Schiff, Eugene, Schmidt, Wolfgang, Schneider, Jeffrey, Schouten, Jeoffrey, Schultz, Michael, Sebastiani, Giada, Semela, David, Sepe, Thoma, Sheikh, Aasim, Sheikh, Muhammad, Sherman, Kenneth, Shibolet, Oren, Shiffman, Mitchell, Siddique, Asma, Sieberhagen, Cyril, Sigal, Samuel, Sikorska, Katarzyna, Simon, Krzysztof, Sinclair, Marie, Skoien, Richard, Solis, Joel, Sood, Siddharth, Souder, Bob, Spivey, Jame, Stal, Per, Stinton, Laura, Strasser, Simone, Svorcan, Petar, Szabo, Gyongzi, Talal, Andrew, Tam, Edward, Tetri, Brent, Thuluvath, Paul, Tobias, Hillel, Tomasiewicz, Krzysztof, Torres, Dawn, Trauner, Michael, Trautwein, Christian, Tsochatzis, Emanuel, Unitt, Esther, Vargas, Victor, Varkonyi, Istvan, Veitsman, Ella, Vespasiani Gentilucci, Umberto, Victor, David, Vierling, John, Vincent, Catherine, Vincze, Aron, von der Ohe, Manfred, Von Roenn, Natasha, Vuppalanchi, Raj, Waters, Michael, Watt, Kymberly, Weltman, Martin, Wieland, Amanda, Wiener, Gregory, Williams A, Alonzo, Williams J, Jeffrey, Wilson, Jason, Yataco, Maria, Yoshida, Eric, Younes, Ziad, Yuan, Liyun, Zivony, Adam, Zogg, Donald, Zoller, Heinz, Zoulim, Fabien, Zuckerman, Eli, Zuin, Massimo, and REGENERATE Study Investigators
- Subjects
Male ,Biopsy ,Clinical Trial, Phase III ,Administration, Oral ,030204 cardiovascular system & hematology ,Chronic liver disease ,Settore MED/04 ,Biomarkers/analysis ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Liver Function Tests ,Non-alcoholic Fatty Liver Disease ,Clinical endpoint ,Medicine ,030212 general & internal medicine ,610 Medicine & health ,Chenodeoxycholic Acid/administration & dosage ,education.field_of_study ,Liver Function Test ,Research Support, Non-U.S. Gov't ,Fatty liver ,Obeticholic acid ,NASH, OBETICHOLIC ACID ,General Medicine ,Middle Aged ,Multicenter Study ,Randomized Controlled Trial ,Administration ,Female ,Biomarkers ,Chenodeoxycholic Acid ,Double-Blind Method ,Humans ,Human ,Oral ,medicine.medical_specialty ,Population ,Placebo ,03 medical and health sciences ,Research Support, N.I.H., Extramural ,Internal medicine ,Journal Article ,education ,Intention-to-treat analysis ,business.industry ,Biomarker ,Interim analysis ,medicine.disease ,Non-alcoholic Fatty Liver Disease/drug therapy ,chemistry ,Human medicine ,business - Abstract
© 2019 Elsevier Ltd. All rights reserved., Background: Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Methods: In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. Findings: Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). Interpretation: Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes.
- Published
- 2019
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