Contributors: Foster, Graham R.; Coppola, Carmine; Derbala, Moutaz; Ferenci, Peter; Orlandini, Alessandra; Reddy, K. Rajender; Tallarico, Ludovico; Shiffman, Mitchell L.; Ahlers, Silke; Bakalos, Georgio; 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, Collin; Bastens, Bori; Brixko, Christian; Cool, Mike; De Galocsy, Chantal; Delwaide, Jean; George, Christophe; Laukens, Pierre; Lefebvre, Veronique; Mulkay, Jean Pierre; Nevens, Frederik; Servais, Benoit; Van Vlierberghe, Han; Horsmans, Yve; 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 Martin; 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, Stiliano; Nikolopoulou, Vassiliki; Giannoulis, Grigori; Manolakopoulos, Spilio; Elefsiniotis, Ioanni; Drakoulis, Christo; Dimitroulopoulos, Dimitrio; Kanatakis, Stiliano; Ketikoglou, Ioanni; Mimidis, Konstantino; Evgenidis, Nikolao; Akriviades, Euaggelo; Vafiadi Zoubouli, Irini; Tsianos, Epameinonda; Mela, Maria; Orfanou, Eleni; Mousoulis, Georgio; Karagiannis, Ioanni; Manesis, Emmanuel; Varga, Marta; Nemesánszky, Elemér; Fried, Katalin; Schuller, Jáno; Szalay, Ferenc; Lengyel, Gabriella
نبذة مختصرة : 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 alfa-2a/ribavirin.
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