title: Role of a 48-week pegylated interferon therapy in hepatitis B e antigen positive HIV-co-infected patients on cART including tenofovir: EMVIPEG study.
abstract: OBJECTIVE
  In hepatitis B e antigen (HBeAg) positive-HIV co-infected patients treated with combined antiretroviral therapy (cART), including tenofovir disoproxil fumarate (TDF), the rate of HBe seroconversion remains low. Whether adding pegylated interferon alfa (PegIFN) could increase the likelihood of HBeAg loss and HBe seroconversion has not been assessed.
  
  
  METHODS
  A 48-week PegIFN therapy was added to HBeAg positive-HIV co-infected patients on TDF and emtricitabine, or lamivudine for at least 6 months. The primary endpoint was HBV sustained response: HBe seroconversion with undetectable HBV DNA levels 24 weeks after completing PegIFN therapy (W72).
  
  
  RESULTS
  Fifty-one patients (49 men, median age 46 years, range: 32-65), were included. Median duration of HIV, HBV infections and TDF therapy was 10.3 (0.6-22), 9.8 (0.5-16), and 3.3 (0.5-6.8)years, respectively. Median baseline CD4 count was 506 (175-1316)/mm(3). HIV viral load was <50 copies/ml in 49 (96%) patients. Nine (18%) patients stopped PegIFN prematurely. Ten (20%) patients experienced HBeAg loss at W72 and four (8%) patients had a HBV sustained response. No HBs seroconversion was observed. Only patients with more than 350 CD4/mm(3) at baseline achieved HBe loss. HBeAg level >10 PEIU/ml at W12 or a quantitative HBsAg decline <0.5 log IU/ml at W24 had 100% and 84% negative predictive values for response, respectively.
  
  
  CONCLUSIONS
  48-week PegIFN additional therapy to cART including TDF did not significantly increase the HBe seroconversion rate, despite an HBeAg loss in 20% of the patients. HBe and HBs kinetics may nevertheless be of help in tailoring and optimising this strategy.
authors.affiliation: Service des Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, INSERM U1052, Lyon, France. Electronic address: patrick.miailhes@chu-lyon.fr.
authors.forename: Patrick
authors.initials: P
authors.lastname: Miailhes
authors.affiliation: Service d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, INSERM U1052, Lyon, France.
authors.forename: Marianne
authors.initials: M
authors.lastname: Maynard-Muet
authors.affiliation: Service d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, INSERM U1052, Lyon, France.
authors.forename: Fanny
authors.initials: F
authors.lastname: Lebossé
authors.affiliation: UMRS-707, Université Paris 6 et INSERM, Santé Publique, APHP, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.affiliation: Service d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, INSERM U1052, Lyon, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Bouix
authors.affiliation: Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, APHP, Paris, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Lascoux-Combe
authors.affiliation: Université Paris Descartes, Inserm U1016, Unité d'Hépatologie, APHP, Hôpital Cochin, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Sogni
authors.affiliation: Center for HIV infection Care, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: David
authors.initials: D
authors.lastname: Rey
authors.affiliation: UMRS-707, Université Paris 6 et INSERM, Santé Publique, APHP, Paris, France.
authors.forename: Yoann
authors.initials: Y
authors.lastname: Barthe
authors.affiliation: Université Paris Descartes, Inserm U1016, Unité d'Hépatologie, APHP, Hôpital Cochin, Paris, France.
authors.forename: Stanislas
authors.initials: S
authors.lastname: Pol
authors.affiliation: Hôpital de La Pitié-Salpêtrière, Service de Médecine Interne, CNRS UMR 7087, Univ Pierre et Marie Curie, Paris, France.
authors.forename: Patrice
authors.initials: P
authors.lastname: Cacoub
authors.affiliation: Service d'Hépatologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, INSERM U1052, Lyon, France.
authors.forename: Fabien
authors.initials: F
authors.lastname: Zoulim
authors.affiliation: Service des Maladies Infectieuses, Hôpital du bocage, Université de Bourgogne, Dijon, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Piroth
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D000998:Antiviral Agents / Q000008:administration & dosage; D018791:CD4 Lymphocyte Count; D060085:Coinfection / Q000188:drug therapy / Q000276:immunology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004337:Drug Carriers; D000068679:Emtricitabine; D005260:Female; D006678:HIV / Q000187:drug effects / Q000276:immunology; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage*; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011994:Recombinant Proteins / Q000008:administration & dosage; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D063065:Organophosphonates; D011994:Recombinant Proteins; D003841:Deoxycytidine; D019259:Lamivudine; D011092:Polyethylene Glycols; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine; C100416:peginterferon alfa-2a
keywords: HBe seroconversion; HIV-HBV co-infection; Hepatitis B e antigen; Pegylated interferon; Tenofovir disoproxil fumarate