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<publisher>HAL CCSD</publisher>
<title lang=en>Telaprevir for HIV/hepatitis C virus-coinfected patients failing treatment with pegylated interferon/ribavirin (ANRS HC26 TelapreVIH): an open-label, single-arm, phase 2 trial.</title>
<creator>Cotte, Laurent</creator>
<creator>Braun, Joséphine</creator>
<creator>Lascoux-Combe, Caroline</creator>
<creator>Vincent, Corine</creator>
<creator>Valantin, Marc-Antoine</creator>
<creator>Sogni, Philippe</creator>
<creator>Lacombe, Karine</creator>
<creator>Neau, Didier</creator>
<creator>Aumaitre, Hugues</creator>
<creator>Batisse, Dominique</creator>
<creator>De Truchis, Pierre</creator>
<creator>Gervais, Anne</creator>
<creator>Michelet, Christian</creator>
<creator>Morlat, Philippe</creator>
<creator>Vittecoq, Daniel</creator>
<creator>Rosa, Isabelle</creator>
<creator>Bertucci, Inga</creator>
<creator>Chevaliez, Stéphane</creator>
<creator>Aboulker, Jean-Pierre</creator>
<creator>Molina, Jean-Michel</creator>
<contributor>Service des maladies infectieuses et tropicales [CHU Pitié-Salpêtrière] ; Assistance publique - Hôpitaux de Paris (AP-HP) - CHU Pitié-Salpêtrière [APHP]</contributor>
<contributor>Service des Maladies Infectieuses et Tropicales A [Bordeaux] ; CHU Bordeaux [Bordeaux] - Groupe hospitalier Pellegrin</contributor>
<contributor>Service d'immunologie ; Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Européen Georges Pompidou [APHP] (HEGP)</contributor>
<contributor>Institut de recherche, santé, environnement et travail [Rennes] (Irset) ; Université d'Angers (UA) - Université des Antilles et de la Guyane (UAG) - Université de Rennes 1 (UR1) - École des Hautes Études en Santé Publique [EHESP] (EHESP) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )</contributor>
<contributor>CHU Pontchaillou [Rennes]</contributor>
<contributor>Service de médecine interne et maladies infectieuses [Bordeaux] ; CHU Bordeaux [Bordeaux] - Groupe hospitalier Saint-André</contributor>
<contributor>Service d'hépato-gastro-entérologie ; CHI Créteil</contributor>
<contributor>Centre National de Référence Virus des hépatites B, C et Delta ; Institut National de la Transfusion Sanguine [Paris] (INTS) - Assistance publique - Hôpitaux de Paris (AP-HP)</contributor>
<contributor>Institut Mondor de Recherche Biomédicale (IMRB) ; Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12) - Institut National de la Santé et de la Recherche Médicale (INSERM) - IFR10</contributor>
<contributor>Essais Therapeutiques et Infection Par Le Vih ; Université Paris-Sud - Paris 11 (UP11) - Institut National de la Santé et de la Recherche Médicale (INSERM)</contributor>
<contributor>Institut Universitaire d'Hématologie ; Université Paris Diderot - Paris 7 (UPD7) - Hopital Saint-Louis, Assistance Publique Hopitaux de Paris</contributor>
<contributor>Inserm</contributor>
<contributor>Service des Maladies Infectieuses et Tropicales [CHU Saint Louis] ; Groupe Hospitalier Saint-Louis-Lariboisière- Fernand-Widal</contributor>
<description>International audience</description>
<source>ISSN: 1058-4838</source>
<source>EISSN: 1537-6591</source>
<source>Clinical Infectious Diseases</source>
<publisher>Oxford University Press (OUP)</publisher>
<identifier>hal-01118447</identifier>
<identifier>https://hal-univ-rennes1.archives-ouvertes.fr/hal-01118447</identifier>
<source>https://hal-univ-rennes1.archives-ouvertes.fr/hal-01118447</source>
<source>Clinical Infectious Diseases, Oxford University Press (OUP), 2014, 59 (12), pp.1768-76. 〈10.1093/cid/ciu659〉</source>
<identifier>PUBMED : 25139963</identifier>
<relation>info:eu-repo/semantics/altIdentifier/pmid/25139963</relation>
<identifier>DOI : 10.1093/cid/ciu659</identifier>
<relation>info:eu-repo/semantics/altIdentifier/doi/10.1093/cid/ciu659</relation>
<language>en</language>
<subject>[SDV] Life Sciences [q-bio]</subject>
<type>info:eu-repo/semantics/article</type>
<type>Journal articles</type>
<description lang=en>Retreatment with pegylated interferon (peg-IFN) and ribavirin (RBV) results in poor sustained virological response (SVR) rates in human immunodeficiency virus (HIV)/hepatitis C virus (HCV)-coinfected patients. There are limited data regarding the use of telaprevir plus peg-IFN/RBV in this population. HIV type 1-infected patients who previously failed ≥12 weeks of peg-IFN/RBV for HCV genotype 1 coinfection were enrolled in a single-arm, phase 2 trial. Patients with cirrhosis and previous null response were excluded. Authorized antiretrovirals were tenofovir, emtricitabine, efavirenz, atazanavir, and raltegravir. All patients received peg-IFN alfa-2a (180 µg/week) plus RBV (1000-1200 mg/day) for 4 weeks, followed by telaprevir (750 mg or 1125 mg every 8 hours with efavirenz) plus peg-IFN/RBV for 12 weeks and peg-IFN/RBV for 32-56 weeks according to virological response at week 8. The primary endpoint was the SVR rate at 24 weeks after the end of treatment (SVR24). Sixty-nine patients started treatment; SVR24 was achieved in 55 (80% [95% confidence interval, 68%-88%). SVR24 was not influenced by baseline fibrosis stage, IL28B genotype, antiretroviral regimen, HCV subtype, CD4 cell count, previous response to HCV treatment, HCV RNA level, or HCV RNA decline at week 4. HCV treatment was discontinued for adverse events (AEs) in 20% of patients, including cutaneous (4%), psychiatric (4%), hematological (6%), and other AEs (6%). Peg-IFN or RBV dose reduction was required in 23% and 43% of patients, respectively. Seventy percent of patients required erythropoietin, blood transfusions, or RBV dose reduction for anemia. Two patients died during the study. No HIV breakthrough was observed. Despite a high discontinuation rate related to toxicity, a substantial proportion of treatment-experienced HIV-coinfected patients achieved SVR24 with a telaprevir-based regimen. Clinical Trials Registration. NCT01332955.</description>
<date>2014-12-15</date>
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