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 peginter-feron alfa-2a/ribavirin. © 2016 Foster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Impact of safety-related dose reductions or discontinuations on sustained virologic response in HCV-infected patients: Results from the GUARD-C Cohort
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; Basho, Jovan; Shabanaj, Gentian; Harxhi, Arjan; Debzi, Nabil; Afredj, Nawel; Guessab, Nawal; Mahindad, Nadir; Mahiou, Hassene; Aissaoui, Magda; Al Qameesh, Jihad; Al Ghandoor, Zuhal; Assene, Collins; Bastens, Boris; Brixko, Christian; Cool, Mike; De Galocsy, Chantal; Delwaide, Jean; George, Christophe; Laukens, Pierre; Lefebvre, Veronique; Mulkay, Jean Pierre; Nevens, Frederik; Servais, Benoit; Van Vlierberghe, Hans; Horsmans, Yves; Henrion, Jean; Sprengers, Dirk; Michielsen, Peter; Bourgeois, Stefan; Lasser, Luc; Langlet, Philippe; Robaeys, Geert; Martinet, Jean Paul; Warzee, Philippe; Hoste, Paul; Reynaert, Hendrik; Juriens, Irène; Decaestecker, Jochen; Van Der Meersch, Filip; Janssens, Filip; Ahmetagic, Sead; Verhaz, Antonija; Bevanda, Milenko; Calkic, Lejla; Ibrahimpasic, Nevzeta; Mesihovic, Rusmir; Mello, Carlos Eduardo; Ruiz, Fernando Jose; Junior, Elson Martins; Ferraz, Maria Lucia; Silva, Giovanni; Mendes, Claudio; Lyra, Andre; Silva, Mariliza Henrique; Gomide, Geisa; Fernandes, Julio Cesar; Pereira, Patricia; Correa, Maria Cassia; Teixeira, Rosangela; Yousry, Ayman; Hanno, Abdelfatah; Gabr, Mamdouh; Omar, Ashraf; Esmat, Gamal; Karatapanis, Stilianos; Nikolopoulou, Vassiliki; Giannoulis, Grigoris; Manolakopoulos, Spilios; Elefsiniotis, Ioannis; Drakoulis, Christos; Dimitroulopoulos, Dimitrios; Kanatakis, Stilianos; Ketikoglou, Ioannis; Mimidis, Konstantinos; Evgenidis, Nikolaos; Akriviades, Euaggelos; Vafiadi Zoubouli, Irini; Tsianos, Epameinondas; Mela, Maria; Orfanou, Eleni; Mousoulis, Georgios; Karagiannis, Ioannis; Manesis, Emmanuel; Varga, Marta; Nemesánszky, Elemér; Fried, Katalin; Schuller, János; Szalay, Ferenc; Lengyel, Gabriella; Tornai, Istvan; Banyai, Tivadar; Lesch, Miklos; Nagy, Istvan; Gervain, Judit; Tusnadi, Anna; Schneider, Ferenc; Szentgyörgyi, László; Hunyady, Bela; Vincze, Aron; Tolvaj, Gyula; Varkonyi, Istvan; Makkai, Erzsébet; Enyedi, Judit; Racz, Istvan; Hausinger, Péter; Váczi, Zsuzsanna; Patai, Árpád; Ozsvár, Zsófia; Lakner, Lilla; Ribiczey, Pál; Bhalla, Ajay; Somani, Sanjay; Luaia, Rosang; Rao, Padaki; Philip, Mathew; Lawate, Parimal; Nagral, Aabha; Sood, Ajit; Parikh, Samir; Merat, Shahin; Nassiri Toosi, Mohsen; Alavian, Seyed Moayed; Zali, Mohammad Reza; Daryani, Nasser Ebrahimi; Drenaggi, Davide; Attili, Adolfo Francesco; Bandiera, Franco; Bassi, Paolo; Bellati, Giorgio; Bellantani, Stefano; Brunetto, Maurizia; Bruno, Savino; Castelli, Francesco; Castellacci, Roberto; Cattelan, Anna Maria; Colombo, Massimo; Craxi, Antonio; D'Angelo, Salvatore; Colombo, Silvia; Demelia, Luigi; Di Perri, Giovanni; Di Giacomo, Antonio; Ferrari, Carlo; Francisci, Daniela; Casinelli, Katia; Ganga, Roberto; Costa, Chiara; Mangia, Alessandra; Russo, Francesco Paolo; Matarazzo, Filippo; Mazzella, Giuseppe; Mazzeo, Maurizio; Memoli, Massimo; Montalbano, Marzia; Montalto, Giuseppe; Pieri, Alessandro; Passariello, Nicola; Picciotto, Antonio; Pietrangelo, Antonello; Pirisi, Mario; Quirino, Tiziana; RAIMONDO, Giovanni ;Rapaccini, Gian Ludovico; Rizzardini, Giuliano; Rizzetto, Mario; Russello, Maurizio; Sabusco, Giuseppe; Santantonio, Teresa; Soardo, Giorgio; Amedea, Alessandri; Verucchi, Gabriella; Vinelli, Francesco; Zignego, Anna Linda; Zuin, Massimo; Ascione, Antonio; Vinci, Maria; Pigozzi, Maria Graziella; Tundo, Paolo; Saracco, Giorgio Maria; Amoroso, Pietro; Andreoni, Massimo; Colletta, Cosimo; Erne, Elke; Megna, Angelo Salomone; Biglino, Alberto; Chiriaco, Piergiorgio; Foti, Giuseppe; Spinzi, Giancarlo; D'Amico, Emilio; Paik, Seung Woon; Ahn, Sang Hoon; Lee, Yun Nah; Kim, Yoonjun; Yang, Jinmo; Han, Sang Young; Varghese, Rosh; Al Gharabally, Abeer; Askar, Haifa; Sharara, Ala; Yaghi, Cesar; Abou Rached, Antoine; Houmani, Zaher; Zaarour, Fouad; Dohaibi, Ahmad; Ivanovski, Ljubomir; Joksimovic, Nenad; Abbas, Zaigham; Memon, Sadik; Mohsin, Aftab; Masood, Siddiq; Hashmi, Zahid; Halota, Waldemar; Deron, Zbigniew; Mazur, Wlodzimierz; Flisiak, Robert; Lipczynski, Artur; Musialik, Joanna; Piekarska, Anna; Augustyniak, Krystyna; Baka Cwierz, Barbara; Simon, Krzysztof; Gietka, Andrzej; Berak, Hanna; Sieklucki, Jerzy; Radowska, Danuta; Szlauer, Bronislawa; Piekos, Tomasz; Olszok, Iwona; Jablkowski, Maciej; Orszulak, Grazyna; Warakomska, Iwona; Aleixo, Maria João; Valente, Cristina; Macedo, Guilherme; Sarmento Castro, Rui; Roxo, Fausto; Faria, Telo; Mansinho, Kamal; Velez, Jorge; Ramos, José Presa; Guerreiro, Horácio; Alberto, Sara; Monteverde, Carlos; Serejo, Fátima; Peixe, Paula; Malhado, José; Curescu, Manuela; Streinu Cercel, Adrian; Caruntu, Florin; Livia, Hara; Preotescu, Liliana; Arama, Victoria; Ancuta, Ioan; Gheorghe, Liana; Stanciu, Carol; Trifan, Anca; Acalovschi, Monica; Andreica, Vasile; Pascu, Oliviu; Lencu, Monica; Sporea, Ioan; Olteanu, Dan; Ionita Radu, Florentina; Fierbinteanu Braticevici, Carmen; Motoc, Adriana; Silaghi, Rodica; Musat, Marioara; Coman, Felicia; Stan, Marioara; Cijevschi, Cristina; Miftode, Egidia; Delic, Dragan; Jesic, Rada; Nozic, Darko; Svorcan, Petar; Fabri, Milotka; Konstantinovic, Ljiljana; Pelemis, Mijomir; Jankovic, Goran; Todorovic, Zoran; Nagorni, Aleksandar; Kupcova, Viera; Skladany, Lubomir; Szantova, Maria; Krkoska, Dusan; Jarcuska, Peter; Schreter, Ivan; Oltman, Marian; Bocakova, Jana; Bunganic, Ivan; Holoman, Jozef; Giguere, Alain; Abdou, Ahmed Mohamed Saleh
2016-01-01
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 peginter-feron alfa-2a/ribavirin. © 2016 Foster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande. La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.