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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Colombo</name><affiliation wicri:level="1"><nlm:aff id="af1"><addr-line>Department of Medicine, Division of Gastroenterology</addr-line>,<institution>Fondazione IRCCS Ca` Granda Ospedale Maggiore Policlinico, Universita` degli Studi di Milano</institution>,<addr-line>Milan</addr-line>,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fernandez, I" sort="Fernandez, I" uniqKey="Fernandez I" first="I" last="Fernández">I. Fernández</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Hospital Universitario 12 de Octubre, Sección de Aparato Digestivo</institution>,<addr-line>Madrid</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Abdurakhmanov, D" sort="Abdurakhmanov, D" uniqKey="Abdurakhmanov D" first="D" last="Abdurakhmanov">D. Abdurakhmanov</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>I.M. Sechenov First Moscow State Medical University, E. M. Tareev Clinic for Nephrology, Internal and Occupational Medicine</institution>,<addr-line>Moscow</addr-line>,<country>Russia</country></nlm:aff><country xml:lang="fr">Russie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ferreira, P A" sort="Ferreira, P A" uniqKey="Ferreira P" first="P A" last="Ferreira">P A Ferreira</name><affiliation wicri:level="1"><nlm:aff id="af4"><addr-line>Viral Hepatitis Division of Infectious Disease</addr-line>,<institution>Outpatient Clinic to HIV, Federal University of São Paulo</institution>,<addr-line>São Paulo</addr-line>,<country>Brazil</country></nlm:aff><country xml:lang="fr">Brésil</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Strasser, S I" sort="Strasser, S I" uniqKey="Strasser S" first="S I" last="Strasser">S I Strasser</name><affiliation wicri:level="1"><nlm:aff id="af5"><institution>AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, University of Sydney</institution>,<addr-line>Sydney</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Urbanek, P" sort="Urbanek, P" uniqKey="Urbanek P" first="P" last="Urbanek">P. Urbanek</name><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Internal Medicine, First Medical Faculty</addr-line>,<institution>Charles University, and Central Military Hospital Prague</institution>,<addr-line>Prague</addr-line>,<country>Czech Republic</country></nlm:aff><country xml:lang="fr">République tchèque</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Moreno, C" sort="Moreno, C" uniqKey="Moreno C" first="C" last="Moreno">C. Moreno</name><affiliation wicri:level="1"><nlm:aff id="af7"><addr-line>Liver Unit, Department of Gastroenterology, Hepatopancreatology and Digestive Oncology</addr-line>,<institution>Erasme University Hospital, Université Libre de Bruxelles</institution>,<addr-line>Brussels</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Streinu Cercel, A" sort="Streinu Cercel, A" uniqKey="Streinu Cercel A" first="A" last="Streinu-Cercel">A. Streinu-Cercel</name><affiliation wicri:level="1"><nlm:aff id="af8"><institution>Carol Davila University of Medicine and Pharmacy, National Institute for Infectious Diseases, "Prof. Dr. Matei Bals"</institution>,<addr-line>Bucharest</addr-line>,<country>Romania</country></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Verheyen, A" sort="Verheyen, A" uniqKey="Verheyen A" first="A" last="Verheyen">A. Verheyen</name><affiliation wicri:level="1"><nlm:aff id="af9"><institution>Janssen Pharmaceutica</institution>,<addr-line>Beerse</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Iraqi, W" sort="Iraqi, W" uniqKey="Iraqi W" first="W" last="Iraqi">W. Iraqi</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>Janssen Pharmaceuticals</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Demasi, R" sort="Demasi, R" uniqKey="Demasi R" first="R" last="Demasi">R. Demasi</name><affiliation wicri:level="1"><nlm:aff id="af11"><institution>Janssen Research and Development</institution>,<addr-line>Titusville, New Jersey</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hill, A" sort="Hill, A" uniqKey="Hill A" first="A" last="Hill">A. Hill</name><affiliation wicri:level="1"><nlm:aff id="af12"><institution>Janssen Research and Development</institution>,<addr-line>High Wycombe</addr-line>,<country>UK</country></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="L Uffer, J M" sort="L Uffer, J M" uniqKey="L Uffer J" first="J M" last="L Uffer">J M L Uffer</name><affiliation wicri:level="1"><nlm:aff id="af13"><institution>Janssen-Cilag AG</institution>,<addr-line>Zug</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lonjon Domanec, I" sort="Lonjon Domanec, I" uniqKey="Lonjon Domanec I" first="I" last="Lonjon-Domanec">I. Lonjon-Domanec</name><affiliation wicri:level="1"><nlm:aff id="af10"><institution>Janssen Pharmaceuticals</institution>,<addr-line>Paris</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Wedemeyer, H" sort="Wedemeyer, H" uniqKey="Wedemeyer H" first="H" last="Wedemeyer">H. 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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></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Oligopeptides</term></keywords><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></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Hepacivirus</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Hépatite C chronique</term></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></keywords></textClass></profileDesc></teiHeader><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><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Ghany, Mg" uniqKey="Ghany M">MG Ghany</name></author><author><name sortKey="Strader, Db" uniqKey="Strader D">DB Strader</name></author><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 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sortKey="Van Der Meer, Aj" uniqKey="Van Der Meer A">AJ Van der Meer</name></author><author><name sortKey="Veldt, Bj" uniqKey="Veldt B">BJ Veldt</name></author><author><name sortKey="Feld, Jj" uniqKey="Feld J">JJ Feld</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bourliere, M" uniqKey="Bourliere M">M Bourlière</name></author><author><name sortKey="Khaloun, A" uniqKey="Khaloun A">A Khaloun</name></author><author><name sortKey="Wartelle Bladou, C" uniqKey="Wartelle Bladou C">C Wartelle-Bladou</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Poordad, Ff" uniqKey="Poordad F">FF Poordad</name></author><author><name sortKey="Mccone, J" uniqKey="Mccone J">J McCone</name></author><author><name sortKey="Bacon, Br" uniqKey="Bacon B">BR Bacon</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Jacobson, Im" uniqKey="Jacobson I">IM Jacobson</name></author><author><name sortKey="Mchutchison, Jg" 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sort="Colombo, M" uniqKey="Colombo M" first="M" last="Colombo">M. Colombo</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Fernandez, I" sort="Fernandez, I" uniqKey="Fernandez I" first="I" last="Fernández">I. Fernández</name></noRegion></country><country name="Russie"><noRegion><name sortKey="Abdurakhmanov, D" sort="Abdurakhmanov, D" uniqKey="Abdurakhmanov D" first="D" last="Abdurakhmanov">D. Abdurakhmanov</name></noRegion></country><country name="Brésil"><noRegion><name sortKey="Ferreira, P A" sort="Ferreira, P A" uniqKey="Ferreira P" first="P A" last="Ferreira">P A Ferreira</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Strasser, S I" sort="Strasser, S I" uniqKey="Strasser S" first="S I" last="Strasser">S I Strasser</name></noRegion></country><country name="République tchèque"><noRegion><name sortKey="Urbanek, P" sort="Urbanek, P" uniqKey="Urbanek P" first="P" last="Urbanek">P. Urbanek</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Moreno, C" sort="Moreno, C" uniqKey="Moreno C" first="C" last="Moreno">C. Moreno</name></noRegion><name sortKey="Verheyen, A" sort="Verheyen, A" uniqKey="Verheyen A" first="A" last="Verheyen">A. Verheyen</name></country><country name="Roumanie"><noRegion><name sortKey="Streinu Cercel, A" sort="Streinu Cercel, A" uniqKey="Streinu Cercel A" first="A" last="Streinu-Cercel">A. Streinu-Cercel</name></noRegion></country><country name="France"><noRegion><name sortKey="Iraqi, W" sort="Iraqi, W" uniqKey="Iraqi W" first="W" last="Iraqi">W. Iraqi</name></noRegion><name sortKey="Lonjon Domanec, I" sort="Lonjon Domanec, I" uniqKey="Lonjon Domanec I" first="I" last="Lonjon-Domanec">I. Lonjon-Domanec</name></country><country name="États-Unis"><noRegion><name sortKey="Demasi, R" sort="Demasi, R" uniqKey="Demasi R" first="R" last="Demasi">R. Demasi</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Hill, A" sort="Hill, A" uniqKey="Hill A" first="A" last="Hill">A. Hill</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="L Uffer, J M" sort="L Uffer, J M" uniqKey="L Uffer J" first="J M" last="L Uffer">J M L Uffer</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Wedemeyer, H" sort="Wedemeyer, H" uniqKey="Wedemeyer H" first="H" last="Wedemeyer">H. Wedemeyer</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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