Contributors: 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
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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