title: Efficacy and safety of direct-acting antiviral regimens in HIV/HCV-co-infected patients - French ANRS CO13 HEPAVIH cohort.
abstract: There is little data available on the use of new oral direct-acting antiviral (DAA) regimens to treat human immunodeficiency virus and hepatitis C virus (HIV/HCV) co-infected patients in real-life settings. Here, the efficacy and safety of all-oral DAA-based regimens in HIV/HCV-co-infected patients enrolled in the French nationwide ANRS CO13 HEPAVIH observational cohort are reported.
  
  
  
  HIV/HCV-co-infected patients enrolled in the ANRS CO13 HEPAVIH observational cohort were included if they began an all-oral DAA-based regimen before 1st May 2015 (12-week regimens) or 1st February 2015 (24-week regimens). Treatment success (SVR12) was defined by undetectable HCV-RNA 12weeks after treatment cessation. Exact logistic regression analysis was used to identify factors associated with SVR12.
  
  
  
  A total of 323 patients (74% men) with a median age of 53years were included, 99% of whom were on combination antiretroviral therapy (cART). HIV RNA load was <50 copies/ml in 88% of patients; median CD4 cell count was 540/mm3; 60% of patients were cirrhotic; 68% had previously received unsuccessful anti-HCV treatment. cART was protease inhibitor (PI)-based in 23%, non-nucleoside reverse transcriptase inhibitor (NNRTI)-based in 15%, and integrase inhibitor (II)-based in 38%, while 24% of patients received other regimens. The SVR12 rate was 93.5% overall (95% confidence interval [CI]: 90.2-95.9), 93.3% (88.8-96.4) in patients with cirrhosis and 93.8% (88.1-97.3) in patients without cirrhosis. The SVR12 rates were 93.1% (84.5-97.7), 91.8% (80.4-97.7) and 95.8% (90.5-98.6) respectively, in patients receiving PI-based, NNRTI-based and II-based cART. In adjusted analysis, SVR12 was not associated with HIV RNA load, the cART regimen, cirrhosis, prior anti-HCV treatment, the duration of anti-HCV therapy, or ribavirin use. The most common adverse effects were fatigue and digestive disorders.
  
  
  
  New all-oral DAA regimens were well-tolerated and yielded high SVR12 rates in HIV/HCV-co-infected patients.
  
  
  
  We evaluated efficacy and safety of all-oral DAA regimens in a large French nationwide observational cohort study of HIV/HCV co-infected patients. Sustained virological response 12weeks after treatment cessation was 93.5% overall. The all-oral DAA regimens were well-tolerated and most common adverse effects were fatigue and digestive disorders.
authors.affiliation: Centre Hospitalier Universitaire de Dijon, Département d'Infectiologie, Dijon, France; Université de Bourgogne, Dijon, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Piroth
authors.affiliation: Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France; CHU de Bordeaux, Pole de sante publique, Service d'information medicale, F-33000 Bordeaux, France. Electronic address: Linda.Wittkop@isped.u-bordeaux2.fr.
authors.forename: Linda
authors.initials: L
authors.lastname: Wittkop
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Saint-Antoine, Service Maladies infectieuses et tropicales, Paris, France; UMPC (Université Pierre et Marie Curie), UMR S1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Lacombe
authors.affiliation: Centre Hospitalier Universitaire de Nice, Service de Médecine Interne, Hôpital l'Archet, Nice, France; Université de Nice-Sophia Antipolis, Nice, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Rosenthal
authors.affiliation: Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Gilbert
authors.affiliation: Service des Maladies Infectieuses et Tropicales, CHU Lyon, Hôpital de la Croix Rousse, Lyon, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Miailhes
authors.affiliation: Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Carrieri
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Tenon, Service Maladies infectieuses et tropicales, Paris, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chas
authors.affiliation: Aix Marseille Univ, APHM Sainte-Marguerite, Service d'Immuno-hématologie clinique, Marseille, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Poizot-Martin
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Bichat Claude Bernard, Service des Maladies Infectieuses et tropicales, Paris, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Gervais
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Henri Mondor, Service Immunologie clinique et Maladies Infectieuses, Immunologie clinique, Créteil, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Dominguez
authors.affiliation: Centre Hospitalier Universitaire de Bordeaux, Service Maladies infectieuses et tropicales Bordeaux, Hôpital Pellegrin, Bordeaux, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Neau
authors.affiliation: Hôpital Foch, unité VIH, Suresnes, France.
authors.forename: David
authors.initials: D
authors.lastname: Zucman
authors.affiliation: Centre Hospitalier Universitaire de Nantes, Service Maladies infectieuses et tropicales, Nantes, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Billaud
authors.affiliation: Centre Hospitalier Universitaire de Bordeaux, Service de Médecine Interne, hôpital Saint-André, Bordeaux, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Morlat
authors.affiliation: Centre Hospitalier de Perpignan, Service Maladies infectieuses et tropicales, Perpignan, France.
authors.forename: Hugues
authors.initials: H
authors.lastname: Aumaitre
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Saint-Louis, Service Maladies infectieuses et tropicales, Paris, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Lascoux-Combe
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Pitié-Salpétrière, Département de Médecine Interne et Immunologie Clinique, Paris, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Simon
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Avicenne, Service Maladies infectieuses et tropicales, Bobigny, France; Université Paris 13 Nord, Bobigny, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Bouchaud
authors.affiliation: Assistance Publique des Hôpitaux de Paris, GH Paris Sud : Service Médecine Interne et Immunologie clinique, Hôpital Bicêtre, Le Kremlin-Bicêtre; Centre Hépato-Biliaire, Hôpital Paul-Brousse,Villejuif, France.
authors.forename: Elina
authors.initials: E
authors.lastname: Teicher
authors.affiliation: Centre Hospitalier Universitaire de Reims, Service de Médecine Interne, Maladies Infectieuses et immunologie clinique, Reims, France; Université de Reims, Champagne-Ardenne, Reims, France.
authors.forename: Firouzé
authors.initials: F
authors.lastname: Bani-Sadr
authors.affiliation: Centre Hospitalier Universitaire de Toulouse, Hôpital Purpan, Service Médecine Interne-Pôle Digestif, Toulouse, France; UMR 152 IRD Université Toulouse III, Paul Sabatier, Toulouse, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Alric
authors.affiliation: Université Paris Sud, Le Kremlin-Bicêtre, France; Assistance Publique des Hôpitaux de Paris, Hôpital Bicêtre, Hôpitaux universitaires Paris Sud, Service Maladies infectieuses et tropicales, Le Kremlin-Bicêtre, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Vittecoq
authors.affiliation: Université Paris Sud, Le Kremlin-Bicêtre, France; Assistance Publique des Hôpitaux de Paris, Groupe Hospitalier Paris Sud, Hôpital Antoine-Béclère, Service Médecine Interne et immunologie, Clamart, France.
authors.forename: François
authors.initials: F
authors.lastname: Boué
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Service de Maladies Infectieuses et Tropicales, Centre d'infectiologie Necker-Pasteur, IHU Imagine, Paris, France.
authors.forename: Claudine
authors.initials: C
authors.lastname: Duvivier
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Pitié-Salpétrière, Service Maladies infectieuses et tropicales, Paris, France.
authors.forename: Marc-Antoine
authors.initials: MA
authors.lastname: Valantin
authors.affiliation: Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Esterle
authors.affiliation: Univ. Bordeaux, ISPED, Inserm, Bordeaux Population Health Research Center, team MORPH3EUS, UMR 1219, CIC-EC 1401, F-33000 Bordeaux, France; CHU de Bordeaux, Pole de sante publique, Service d'information medicale, F-33000 Bordeaux, France.
authors.forename: François
authors.initials: F
authors.lastname: Dabis
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Cochin, Service d'Hépatologie, Paris, France; INSERM U-1223 - Institut Pasteur, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Sogni
authors.affiliation: Assistance Publique des Hôpitaux de Paris, Hôpital Cochin, Service Maladies infectieuses et tropicales, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Salmon
mesh_terms: D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D060085:Coinfection / Q000188:drug therapy*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged
chemical_list: D000998:Antiviral Agents
keywords: All-oral DAA; HIV/HCV co-infection; Sustained virological response