Background and Aim: In cirrhotic patients with HCV infection and severe thrombocytopenia (<80,000 cell/mL), therapy with Peg- Interferon (Peg-IFN) and ribavirin is deferred due to safety concerns related to hematological complications. Methods: 555 consecutive cirrhotic patients, naïve to therapy, were enrolled prospectively in an observational study of therapy with either Peg-IFN alpha-2a or alpha-2b and ribavirin in Italy (the PROBE study). Incidence and severity of thrombocytopenia and neutropenia during treatment were the main endpoints of this study; sustained virological response (SVR) constituted a secondary outcome. Results: HCV genotype 1 was most prevalent (52%). At baseline, 110 patients (20%) presented with PLT levels <80,000/mL (group A), 333 (60%) with levels between 81,000 and 139,000/mL (group B), and 112 (20%) with levels ≥140,000/mL. Dose reductions of Peg-IFN were more frequent in Group A (33%) than in Group B (19%), or Group C (12%). Dose reductions of ribavirin were noted in 24%, 23%, and 21% of Groups A, B and C, respectively. Overall, 44.3% of patients developed neutropenia (absolute neutrophil count <1,000/mL). Incidence of neutropenia was higher in Groups A and B (55.5% and 44.1%, respectively) than in Group C patients (33.9%). After starting treatment, platelet count dropped in all patients. The mean relative decrease in platelet count was similar among the three groups of patients. Nadir values of platelet counts over treatment were graded 75,000 and 50,000/mL in 29.1%, 37.5%, and 8.9% of Group A, B, and C, respectively. Values were between 49,000 and 20,00/ml in 54.5%, 20.4% and 1.8% in the three groups, respectively. Overall, 213 patients attained an SVR (38%). SVR rates were 30%, 40.5%, and 45.5% in Groups A, B, and C, respectively (Cochran-Armitage trend test, P = 0.02). No patients complained of severe hemorrhagic or infective events during therapy. Conclusion: This investigation confronts the assumption of thrombocytopenia being a limiting factor to antiviral therapy in patients with HCV-related, compensated cirrhosis and severe thrombocytopenia. In this setting, the study reveals the safety of treatment, and documents that measurement of platelets counts before therapy provides clinically relevant information on treatment outcome, as SVR rates independently and inversely related to the degree of thrombocytopenia.
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