1. Predictive variables of sustained virological response after early discontinuation of triple therapy with telaprevir for genotype-1 HCV infection.
- Author
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Acero Fernández D, Morillas Cunill R, Ferri Iglesias MJ, Torras Collell X, Vergara Gómez M, Zaragoza Velasco N, López Nuñez C, Forné Bardera M, Delgado Gómez M, Barenys Lacha M, Torres Salinas M, Villar Fernández M, Durández Lázaro R, and Mariño Mendez Z
- Subjects
- Adult, Aged, Antiviral Agents administration & dosage, Antiviral Agents adverse effects, Drug Therapy, Combination, Female, Genotype, Health Care Surveys, Hepacivirus genetics, Hepacivirus isolation & purification, Hepatitis C, Chronic virology, Humans, Male, Middle Aged, Oligopeptides administration & dosage, Oligopeptides adverse effects, Prognosis, Proline administration & dosage, Proline analogs & derivatives, Proline therapeutic use, RNA, Viral blood, Retrospective Studies, Young Adult, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Oligopeptides therapeutic use, Sustained Virologic Response, Viremia drug therapy
- Abstract
Background: Pivotal phase studies of telaprevir (TLV) and boceprevir (BOV) showed 10-56% rates of early treatment interruption. However, there have been no reports on the sustained virological response (SVR) rates of these patients., Aim: To assess the SVR rate in a large cohort of patients who discontinued triple therapy with TLV or BOV for reasons other than stopping rules and to identify variables predicting SVR., Material and Method: A survey was sent to 15 hospitals in Catalonia asking them to report all TLV/BOV treatments finished by 31 May 2014. Demographic, clinical, laboratory, liver fibrosis and therapeutic data were recorded for treatments with early discontinuation. Logistic regression analysis, ROC curves and prognostic assessment of the variables identified were calculated., Results: Twelve hospitals responded to the survey, representing 467 treatments and 121 (21.2%) early discontinuations, 76 (62.8%) due to stopping rules and 45 (37.2%) for other reasons. Early discontinuation was more frequent with BOV [38.2% (50/131) versus 21.1% (71/336) p<0.005], mainly due to stopping rules [78% (39/50) versus 52.1% (37/71); p=0.004]. SVR was achieved in 21/121 patients (17.4%), 19/71 (26.8%) treated with TLV and 2/50 (4.0%) treated with BOV. In patients discontinuing treatment for reasons other than stopping rules, SVR was achieved in 19/37 (55.9%) treated with TLV and in 2/11 (18.2%) treated with BOV. The SVR rate in patients treated with TLV who discontinued due to a severe adverse event was 61.5% (16/26). A logistic regression analysis was performed only with triple therapy with TLV and early discontinuation. The predictive variables of SVR were undetectable HCV-RNA at treatment week 4 and treatment length longer than 11 weeks. Treatment duration longer than 11 weeks showed the best accuracy (0.794), with a positive predictive value of 0.928., Conclusions: Early discontinuation of TLV-based triple therapy due to reasons other than stopping rules still have a significant SVR rate (55.9%). Undetectable HVC-RNA at week 4 of treatment and treatment duration longer than 11 weeks are predictive of SVR in this subset of patients., (Copyright © 2015 Elsevier España, S.L.U. y AEEH y AEG. All rights reserved.)
- Published
- 2016
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