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1. HIV lipodystrophy in participants randomised to lopinavir/ritonavir (LPV/r) +2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTI) or LPV/r + raltegravir as second-line antiretroviral therapy.

Author

Allison Martin, Cecilia L Moore, Patrick W G Mallon, Jennifer F Hoy, Sean Emery, Waldo H Belloso, Praphan Phanuphak, Samuel Ferret, David A Cooper, Mark A Boyd, and Second-Line Study Team

Subjects
Medicine, Science
Abstract

ObjectiveTo compare changes over 48 weeks in body fat, lipids, Metabolic Syndrome and cardiovascular disease risk between patients randomised 1:1 to lopinavir/ritonavir (r/LPV) plus raltegravir (RAL) compared to r/LPV plus 2-3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) as second-line therapy.MethodsParticipants were HIV-1 positive (>16 years) failing first-line treatment (2 consecutive HIV RNA >500 copies/mL) of NNRTI +2N(t)RTI. Whole body dual energy x-ray absorptiometry was performed at baseline and week 48. Data were obtained to calculate the Metabolic Syndrome and Framingham cardiovascular disease (CVD) risk score. Linear regression was used to compare mean differences between arms. Logistic regression compared incidence of metabolic syndrome. Associations between percent limb fat changes at 48 weeks with baseline variables were assessed by backward stepwise multivariate linear regression. Analyses were adjusted for gender, body mass index and smoking status.Results210 participants were randomised. The mean (95% CI) increase in limb fat over 48 weeks was 15.7% (5.3, 25.9) or 0.9 kg (0.2, 1.5) in the r/LPV+N(t)RTI arm and 21.1% (11.1, 31,1) or 1.3 kg (0.7, 1.9) in the r/LPV+RAL arm, with no significant difference between treatment arms (-5.4% [-0.4 kg], p>0.1). Increases in total body fat mass (kg) and trunk fat mass (kg) were also similar between groups. Total:HDL cholesterol ratio was significantly higher in the RAL arm (mean difference -0.4 (1.4); p = 0.03), there were no other differences in lipid parameters between treatment arms. There were no statistically significant differences in CVD risk or incidence of Metabolic Syndrome between the two treatment arms. The baseline predictors of increased limb fat were high viral load, high insulin and participant's not taking lipid lowering treatment.ConclusionIn patients switching to second line therapy, r/LPV combined with RAL demonstrated similar improvements in limb fat as an N(t)RTI + r/LPV regimen, but a worse total:HDL cholesterol ratio over 48 weeks.Trial registrationThis clinical trial is registered on Clinicaltrials.gov, registry number NCT00931463 http://clinicaltrials.gov/ ct2/show/NCT00931463?term = NCT00931463&rank = 1.

Published
2013
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2. Impact of low-level-viremia on HIV-1 drug-resistance evolution among antiretroviral treated-patients.

Author

Constance Delaugerre, Sébastien Gallien, Philippe Flandre, Dominique Mathez, Rishma Amarsy, Samuel Ferret, Julie Timsit, Jean-Michel Molina, and Pierre de Truchis

Subjects
Medicine, Science
Abstract

BACKGROUND: Drug-resistance mutations (DRAM) are frequently selected in patients with virological failure defined as viral load (pVL) above 500 copies/ml (c/mL), but few resistance data are available at low-level viremia (LLV). Our objective was to determine the emergence and evolution of DRAM during LLV in HIV-1-infected patients while receiving antiretroviral therapy (ART). METHODS: Retrospective analysis of patients presenting a LLV episode defined as pVL between 40 and 500 c/mL on at least 3 occasions during a 6-month period or longer while on the same ART. Resistance genotypic testing was performed at the onset and at the end of LLV period. Emerging DRAM was defined during LLV if never detected on baseline genotype or before. RESULTS: 48 patients including 4 naive and 44 pretreated (median 9 years) presented a LLV episode with a median duration of 11 months. Current ART included 2NRTI (94%), ritonavir-boosted PI (94%), NNRTI (23%), and/or raltegravir (19%). Median pVL during LLV was 134 c/mL. Successful resistance testing at both onset and end of the LLV episode were obtained for 37 patients (77%), among who 11 (30%) acquired at least 1 DRAM during the LLV period: for NRTI in 6, for NNRTI in 1, for PI in 4, and for raltegravir in 2. During the LLV period, number of drugs with genotypic resistance increased from a median of 4.5 to 6 drugs. Duration and pVL level of LLV episode, duration of previous ART, current and nadir CD4 count, number of baseline DRAM and GSS were not identified as predictive factors of resistance acquisition during LLV, probably due to limited number of patients. CONCLUSION: Persistent LLV episodes below 500 c/ml while receiving ART is associated with emerging DRAM for all drug classes and a decreasing in further therapeutic options, suggesting to earlier consider resistance monitoring and ART optimization in this setting.

Published
2012
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3. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial

Author

Patrick Mercié, Julie Arsandaux, Christine Katlama, Samuel Ferret, Aurélie Beuscart, Christian Spadone, Claudine Duvivier, Jacques Reynes, Nathalie Wirth, Laetitia Moinot, Antoine Bénard, David Zucman, Xavier Duval, Jean-Michel Molina, Bruno Spire, Catherine Fagard, Geneviève Chêne, Hélène Allaguy-Salachy, Henri-Jean Aubin, Claudine Bernard-Henry, Claude Beuscart, Anne Borgne, Olivier Bouchaud, Charles Brahmy, Dominique Breilh, André Cabié, Claude Cateland, Antoine Cheret, Sandrine Couffin-Cadiergues, Marie-Dominique Dautzenberg, Pierre Dellamonica, Pascale Denis-Kandel, Christine Denis-Vatant, Michel Detilleux, Michel Dupon, Brigitte El Harrar, Marie Christine Fagnen Sylvaire, Simone Guillermet, Christine Jacomet, Vincent Jeantils, Marek Korzek, Estibaliz Lazaro, Béatrice Le Maitre, Frédéric Lucht, Marianne Maquet, Audrey Mathieu, Thierry May, Sonia Merigeaud, Philippe Morlat, Alissa Naqvi, Didier Neau, Jean Perriot, Sandrine Pierre-François, Isabelle Poizot-Martin, Elisabeth Quoix, Matthieu Rebillard, Caroline Roussillon, Eric Rosenthal, Thierry Sainte-Marie, Dominique Salmon-Céron, Luminita Schneider, Anne Simon, Malika Soussi, Albert Sotto, Anne-Marie Taburet, Elina Teicher, Monique Termote, Valery Trosini-Desert, Renaud Verdon, Jean-Paul Viard, Daniel Vittecoq, Muriel Vray, David Youssi, Service de Médecine Interne et Immunologie Clinique [CHU Bordeaux] (Pôle Médecine Interne), CHU Bordeaux [Bordeaux], Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Service des maladies infectieuses et tropicales [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-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], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'infectiologie Necker-Pasteur [CHU Necker], Institut Pasteur [Paris]-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection à VIH, réservoirs, diversité génétique et résistance aux antirétroviraux (ARV) (EA 7327), Université Paris Descartes - Paris 5 (UPD5), Université Sorbonne Paris Cité (USPC), Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques er émergentes (TransVIHMI), Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Université Montpellier 1 (UM1), Département Maladies Infectieuses et Tropicales, Hôpital Universitaire, Montpellier, France, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service d’information Médicale [CHU de Bordeaux] (Pôle de Santé Publique), Service de Médecine Interne [Hôpital Foch, Suresnes] (SMI), Hôpital Foch [Suresnes], CIC Bichat [AP-HP, Hôpital Bichat-Claude-Bernard] (CIC 1425 Inserm), 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)-Institut National de la Santé et de la Recherche Médicale (INSERM), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC), Service des Maladies Infectieuses et Tropicales [CHU Saint Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Génétique et Ecologie des Virus, Génétique des Virus et Pathogénèse des Maladies Virales, Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), ANRS 144 Inter-ACTIV study group : Allaguy-Salachy H, Arsandaux J, Aubin HJ, Bénard A, Bernard-Henry C, Beuscart A, Beuscart C, Borgne A, Bouchaud O, Brahmy C, Breilh D, Cabié A, Cateland C, Chêne G, Cheret A, Couffin-Cadiergues S, Dautzenberg MD, Dellamonica P, Denis-Kandel P, Denis-Vatant C, Detilleux M, Dupon M, Duval X, Duvivier C, El Harrar B, Fagard C, Fagnen Sylvaire MC, Ferret S, Guillermet S, Jacomet C, Jeantils V, Katlama C, Korzek M, Lazaro E, Le Maitre B, Lucht F, Maquet M, Mathieu A, May T, Mercié P, Merigeaud S, Moinot L, Molina JM, Morlat P, Naqvi A, Neau D, Perriot J, Pierre-François S, Poizot-Martin I, Quoix E, Rebillard M, Reynes J, Roussillon C, Rosenthal E, Sainte-Marie T, Salmon-Céron D, Schneider L, Simon A, Soussi M, Sotto A, Spadone C, Spire B, Taburet AM, Teicher E, Termote M, Trosini-Desert V, Verdon R, Viard JP, Vittecoq D, Vray M, Wirth N, Youssi D, Zucman D., Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Institut Pasteur [Paris] (IP)-CHU Necker - Enfants Malades [AP-HP], Centre Médical de l'Institut Pasteur (CMIP), Institut Pasteur [Paris] (IP), Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes (TransVIHMI), Institut de Recherche pour le Développement (IRD)-Université de Yaoundé I-Université Cheikh Anta Diop [Dakar, Sénégal] (UCAD)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Maladies Infectieuses et Tropicales [CHU Pitié-Salpêtrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Dupuis, Christine

Subjects
Adult, Counseling, Male, medicine.medical_specialty, Epidemiology, medicine.medical_treatment, Immunology, Population, HIV Infections, Placebo, Drug Administration Schedule, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Virology, Internal medicine, medicine, Humans, Nicotinic Agonists, 030212 general & internal medicine, education, Varenicline, education.field_of_study, 030505 public health, business.industry, Incidence (epidemiology), Smoking, Odds ratio, Middle Aged, 3. Good health, Clinical trial, Treatment Outcome, Infectious Diseases, chemistry, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Smoking cessation, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, France, 0305 other medical science, business
Abstract

International audience; BACKGROUND:Tobacco smoking is common in people living with HIV, but high-quality evidence on interventions for smoking cessation is not available in this population. We aimed to assess the efficacy and safety of varenicline with counselling to aid smoking cessation in people living with HIV.METHODS:The ANRS 144 Inter-ACTIV randomised, parallel, double-blind, multicentre, placebo-controlled phase 3 trial was done at 30 clinical hospital sites in France. People living with HIV who had smoked at least ten cigarettes per day for 1 year or longer, were motivated to stop smoking, were not dependent on another psychoactive substance, and had no history of depression or suicide attempt were eligible. Using a computer-generated randomisation sequence, we allocated (1:1) the patients to receive either varenicline titrated to two 0·5 mg doses twice daily or placebo twice daily for 12 weeks, plus face-to-face counselling. Patients and investigators were masked to treatment group allocation. Patients who were not abstinent at week 24 were offered open-label varenicline for 12 additional weeks. The primary outcome was the proportion of smokers continuously abstinent from week 9 to week 48. Smoking status was confirmed by carbon monoxide in exhaled air. Primary analyses were done in both the intention-to-treat (ITT) population and modified ITT (mITT) population, which comprised all patients who took at least one tablet of their assigned study treatment. The safety analyses were done in the mITT population. The trial is registered at ClinicalTrials.gov, number NCT00918307. The trial status is complete.FINDINGS:From Oct 26, 2009, to Dec 20, 2012, of 303 patients assessed for eligibility, 248 patients were randomly assigned to the varenicline group (n=123) or the placebo group (n=125). After randomisation, one participant initially assigned to the placebo group was excluded from the ITT analysis for a regulatory reason (no French health-care coverage). 102 patients in the varenicline group and 111 patients in the placebo group received at least one dose of their assigned treatment and were included in the mITT analysis. In the ITT analysis, varenicline was associated with a higher proportion of patients achieving continuous abstinence over the study period (week 9-48): 18 (15%, 95% CI 8-21) of 123 in the varenicline group versus eight (6%, 2-11) of 124 in the placebo group, adjusted odds ratio (OR) 2·5 (95% CI 1·0-6·1; p=0·041). In the mITT analysis, varenicline was also associated with higher continuous abstinence: 18 (18%, 95% CI 10-25) of 102 versus eight (7%, 2-12) of 111 in the placebo group (adjusted OR 2·7, 95% CI 1·1-6·5; p=0·029). The incidence of depression was 2·4 per 100 person-years (95% CI 0·6-9·5; two [2%] of 102) in the varenicline group and 12·4 per 100 person-years (95% CI 6·9-22·5; 11 [10%] of 111) in the placebo group. 14 (7%) of 213 participants had 18 cardiovascular events: six (6%) of 102 people in the varenicline group and eight (7%) of 111 people in the placebo group.INTERPRETATION:Varenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care.FUNDING:The French National Institute for Health and Medical Research (INSERM)-French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Pfizer.

Published
2018
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4. Bone mineral density in HIV participants randomized to raltegravir and lopinavir/ritonavir compared with standard second line therapy

Author

Sean Emery, Patrick W. G. Mallon, Allison Martin, David A. Cooper, Praphan Phanuphak, Mark A. Boyd, Samuel Ferret, Cecilia L. Moore, Jennifer F Hoy, and Waldo H. Belloso

Subjects
Male, Lopinavir/ritonavir, HIV Infections, Pharmacology, Gastroenterology, Lopinavir, law.invention, Raltegravir Potassium, South Africa, Absorptiometry, Photon, Randomized controlled trial, immune system diseases, law, Bone Density, Risk Factors, Prevalence, Immunology and Allergy, Femur, Bone mineral, Lumbar Vertebrae, virus diseases, Clinical Science, Thailand, Pyrrolidinones, Infectious Diseases, Treatment Outcome, second line therapy, Reverse Transcriptase Inhibitors, Female, raltegravir, medicine.drug, musculoskeletal diseases, Adult, medicine.medical_specialty, Immunology, antiretroviral therapy, Argentina, India, Internal medicine, medicine, Humans, Second-line therapy, Ritonavir, business.industry, Malaysia, HIV, HIV Protease Inhibitors, Raltegravir, tenofovir, Bone Diseases, Metabolic, Osteoporosis, business, bone mineral density
Abstract

Objective: To compare changes over 48 weeks in bone mineral density (BMD) between participants randomized to lopinavir/ritonavir (LPV/r) + raltegravir (RAL) or LPV/r + 2–3 nucleoside/nucleotide reverse transcriptase inhibitors (N(t)RTIs) as second line therapy. Design: 48-week open-label sub-study of the Second Line trial conducted in South Africa, India, Thailand, Malaysia and Argentina. Methods: Dual energy X-ray absorptiometry scans of proximal femur and lumbar spine were performed at baseline and week 48. Linear regression was used to compare means of differences between arms. McNemars test compared osteopenia and osteoporosis. Associations between percentage BMD changes and baseline variables were assessed by multivariate linear regression. Results: Two hundred and ten participants were randomized. Analyses were adjusted for sex, BMI and smoking status. Mean (95% CI) proximal femur BMD% reduced over 48 weeks by −5.2% (−6.7 to −3.8%) in the LPV/r+2-3N(t)RTIs arm and by −2.9% (−4.3 to −1.5%) in the LPV/r+RAL arm (P = 0.0001). Lumbar spine BMD reduced by −4.2% (−5.7 to −2.7%) in the LPV/r+2-3N(t)RTIs arm and by −2.0% (−3.5 to −0.6%) in the LPV/r+RAL arm (P = 0.0006). The incidence of osteopenia (7.6%) and osteoporosis (2.0%) assessed over 48 weeks were similar between arms. Reduced BMD over 48 weeks was significantly associated with longer duration of tenofovir on study [% change (SE) −1.58 (0.38) femur, −1.65 (0.38) spine, P = 0.0001] and low baseline BMI [% change (SE) 0.5 (0.13) femur, 0.17 (0.07) spine; P

Published
2013

5. Incidence of Herpes Zoster in HIV-Infected Adults in the Combined Antiretroviral Treatment (cART) Era: Results from the FHDH-ANRS CO4 Cohort

Author

Hana Selinger-Leneman, Arnaud de la Blanchardiere, Thomas Hanslik, Odile Launay, Christian Rabaud, Pierre Tattevin, David Rey, Sophie Grabar, Samuel Ferret, Vincent Daneluzzi, Dominique Costagliola, Anne-Sophie Lascaux, Pierre de Truchis, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service des maladies infectieuses et réanimation médicale [Rennes] = Infectious Disease and Intensive Care [Rennes], CHU Pontchaillou [Rennes], CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital Raymond Poincaré [AP-HP], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CHU Strasbourg, Hôpital Max Fourestier, Nanterre, Service de maladies infectieuses et tropicales [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Service d'immunologie clinique [Créteil], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Hôpital Ambroise Paré [AP-HP], Agence Nationale de Recherches sur le SIDA et les hépatites virales (ANRS), INSERM, and the French Ministry of Health., Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Institut Pierre Louis d'Epidémiologie et de Santé Publique ( iPLESP ), Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Paris Descartes - Paris 5 ( UPD5 ), CHU Cochin [AP-HP], Service des maladies infectieuses et réanimation médicale, Université de Rennes 1 ( UR1 ), Université de Rennes ( UNIV-RENNES ) -Université de Rennes ( UNIV-RENNES ) -Hôpital Pontchaillou, Hopital Raymond Poincaré, Garches, Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ), Assistance publique - Hôpitaux de Paris (AP-HP)-Université Paris Diderot - Paris 7 ( UPD7 ) -Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Hôpital Ambroise Paré, Université de Versailles Saint-Quentin-en-Yvelines ( UVSQ ) -Assistance publique - Hôpitaux de Paris (AP-HP), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)

Subjects
Microbiology (medical), Cart, Adult, Male, medicine.medical_specialty, Adolescent, Population, HIV Infections, Risk Assessment, Herpes Zoster, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Acquired immunodeficiency syndrome (AIDS), [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Internal medicine, Antiretroviral Therapy, Highly Active, Epidemiology, Medicine, Humans, 030212 general & internal medicine, education, Aged, Aged, 80 and over, 0303 health sciences, education.field_of_study, 030306 microbiology, business.industry, Incidence (epidemiology), Incidence, HIV, cohort, Middle Aged, Immune reconstitution, medicine.disease, Confidence interval, 3. Good health, [ SDV.MHEP.MI ] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Infectious Diseases, Anti-Retroviral Agents, Relative risk, Cohort, Immunology, Female, epidemiology, France, business
Abstract

Background Recent studies have shown a decrease in the incidence of herpes zoster (HZ) among human immunodeficiency virus (HIV)-infected patients since the combined antiretroviral therapy (cART) era, but more data are needed on a possible increase in the risk early after cART initiation. Methods We studied HZ incidence and risk factors among patients followed in the French Hospital Database on HIV (FHDH) between 1992 and 2011. Standardized incidence ratios (SIRs) were used for comparison with the general population between 2005 and 2008. The risk of HZ following cART initiation (0-5 and ≥6 months) was studied with Poisson regression models. Results A total of 7167 cases of incident HZ were diagnosed among 91 044 individuals (583 125 person-years [PY]). The incidence declined significantly, from 2955 per 100 000 PY in 1992-1996 to 628 per 100 000 PY in 2009-2011. This decline was mainly explained by cART (relative risk [RR], 0.60; 95% confidence interval {CI}, .57-.64). The risk of HZ was associated with low CD4 cell counts, high HIV RNA levels, low CD4/CD8 ratios, and prior AIDS. Compared to the general population, the risk of HZ was higher in HIV-infected patients (overall SIR, 2.7; 95% CI, 2.6-2.9), particularly those aged 15-44 years (SIR, 4-6). In ART-naive patients, a moderate increase in the HZ risk was observed during the first 6 months of cART, with a peak at 3 months (RR, 1.47; 95% CI, 1.26-1.73), a finding that disappeared after adjustment for the current CD4 cell count (RR, 1.03; 95% CI, .81-1.32). Conclusions The risk of HZ has declined markedly among HIV-infected patients in the cART era, but remains 3 times higher than in the general population. The risk increases moderately during the first 6 months of cART.

Published
2015
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6. Bone mineral density over 96 weeks in adults failing first-line therapy randomized to raltegravir/lopinavir/ritonavir compared with standard second-line therapy

Author

Janaki Amin, Praphan Phanuphak, Samuel Ferret, Hila Haskelberg, Patrick W. G. Mallon, Mark A. Boyd, David A. Cooper, Sean Emery, Waldo H. Belloso, Jennifer F Hoy, and Cecilia L. Moore

Subjects
musculoskeletal diseases, Adult, Male, medicine.medical_specialty, Bone density, Anti-HIV Agents, Population, Urology, Lopinavir/ritonavir, Lopinavir, Absorptiometry, Photon, Bone Density, Raltegravir Potassium, medicine, Humans, Pharmacology (medical), Longitudinal Studies, education, Pelvic Bones, education.field_of_study, Ritonavir, business.industry, Raltegravir, Confidence interval, Pyrrolidinones, Spine, Infectious Diseases, Female, business, Body mass index, medicine.drug
Abstract

Objective: To compare bone mineral density (BMD) changes over 96 weeks in adults virologically failing standard first-line therapy, randomized to raltegravir plus lopinavir/ritonavir (RAL + LPV/r) or conventional 2-3 nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs] + LPV/r second-line therapy.Methods: Participants underwent dual-energy x-ray absorptiometry at baseline and weeks 48 and 96 to measure total hip and lumbar spine BMD. Analyses were adjusted for gender, body mass index, and smoking. Linear regression was used to compare between-group differences, logistic regression for low BMD (hip or spine Z-score

Published
2014

7. Quality of travel health advice in a French travel medicine and vaccine center: a prospective observational study

Author

Samuel Ferret, Marie-Anne Bouldouyre, Juliette Pavie, Samia Hamane, Jean-Michel Molina, Nathalie Colin de Verdière, Nathalie De Castro, Diane Ponscarme, and Anne Rachline

Subjects
Adult, Male, medicine.medical_specialty, Paris, Asia, Consultants, Endemic Diseases, Hepatitis A vaccine, Yellow fever vaccine, Ambulatory Care Facilities, Antimalarials, Surveys and Questionnaires, parasitic diseases, Health care, Outcome Assessment, Health Care, Yellow Fever, medicine, Travel medicine, Humans, Prospective Studies, Practice Patterns, Physicians', Africa South of the Sahara, Decision Making, Computer-Assisted, Quality of Health Care, Travel, Vaccines, business.industry, Malaria prophylaxis, Vaccination, Hepatitis A, General Medicine, South America, medicine.disease, Malaria, Family medicine, Immunology, Female, Guideline Adherence, business, Travel Medicine, medicine.drug
Abstract

Background. The number of international trips undertaken by French citizens is rising and we wished to assess the appropriateness of advices given to travelers in a vaccine and travel medicine center in France. Methods. We conducted a 3-month prospective study in one center in Paris where prescriptions and advice to travelers are given by trained physicians in travel medicine who have access to a computerized decision support system (Edisan). A questionnaire was used to record trip characteristics, patients' demographics, and prescriptions. Main outcome measure was the adequacy of prescriptions for malaria prophylaxis, yellow fever, and hepatitis A vaccines to French guidelines. Results. A total of 730 subjects were enrolled in this study, with a median age of 28 years. Travel destinations were sub-Saharan Africa (58%), Asia (21%), and South America (18%). Among the 608 patients (83%) traveling to malaria-endemic areas, malaria prophylaxis was in accordance with guidelines in 578/608 patients (95.1%, 95% CI: 93–96.5), and doxycycline was the regimen of choice (48%). Inappropriate malaria prophylaxis was given to eight patients, one of whom developed plasmodium falciparum malaria. All 413 patients (100%, 95% CI: 99–100) traveling to yellow fever-endemic areas who needed vaccination were correctly vaccinated. However, three patients received yellow fever vaccination without indication. Also, 442 of 454 patients (97.4%, 95% CI: 95.4–98.5) eligible to receive hepatitis A vaccination were immunized. Conclusion. Appropriate advice for malaria prophylaxis, yellow fever, and hepatitis A vaccinations was provided in a travel medicine and vaccine center where trained physicians used a computerized decision support system. Even in this setting, however, errors can occur and professional practices should be regularly assessed to improve health care.

Published
2012

8. Impact of Low-Level-Viremia on HIV-1 Drug-Resistance Evolution among Antiretroviral Treated-Patients

Author

Philippe Flandre, S. Gallien, Jean-Michel Molina, Constance Delaugerre, Samuel Ferret, Rishma Amarsy, Pierre de Truchis, Dominique Mathez, and Julie Timsit

Subjects
Male, Human immunodeficiency virus (HIV), lcsh:Medicine, HIV Infections, Drug resistance, medicine.disease_cause, 0302 clinical medicine, 030212 general & internal medicine, lcsh:Science, 0303 health sciences, Multidisciplinary, Drug Information, HIV diagnosis and management, Middle Aged, Viral Load, Antivirals, 3. Good health, AIDS, Anti-Retroviral Agents, HIV epidemiology, Medicine, Infectious diseases, Female, Viral load, Research Article, medicine.drug, Adult, Drugs and Devices, medicine.medical_specialty, Sexually Transmitted Diseases, Viremia, Viral diseases, Microbiology, Evolution, Molecular, 03 medical and health sciences, Virology, Internal medicine, Drug Resistance, Viral, Retroviruses, Low level viremia, medicine, Humans, Biology, Retrospective Studies, 030306 microbiology, business.industry, lcsh:R, HIV, Retrospective cohort study, medicine.disease, Raltegravir, Antiretroviral therapy, CD4 Lymphocyte Count, Viral Classification, Mutation, Immunology, HIV-1, lcsh:Q, business
Abstract

Background Drug-resistance mutations (DRAM) are frequently selected in patients with virological failure defined as viral load (pVL) above 500 copies/ml (c/mL), but few resistance data are available at low-level viremia (LLV). Our objective was to determine the emergence and evolution of DRAM during LLV in HIV-1-infected patients while receiving antiretroviral therapy (ART). Methods Retrospective analysis of patients presenting a LLV episode defined as pVL between 40 and 500 c/mL on at least 3 occasions during a 6-month period or longer while on the same ART. Resistance genotypic testing was performed at the onset and at the end of LLV period. Emerging DRAM was defined during LLV if never detected on baseline genotype or before. Results 48 patients including 4 naive and 44 pretreated (median 9 years) presented a LLV episode with a median duration of 11 months. Current ART included 2NRTI (94%), ritonavir-boosted PI (94%), NNRTI (23%), and/or raltegravir (19%). Median pVL during LLV was 134 c/mL. Successful resistance testing at both onset and end of the LLV episode were obtained for 37 patients (77%), among who 11 (30%) acquired at least 1 DRAM during the LLV period: for NRTI in 6, for NNRTI in 1, for PI in 4, and for raltegravir in 2. During the LLV period, number of drugs with genotypic resistance increased from a median of 4.5 to 6 drugs. Duration and pVL level of LLV episode, duration of previous ART, current and nadir CD4 count, number of baseline DRAM and GSS were not identified as predictive factors of resistance acquisition during LLV, probably due to limited number of patients. Conclusion Persistent LLV episodes below 500 c/ml while receiving ART is associated with emerging DRAM for all drug classes and a decreasing in further therapeutic options, suggesting to earlier consider resistance monitoring and ART optimization in this setting.

Published
2012
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9. Integrating Human Immunodeficiency Virus-Specific Elements in the Treatment of Tobacco Dependence (ANRS 144 Inter-ACTIV)

Author

Tangui, Barré, Laetitia, Moinot, Bruno, Spire, Camelia, Protopopescu, Morgane, Bureau, Julie, Arsandaux, Camille, Gilbert, Patrick, Mercié, Fabienne, Marcellin, Linda, Wittkop, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut des sciences de la santé publique [Marseille] (ISSPAM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Biothérapies des maladies génétiques et cancers, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), and ANRS 144 Inter-ACTIV Study Group: Claudine Bernard-Henry, Claude Beuscart, Olivier Bouchaud, André Cabié, Antoine Cheret, Pierre Dellamonica, Michel Dupon, Xavier Duval, Claudine Duvivier, Brigitte El Harrar, Christine Jacomet, Vincent Jeantils, Christine Katlama, Estibaliz Lazaro, Frédéric Lucht, Thierry May, Jean-Michel Molina, Philippe Morlat, Didier Neau, Jacques Reynes, Eric Rosenthal, Dominique Salmon-Céron, Anne Simon, Albert Sotto, Elina Teicher, Renaud Verdon, Jean-Paul Viard, Daniel Vittecoq, David Zucman, Hélène Allaguy-Salachy, Anne Borgne, Charles Brahmy, Claude Cateland, Marie-Dominique Dautzenberg, Pascale Denis-Kandel, Christine Denis-Vatant, Michel Detilleux, Brigitte El Harrar, Marie Christine Fagnen Sylvaire, Samuel Ferret, Simone Guillermet, Béatrice Le Maitre, Marianne Maquet, Sonia Merigeaud, Alissa Naqvi, Jean Perriot, Sandrine Pierre-François, Elisabeth Quoix, Matthieu Rebillard, Eric Rosenthal, Thierry Sainte-Marie, Luminita Schneider, Albert Sotto, Valery Trosini-Desert, Nathalie Wirth, David Youssi, Patrick Mercié, Antoine Bénard, Dominique Breilh, Geneviève Chêne, Sandrine Couffin-Cadiergues, Xavier Duval, Samuel Ferret, Christian Spadone, Bruno Spire, Nathalie Wirth, Muriel Vray, Henri-Jean Aubin, Marek Korzek, Isabelle Poizot-Martin, Anne-Marie Taburet, Julie Arsandaux, Aurélie Beuscart, Geneviève Chêne, Catherine Fagard, Camille Gilbert, Audrey Mathieu, Laetitia Moinot, Caroline Roussillon, Malika Soussi, Ludivine Taïeb, Monique Termote, Linda Wittkop.

Subjects
Microbiology (medical), Infectious Diseases, [SDV]Life Sciences [q-bio], Humans, HIV, HIV Infections, Tobacco Use Disorder, Review Article
Abstract

More than 40% of people with human immunodeficiency virus (PWH) in the United States smoke tobacco cigarettes. Among those on antiretroviral therapy, smoking decreases life expectancy more than human immunodeficiency virus (HIV) itself. Most PWH who smoke want to quit, but tobacco dependence treatment has not been widely integrated into HIV care. This article summarizes the epidemiology of tobacco use among PWH, health consequences of tobacco use and benefits of cessation in PWH, and studies of treatment for tobacco dependence among the general population and among PWH. We provide practical guidance for providers to treat tobacco dependence among PWH. A 3-step Ask-Advise-Connect framework includes asking about tobacco use routinely during clinical encounters, advising about tobacco cessation with emphasis on the benefits of cessation, and actively connecting patients to cessation treatments, including prescription of pharmacotherapy (preferably varenicline) and direct connection to behavioral interventions via telephone quitline or other means to increase the likelihood of a successful quit attempt.

Published
2022
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