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1. Immunogenicity and safety of yellow fever vaccine in HIV-1-infected patients

Author

Jean-Pierre Aboulker, Christine Durier, Odile Launay, Séverine Mercier-Delarue, François Simon, Sophie Matheron, Nathalie Colin de Verdiere, Sophie Even, Vincent Meiffrédy, Assia Samri, Jean-Michel Molina, and Brigitte Autran

Subjects
0301 basic medicine, Adult, Male, Enzyme-Linked Immunospot Assay, Adolescent, T-Lymphocytes, 030231 tropical medicine, Immunology, Yellow fever vaccine, HIV Infections, Antibodies, Viral, 03 medical and health sciences, Interferon-gamma, Young Adult, 0302 clinical medicine, Neutralization Tests, Yellow Fever, Immunology and Allergy, Medicine, Humans, Prospective Studies, Young adult, Prospective cohort study, biology, business.industry, Immunogenicity, Yellow fever, Yellow Fever Vaccine, virus diseases, Middle Aged, medicine.disease, Virology, Antibodies, Neutralizing, Vaccination, 030104 developmental biology, Infectious Diseases, Immunization, biology.protein, Female, Antibody, business, medicine.drug
Abstract

The objective of this study is to investigate immunogenicity and safety of the yellow fever vaccine (YFV) in HIV-infected (HIV+) patients with high CD4 T-cell counts.In this prospective, comparative study of YFV-naive adults: 40 HIV+ under antiretroviral therapy (ART) with CD4 T-cell count above 350 cells/μl and plasma HIV-RNA less than 50 copies/ml for at least 6 months and 31 HIV-negative (HIV-) received one injection of the YF-17D strain vaccine.Serologic response was assessed by using a plaque reduction neutralizing test and YFV-specific T cells by using an INFγ-Elispot assay.YFV was well tolerated in both groups. Most participants had asymptomatic YFV viremia at day (D) 7 after vaccination (77% of HIV- and 82% of HIV+, P = 0.58), with higher plasma level of YFV RNA in HIV+ than in HIV- (median 2.46 log10 copies/ml (range: 1.15-4.16) and 1.91 log10 copies/ml (1.15-3.19), respectively, P = 0.011). A significant but transient decrease in CD4 cell counts was seen at D7 in both groups, more pronounced in HIV- than in HIV+ patients (-261.5 versus -111.5 cells/μl, respectively, P = 0.0003), but no HIV breakthrough was observed in plasma. All participants developed protective neutralizing antibody levels from D28 and up to 1 year after injection. At D91, fewer HIV+ than HIV- participants exhibited YFV T-cell response (20 versus 54%, respectively, P = 0.037).At 1 year, YFV was immunogenic and well tolerated in HIV-infected adults under ART with CD4 T-cell counts above 350 cells/μl. However, a lower immunity of YFV T cells in HIV-infected patients was observed as compared with HIV- participants.NCT01426243.

Published
2018

2. Intensification of Antiretroviral Therapy through Addition of Enfuvirtide in Naive HIV-1-Infected Patients with Severe Immunosuppression Does Not Improve Immunological Response: Results of a Randomized Multicenter Trial (ANRS 130 Apollo)

Author

Charlotte Charpentier, Véronique Joly, Carine Grondin, Sophie Tabuteau, Yazdan Yazdanpanah, François Raffi, André Cabié, Catherine Fagard, Patrick Yeni, Geneviève Chêne, Nathalie Colin de Verdiere, Diane Descamps, Service de maladies infectieuses et tropicales, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire de Virologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Modélisation, Aide à la Décision, et Coût-Efficacité en Maladies Infectieuses (ATIP-Avenir Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM), Service des Maladies Infectieuses et Tropicales, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Maladies infectieuses et tropicales, Centre d'Investigation Clinique Antilles-Guyane (CIC - Antilles Guyane), CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française]-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -Institut National de la Santé et de la Recherche Médicale (INSERM)-Université des Antilles et de la Guyane (UAG), ANRS (French National Agency for Research on AIDS and Viral Hepatitis), ANRS 130 Apollo Trial Group, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université des Antilles et de la Guyane (UAG)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pointe-à-Pitre/Abymes [Guadeloupe] -CHU de Fort de France-Centre Hospitalier Andrée Rosemon [Cayenne, Guyane Française], Le Corre, Morgane, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Université Bordeaux Segalen - Bordeaux 2

Subjects
CD4-Positive T-Lymphocytes, Cyclopropanes, Male, Enfuvirtide, MESH: CD4 Lymphocyte Count, MESH: HIV Envelope Protein gp41, HIV Infections, Deoxycytidine, MESH: Antiretroviral Therapy, Highly Active, Lopinavir, MESH: HIV-1, chemistry.chemical_compound, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Emtricitabine, Pharmacology (medical), 030212 general & internal medicine, MESH: Anti-HIV Agents, MESH: Peptide Fragments, MESH: Treatment Outcome, 0303 health sciences, MESH: Lopinavir, MESH: CD4-Positive T-Lymphocytes, virus diseases, MESH: HIV Infections, Viral Load, HIV Envelope Protein gp41, 3. Good health, Drug Combinations, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, Treatment Outcome, Infectious Diseases, MESH: RNA, Viral, MESH: Benzoxazines, Alkynes, RNA, Viral, Female, medicine.symptom, MESH: Viral Load, MESH: Organophosphonates, Viral load, medicine.drug, Adult, medicine.medical_specialty, MESH: Adenine, MESH: Immune Tolerance, Efavirenz, Anti-HIV Agents, Organophosphonates, Antiviral Agents, Asymptomatic, 03 medical and health sciences, Multicenter trial, Internal medicine, Immune Tolerance, medicine, Humans, Tenofovir, [SDV.MP] Life Sciences [q-bio]/Microbiology and Parasitology, MESH: Drug Combinations, Pharmacology, MESH: Humans, Ritonavir, 030306 microbiology, business.industry, Adenine, MESH: Deoxycytidine, MESH: Adult, MESH: Male, Peptide Fragments, Benzoxazines, CD4 Lymphocyte Count, Surgery, chemistry, HIV-1, MESH: Ritonavir, business, MESH: Female
Abstract

We studied whether addition of enfuvirtide (ENF) to a background combination antiretroviral therapy (cART) would improve the CD4 cell count response at week 24 in naive patients with advanced HIV disease. ANRS 130 Apollo is a randomized study, conducted in naive HIV-1-infected patients, either asymptomatic with CD4 counts of 3 or stage B/C disease with CD4 counts of 3 . Patients received tenofovir-emtricitabine with lopinavir-ritonavir (LPV/r) or efavirenz and were randomized to receive ENF for 24 weeks (ENF arm) or not (control arm). The primary endpoint was the proportion of patients with CD4 counts of ≥200/mm 3 at week 24. A total of 195 patients were randomized: 73% had stage C disease, 78% were male, the mean age was 44 years, the median CD4 count was 30/mm 3 , and the median HIV-1 RNA load was 5.4 log 10 copies/ml. Eighty-one percent of patients received LPV/r. One patient was lost to follow-up, and eight discontinued the study (four in each arm). The proportions of patients with CD4 counts of ≥200/mm 3 at week 24 were 34% and 38% in the ENF and control arms, respectively ( P = 0.53). The proportions of patients with HIV-1 RNA loads of P < 0.02), and the proportion reached 79% in both arms at week 48. Twenty (20%) and 12 patients (13%) in the ENF and control arms, respectively, experienced at least one AIDS event during follow-up ( P = 0.17). Although inducing a more rapid virological response, addition of ENF to a standard cART does not improve the immunological outcome in naive HIV-infected patients with severe immunosuppression.

Published
2013
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3. Role and evolution of viral tropism in patients with advanced HIV disease receiving intensified initial regimen in the ANRS 130 APOLLO trial

Author

S. Couffin-Cadiergues, Delphine Bonnet, C Merle de Boever, J. M. Livrozet, S. Ben Abdallah, Patrick Yeni, D. Makhloufi, N. El Alami Talbi, M. P. Drogoul, R. Dhote, Daniel Vittecoq, B. C. Phung, N. Benmakhlouf, S Ferrando, S Breaud, F Touam, G. Melica, Pierre Tattevin, Faouzi Souala, C. Augustin-Normand, S. Wassoumbou, F. Sanderson, I. Suaud, P. De Truchis, Jean-Claude Melchior, P. Guadagnin, D. Neau, S. Pavel, B. Warde, O. Taulera, J. Durant, B. Liauthaud, V. Gueripel, P. Sellier, C. Leport, J. L. Touraine, Sophie Leautez-Nainville, N. de Castro, M. A. Arthus, A. Rachline, S. Neuville, Charlotte Charpentier, Sophie Abgrall, M. Bonmarchand, E Aïssi, J. M. Ragnaud, J. F. Faucher, Pascal Pugliese, G. Le Facher, C. Bechara, François Raffi, L. Iordache, O. Derradji, Sophie Tabuteau, A. Frosch, François Bricaire, M. C. Pertusa, J. G. Fuzibet, Y. Mouton, S. Dominguez, P. Dion, I Perbost, Lorraine Letranchant, Jean-François Delfraissy, F. De Salvador, T. Kandel, V. Joly, C. Lascoux-Combe, Cécile Goujard, David Rey, Sylvie Radenne, Michel Dupon, Marc-Antoine Valantin, S. Stegman, F. Bastides, A Brunet, H. Aumaître, M. Lafaurie, V. Reliquet, Christine Katlama, H. Gros, R. Mansouri, J. Delgado, E. Rosenthal, J. Rivalain, G. Pialloux, Cédric Arvieux, David Boutoille, S. Gallien, G. Lepeu, S. Ferret, T. May, M. Parrinello, M. Bentata, Jean-François Bergmann, O. Aubry, J. M. Besnier, Christian Trepo, M. Vassalo, H. Kouadio, Olivier Lortholary, Jean-Albert Gastaut, H. Cordel, H. Dutronc, V. Rahelinirina, P. Lack, Jade Ghosn, Catherine Fagard, J. F. Dailloux, S. Boucherit, P. Honoré-Berlureau, J. M. Chennebault, T. Tahi, Yazdan Yazdanpanah, I. Louis, P. Le Bret, J. M. Estavoyer, J. J. Laurichesse, V. Rabier, I. Schlienger, O. Danne, Jean-Michel Molina, Bruno Hoen, B. Lebouché, Louis Bernard, D. Le, E. Peyrouse, I. Raymond, A. Gervais, Benoit Visseaux, L. Blum, C. Fontaine, Christine Burty, Y Quertainmont, M. Poupard, S Bouchez, J. J. Jourdain, C Cheneau, H. Castillo, Eric Billaud, J. M. Lang, André Cabié, A. Soufflet, J. M. Chapplain, O. Mounoury, B. Bonnet, D. Salmon-Ceron, P. Jouve, V. Mondain, P. Nau, I. Fournier, F. Bailly, J. M. Jacquet, N. Colin de Verdière, C Biron, P. Chiarello, D. Sereni, S. Pierre François, G. Fabre, Juliette Pavie, Lucile Larrouy, F. Rouges, Nathalie Colin de Verdiere, A. Rami, T. Lukiana, M. Maynard, P. Miailhes, J. Delaune, P. Abgueguen, A. Sobel, M. Revest, Clotilde Allavena, S. Herson, Olivier Bouchaud, M. Malet, H. Hüe, M. Iguertsira, A. Leplatois, Jean-Paul Viard, A. Simon, Pierre Dellamonica, Isabelle Poizot-Martin, J. Loison, E. Teicher, M. Lagrange, K. Koffi, E. Pichard, Diane Descamps, M. Ratajczak, Christian Michelet, Loïc Guillevin, A. Krivitzky, W. Kamouh, C. Chesnel, Laurence Slama, J. Cailhol, M. Partisani, N. Agher, Luminita Schneider, S. Boucly, Y. Levy, Laurent Boyer, Jacques Reynes, A. Diallo, M. Môle, N. Bennamar, Laurent Cotte, F. Brunel-Delmas, Philippe Morlat, V. Thoirain, A Foltzer, Laurent Hustache-Mathieu, H. Berthé, Jean-Daniel Lelièvre, C. Tramoni, P. Yeni, Philippe Van de Perre, M. Gory, C. Brunet-François, W. Rozenbaum, M. Saada, Christian Perronne, M. Medus, C. Chakvetadze, T. Huynh, C. Pintado, G. Pahlavan, J. L. Esnault, J. Clarissou, D. Radia, V. Frixon-Marin, E. Boulanger, F. Jeanblanc, P. Choutet, C Ceppi, V. Prendki, Sylvie Abel, Véronique Joly, A. Certain, G. Pichancourt, V. Beaujolais, O. Faucher, C Brochier, Diane Ponscarme, P. Fischer, Aurélie Beuscart, Hugues Melliez, Laboratoire de Virologie, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de maladies infectieuses et tropicales, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Epidémiologie et Biostatistique [Bordeaux], Université Bordeaux Segalen - Bordeaux 2-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de maladies infectieuses et tropicales [Saint-Louis], Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Maladies infectieuses et tropicales, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-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 ), ANRS 130 APOLLO Trial Study Group, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université d'Angers (UA)-Université de Rennes (UR)-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 ), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)

Subjects
Enfuvirtide, enfuvirtide, MESH: HIV Envelope Protein gp41, viruses, HIV Infections, Drug resistance, MESH: Antiretroviral Therapy, Highly Active, law.invention, MESH: HIV-1, Randomized controlled trial, law, Antiretroviral Therapy, Highly Active, Genotype, Pharmacology (medical), MESH: Anti-HIV Agents, MESH: Peptide Fragments, MESH: Evolution, Molecular, MESH: Aged, 0303 health sciences, MESH: Middle Aged, MESH: Drug Resistance, Viral, tropism, MESH: HIV Infections, Middle Aged, HIV Envelope Protein gp41, switch, 3. Good health, Infectious Diseases, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, MESH: Young Adult, medicine.drug, Adult, Microbiology (medical), Adolescent, Anti-HIV Agents, Mutation, Missense, Biology, Evolution, Molecular, resistance, Young Adult, 03 medical and health sciences, HIV DNA, Drug Resistance, Viral, medicine, Humans, In patient, Tropism, Aged, 030304 developmental biology, Pharmacology, MESH: Adolescent, MESH: Mutation, Missense, MESH: Humans, 030306 microbiology, MESH: Adult, Virology, Peptide Fragments, Viral Tropism, Regimen, HIV-1, Tissue tropism, MESH: Viral Tropism
Abstract

International audience; OBJECTIVES: The aims of the study were to assess in patients with advanced HIV disease receiving antiretroviral therapy (ART) intensification with enfuvirtide (i) resistance at virological failure (VF), (ii) impact of baseline tropism on immunovirological response, and (iii) HIV-1 DNA tropism evolution during ART. METHODS: The ANRS 130 APOLLO randomized trial evaluated in naive patients the immunovirological impact of standard ART without (control arm) or with enfuvirtide. Tropism was determined on RNA and DNA by V3-loop sequencing interpreted using the Geno2Pheno algorithm. RESULTS: At baseline the median CD4 cell count was 30 cells/mm(3). Among the 170 patients assessable in this virological substudy, HIV-1 RNA tropism was as follows: 60% of viruses were R5 and 40% were R5X4/X4. HIV-1 DNA tropism was as follows: 54% were R5 and 46% were R5X4/X4. At week 24, 39% and 49% of patients experienced VF in the enfuvirtide and control arms, respectively. In the enfuvirtide arm, only resistance-associated mutations to enfuvirtide were detected. In the control arm, two patients displayed drug-resistant viruses at the time of VF. No impact of baseline tropism was observed on immunovirological response, regardless of the study arm. Among the 25 patients experiencing DNA tropism switch between baseline and week 24, 16 (64%) switched from R5 to R5X4/X4. These latter were mostly successfully suppressed patients receiving enfuvirtide and exhibiting poorer immunological response. CONCLUSIONS: Baseline RNA tropism had no impact on the immunovirological response. Drug resistance mutations were only detected for the fusion inhibitor. Finally, the mechanism of replenishment of the viral cellular reservoir with X4 viruses observed needs to be further analysed.

Published
2013
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4. Spontaneous hepatic decompensation in patients coinfected with HIV and hepatitis C virus during interferon-ribavirin combination treatment

Author

M. Bonarek, Eric Rosenthal, Stanislas Pol, Nathalie Colin de Verdiere, Patrice Morand, Firouzé Bani-Sadr, Fabrice Carrat, Anrs Hc –Ribavic Study Team, Françoise Lunel-Fabiani, Christian Perronne, Lionel Piroth, Gilles Pialoux, and Patrice Cacoub

Subjects
Microbiology (medical), Adult, Male, medicine.medical_specialty, Cirrhosis, Hepatitis C virus, Hepacivirus, HIV Infections, Interferon alpha-2, medicine.disease_cause, Gastroenterology, Antiviral Agents, Virus, Polyethylene Glycols, chemistry.chemical_compound, Interferon, Internal medicine, Ribavirin, medicine, Humans, Didanosine, biology, business.industry, Interferon-alpha, Odds ratio, Middle Aged, biology.organism_classification, medicine.disease, Hepatitis C, Recombinant Proteins, Infectious Diseases, chemistry, Immunology, Drug Therapy, Combination, Female, business, Liver Failure, medicine.drug
Abstract

Spontaneous hepatic decompensation was observed in 7 of 383 patients coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) who were receiving treatment with interferon and ribavirin. Multivariate analysis identified the following risk factors: didanosine use (odds ratio [OR], 8.8; 95% confidence interval [CI], 1.2–102.3; P

Published
2005

5. Hepatitis Rebound after Infection with Yellow Fever Virus

Author

Blandine Denis, David Chirio, Diane Ponscarme, Ségolène Brichler, Nathalie Colin de Verdière, François Simon, and Jean-Michel Molina

Subjects
Yellow fever, persistent hepatitis, Brazil, viruses, France, hepatitis, Medicine, Infectious and parasitic diseases, RC109-216
Abstract

In 2018, yellow fever with hepatitis was diagnosed for 2 unvaccinated travelers returning to France from Brazil. Hepatitis persisted for >6 months; liver enzyme levels again increased 2 months after disease onset with no detection of yellow fever virus RNA or other pathogens. Persistent hepatitis with hepatic cytolysis rebound probably resulted from immune response.

Published
2019
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6. Screening test for neutralizing antibodies against yellow fever virus, based on a flavivirus pseudotype.

Author

Séverine Mercier-Delarue, Christine Durier, Nathalie Colin de Verdière, Jean-Dominique Poveda, Vincent Meiffrédy, Maria Dolores Fernandez Garcia, Stéphane Lastère, Raymond Césaire, Jean-Claude Manuggera, Jean-Michel Molina, Ali Amara, and François Simon

Subjects
Medicine, Science
Abstract

Given the possibility of yellow fever virus reintroduction in epidemiologically receptive geographic areas, the risk of vaccine supply disruption is a serious issue. New strategies to reduce the doses of injected vaccines should be evaluated very carefully in terms of immunogenicity. The plaque reduction test for the determination of neutralizing antibodies (PRNT) is particularly time-consuming and requires the use of a confinement laboratory. We have developed a new test based on the use of a non-infectious pseudovirus (WN/YF17D). The presence of a reporter gene allows sensitive determination of neutralizing antibodies by flow cytometry. This WN/YF17D test was as sensitive as PRNT for the follow-up of yellow fever vaccinees. Both tests lacked specificity with sera from patients hospitalized for acute Dengue virus infection. Conversely, both assays were strictly negative in adults never exposed to flavivirus infection or vaccination, and in patients sampled some time after acute Dengue infection. This WN/YF17D test will be particularly useful for large epidemiological studies and for screening for neutralizing antibodies against yellow fever virus.

Published
2017
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