Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
Identifieur interne : 001564 ( Ncbi/Checkpoint ); précédent : 001563; suivant : 001565Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C
Auteurs : M. Colombo [Italie] ; I. Fernández [Espagne] ; D. Abdurakhmanov [Russie] ; P A Ferreira [Brésil] ; S I Strasser [Australie] ; P. Urbanek [République tchèque] ; C. Moreno [Belgique] ; A. Streinu-Cercel [Roumanie] ; A. Verheyen [Belgique] ; W. Iraqi [France] ; R. Demasi [États-Unis] ; A. Hill [Royaume-Uni] ; J M L Uffer [Suisse] ; I. Lonjon-Domanec [France] ; H. Wedemeyer [Allemagne]Source :
- Gut [ 0017-5749 ] ; 2013.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Analyse multivariée, Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Association de médicaments, Calendrier d'administration des médicaments, Cirrhose du foie (virologie), Femelle, Génotype, Hepacivirus (génétique), Humains, Hépatite C chronique (), Hépatite C chronique (traitement médicamenteux), Interféron alpha (usage thérapeutique), Modèles linéaires, Mâle, Oligopeptides (effets indésirables), Oligopeptides (usage thérapeutique), Polyéthylène glycols (usage thérapeutique), Protéines recombinantes (usage thérapeutique), Ribavirine (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Études de suivi, Études prospectives.
- MESH :
- effets indésirables : Antiviraux, Oligopeptides.
- génétique : Hepacivirus.
- traitement médicamenteux : Hépatite C chronique.
- usage thérapeutique : Antiviraux, Interféron alpha, Oligopeptides, Polyéthylène glycols, Protéines recombinantes, Ribavirine.
- virologie : Cirrhose du foie.
- Adulte, Adulte d'âge moyen, Analyse multivariée, Association de médicaments, Calendrier d'administration des médicaments, Femelle, Génotype, Humains, Hépatite C chronique, Modèles linéaires, Mâle, Résultat thérapeutique, Sujet âgé, Études de suivi, Études prospectives.
English descriptors
- KwdEn :
- Adult, Aged, Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Genotype, Hepacivirus (genetics), Hepatitis C, Chronic (complications), Hepatitis C, Chronic (drug therapy), Humans, Interferon-alpha (therapeutic use), Linear Models, Liver Cirrhosis (virology), Male, Middle Aged, Multivariate Analysis, Oligopeptides (adverse effects), Oligopeptides (therapeutic use), Polyethylene Glycols (therapeutic use), Prospective Studies, Recombinant Proteins (therapeutic use), Ribavirin (therapeutic use), Treatment Outcome.
- MESH :
- chemical , adverse effects : Antiviral Agents, Oligopeptides.
- chemical , therapeutic use : Antiviral Agents, Interferon-alpha, Oligopeptides, Polyethylene Glycols, Recombinant Proteins, Ribavirin.
- complications : Hepatitis C, Chronic.
- drug therapy : Hepatitis C, Chronic.
- genetics : Hepacivirus.
- virology : Liver Cirrhosis.
- Adult, Aged, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Genotype, Humans, Linear Models, Male, Middle Aged, Multivariate Analysis, Prospective Studies, Treatment Outcome.
Abstract
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).
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.
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).
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.
Url:
DOI: 10.1136/gutjnl-2013-305667
PubMed: 24201995
PubMed Central: 4078754
Affiliations:
- Allemagne, Australie, Belgique, Brésil, Espagne, France, Italie, Roumanie, Royaume-Uni, Russie, République tchèque, Suisse, États-Unis
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PMC:4078754Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C</title>
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<author><name sortKey="Abdurakhmanov, D" sort="Abdurakhmanov, D" uniqKey="Abdurakhmanov D" first="D" last="Abdurakhmanov">D. Abdurakhmanov</name>
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<author><name sortKey="Streinu Cercel, A" sort="Streinu Cercel, A" uniqKey="Streinu Cercel A" first="A" last="Streinu-Cercel">A. Streinu-Cercel</name>
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<author><name sortKey="Wedemeyer, H" sort="Wedemeyer, H" uniqKey="Wedemeyer H" first="H" last="Wedemeyer">H. Wedemeyer</name>
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,<addr-line>Hannover</addr-line>
,<country>Germany</country>
</nlm:aff>
<country xml:lang="fr">Allemagne</country>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Antiviral Agents (adverse effects)</term>
<term>Antiviral Agents (therapeutic use)</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Genotype</term>
<term>Hepacivirus (genetics)</term>
<term>Hepatitis C, Chronic (complications)</term>
<term>Hepatitis C, Chronic (drug therapy)</term>
<term>Humans</term>
<term>Interferon-alpha (therapeutic use)</term>
<term>Linear Models</term>
<term>Liver Cirrhosis (virology)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multivariate Analysis</term>
<term>Oligopeptides (adverse effects)</term>
<term>Oligopeptides (therapeutic use)</term>
<term>Polyethylene Glycols (therapeutic use)</term>
<term>Prospective Studies</term>
<term>Recombinant Proteins (therapeutic use)</term>
<term>Ribavirin (therapeutic use)</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Analyse multivariée</term>
<term>Antiviraux (effets indésirables)</term>
<term>Antiviraux (usage thérapeutique)</term>
<term>Association de médicaments</term>
<term>Calendrier d'administration des médicaments</term>
<term>Cirrhose du foie (virologie)</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Hepacivirus (génétique)</term>
<term>Humains</term>
<term>Hépatite C chronique ()</term>
<term>Hépatite C chronique (traitement médicamenteux)</term>
<term>Interféron alpha (usage thérapeutique)</term>
<term>Modèles linéaires</term>
<term>Mâle</term>
<term>Oligopeptides (effets indésirables)</term>
<term>Oligopeptides (usage thérapeutique)</term>
<term>Polyéthylène glycols (usage thérapeutique)</term>
<term>Protéines recombinantes (usage thérapeutique)</term>
<term>Ribavirine (usage thérapeutique)</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Études de suivi</term>
<term>Études prospectives</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term>
<term>Oligopeptides</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term>
<term>Interferon-alpha</term>
<term>Oligopeptides</term>
<term>Polyethylene Glycols</term>
<term>Recombinant Proteins</term>
<term>Ribavirin</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatitis C, Chronic</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term>
<term>Oligopeptides</term>
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</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antiviraux</term>
<term>Interféron alpha</term>
<term>Oligopeptides</term>
<term>Polyéthylène glycols</term>
<term>Protéines recombinantes</term>
<term>Ribavirine</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Cirrhose du foie</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Liver Cirrhosis</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Genotype</term>
<term>Humans</term>
<term>Linear Models</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multivariate Analysis</term>
<term>Prospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Analyse multivariée</term>
<term>Association de médicaments</term>
<term>Calendrier d'administration des médicaments</term>
<term>Femelle</term>
<term>Génotype</term>
<term>Humains</term>
<term>Hépatite C chronique</term>
<term>Modèles linéaires</term>
<term>Mâle</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Études de suivi</term>
<term>Études prospectives</term>
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<front><div type="abstract" xml:lang="en"><sec><title>Background and aim</title>
<p>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).</p>
</sec>
<sec><title>Methods</title>
<p>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.</p>
</sec>
<sec><title>Results</title>
<p>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).</p>
</sec>
<sec><title>Conclusions</title>
<p>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.</p>
</sec>
</div>
</front>
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<author><name sortKey="Strader, Db" uniqKey="Strader D">DB Strader</name>
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<author><name sortKey="Thomas, Dl" uniqKey="Thomas D">DL Thomas</name>
</author>
</analytic>
</biblStruct>
<biblStruct></biblStruct>
<biblStruct><analytic><author><name sortKey="Ghany, Mg" uniqKey="Ghany M">MG Ghany</name>
</author>
<author><name sortKey="Nelson, Dr" uniqKey="Nelson D">DR Nelson</name>
</author>
<author><name sortKey="Strader, Db" uniqKey="Strader D">DB Strader</name>
</author>
</analytic>
</biblStruct>
<biblStruct><analytic><author><name sortKey="Dusheiko, G" uniqKey="Dusheiko G">G Dusheiko</name>
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