000			nab a22 7a 4500
999			_c16595 _d16595
003			PC16595
005			20211005132312.0
008			210827b xxu||||| |||| 00| 0 eng d
040			_cH12O
041			_aeng
100			_91208 _aFernández Vázquez, Inmaculada _eAparato Digestivo
245	0	0	_aSafety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C. _h[artículo]
260			_bGut, _c2014
300			_a63(7):1150-8.
500			_aFormato Vancouver: Colombo M, Fernández I, Abdurakhmanov D, Ferreira PA, Strasser SI, Urbanek P et al. Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C. Gut. 2014 Jul;63(7):1150-8.
501			_aPMID: 24201995 PMC4078754
504			_aContiene 28 referencias
520			_aBackground and aim: Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods: 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results: 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53% cirrhosis, 22% HCV-1a). By week 12, HCV RNA was undetectable in 85% of naives, 88% of relapsers, 80% of partial responders and 72% of null responders. Overall, 931 patients (59%) developed grade 1-4 anaemia (grade 3/4 in 31%), 630 (40%) dose reduced RBV, 332 (21%) received erythropoietin and 157 (10%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12%). Seven patients died (0.4%, six had cirrhosis). Conclusions: In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.
710			_9273 _aServicio de Medicina del Aparato Digestivo
856			_uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078754/pdf/gutjnl-2013-305667.pdf _yAcceso libre
942			_2ddc _cART _n0