000046945 001__ 46945
000046945 005__ 20210121114445.0
000046945 0247_ $$2doi$$a10.3748/wjg.v21.i30.9163
000046945 0248_ $$2sideral$$a92070
000046945 037__ $$aART-2015-92070
000046945 041__ $$aeng
000046945 100__ $$aSalmerón, J.
000046945 245__ $$aEffectiveness and safety of first-generation protease inhibitors in clinical practice: Hepatitis C virus patients with advanced fibrosis
000046945 260__ $$c2015
000046945 5060_ $$aAccess copy available to the general public$$fUnrestricted
000046945 5203_ $$aAIM: To evaluates the effectiveness and safety of the first generation, NS3/4A protease inhibitors (PIs) in clinical practice against chronic C virus, especially in patients with advanced fibrosis.
METHODS: Prospective study and non-experimental analysis of a multicentre cohort of 38 Spanish hospitals that includes patients with chronic hepatitis C genotype 1, treatment-nai¨ve (TN) or treatment-experienced (TE),
who underwent triple therapy with the first generation NS3/4A protease inhibitors, boceprevir (BOC) and telaprevir (TVR), in combination with pegylated interferon and ribavirin. The patients were treatment in routine practice settings. Data on the study population and on adverse clinical and virologic effects were compiled during the treatment period and during follow up.
RESULTS: One thousand and fifty seven patients were included, 405 (38%) were treated with BOC and 652 (62%) with TVR. Of this total, 30% (n = 319) were TN and the remaining were TE: 28% (n = 298) relapsers, 12% (n = 123) partial responders (PR), 25% (n = 260) null-responders (NR) and for 5% (n = 57) with prior response unknown. The rate of sustained virologic response (SVR) by intention-to-treatment (ITT) was greater in those treated with TVR (65%) than in those treated with BOC (52%) (P < 0.0001), whereas by modified intention-to-treatment (mITT) no were found significant differences. By degree of fibrosis, 56% of patients were F4 and the highest SVR rates were recorded in the non-F4 patients, both TN and TE. In the analysis by groups, the TN patients treated with TVR by ITT showed a higher SVR (P = 0.005). However, by mITT there were no significant differences between BOC and TVR. In the multivariate analysis by mITT, the significant SVR factors were relapsers, IL28B CC and non-F4; the type of treatment (BOC or TVR) was not significant. The lowest SVR values were presented by the F4-NR patients, treated with BOC (46%) or with TVR (45%). 28% of the patients interrupted the treatment, mainly by non-viral response (51%): this outcome was more frequent in the TE than in the TN patients (57% vs 40%, P = 0.01). With respect to severe haematological disorders, neutropaenia was more likely to affect the patients treated with BOC (33% vs 20%, P = 0.0001), and thrombocytopaenia and anaemia, the F4 patients (P = 0.000, P = 0.025, respectively).
CONCLUSION: In a real clinical practice setting with a high proportion of patients with advanced fibrosis, effectiveness of first-generation PIs was high except for NR patients, with similar SVR rates being achieved by BOC and TVR.
000046945 540__ $$9info:eu-repo/semantics/openAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000046945 590__ $$a2.787$$b2015
000046945 591__ $$aGASTROENTEROLOGY & HEPATOLOGY$$b38 / 79 = 0.481$$c2015$$dQ2$$eT2
000046945 592__ $$a1.107$$b2015
000046945 593__ $$aMedicine (miscellaneous)$$c2015$$dQ1
000046945 593__ $$aGastroenterology$$c2015$$dQ1
000046945 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000046945 700__ $$aVinaixa, C.
000046945 700__ $$aBerenguer, R.
000046945 700__ $$aPascasio, J.M.
000046945 700__ $$aRuano, J.J.S.
000046945 700__ $$aSerra, M.Á.
000046945 700__ $$aGila, A.
000046945 700__ $$aDiago, M.
000046945 700__ $$aRomero-Gómez, M.
000046945 700__ $$aNavarro, J.M.
000046945 700__ $$aTestillano, M.
000046945 700__ $$aFernández, C.
000046945 700__ $$aEspinosa, D.
000046945 700__ $$aCarmona, I.
000046945 700__ $$aPons, J.A.
000046945 700__ $$aJorquera, F.
000046945 700__ $$aRodriguez, F.J.
000046945 700__ $$aPérez, R.
000046945 700__ $$aMontero, J.L.
000046945 700__ $$aGranados, R.
000046945 700__ $$aFernández, M.
000046945 700__ $$aMartín, A.B.
000046945 700__ $$aDe Rueda, P.M.
000046945 700__ $$aQuiles, R.
000046945 700__ $$aBerenguer, M.
000046945 700__ $$aPrieto, M.
000046945 700__ $$aSousa, J.M.
000046945 700__ $$aCuaresma, M.
000046945 700__ $$aFerrer, M.T.
000046945 700__ $$aEscolano, E.
000046945 700__ $$aMillán, R.
000046945 700__ $$aAguilar, V.M.
000046945 700__ $$aAlonso, S.
000046945 700__ $$aGutiérrez, M.L.
000046945 700__ $$aLópez, M.A.
000046945 700__ $$aNogueras, F.
000046945 700__ $$aMartín, J.M.
000046945 700__ $$aMontero, J.
000046945 700__ $$0(orcid)0000-0003-2041-3147$$aSimón, M.A.$$uUniversidad de Zaragoza
000046945 700__ $$aSánchez, G.
000046945 700__ $$aFuentes, J.
000046945 700__ $$aGonzález, A.
000046945 700__ $$aAmoros, A.
000046945 700__ $$aPérez, F.
000046945 700__ $$aCasado, M.
000046945 700__ $$aPeláez, G.
000046945 700__ $$aGonzález, M.
000046945 700__ $$aOrtega, A.
000046945 700__ $$aGarcía, M.
000046945 700__ $$aAndrade, R.
000046945 700__ $$aMartín, M.I.
000046945 700__ $$aBaeyens, E.
000046945 700__ $$aGonzález, O.
000046945 700__ $$aRodríguez, S.
000046945 700__ $$aMartín, E.
000046945 700__ $$aConde, P.
000046945 700__ $$aHallal, H.
000046945 700__ $$aEstévez, M.
000046945 700__ $$aJordan, T.
000046945 700__ $$aMolina, E.
000046945 700__ $$aJurado, A.
000046945 700__ $$aLlamoza, C.
000046945 700__ $$aBernal, V.
000046945 700__ $$aCortés, L.
000046945 700__ $$aJiménez, F.
000046945 700__ $$aVázquez, J.M.
000046945 700__ $$aAlmanzor, E.
000046945 700__ $$aArenas, J.
000046945 700__ $$aSousa, F.L.
000046945 700__ $$aMacías, M.A.
000046945 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000046945 773__ $$g21, 30 (2015), 9163-9174$$tWorld Journal of Gastroenterology$$x1007-9327
000046945 8564_ $$s1219585$$uhttps://zaguan.unizar.es/record/46945/files/texto_completo.pdf$$yVersión publicada
000046945 8564_ $$s26517$$uhttps://zaguan.unizar.es/record/46945/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
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000046945 951__ $$a2021-01-21-10:42:50
000046945 980__ $$aARTICLE