3 results on '"GUARD-C Study Group"'
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2. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort
- Author
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GUARD C, Study Group, Hassanein, T, Bakalos, G, Ahlers, S, Shiffman, Ml, Tallarico, L, Reddy, Kr, Orlandini, A, Ferenci, P, Derbala, M, Coppola, C, Foster, Gr, Basho, J, Shabanaj, G, Harxhi, A, Debzi, N, Afredj, N, Guessab, N, Mahindad, N, Mahiou, H, Aissaoui, M, Al Qameesh, J, Al Ghandoor, Z, Assene, C, Bastens, B, Brixko, C, Cool, M, De Galocsy, C, Delwaide, J, George, C, Laukens, P, Lefebvre, V, Mulkay, Jp, Nevens, F, Servais, B, Van Vlierberghe, H, Horsmans, Y, Henrion, J, Sprengers, D, Michielsen, P, Bourgeois, S, Lasser, L, Langlet, P, Robaeys, G, Martinet, Jp, Warzee, P, Hoste, P, Reynaert, H, Juriens, I, Decaestecker, J, Van Der Meersch, F, Janssens, F, Ahmetagic, S, Verhaz, A, Bevanda, M, Calkic, L, Ibrahimpasic, N, Mesihovic, R, Mello, Ce, Ruiz, Fj, Martins Junior, E, Ferraz, Ml, Silva, G, Mendes, C, Lyra, A, Silva, Mh, Gomide, G, Fernandes, Jc, Pereira, P, Correa, Mc, Teixeira, R, Yousry, A, Hanno, A, Gabr, M, Omar, A, Esmat, G, Karatapanis, S, Nikolopoulou, V, Giannoulis, G, Manolakopoulos, S, Elefsiniotis, I, Drakoulis, C, Dimitroulopoulos, D, Kanatakis, S, Ketikoglou, I, Mimidis, K, Evgenidis, N, Akriviades, E, Vafiadi Zoubouli, I, Tsianos, E, Mela, M, Orfanou, E, Mousoulis, G, Karagiannis, I, Manesis, E, Varga, M, Nemesánszky, E, Fried, K, Schuller, J, Szalay, F, Lengyel, G, Tornai, I, Banyai, T, Lesch, M, Nagy, I, Gervain, J, Tusnadi, A, Schneider, F, Szentgyörgyi, L, Hunyady, B, Vincze, A, Tolvaj, G, Varkonyi, I, Makkai, E, Enyedi, J, Racz, I, Hausinger, P, Váczi, Z, Patai, Á, Ozsvár, Z, Lakner, L, Ribiczey, P, Bhalla, A, Somani, S, Luaia, R, Rao, P, Philip, M, Lawate, P, Nagral, A, Sood, A, Parikh, S, Merat, S, Nassiri Toosi, M, Alavian, Sm, Zali, Mr, Daryani, Ne, Drenaggi, D, Attili, Af, Bandiera, F, Bassi, P, Bellati, G, Bellantani, S, Brunetto, MAURIZIA ROSSANA, Bruno, S, Castelli, F, Castellacci, R, Cattelan, Am, Colombo, M, Craxi, A, D'Angelo, S, Colombo, S, Demelia, L, Di Perri, G, Di Giacomo, A, Ferrari, C, Francisci, D, Casinelli, K, Ganga, R, Costa, C, Mangia, A, Russo, Fp, Matarazzo, F, Mazzella, G, Mazzeo, M, Memoli, M, Montalbano, M, Montalto, G, Pieri, A, Passariello, N, Picciotto, A, Pietrangelo, A, Pirisi, M, Quirino, T, Raimondo, G, Rapaccini, Gl, Rizzardini, G, Rizzetto, M, Russello, M, Sabusco, G, Santantonio, T, Soardo, G, Amedea, A, Verucchi, G, Vinelli, F, Zignego, Al, Zuin, M, Ascione, A, Vinci, M, Pigozzi, Mg, Tundo, P, Saracco, Gm, Amoroso, P, Andreoni, M, Colletta, C, Erne, E, Megna, As, Biglino, A, Chiriaco, P, Foti, G, Spinzi, G, D'Amico, E, Paik, Sw, Ahn, Sh, Lee, Yn, Kim, Y, Yang, J, Han, Sy, Varghese, R, Al Gharabally, A, Askar, H, Sharara, A, Yaghi, C, Rached, Aa, Houmani, Z, Zaarour, F, Dohaibi, A, Ivanovski, L, Joksimovic, N, Abbas, Z, Memon, S, Mohsin, A, Masood, S, Hashmi, Z, Halota, W, Deron, Z, Mazur, W, Flisiak, R, Lipczynski, A, Musialik, J, Piekarska, A, Augustyniak, K, Baka Cwierz, B, Simon, K, Gietka, A, Berak, H, Sieklucki, J, Radowska, D, Szlauer, B, Piekos, T, Olszok, I, Jablkowski, M, Orszulak, G, Warakomska, I, Aleixo, Mj, Valente, C, Macedo, G, Sarmento Castro, R, Roxo, F, Faria, T, Mansinho, K, Velez, J, Ramos, Jp, Guerreiro, H, Alberto, S, Monteverde, C, Serejo, F, Peixe, P, Malhado, J, Curescu, M, Streinu Cercel, A, Caruntu, F, Livia, H, Preotescu, L, Arama, V, Ancuta, I, Gheorghe, L, Stanciu, C, Trifan, A, Acalovschi, M, Andreica, V, Pascu, O, Lencu, M, Sporea, I, Olteanu, D, Ionita Radu, F, Fierbinteanu Braticevici, C, Motoc, A, Silaghi, R, Musat, M, Coman, F, Stan, M, Cijevschi, C, Miftode, E, Delic, D, Jesic, R, Nozic, D, Svorcan, P, Fabri, M, Konstantinovic, L, Pelemis, M, Jankovic, G, Todorovic, Z, Nagorni, A, Kupcova, V, Skladany, L, Szantova, M, Krkoska, D, Jarcuska, P, Schreter, I, Oltman, M, Bocakova, J, Bunganic, I, Holoman, J, Giguere, A, Abdou, A. M., Basic (bio-) Medical Sciences, Gastroenterology, Laboratory of Molecullar and Cellular Therapy, Liver Cell Biology, Michielsen, Peter, GUARD-C Study Group, Graham R. Foster, Carmine Coppola, Moutaz Derbala, Peter Ferenci, Alessandra Orlandini, K. Rajender Reddy, Ludovico Tallarico, Mitchell L. Shiffman, Silke Ahler, Georgios Bakalo, Tarek Hassanein, GUARD-C Study Group: [.., Davide Drenaggi, Adolfo Francesco Attili, Franco Bandiera, Paolo Bassi, Giorgio Bellati, Stefano Bellantani, Maurizia Brunetto, Savino Bruno, Francesco Castelli, Roberto Castellacci, Anna Maria Cattelan, Massimo Colombo, Antonio Craxi, Salvatore D'angelo, Silvia Colombo, Luigi Demelia, Giovanni Di Perri, Antonio Di Giacomo, Carlo Ferrari, Daniela Francisci, Katia Casinelli, Roberto Ganga, Chiara Costa, Alessandra Mangia, Francesco Paolo Russo, Filippo Matarazzo, Giuseppe Mazzella, Maurizio Mazzeo, Massimo Memoli, Marzia Montalbano, Giuseppe Montalto, Alessandro Pieri, Nicola Passariello, Antonio Picciotto, Antonello Pietrangelo, Mario Pirisi, Tiziana Quirino, Giovanni Raimondo, Gian Ludovico Rapaccini, Giuliano Rizzardini, Mario Rizzetto, Maurizio Russello, Giuseppe Sabusco, Teresa Santantonio, Giorgio Soardo, Alessandri Amedea, Gabriella Verucchi, Francesco Vinelli, Anna Linda Zignego, Massimo Zuin, Antonio Ascione, Maria Vinci, Maria Graziella Pigozzi, Paolo Tundo, Giorgio Maria Saracco, Pietro Amoroso, Massimo Andreoni, Cosimo Colletta, Elke Erne, Angelo Salomone Megna, Alberto Biglino, Piergiorgio Chiriaco, Giuseppe Foti, Giancarlo Spinzi, Emilio D'amico, …], Foster G.R., Coppola C., Derbala M., Ferenci P., Orlandini A., Reddy K.R., Tallarico L., Shiffman M.L., Ahlers S., Bakalos G., Hassanein T., Basho J., Shabanaj G., Harxhi A., Debzi N., Afredj N., Guessab N., Mahindad N., Mahiou H., Aissaoui M., Al Qameesh J., Al Ghandoor Z., Assene C., Bastens B., Brixko C., Cool M., De Galocsy C., Delwaide J., George C., Laukens P., Lefebvre V., Mulkay J.-P., Nevens F., Servais B., Van Vlierberghe H., Horsmans Y., Henrion J., Sprengers D., Michielsen P., Bourgeois S., Lasser L., Langlet P., Robaeys G., Martinet J.-P., Warzee P., Hoste P., Reynaert H., Juriens I., Decaestecker J., Van Der Meersch F., Janssens F., Ahmetagic S., Verhaz A., Bevanda M., Calkic L., Ibrahimpasic N., Mesihovic R., Mello C.E., Ruiz F.J., Junior E.M., Ferraz M.L., Silva G., Mendes C., Lyra A., Silva M.H., Gomide G., Fernandes J.C., Pereira P., Correa M.C., Teixeira R., Yousry A., Hanno A., Gabr M., Omar A., Esmat G., Karatapanis S., Nikolopoulou V., Giannoulis G., Manolakopoulos S., Elefsiniotis I., Drakoulis C., Dimitroulopoulos D., Kanatakis S., Ketikoglou I., Mimidis K., Evgenidis N., Akriviades E., Vafiadi-Zoubouli I., Tsianos E., Mela M., Orfanou E., Mousoulis G., Karagiannis I., Manesis E., Varga M., Nemesanszky E., Fried K., Schuller J., Szalay F., Lengyel G., Tornai I., Banyai T., Lesch M., Nagy I., Gervain J., Tusnadi A., Schneider F., Szentgyorgyi L., Hunyady B., Vincze A., Tolvaj G., Varkonyi I., Makkai E., Enyedi J., Racz I., Hausinger P., Vaczi Z., Patai A., Ozsvar Z., Lakner L., Ribiczey P., Bhalla A., Somani S., Luaia R., Rao P., Philip M., Lawate P., Nagral A., Sood A., Parikh S., Merat S., Nassiri-Toosi M., Alavian S.-M., Zali M.R., Daryani N.E., Drenaggi D., Attili A.F., Bandiera F., Bassi P., Bellati G., Bellantani S., Brunetto M., Bruno S., Castelli F., Castellacci R., Cattelan A.M., Colombo M., Craxi A., D'angelo S., Colombo S., Demelia L., Di Perri G., Di Giacomo A., Ferrari C., Francisci D., Casinelli K., Ganga R., Costa C., Mangia A., Russo F.P., Matarazzo F., Mazzella G., Mazzeo M., Memoli M., Montalbano M., Montalto G., Pieri A., Passariello N., Picciotto A., Pietrangelo A., Pirisi M., Quirino T., Raimondo G., Rapaccini G.L., Rizzardini G., Rizzetto M., Russello M., Sabusco G., Santantonio T., Soardo G., Amedea A., Verucchi G., Vinelli F., Zignego A.L., Zuin M., Ascione A., Vinci M., Pigozzi M.G., Tundo P., Saracco G.M., Amoroso P., Andreoni M., Colletta C., Erne E., Megna A.S., Biglino A., Chiriaco P., Foti G., Spinzi G., D'amico E., Paik S.W., Ahn S.-H., Lee Y.N., Kim Y., Yang J., Han S.Y., Varghese R., Al Gharabally A., Askar H., Sharara A., Yaghi C., Abou Rached A., Houmani Z., Zaarour F., Dohaibi A., Ivanovski L., Joksimovic N., Abbas Z., Memon S., Mohsin A., Masood S., Hashmi Z., Halota W., Deron Z., Mazur W., Flisiak R., Lipczynski A., Musialik J., Piekarska A., Augustyniak K., Baka-Cwierz B., Simon K., Gietka A., Berak H., Sieklucki J., Radowska D., Szlauer B., Piekos T., Olszok I., Jablkowski M., Orszulak G., Warakomska I., Aleixo M.J., Valente C., Macedo G., Sarmento-Castro R., Roxo F., Faria T., Mansinho K., Velez J., Ramos J.P., Guerreiro H., Alberto S., Monteverde C., Serejo F., Peixe P., Malhado J., Curescu M., Streinu-Cercel A., Caruntu F., Livia H., Preotescu L., Arama V., Ancuta I., Gheorghe L., Stanciu C., Trifan A., Acalovschi M., Andreica V., Pascu O., Lencu M., Sporea I., Olteanu D., Ionita-Radu F., Fierbinteanu-Braticevici C., Motoc A., Silaghi R., Musat M., Coman F., Stan M., Cijevschi C., Miftode E., Delic D., Jesic R., Nozic D., Svorcan P., Fabri M., Konstantinovic L., Pelemis M., Jankovic G., Todorovic Z., Nagorni A., Kupcova V., Skladany L., Szantova M., Krkoska D., Jarcuska P., Schreter I., Oltman M., Bocakova J., Bunganic I., Holoman J., Giguere A., Abdou A.M.S., UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, and UCL - (SLuc) Service de gastro-entérologie
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Genetics and Molecular Biology (all) ,Male ,Chronic Hepatitis ,Hepacivirus ,Ribavirin/adverse effects ,Asthenia/chemically induced ,Polyethylene Glycol ,Biochemistry ,Polyethylene Glycols ,Body Mass Index ,Chronic Liver Disease ,0302 clinical medicine ,Neutropenia/chemically induced ,Interferon-alpha/adverse effects ,Medicine ,Chronic ,lcsh:Science ,Liver Diseases ,virus diseases ,Antiviral Agents/adverse effects ,Cohort ,Science & Technology - Other Topics ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Cohort study ,Human ,medicine.medical_specialty ,Alpha interferon ,Gastroenterology and Hepatology ,Antiviral Agents ,Microbiology ,Dose-Response Relationship ,03 medical and health sciences ,Pharmacotherapy ,Hepatitis C, Chronic/drug therapy ,Dose Prediction Methods ,Drug Therapy ,Anemia/chemically induced ,Humans ,Hemoglobin ,Aged ,Medicine and health sciences ,Biochemistry, Genetics and Molecular Biology (all) ,Hepaciviru ,Science & Technology ,Dose-Response Relationship, Drug ,Flaviviruses ,lcsh:R ,Organisms ,Biology and Life Sciences ,Proteins ,medicine.disease ,digestive system diseases ,chemistry ,Agricultural and Biological Sciences (all) ,Withholding Treatment ,Asthenia ,Immunology ,Proportional Hazards Model ,lcsh:Q ,Human medicine ,RNA viruses ,Physiology ,lcsh:Medicine ,Peginterferon-alfa ,Polyethylene Glycols/adverse effects ,Adult ,Anemia ,Cohort Studies ,Female ,Hepatitis C, Chronic ,Host-Pathogen Interactions ,Interferon-alpha ,Middle Aged ,Neutropenia ,Outcome Assessment (Health Care) ,Proportional Hazards Models ,RNA, Viral ,Recombinant Proteins ,Ribavirin ,Medicine (all) ,chemistry.chemical_compound ,Outcome Assessment, Health Care ,Medicine and Health Sciences ,030212 general & internal medicine ,Viral ,Pathology and laboratory medicine ,Multidisciplinary ,biology ,Hepatitis C virus ,Pharmaceutics ,Hepatitis C ,Hematology ,Recombinant Protein ,Outcome Assessment (Health Care)/methods ,Medical microbiology ,Host-Pathogen Interaction ,Multidisciplinary Sciences ,Physiological Parameters ,Research Design ,Combination ,Viruses ,Drug ,Pathogens ,Host-Pathogen Interactions/drug effects ,Research Article ,Clinical Research Design ,Research and Analysis Methods ,Internal medicine ,Recombinant Proteins/adverse effects ,RNA, Viral/blood ,Antiviral Agent ,business.industry ,Body Weight ,Hepacivirus/drug effects ,Viral pathogens ,biology.organism_classification ,Hepatitis viruses ,Microbial pathogens ,RNA ,Adverse Events ,Cohort Studie ,business - Abstract
Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA
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- 2015
3. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort.
- Author
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UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Foster, Graham R, Coppola, Carmine, Derbala, Moutaz, Ferenci, Peter, Orlandini, Alessandra, Reddy, K Rajender, Tallarico, Ludovico, Shiffman, Mitchell L, Ahlers, Silke, Bakalos, Georgios, Hassanein, Tarek, Guard-c Study group, Horsmans, Yves, UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, UCL - (SLuc) Service de gastro-entérologie, Foster, Graham R, Coppola, Carmine, Derbala, Moutaz, Ferenci, Peter, Orlandini, Alessandra, Reddy, K Rajender, Tallarico, Ludovico, Shiffman, Mitchell L, Ahlers, Silke, Bakalos, Georgios, Hassanein, Tarek, Guard-c Study group, and Horsmans, Yves
- Abstract
BACKGROUND: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. METHODS: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA <50 IU/mL) were conducted in 951 Caucasian, noncirrhotic genotype (G)1 patients assigned to peginterferon alfa-2a/ribavirin for 48 weeks. The probability of SVR24 was identified by a baseline scoring system (range: 0-9 points) on which scores of 5 to 9 and <5 represent high and low probability of SVR24, respectively. RESULTS: SVR24 rates were 46.1% (754/1634), 77.1% (279/362), 68.0% (514/756), and 51.3% (203/396), respectively, in G1, 2, 3, and 4 patients. Overall, 16.9% and 21.8% patients experienced ≥1 sr-RD for peginterferon alfa and ribavirin, respectively. Among Caucasian noncirrhotic G1 patients: female sex, lower body mass index, pre-existing cardiovascular/pulmonary disease, and low hematological indices were prognostic factors of sr-RD; SVR24 was lower in patients with ≥1 vs. no sr-RD by Week 4 (37.9% vs. 54.4%; P = 0.0046) and Week 12 (41.7% vs. 55.3%; P = 0.0016); sr-RD by Week 4/12 significantly reduced SVR24 in patients with scores <5 but not ≥5. CONCLUSIONS: In conclusion, sr-RD to peginterferon alfa-2a/ribavirin significantly impacts on SVR24 rates in treatment-naive G1 noncirrhotic Caucasian patients. Baseline characteristics can help select patients with a high probability of SVR24 and a low probability of sr-RD with peginterferon
- Published
- 2016
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