1. Anti-HBV DNA vaccination does not prevent relapse after discontinuation of analogues in the treatment of chronic hepatitis B: a randomised trial—ANRS HB02 VAC-ADN
- Author
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H, Fontaine, S, Kahi, C, Chazallon, M, Bourgine, A, Varaut, C, Buffet, O, Godon, J F, Meritet, Y, Saïdi, M L, Michel, D, Scott-Algara, J P, Aboulker, S, Pol, A, Vallet-Pichard, Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), Essais Thérapeutiques et Maladies Infectieuses, Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pathogenèse des Virus de l'Hépatite B (PVHB), Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hépato-Gastro-Entérologie [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Service de Virologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Régulation des Infections Rétrovirales, Institut Pasteur [Paris], The trial was sponsored and funded by The National Agency for Research on Aids and Viral Hepatitis., Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pasteur [Paris] (IP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), and Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
- Subjects
Male ,MESH: Treatment Failure ,Gastroenterology ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Recurrence ,law ,Vaccines, DNA ,Prospective Studies ,Treatment Failure ,Prospective cohort study ,Anti hbv ,0303 health sciences ,MESH: Middle Aged ,virus diseases ,Middle Aged ,Hepatitis B ,3. Good health ,Female ,030211 gastroenterology & hepatology ,MESH: Antiviral Agents ,Adult ,medicine.medical_specialty ,MESH: Hepatitis B, Chronic ,Antiviral Agents ,DNA vaccination ,03 medical and health sciences ,Hepatitis B, Chronic ,Immune system ,Internal medicine ,medicine ,Humans ,Hepatitis B Vaccines ,030304 developmental biology ,MESH: Hepatitis B Vaccines ,MESH: Humans ,business.industry ,MESH: Adult ,medicine.disease ,MESH: Prospective Studies ,MESH: Male ,MESH: Recurrence ,MESH: Vaccines, DNA ,Discontinuation ,Clinical trial ,Immunology ,[SDV.IMM.VAC]Life Sciences [q-bio]/Immunology/Vaccinology ,business ,MESH: Female - Abstract
International audience; Objective: The antiviral efficacy of nucleos(t)ide analogues whose main limitation is relapse after discontinuation requires long-term therapy. To overcome the risk of relapse and virological breakthrough during long-term therapy, we performed a phase I/II, open, prospective, multicentre trial using a HBV envelope-expressing DNA vaccine.Design: 70 patients treated effectively with nucleos(t)ide analogues for a median of 3 years (HBV DNA 120 IU/mL) or impossibility of stopping treatment at week 48.Results: Reactivation occurred in 97% of each group after a median 28 days without liver failure but with an HBV DNA
- Published
- 2014