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Objetivo: Comparar el perfil de seguridad telaprevir (TLV) y boceprevir (BOC) entre sí y con lo descrito en ensayos clínicos (EECC). Material y método: Estudio multicéntrico observacional retrospectivo. Variables recogidas: edad, sexo, tipo de paciente (naïve, no respondedor o recidivantes), fibroscan, Hb nadir, recuento de neutrófilos y plaquetas, presencia de exantema, malestar anorrectal, número de pacientes tratados con estimuladores de la eritropoyesis (EPO) y factores estimuladores de colonias de granulocitos (G-CSF). Resultados: BOC vs EECC: anemia (56,5% vs. 49%), trombocitopenia (56,5% vs. 32%; p = 0,023). Neutropenia (17,4% vs. 29,5%). Utilización de EPO (13% vs. 43%; p = 0,008), prurito (13% vs. 21,1%), exantema (8,7% vs. 16,1%); molestias anorrectales (4,3% vs. 0%; p = 0,0001), disgeusia (47,8% vs. 37%). TLV vs. EECC: anemia (51,2% vs. 32%; p = 0,014), neutropenia (2,3 vs. 3,6%), trombocitopenia (41,9% vs. 27,4%; p = 0,05), prurito (39,5 vs. 47%), exantema (16,3% vs. 55%; p < 0,001), molestias anorrectales (39,5% vs. 26%). Disgeusia (14% vs. 9,5%). BOC vs. TLV: anemia (56,5% vs. 51,2%), neutropenia (17,4% vs. 2,3%), trombocitopenia (56,5% vs. 41,9%), exantema (8,7% vs. 16,3%), prurito (39,5% vs. 13%) y molestias anorrectales (4,3% vs. 39,5%; p = 0,006), disgeusia (47,8% vs. 14%; p = 0,007) EPO (13% vs. 25,6%). G-CSF se utilizó para un paciente tratado con TLV. Conclusiones: 1. BOC y TLV han mostrado un perfil de seguridad peor que en los EECC en cuanto a anemia, trombocitopenia y malestar anorrectal. 2. Al igual que en EECC, anemia, neutropenia y trombocitopenia fueron más frecuentes con BOC. Por otro lado los pacientes tratados con TLV presentaron más prurito, exantema y malestar anorrectal. Purpose: To compare the safety profile of telaprevir (TLV) and boceprevir (BOC) with each other and with those described in clinical trials (CT). Material and methods: Retrospective multicenter observational study. Variables collected: age, sex, type of patient (naive, nonresponder or recurrent), fibroscan, Hb nadir, neutrophil and platelet count, presence of rash, anorectal discomfort, number of patients treated with erythropoiesis stimulating factors (EPO) and colony stimulating factors granulocyte (G-CSF). Results: BOC vs CT: anemia (56.5% vs. 49%.), Thrombocytopenia (56.5% vs 32%, p = 0.023). neutropenia (17.4% vs. 29.5%). Use of EPO (13% vs 43%;. p = 0.008), pruritus (13% vs. 21.1%), rash (16.1% vs. 8.7%), anorectal discomfort (4.3% vs. 0%, p = 0.0001), dysgeusia (47.8% vs. 37%). TLV vs. CT: anemia (51.2% vs. 32%, p = 0.014), neutropenia (2.3 vs 3.6%), thrombocytopenia (41.9% vs. 27.4%, p = 0.05), pruritus (39.5% vs 47), rash (16.3% vs 55%, P < 0.001), anorectal discomfort (39.5% vs 26%), dysgeusia (14% vs. 9.5%). BOC vs TLV: anemia (56.5% vs 51.2%), neutropenia (17.4% vs 2.3%), thrombocytopenia (56.5% vs 41.9%), rash (8.7% vs 16.3%), pruritus (39.5% vs 13%) and anorectal discomfort (4.3% vs 39.5%, P = 0.006), dysgeusia (14% vs 47.8%, P = 0.007), EPO (13% vs. 25.6%). GCSF was used for a patient treated with TLV. Conclusions: 1. BOC and TLV have shown a worse safety profile for anemia, thrombocytopenia and anorectal discomfort than those described in CT. 2. As in CT, anemia, neutropenia and thrombocytopenia were more common with BOC. Patients treated with TLV experienced more pruritus, rash and anorectal discomfort. |
