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1. Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn’s disease: a multicentre, prospective study

Author

Stanley Cohen, Jordi Rimola, Joel G Fletcher, Monika Fischer, David Henry Bruining, Salvatore Oliva, Mark R Fleisher, Linda Cummings, Mukund Venu, Laurel Fisher, Tuba Esfandyari, Kara De Felice, Michael Chiorean, Dario Sorrentino, David Pound, Felix Tiongco, Michael Rice, Pramod Malik, Jack DiPalma, Razvan Arsenescu, Brian Garvin, Carl Raczkowski, Abraham Eliakim, Cristina Carretero Ribon, Leung Wai-Keung, Bruno Rosa, Cristiano Spada, Mattitiahu Waterman, Daniel Mishkin, Blair Lewis, Rendon Nelson, and Werner Dolak

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Introduction Crohn’s disease diagnosis and monitoring remains a great clinical challenge and often requires multiple testing modalities. Assessing Crohn’s disease activity in the entire gastrointestinal (GI) tract using a panenteric capsule endoscopy (CE) system could be used as an alternative to colonoscopy and cross-sectional imaging. This study assessed the accuracy and safety of panenteric CE in Crohn’s disease as compared with ileocolonoscopy (IC) and/or magnetic resonance enterography (MRE).Methods A prospective, multicentre study was performed in subjects with established Crohn’s disease. Individuals with proven small bowel patency underwent a standardised bowel preparation, followed by CE ingestion and IC either the same or following day. MRE, IC, and CE interpretations were performed by blinded central readers using validated scoring systems. The primary endpoint was the overall sensitivity of CE vs MRE and/or IC in Crohn’s disease subjects.Results Study enrolment included 158 subjects from 21 sites in the USA, Austria, and Israel. Of those, 99 were included in the analysis. Imaging modality scores indicated none to mild inflammation in the proximal small bowel and colon, but discrepant levels of inflammation in the terminal ileum. Overall sensitivity for active enteric inflammation (CE vs MRE and/or IC) was 94% vs 100% (p=0.125) and specificity was 74% vs 22% (p=0.001). Sensitivity of CE was superior to MRE for enteric inflammation in the proximal small bowel (97% vs 71%, p=0.021), and similar to MRE and/or IC in the terminal ileum and colon (p=0.500–0.625). There were seven serious adverse advents of which three were related to the CE device.Conclusion Panenteric CE is a reliable tool for assessing Crohn’s disease mucosal activity and extent compared with more invasive methods. This study demonstrates high performance of the panenteric CE as compared to MRE and/or IC without the need for multiple tests in non-stricturing Crohn’s disease.Trial registration number ClinicalTrials.gov NCT03241368

Published
2020
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2. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort

Author

Arun J. Sanyal, Breda Munoz, Kenneth Cusi, A. Sidney Barritt, Mark Muthiah, Andrea R. Mospan, K. Rajender Reddy, Roberto Firpi-Morell, Paul J. Thuluvath, Kalyan Ram Bhamidimarri, Michael W. Fried, Manal Abdelmalek, Humberto Aguilar, Aijaz Ahmed, Alina Allen, Sarah Barlow, Sid Barritt, David Bernstein, Kaylan Bhamidimarri, Liana Billings, Kyle Brown, Robert Brown, Karen Corbin, Andrew deLemos, Karan Emerick, Maged Adel Ghali, Zachary Henry, Whitney Jackson, Sujit Janardhan, Mohammad Kabbany, Nyingi Kemmer, David Koch, Justin Kupec, Charles Landis, Mary Katherine Lawrence, Cynthia Levy, Steven Lidofsky, Anna Lok, Velimir Luketic, Enrique Martinez, Craig McClain, Patrick McKiernan, Ellen Mitchell, Mazen Noureddin, Sirish Palle, Yen Pham, David Pound, Rajender Reddy, Fredric Regenstein, Mary Rinella, Fedja Rochling, Bryan Rudolph, Vinod Rustgi, Adnan Said, Niharika Samala, Souvik Sarkar, Kenneth Sherman, Mitchell Shiffman, Coleman Smith, Jawahar Taunk, Brent Tetri, Paul Thuluvath, Huy Trinh, Elizabeth Verna, Miriam Vos, L. Michael Weiss, Mark Wong, Kathleen Wyne, and Stavra Xanthakos

Subjects
Hepatology, Gastroenterology
Published
2023
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3. Multicentre, prospective, randomised study comparing the diagnostic yield of colon capsule endoscopy versus CT colonography in a screening population (the TOPAZ study)

Author

Neofytos P. Papageorgiou, Mark R Fleisher, Steven Fern, Elizabeth Rajan, Brooks D. Cash, David Pound, Ignacio Fernandez-Urien, David Kastenberg, Ira Schmelkin, Robyn Haithcock, and Douglas K. Rex

Subjects
Male, Screening test, Population, Colonic Polyps, Capsule Endoscopy, law.invention, 03 medical and health sciences, 0302 clinical medicine, Capsule endoscopy, law, Clinical endpoint, Humans, Mass Screening, Medicine, Prospective Studies, 030212 general & internal medicine, education, Trial registration, Aged, education.field_of_study, Average risk, business.industry, Gastroenterology, Middle Aged, digestive system diseases, Optical colonoscopy, Colorectal cancer screening, Female, 030211 gastroenterology & hepatology, Colorectal Neoplasms, Nuclear medicine, business, Colonography, Computed Tomographic
Abstract

ObjectiveColon capsule endoscopy (CCE) has shown promise for colorectal neoplasia detection compared with optical colonoscopy (OC), but has not been compared with other screening tests in average risk screening patients.DesignPatients 50 to 75 years of age (African Americans, 45–75 years) were randomised to CCE or CT colonography (CTC) and subsequent blinded OC. The primary endpoint was diagnostic yield of polyps ≥6 mm with CCE or CTC. Secondary endpoints included accuracy for size and histology, examination completeness, number/proportion of subjects with polyps and adenomas ≥6 mm and ≥10 mm, subject satisfaction and safety.ResultsFrom 320 enrolled subjects, data from 286 (89.4%) were evaluable. The proportion of subjects with any polyp ≥6 mm confirmed by OC was 31.6% for CCE versus 8.6% for CTC (pPr non-inferiority and superiority=0.999). The diagnostic yield of polyps ≥10 mm was 13.5% with CCE versus 6.3% with CTC (pPr non-inferiority=0.9954). The sensitivity and specificity of CCE for polyps ≥6 mm was 79.2% and 96.3% while that of CTC was 26.8% and 98.9%. The sensitivity and specificity of CCE for polyps ≥10 mm was 85.7% and 98.2% compared with 50% and 99.1% for CTC. Both tests were well tolerated/safe.ConclusionCCE was superior to CTC for detection of polyps ≥6 mm and non-inferior for identification of polyps ≥10 mm. CCE should be considered comparable or superior to CTC as a colorectal neoplasia screening test, although neither test is as effective as OC.Trial registration numberClinicalTrials.gov no: NCT02754661.

Published
2020
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4. Multicenter, randomized study to optimize bowel for colon capsule endoscopy

Author

Carly E. Sokach, Neofytos P. Papageorgiou, David Kastenberg, Wilmot C Burch, Ignacio Fernández-Urién Sainz, Douglas K. Rex, David Pound, Pankaj K. Kashyap, and David P. Romeo

Subjects
medicine.medical_specialty, medicine.medical_treatment, Colon cleansing, Cathartic, Colonoscopy, Diatrizoate, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Capsule endoscopy, law, Internal medicine, Medicine, Large intestine, medicine.diagnostic_test, business.industry, General Medicine, Regimen, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Diatrizoate Meglumine, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

AIM To assess the cleansing efficacy and safety of a new Colon capsule endoscopy (CCE) bowel preparation regimen. METHODS This was a multicenter, prospective, randomized, controlled study comparing two CCE regimens. Subjects were asymptomatic and average risk for colorectal cancer. The second generation CCE system (PillCam® COLON 2; Medtronic, Yoqneam, Israel) was utilized. Preparation regimens differed in the 1st and 2nd boosts with the Study regimen using oral sulfate solution (89 mL) with diatrizoate meglumine and diatrizoate sodium solution ("diatrizoate solution") (boost 1 = 60 mL, boost 2 = 30 mL) and the Control regimen oral sulfate solution (89 mL) alone. The primary outcome was overall and segmental colon cleansing. Secondary outcomes included safety, polyp detection, colonic transit, CCE completion and capsule excretion ≤ 12 h. RESULTS Both regimens had similar cleansing efficacy for the whole colon (Adequate: Study = 75.9%, Control = 77.3%; P = 0.88) and individual segments. In the Study group, CCE completion was superior (Study = 90.9%, Control = 76.9%; P = 0.048) and colonic transit was more often < 40 min (Study = 21.8%, Control = 4%; P = 0.0073). More Study regimen subjects experienced adverse events (Study = 19.4%, Control = 3.4%; P = 0.0061), and this difference did not appear related to diatrizoate solution. Adverse events were primarily gastrointestinal in nature and no serious adverse events related either to the bowel preparation regimen or the capsule were observed. There was a trend toward higher polyp detection with the Study regimen, but this did not achieve statistical significance for any size category. Mean transit time through the entire gastrointestinal tract, from ingestion to excretion, was shorter with the Study regimen while mean colonic transit times were similar for both study groups. CONCLUSION A CCE bowel preparation regimen using oral sulfate solution and diatrizoate solution as a boost agent is effective, safe, and achieved superior CCE completion.

Published
2017
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5. Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

Author

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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6. 479 A MULTICENTER, PROSPECTIVE, RANDOMIZED STUDY COMPARING THE DIAGNOSTIC YIELD OF COLON CAPSULE ENDOSCOPY VERSUS COMPUTED TOMOGRAPHIC COLONOGRAPHY IN A SCREENING POPULATION. RESULTS OF THE TOPAZ STUDY

Author

Brooks D. Cash, Mark R. Fleisher, Ignacio Fernandez-Urien, Steven Fern, Doug Rex, Alain Hyman, Elizabeth Rajan, David Kastenberg, David Pound, Neofytos P. Papageorgiou, Joseph Maklansky, and Robyn Haithcock

Subjects
education.field_of_study, Yield (engineering), business.industry, Population, Gastroenterology, engineering.material, law.invention, Topaz, Capsule endoscopy, law, engineering, Medicine, Radiology, Nuclear Medicine and imaging, Computed Tomographic Colonography, Prospective randomized study, business, Nuclear medicine, education
Published
2019
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7. Safety and tolerability of ledipasvir/sofosbuvir with and without ribavirin in patients with chronic hepatitis C virus genotype 1 infection: Analysis of phase III ION trials

Author

Stuart C. Gordon, Stefan Zeuzem, Kris V. Kowdley, Alessandra Mangia, John G. McHutchison, Saleh A. Alqahtani, Mark S. Sulkowski, Xiao Ding, K. Rajender Reddy, Michael W. Fried, Patrick Marcellin, Jenny C. Yang, Nezam H. Afdhal, Paul Y. Kwo, Phillip S. Pang, and David Pound

Subjects
Adult, Liver Cirrhosis, Male, Ledipasvir, medicine.medical_specialty, Adolescent, Genotype, Sofosbuvir, Hepatitis C virus, Hepacivirus, medicine.disease_cause, Antiviral Agents, Gastroenterology, Young Adult, chemistry.chemical_compound, Internal medicine, Ribavirin, medicine, Humans, Adverse effect, Aged, Aged, 80 and over, Fluorenes, Hepatology, business.industry, Hepatitis C, Hepatitis C, Chronic, Middle Aged, medicine.disease, Surgery, chemistry, Tolerability, Concomitant, Benzimidazoles, Drug Therapy, Combination, Female, Uridine Monophosphate, business, medicine.drug
Abstract

In phase III studies, treatment with the once-daily fixed-dose combination tablet of ledipasvir/sofosbuvir (LDV/SOF) with and without ribavirin (RBV) resulted in high rates of sustained virological response (SVR) in patients chronically infected with genotype 1 hepatitis C virus, including those with compensated cirrhosis. We conducted an analysis of data from these trials to compare the safety and tolerability profile of LDV-SOF with and without RBV. We analyzed treatment-emergent adverse events (AEs) and laboratory abnormalities in patients who were randomized to 8, 12, and 24 weeks of LDV/SOF with or without RBV. In total, data from 1,952 patients (of whom 872 received LDV/SOF with RBV and 1,080 received LDV/SOF alone) were analyzed. Overall, 308 patients (16%) were African American, 224 (11%) had compensated cirrhosis, 501 (26%) had a body mass index ≥30 kg/m2, and 440 (23%) were treatment experienced. Treatment-related AEs occurred in 71% and 45% of patients treated with and without RBV, respectively, including fatigue, insomnia, irritability, and rash/pruritus. Patients receiving RBV with LDV/SOF were more likely to require dose modification, interruptions of treatment resulting from AEs, or require the use of concomitant medications than those receiving LDV/SOF alone. Rates of treatment-related serious AEs and discontinuations resulting from AEs were similarly low (

Published
2015
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8. Resistance-associated amino acid variants associated with boceprevir plus pegylated interferon-α2b and ribavirin in patients with chronic hepatitis C in the SPRINT-1 Trial F

Author

John M. Vierling, Stuart C. Gordon, David Pound, Paul Y. Kwo, M. Davis, Eric Lawitz, Richard J. O. Barnard, Natarajan Ravendhran, Ira M. Jacobson, Eugene R. Schiff, Daria J. Hazuda, Jonathan McCone, Lorenzo Rossaro, Anita Y. M. Howe, John A. Howe, Eirum Chaudhri, Janice K. Albrecht, Ping Qiu, Lisa D. Pedicone, Robert Ralston, Clifford A. Brass, and Robert A. Ogert

Subjects
medicine.medical_specialty, animal structures, Genotype, Proline, Hepacivirus, Population, Alpha interferon, Interferon alpha-2, Gastroenterology, Polyethylene Glycols, law.invention, chemistry.chemical_compound, Randomized controlled trial, Recurrence, Pegylated interferon, law, Internal medicine, Boceprevir, Drug Resistance, Viral, Ribavirin, medicine, Humans, education, education.field_of_study, biology, business.industry, Interferon-alpha, General Medicine, Hepatitis C, Hepatitis C, Chronic, biology.organism_classification, medicine.disease, Recombinant Proteins, Treatment Outcome, Amino Acid Substitution, chemistry, RNA, Viral, Drug Therapy, Combination, business, medicine.drug
Abstract

BACKGROUND Resistance to direct-acting antivirals represents a new challenge in the treatment of chronic hepatitis C. METHODS SPRINT-1 was a randomized study of treatment-naive patients with genotype (G) 1 hepatitis C infection (n=595) that evaluated the safety and efficacy of boceprevir (BOC) when added to pegylated interferon-α2b plus ribavirin (PR). Plasma samples collected at protocol-specified visits were analysed by population sequencing for detection of BOC-associated resistance-associated variants (RAVs). RESULTS A total of 17/24 (71%) patients randomized to BOC with baseline RAVs achieved sustained virological response (SVR). V55A/I (n=14), Q41H (n=11) and T54S (n=9) were the most frequently detected polymorphisms at baseline. Seven non-SVR patients with baseline RAVs had V55A (relapse, n=3; breakthrough, n=1; and non-response, n=1) and/or R155K (non-response, n=2). In total, 63/144 (44%) patients with sequenced post-baseline samples (2 SVR, 61 non-SVR) had detectable RAVs after BOC treatment (G1a: R155K [39/49; 80%], V36M [37/49; 76%] and T54S [24/49; 49%]; G1b: T54S [3/11; 27%], T54A [4/11; 35%], A156S [2/11; 18%] and V170A [2/11; 18%]). RAV frequency varied according to the virological response: 90%, 67%, 27% and 37% of breakthrough, incomplete virological response, relapse and non-responder patients, respectively, had post-baseline RAVs present. Similar RAVs were identified in both the PR lead-in and no-lead-in arms and the frequency of post-baseline RAVs was highest in the low-dose ribavirin arm. CONCLUSIONS SVR rates were not compromised among patients with RAVs at baseline; however, a lower starting mg/kg dose of ribavirin was associated with a higher frequency of post-baseline RAVs.

Published
2013
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9. Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-Label, Phase 2 Trial

Author

Luisa M. Stamm, David E. Bernstein, Maribel Rodríguez-Torres, Naoky Tsai, Hadas Dvory-Sobol, John G. McHutchison, Paul Y. Kwo, John E. Poulos, Myron J. Tong, M. Davis, Stuart C. Gordon, Diana M. Brainard, Gregory T. Everson, Kris V. Kowdley, Raymond T. Chung, Edward Gane, Catherine A.M. Stedman, David Pound, K.P. Etzkorn, Mindie H. Nguyen, Omer Khalid, Kimberly L. Beavers, Sophia Lu, and Jenny C. Yang

Subjects
Cyclopropanes, Male, Cirrhosis, Aminoisobutyric Acids, Sofosbuvir, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Non-Genotype 1 HCV, 0302 clinical medicine, 030212 general & internal medicine, Aged, 80 and over, Sulfonamides, Hepatitis C, Middle Aged, Clinical Trial, Drug Combinations, Treatment Outcome, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Female, medicine.drug, Adult, medicine.medical_specialty, Macrocyclic Compounds, Adolescent, Genotype, Proline, Hepatitis C virus, Voxilaprevir, Lactams, Macrocyclic, Direct-Acting Antiviral, Sofosbuvir/velpatasvir, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, Drug Administration Schedule, 03 medical and health sciences, Young Adult, Leucine, Internal medicine, Quinoxalines, medicine, Humans, Adverse effect, DAA, Aged, Hepatology, business.industry, Hepatitis C, Chronic, medicine.disease, Regimen, Immunology, Carbamates, Serine Proteases, business, Follow-Up Studies
Abstract

Background & Aims Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections whose prior course of antiviral therapy has failed, and the feasibility of shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients. Methods We performed a multicenter, open-label trial at 32 sites in the United States and 2 sites in New Zealand from March 3, 2015 to April 27, 2015. Our study included 128 treatment-naive and treatment-experienced patients (1 with HCV genotype 1b; 33 with HCV genotype 2; 74 with HCV genotype 3; 17 with genotype HCV 4; and 3 with HCV genotype 6), with or without compensated cirrhosis. All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination tablet) and GS-9857 (100 mg) once daily for 6–12 weeks. The primary end point was sustained virologic response 12 weeks after treatment (SVR12). Results After 6 weeks of treatment, SVR12s were achieved by 88% of treatment-naive patients without cirrhosis (29 of 33; 95% confidence interval, 72%–97%). After 8 weeks of treatment, SVR12s were achieved by 93% of treatment-naive patients with cirrhosis (28 of 30; 95% CI, 78%–99%). After 12 weeks of treatment, SVR12s were achieved by all treatment-experienced patients without cirrhosis (36 of 36; 95% CI, 90%–100%) and 97% of treatment-experienced patients with cirrhosis (28 of 29; 95% CI, 82%–100%). The most common adverse events were headache, diarrhea, fatigue, and nausea. Three patients (1%) discontinued treatment due to adverse events. Conclusions In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatment-naive patients or 12 weeks in treatment-experienced patients) to be safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis. ClinicalTrials.gov ID: NCT02378961.

Published
2016

10. Peginterferon alfa-2b and weight-based or flat-dose ribavirin in chronic hepatitis C patients: A randomized trial

Author

Stuart C. Gordon, Rvikumar Vemuru, Mark Eisner, Jay Cowan, James Ehrlich, Alain Ades, Clifford A. Brass, Micheal David Bernstein, Steve Chen, Donald Hillebrand, Donald Wadland, Lyle Shlager, C. Smith, Lou Gelrud, Mark Levstik, Helen Wong, Stephen A. Harrison, Andrew Nelson, Raj Bhandari, David Dies, Mordechai Rabinovitz, Edward A. Galen, B. Freilich, K. Digregorio, Curt Hagendom, Thomas Hargrave, Paul Bermanski, David Maccini, Samuel B. Ho, Ronald Pruitt, Terence Reisman, Thomas Allen, Robert S. Brown, Michael Cox, David Schulman, Ramsey Cheung, Fred Kilby, J. Lynn Cochran, Thomas McDonald, James Thornton, John Jolley, John Serini, Albert D. Min, Fredrich Loura, Lino Deguzman, Luis Marsano, Robert Finkel, Helen S. Te, Michael G Rahmin, Mark Jonas, Kip Lyche, Jean Luc Szpakowski, George Abraham, Alex D. Lee, Pabak Mukhopadhyay, Firdous Siddiqui, Robert Strauss, William Kaplan, Michael Ryan, Eliot Godofsky, Stephen J. Lanspa, Lawton Shick, Jose Franco, Louis Griffel, Rise Stribling, Avanish Aggarwal, Clive Albert, Thomas Rosenfield, Rockford Yapp, Vijay Balan, Arthur Berman, Nezam H. Afdhal, Maurice Cerulli, Paul Yudelman, Robert Herring, Donate Ricci, Michael Henry, Michael Bloom, Daniel Meline, Barry Migicovsky, Peter Varunok, Peter W Gardner, Gerald Siciliano, Natarjan Bala, Craig J. Peine, P. Kwo, Thomas Noble, David F. Stein, Thuan T. Nguyen, Geoffrey Zucker, Julie E Spivack, John Kichner, Robert G. Gish, Michael Fried, Murali Shankar, Norman Gitlin, James E. Nelson, David Hurwich, Darrell Schwertner, Ronald Wasserman, Douglas D. Dalke, Thai Van Pham, Geronimo Sahagun, Norah A. Terrault, Naoky Tsai, Steven Han, Tarek Hassanein, Thomas Sepe, Seth Richter, Howard Paul Monsour, Micheal Lyons, R. Agrawal, Bennett Cecil, Joseph Polito, Douglas Levin, James Srour, Allan Weston, Larry Weprin, Raymond Kenny, Edward Lebovics, Michael Demicco, Terry Box, Kenneth Diamond, Lawrence Kim, Stephen Kelly, Martin Black, Jeffrey Fenyves, Ellen Shaw, Raymond A. Rubin, James E. Cox, Franco Felizarta, John E. Gross, Ira Lobis, David H. Van Thiel, Bonnie Bock, Lawrence Stein, James D. Lewis, Steven Palley, Ronald Rinker, Joanna Ready, Vinod K. Rustgi, Michael Epstein, David H Berman, Gary Matusow, Walid Baddoura, Gerond Lake-Bakaar, John S. Goff, Scott Wiesen, Neil Brodsky, Fredric Regenstein, Arnold Levin, Bhupinder S. Anand, Stephen Esposito, K. Rajender Reddy, Lisa Ozick, Adil E. Wakil, Karl Esrason, Pierre Nader, David Nunes, David Feldman, K. Ganeshappa, Alan Fixelle, Martha Ghosh, Douglas Brouillette, Victor Araya, Hillel Tobias, David Pound, Louis R. Lambiase, S. Lawrence Rothman, Mark J. Murphy, Jonathan David, James Levin, Steve Carlson, Nathan Kam, Michael S. Dragutsky, Trong Nguyen Tuan, Graham Woolf, Whit Knapple, Donna Goldman, Kenneth R. DeVault, Simon Cofrancesco, Mitchell L. Shiffman, Charles Bedard, Paul Y. Kwo, Rodger Perez, Steven L. Flamm, Keith Tolman, Hulya Levendoglu, Timothy Cavacini, Robert Reindollar, Vance VanDrake, Donald M. Jensen, David Winston, Robert A. Levine, Robert Manning, John R. Lake, John J. Santoro, Scott Becker, Mary Pat Pauly, John M. Vierling, Joseph DePasquale, Jorge Herrera, Diana Sylvestre, Natarajan Ravendhran, Mark Smith, Kevin Dye, M. Davis, Frank Klion, Kevin Behrle, Alan Epstein, William Lyles, Brian K. Hudes, Greg Galler, David I. Bernstein, Jonathon Jensen, Jeffery Cooley, Thomas J. Layden, Carl D'Angelo, Fredric D. Gordon, Myron Brand, David Gabbazaideh, Leon Rigberg, Neville R. Pimstone, Jonathan McCone, Ira M. Jacobson, Tim M Jenkins, John W. King, Harry Matossian, William A. Ross, and Rudra Rai

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Genotype, Hepatitis C virus, Alpha interferon, Hepacivirus, Interferon alpha-2, medicine.disease_cause, Antiviral Agents, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, Pegylated interferon, Internal medicine, Ribavirin, medicine, Humans, Prospective Studies, Interferon alfa, Aged, Dose-Response Relationship, Drug, Hepatology, business.industry, Body Weight, Interferon-alpha, Middle Aged, Hepatitis C, Recombinant Proteins, Surgery, Treatment Outcome, chemistry, RNA, Viral, Peginterferon alfa-2b, Drug Therapy, Combination, Female, business, Viral load, medicine.drug
Abstract

This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 μg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [

Published
2007
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11. A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for Colon Capsule Endoscopy: 2016 ACG Presidential Poster Award

Author

David Pound, Douglas K. Rex, David P. Romeo, Wilmot C Burch, Pankaj K. Kashyap, and David Kastenberg

Subjects
medicine.medical_specialty, Regimen, Hepatology, Randomized controlled trial, Capsule endoscopy, law, business.industry, Gastroenterology, Bowel preparation, medicine, business, law.invention, Surgery
Published
2016
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12. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis

Author

Kris V, Kowdley, Stuart C, Gordon, K Rajender, Reddy, Lorenzo, Rossaro, David E, Bernstein, Eric, Lawitz, Mitchell L, Shiffman, Eugene, Schiff, Reem, Ghalib, Michael, Ryan, Vinod, Rustgi, Mario, Chojkier, Robert, Herring, Adrian M, Di Bisceglie, Paul J, Pockros, G Mani, Subramanian, Di, An, Evguenia, Svarovskaia, Robert H, Hyland, Phillip S, Pang, William T, Symonds, John G, McHutchison, Andrew J, Muir, David, Pound, Michael W, Fried, and Ziad, Younes

Subjects
Simeprevir, Ledipasvir, Adult, Male, medicine.medical_specialty, Sofosbuvir, Genotype, Voxilaprevir, Hepacivirus, Gastroenterology, Antiviral Agents, Drug Administration Schedule, chemistry.chemical_compound, Young Adult, Internal medicine, Drug Resistance, Viral, Ribavirin, medicine, Humans, Aged, Fluorenes, business.industry, General Medicine, Hepatitis C, Hepatitis C, Chronic, Middle Aged, Viral Load, medicine.disease, Regimen, chemistry, Paritaprevir, Immunology, RNA, Viral, Benzimidazoles, Drug Therapy, Combination, Female, business, Uridine Monophosphate, medicine.drug
Abstract

BACKGROUND High rates of sustained virologic response were observed among patients with hepatitis C virus (HCV) infection who received 12 weeks of treatment with the nucleotide polymerase inhibitor sofosbuvir combined with the NS5A inhibitor ledipasvir. This study examined 8 weeks of treatment with this regimen. METHODS In this phase 3, open-label study, we randomly assigned 647 previously untreated patients with HCV genotype 1 infection without cirrhosis to receive ledipasvir and sofosbuvir (ledipasvir–sofosbuvir) for 8 weeks, ledipasvir–sofosbuvir plus ribavirin for 8 weeks, or ledipasvir–sofosbuvir for 12 weeks. The primary end point was sustained virologic response at 12 weeks after the end of therapy. RESULTS The rate of sustained virologic response was 94% (95% confidence interval [CI], 90 to 97) with 8 weeks of ledipasvir–sofosbuvir, 93% (95% CI, 89 to 96) with 8 weeks of ledipasvir–sofosbuvir plus ribavirin, and 95% (95% CI, 92 to 98) with 12 weeks of ledipasvir–sofosbuvir. As compared with the rate of sustained virologic response in the group that received 8 weeks of ledipasvir–sofosbuvir, the rate in the 12-week group was 1 percentage point higher (97.5% CI, −4 to 6) and the rate in the group that received 8 weeks of ledipasvir–sofosbuvir with ribavirin was 1 percentage point lower (95% CI, −6 to 4); these results indicated noninferiority of the 8-week ledipas vir–sofosbuvir regimen, on the basis of a noninferiority margin of 12 percentage points. Adverse events were more common in the group that received ribavirin than in the other two groups. No patient who received 8 weeks of only ledipasvir–sofosbuvir discontinued treatment owing to adverse events. CONCLUSIONS Ledipasvir–sofosbuvir for 8 weeks was associated with a high rate of sustained virologic response among previously untreated patients with HCV genotype 1 infection without cirrhosis. No additional benefit was associated with the inclusion of ribavirin in the regimen or with extension of the duration of treatment to 12 weeks. (Funded by Gilead Sciences; ION-3 ClinicalTrials.gov number, NCT01851330.)

Published
2014

13. High Efficacy of Sofosbuvir/Velpatasvir Plus GS-9857 for 12 Weeks in Treatment-Experienced Genotype 1-6 HCV-Infected Patients, Including Those Previously Treated with Direct-Acting Antivirals

Author

Ronald Nahass, M. Davis, J.C. Yang, Federico Hinestrosa, E.J. Gane, Robert Herring, Mindie H. Nguyen, R.T. Chung, Eugene R. Schiff, Maribel Rodriguez-Torres, Ziad Younes, Di An, Michael P. Curry, Kris V. Kowdley, David Pound, Paul Y. Kwo, D.M. Brainard, Nancy Reau, Kyle Etzkorn, T.T. Tran, L.M. Stamm, John G. McHutchison, K.R. Reddy, Ira M. Jacobson, M. Bennet, Hadas Dvory-Sobol, and Eric Lawitz

Subjects
0301 basic medicine, Hepatology, business.industry, DIRECT ACTING ANTIVIRALS, Sofosbuvir/velpatasvir, Virology, Treatment experienced, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Genotype, Medicine, 030211 gastroenterology & hepatology, business, Previously treated
Published
2016
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14. High Efficacy of Sofosbuvir/Velpatasvir Plus GS-9857 for 12 Weeks in Treatment-Experienced Genotype 1-6 HCV-Infected Patients, Including Those Previously Treated with Direct-Acting Antivirals: 2016 ACG Presidential Poster Award

Author

Ronald Nahass, Kris V. Kowdley, Eugene R. Schiff, Rajender Reddy, John G. McHutchison, Jenny C. Yang, Robert Herring, Maribel Rodriguez-Torres, Raymond T. Chung, Edward Gane, Joseph Llewellyn, Tram Tran, Frederico Hinestrosa, Michael P. Curry, David Pound, Luisa M. Stamm, Mindie H. Nguyen, Kyle Etzkorn, Paul Y. Kwo, Nancy Reau, Ira M. Jacobson, Diana M. Brainard, M. Davis, Erik Lawitz, and Michael B. Bennett

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Genotype, Gastroenterology, medicine, Previously treated, business, DIRECT ACTING ANTIVIRALS, Sofosbuvir/velpatasvir, Treatment experienced
Published
2016
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15. O56 SOFOSBUVIR/LEDIPASVIR WITH AND WITHOUT RIBAVIRIN FOR 8 WEEKS COMPARED TO SOFOSBUVIR/LEDIPASVIR FOR 12 WEEKS IN TREATMENT-NAÏVE NON-CIRRHOTIC GENOTYPE-1 HCV-INFECTED PATIENTS: THE PHASE 3 ION-3 STUDY

Author

William T. Symonds, David E. Bernstein, John G. McHutchison, David Pound, Michael Fried, Andrew J. Muir, G.C. Stuart, Rajender Reddy, Robert H. Hyland, E.S. Svarovskaia, Paul J. Pockros, Di An, Kris V. Kowdley, P.S. Pang, and Lorenzo Rossaro

Subjects
Ledipasvir, medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Ribavirin, Gastroenterology, Therapy naive, chemistry.chemical_compound, chemistry, Internal medicine, Genotype, medicine, business, medicine.drug
Published
2014
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16. Flexible sigmoidoscopy plus air contrast barium enema versus colonoscopy for suspected lower gastrointestinal bleeding

Author

Robert H. Hawes, Lawrence Lumeng, John C. Lappas, Douglas K. Rex, Glen A. Lehman, Katherine W. O'Connor, Robert S. Dittus, David Pound, and Richard A. Weddle

Subjects
Male, medicine.medical_specialty, Lower gastrointestinal bleeding, Cost-Benefit Analysis, medicine.medical_treatment, Colonic Polyps, Colonoscopy, Rectum, Enema, Gastroenterology, Colonic Diseases, chemistry.chemical_compound, Internal medicine, medicine, Humans, Sigmoidoscopy, Randomized Controlled Trials as Topic, Barium enema, Hepatology, medicine.diagnostic_test, business.industry, Middle Aged, medicine.disease, digestive system diseases, Surgery, Diverticulosis, Pneumoradiography, Barium sulfate, medicine.anatomical_structure, chemistry, Female, Barium Sulfate, Gastrointestinal Hemorrhage, business
Abstract

A randomized, controlled trial was performed to compare the diagnostic yields and cost-effectiveness of two strategies for the evaluation of nonemergent lower gastrointestinal bleeding. Three hundred eighty patients aged greater than or equal to 40 yr were randomized to undergo initial flexible sigmoidoscopy plus air contrast barium enema or colonoscopy; 332 completed the initial studies. Initial colonoscopy detected more cases of polyps less than 9 mm in size, adenomas, and arteriovenous malformations but fewer cases of diverticulosis. No significant difference was found between strategies in the number of patients detected with cancers or polyps greater than or equal to 9 mm in size. In both strategies, cancers were more common in subjects aged greater than or equal to 55 yr (8% overall) than in those aged less than 55 yr (1%). Among patients aged less than 55 yr with suspected lower gastrointestinal bleeding, initial flexible sigmoidoscopy plus air contrast barium enema is a more cost-effective strategy for the detection of colonic neoplasms than initial colonoscopy. However, initial colonoscopy is more cost effective for those aged greater than or equal to 55 yr.

Published
1990
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17. 764 Sofosbuvir/Ledipasvir With and Without Ribavirin for 8 Weeks Compared to Sofosbuvir/Ledipasvir for 12 Weeks in Treatment-Naive Non-Cirrhotic Genotype-1 HCV-Infected Patients: The Phase 3 Ion-3 Study

Author

Rob H. Hyland, Stuart C. Gordon, Andrew J. Muir, Di An, Kris V. Kowdley, Evguenia S. Svarovskaia, K. Rajender Reddy, William T. Symonds, John G. McHutchison, Lorenzo Rossaro, David I. Bernstein, Paul J. Pockros, David Pound, Michael Fried, and Phil Pang

Subjects
Ledipasvir, medicine.medical_specialty, Hepatology, Sofosbuvir, business.industry, Ribavirin, Gastroenterology, Therapy naive, chemistry.chemical_compound, chemistry, Internal medicine, Genotype, medicine, business, medicine.drug
Published
2014
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18. 2016 LONG-TERM OUTCOMES FOLLOWING COMBINATION TREATMENT WITH BOCEPREVIR PLUS PEG-INTRON/RIBAVIRIN (P/R) IN PATIENTS WITH CHRONIC HEPATITIS C, GENOTYPE 1 (CHC-G1)

Author

E.J. Lawitz, R. Ralston, Jonathan McCone, Joseph S. Galati, John M. Vierling, Lorenzo Rossaro, Natarajan Ravendhran, W. Cassidy, David Pound, S.C. Gordon, M. Davis, R. Esteban-Mur, Greg Galler, Marc Bourlière, Ira M. Jacobson, John W. King, Janice K. Albrecht, Patricia Mendez, Clifford A. Brass, and Frank H. Anderson

Subjects
medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Intron, Gastroenterology, chemistry.chemical_compound, chemistry, Chronic hepatitis, Internal medicine, Boceprevir, PEG ratio, Genotype, Long term outcomes, medicine, In patient, business
Published
2010
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19. BIOAVAILABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF TORSEMIDE IN PATIENTS WITH CIRRHOSIS

Author

D Craig Brater, William G. Kramer, David Rudy, David Pound, Paula K Green, Steven Schwartz, and University of Groningen

Subjects
Adult, Liver Cirrhosis, Male, Cirrhosis, medicine.medical_treatment, Administration, Oral, Biological Availability, Pharmacology, FUROSEMIDE, Pharmacokinetics, medicine, Humans, Pharmacology (medical), HEPATIC CIRRHOSIS, Diuretics, Aged, Volume of distribution, Sulfonamides, business.industry, Furosemide, Torsemide, Middle Aged, medicine.disease, Bioavailability, Pharmacodynamics, Injections, Intravenous, Female, TORASEMIDE, ASCITES, Diuretic, business, Half-Life, medicine.drug
Abstract

The bioavailability, pharmacokinetics, and pharmacodynamics of torsemide (10 mg orally and intravenously) were determined in a randomized crossover clinical trial with 12 patients with ascites caused by cirrhosis. Torsemide was rapidly absorbed with a bioavailability of 96.3% (confidence interval, 84% to 109%). Compared with healthy subjects, patients with cirrhosis exhibit a decrease in nonrenal clearance and increases in bioavailability, volume of distribution, renal clearance, elimination half-life, and percentage of the dose excreted into the urine. A greater proportion of the dose is delivered to the site of action over a more prolonged period of time. In spite of a shift of the pharmacodynamic curve to the right in patients with cirrhosis, there was no significant difference in natriuresis. Pharmacokinetic changes of torsemide in cirrhosis therefore compensate for the pharmacodynamic abnormality.

Published
1993

20. 4 HCV SPRINT-1 FINAL RESULTS: SVR 24 FROM A PHASE 2 STUDY OF BOCEPREVIR PLUS PEGINTRON™ (PEGINTERFERON ALFA-2B)/RIBAVIRIN IN TREATMENT- NAIVE SUBJECTS WITH GENOTYPE-1 CHRONIC HEPATITIS C

Author

S.C. Gordon, P. Kwo, Ira M. Jacobson, Jonathan McCone, Natarajan Ravendhran, M. Davis, David Pound, E. Chaudhri, John M. Vierling, Kenneth Koury, Janice K. Albrecht, Frank H. Anderson, Clifford A. Brass, Eugene R. Schiff, Joseph S. Galati, R. Rubin, Lorenzo Rossaro, and E.J. Lawitz

Subjects
medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Phases of clinical research, Gastroenterology, Therapy naive, chemistry.chemical_compound, Chronic hepatitis, Sprint, chemistry, Boceprevir, Internal medicine, Genotype, medicine, Peginterferon alfa-2b, business, medicine.drug
Published
2009
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21. 995 INTERIM RESULTS FROM HCV SPRINT-1: RVR/EVR FROM PHASE 2 STUDY OF BOCEPREVIR PLUS PEGINTRONTM (PEGINTERFERON ALFA-2B)/RIBAVIRIN IN TREATMENT-NAIVE SUBJECTS WITH GENOTYPE-1 CHC

Author

Jonathan McCone, Lisa D. Pedicone, P. Mukhopadhyay, P. Kwo, David Pound, E. Chaudhri, Eugene R. Schiff, John M. Vierling, Natarajan Ravendhran, Frank H. Anderson, S.C. Gordon, Janice K. Albrecht, Ira M. Jacobson, Joseph S. Galati, E.J. Lawitz, R. Rubin, M. Davis, and Lorenzo Rossaro

Subjects
medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Phases of clinical research, Gastroenterology, Therapy naive, chemistry.chemical_compound, chemistry, Sprint, Internal medicine, Boceprevir, Interim, Genotype, medicine, Peginterferon alfa-2b, business, medicine.drug
Published
2008
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22. Transmission of idiopathic (autoimmune) thrombocytopenic purpura by liver transplantation

Author

David Pound, Janice G. McFarland, Richard H. Aster, Ronald S. Filo, Peter J. Friend, Konstance Arnold, Mark D. Pescovitz, Steven B. Leapman, Ronald Hoffman, Leo J. McCarthy, and Laurence Lumeng

Subjects
Adult, Blood Platelets, Male, medicine.medical_treatment, Spleen, Liver transplantation, Autoimmune Diseases, Postoperative Complications, Medicine, Humans, Platelet, Autoantibodies, Glycoproteins, Autoimmune disease, business.industry, Autoantibody, General Medicine, Mononuclear phagocyte system, Middle Aged, medicine.disease, Tissue Donors, Liver Transplantation, Transplantation, Purpura, medicine.anatomical_structure, Purpura, Thrombocytopenic, Immunoglobulin G, Immunology, Female, medicine.symptom, business
Abstract

Chronic idiopathic thrombocytopenic purpura is an autoimmune disorder in which the destruction of autologous platelets is mediated by autoantibodies directed against platelet-surface constituents.1 Glycoproteins IIb and IIIa, which exist in the platelet membrane in a 1:1 complex (IIb-IIIa), appear to be the main target molecules for these autoantibodies.2 3 4 The destruction of autologous platelets is thought to result from the ingestion of autoantibody-coated platelets by phagocytic cells in the spleen and other organs.1 The functional state of the reticuloendothelial system may influence the rate of cell destruction in individual patients.5 We recently encountered a patient who had severe, life-threatening thrombocytopenia after . . .

Published
1990

23. 1225 Anti-depressant use in patients receiving interferon alfa and ribavirin for chronic hepatitis C

Author

Paul Y. Kwo, Beverly Musick, John J. Santoro, Eugenio R. Grunvald, Richard S. Aycock, Frederic A. Stelzer, David Pound, George J. Eckert, Brian K. Hudes, and Brett R. Neustater

Subjects
medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Gastroenterology, chemistry.chemical_compound, Chronic hepatitis, chemistry, Internal medicine, medicine, Anti depressant, In patient, business, Interferon alfa, medicine.drug
Published
2003
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24. Alpha-interferon with ribavirin for the treatment of chronic hepatitis C in treatment naive patients

Author

Paul Y. Kwo, Naga Chalasani, David W. Crabb, Robert Pintozzi, Reid M. Ness, David Pound, Charles Lansford, James M. McGill, Sheryl Fields, Oscar W. Cummings, Won Cho, and Thomas F. Imperiale

Subjects
medicine.medical_specialty, Hepatology, business.industry, Ribavirin, Gastroenterology, Alpha interferon, Therapy naive, chemistry.chemical_compound, Chronic hepatitis, chemistry, Internal medicine, medicine, business
Published
2000
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25. Comparison of three nonsurgical treatments for bleeding esophageal varices

Author

G. Becker, P. Snodgrass, K. Kopecky, R. McHenry, L. Lumeng, J. Hast, R. Brunelle, Katherine W. O'Connor, R. Weddle, David W. Crabb, R. Holden, A. Lui, H. Yune, P. Christiansen, M. Compton, Glen A. Lehman, E. Cockerill, Douglas K. Rex, David Pound, E. Klatte, and Robert H. Hawes

Subjects
Chemotherapy, medicine.medical_specialty, Varix, Blood transfusion, Hepatology, Esophageal disease, business.industry, medicine.medical_treatment, Gastroenterology, Propranolol, medicine.disease, Surgery, Liver disease, Anesthesia, medicine, Sclerotherapy, Varices, business, medicine.drug
Abstract

Ninety-seven patients with recent or active variceal bleeding were randomly assigned to oral propranolol, endoscopic sclerotherapy plus oral propranolol, or transhepatic sclerotherapy plus oral propranolol. The effects of treatment on the number of units transfused, rebleeding of any magnitude, major rebleeding, and death were assessed in these patients, 82% of whom were alcoholic and 81% Child's Class C. After a minimum follow-up interval of 2 yr (range, 27-65 mo), major rebleeding rates were 65% for propranolol alone, 45% for endoscopic sclerotherapy plus propranolol, and 60% for transhepatic sclerotherapy plus propranolol. The corresponding death rates were 81% for propranolol alone, 55% for endoscopic sclerotherapy plus propranolol, and 66% for transhepatic sclerotherapy plus propranolol (p = 0.03). Thirty-three patients (34%) never received propranolol; 8 due to medical contraindications and 25 because they died or bled enough to meet the definition of treatment failure within 3 or 4 days of randomizations (no significant differences among treatment groups). Patients assigned to propranolol alone bled sooner, bled more units, and had a higher mortality rate than patients treated by endoscopic sclerotherapy plus propranolol. Patients treated with transhepatic sclerotherapy plus propranolol had intermediate results. Propranolol alone is inadequate treatment for esophageal variceal bleeding in patients with advanced liver disease.

Published
1989
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