• Je něco špatně v tomto záznamu ?

Sustained virological response with telaprevir in 1,078 patients with advanced hepatitis C: the international telaprevir access program

M. Colombo, S. Strasser, C. Moreno, P. Abrao Ferreira, P. Urbanek, I. Fernández, D. Abdurakmonov, A. Streinu-Cercel, A. Verheyen, W. Iraqi, R. DeMasi, A. Hill, I. Lonjon-Domanec, H. Wedemeyer,

. 2014 ; 61 (5) : 976-83.

Jazyk angličtina Země Nizozemsko

Typ dokumentu klinické zkoušky, časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc15023321

BACKGROUND & AIMS: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). METHODS: 1078 patients with bridging fibrosis (n=552) or cirrhosis (n=526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/mm(3), Hb >12/13 g/dl) and liver function (Albumin >3.3g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. RESULTS: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR)=1.51, 95% CI 1.31-2.00, p=0.005), (B) subtype 1b (OR=1.63, 95% CI 1.18-2.24, p=0.0029), (C) alpha-fetoprotein <10 ng/ml (OR=2.50, 95% CI 1.87-3.36, p<0.0001) and (D) any prior response other than null (OR=3.29, 95% CI 2.40-4.52, p<0.0001). SVR24 rose for patients who had more of these predictive factors: 6/32 (19%) for none, 38/139 (27%) for 1, 129/260 (50%) for 2, 202/329 (61%) for 3, and 194/235 (83%) for 4 factors. Grade 2-4 treatment-related adverse events (AE) were experienced by 719 (67%) patients; 169 (16%) discontinued therapy for AE and 7 (0.6%) died during the PR tail. CONCLUSIONS: Naïve and experienced patients with advanced fibrosis or cirrhosis due to HCV-1 who have compensated bone marrow and liver function, can effectively and safely be treated by TVR triple therapy. Baseline predictors of outcome have been identified to optimize pre-treatment counselling.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc15023321
003      
CZ-PrNML
005      
20150729113050.0
007      
ta
008      
150709s2014 ne f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.jhep.2014.06.005 $2 doi
035    __
$a (PubMed)24946280
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ne
100    1_
$a Colombo, Massimo $u Department of Medicine, Division of Gastroenterology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. Electronic address: massimo.colombo@unimi.it.
245    10
$a Sustained virological response with telaprevir in 1,078 patients with advanced hepatitis C: the international telaprevir access program / $c M. Colombo, S. Strasser, C. Moreno, P. Abrao Ferreira, P. Urbanek, I. Fernández, D. Abdurakmonov, A. Streinu-Cercel, A. Verheyen, W. Iraqi, R. DeMasi, A. Hill, I. Lonjon-Domanec, H. Wedemeyer,
520    9_
$a BACKGROUND & AIMS: There is little information regarding the extent to which difficult to cure patients with advanced liver fibrosis, due to hepatitis C virus genotype-1 (HCV-1) can successfully and safely be treated with triple therapy with telaprevir (TVR), pegylated interferon alpha (P) and ribavirin (R). In the TVR early access program HEP3002 we aimed to explore treatment safety and efficacy, and identify predictors of sustained virological response at week 24 (SVR24). METHODS: 1078 patients with bridging fibrosis (n=552) or cirrhosis (n=526) diagnosed by either liver biopsy or non-invasive markers, with compensated bone marrow (neutrophils >1500/mm(3), Hb >12/13 g/dl) and liver function (Albumin >3.3g/dl, Platelets >90,000/ml) received TVR PR for 12 weeks, followed by a PR tail according to label. RESULTS: Overall, 614 (57%) achieved SVR24 by intention-to-treat analysis. The SVR24 rate was 68% in 221 treatment naïve patients (62.8% F4), 72% in 356 prior relapsers (64.4% F4), 55% in 139 partial responders (53.2% F4), and 34% in 294 null responders (28.6% F4). The SVR24 rate to response-guided therapy (24 weeks treatment duration if undetectable viremia at weeks 4 and 12) was 84% in 222 naïve/relapser F3 patients. Independent predictors of response were: (A) F3 (odds ratio (OR)=1.51, 95% CI 1.31-2.00, p=0.005), (B) subtype 1b (OR=1.63, 95% CI 1.18-2.24, p=0.0029), (C) alpha-fetoprotein <10 ng/ml (OR=2.50, 95% CI 1.87-3.36, p<0.0001) and (D) any prior response other than null (OR=3.29, 95% CI 2.40-4.52, p<0.0001). SVR24 rose for patients who had more of these predictive factors: 6/32 (19%) for none, 38/139 (27%) for 1, 129/260 (50%) for 2, 202/329 (61%) for 3, and 194/235 (83%) for 4 factors. Grade 2-4 treatment-related adverse events (AE) were experienced by 719 (67%) patients; 169 (16%) discontinued therapy for AE and 7 (0.6%) died during the PR tail. CONCLUSIONS: Naïve and experienced patients with advanced fibrosis or cirrhosis due to HCV-1 who have compensated bone marrow and liver function, can effectively and safely be treated by TVR triple therapy. Baseline predictors of outcome have been identified to optimize pre-treatment counselling.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a antivirové látky $x aplikace a dávkování $x terapeutické užití $7 D000998
650    _2
$a kombinovaná farmakoterapie $7 D004359
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a Hepacivirus $x klasifikace $x účinky léků $x genetika $7 D016174
650    _2
$a chronická hepatitida C $x farmakoterapie $x virologie $7 D019698
650    _2
$a lidé $7 D006801
650    _2
$a interferon alfa $x aplikace a dávkování $7 D016898
650    _2
$a jaterní cirhóza $x farmakoterapie $x virologie $7 D008103
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a oligopeptidy $x aplikace a dávkování $x terapeutické užití $7 D009842
650    _2
$a polyethylenglykoly $x aplikace a dávkování $7 D011092
650    _2
$a rekombinantní proteiny $x aplikace a dávkování $7 D011994
650    _2
$a ribavirin $x aplikace a dávkování $7 D012254
650    _2
$a výsledek terapie $7 D016896
650    _2
$a mladý dospělý $7 D055815
655    _2
$a klinické zkoušky $7 D016430
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
700    1_
$a Strasser, Simone $u AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia.
700    1_
$a Moreno, Christophe $u Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium.
700    1_
$a Abrao Ferreira, Paulo $u Outpatient Clinic to HIV and Viral Hepatitis Division of Infectious Disease, Federal University of São Paulo, São Paulo, Brazil. $7 gn_A_00000808
700    1_
$a Urbanek, Petr $u Department of Internal Medicine, First Medical Faculty, Charles University, and Central Military Hospital Prague, Prague, Czech Republic.
700    1_
$a Fernández, Inmaculada $u Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo, Madrid, Spain.
700    1_
$a Abdurakmonov, Djamal $u I.M. Sechenov First Moscow State Medical University, E.M. Tareev Clinic for Nephrology, Internal and Occupational Medicine, Moscow, Russia. $7 gn_A_00000474
700    1_
$a Streinu-Cercel, Adrian $u Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Bucharest, Romania.
700    1_
$a Verheyen, Anke $u Janssen Pharmaceutica, Beerse, Belgium.
700    1_
$a Iraqi, Wafae $u Janssen Pharmaceuticals, Paris, France.
700    1_
$a DeMasi, Ralph $u Tibotec Inc., Titusville, NJ, USA.
700    1_
$a Hill, Andrew $u MetaVirology Ltd, London, UK.
700    1_
$a Lonjon-Domanec, Isabelle $u Janssen Pharmaceuticals, Paris, France.
700    1_
$a Wedemeyer, Heiner $u Medizinische Hochschule Hannover, Hannover, Germany.
773    0_
$w MED00010017 $t Journal of hepatology $x 1600-0641 $g Roč. 61, č. 5 (2014), s. 976-83
856    41
$u https://pubmed.ncbi.nlm.nih.gov/24946280 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20150709 $b ABA008
991    __
$a 20150729113137 $b ABA008
999    __
$a ok $b bmc $g 1083659 $s 906314
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2014 $b 61 $c 5 $d 976-83 $i 1600-0641 $m Journal of hepatology $n J Hepatol $x MED00010017
LZP    __
$a Pubmed-20150709

Najít záznam

Citační ukazatele

Možnosti archivace