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1. Lancet HIV

Author

Roland Landman, Thomas-d'Aquin Toni, Coumba Toure-Kane, Daouda K. Minta, Gilles Peytavin, Frederic N. Ello, Eugène Messou, Almoustapha Issiaka Maiga, Jacques Zoungrana, Laure-Amelie de Monteynard, Mamadou Cisse, Ismael Diallo, Mouhamadou Baïla Diallo, Adrien Sawadogo, Xavier Anglaret, Lassana Sangaré, Amani Anzian, Malika Congo-Ouédraogo, Sophie Karcher, Jérome Le Carrou, Guillaume Bado, Serge Eholié, Marie-Laure Chaix, P M Girard, Audrey Gabassi, Delphine Gabillard, Aïda Benalycherif, Raoul Moh, Joseph Y Drabo, Moussa Seydi, 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), and Agence Nationale de Recherches sur le Sida et les Hépatites Virales

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Epidemiology, Clinical Decision-Making, Immunology, Psychological intervention, HIV Infections, Medication Adherence, IDLIC, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Acquired immunodeficiency syndrome (AIDS), Raltegravir Potassium, Virology, Internal medicine, medicine, Humans, Prospective Studies, Treatment Failure, 030212 general & internal medicine, Medical prescription, PACCI, Prospective cohort study, Darunavir, Ritonavir, business.industry, Middle Aged, Viral Load, medicine.disease, 030112 virology, 3. Good health, Africa, Western, Regimen, Treatment Outcome, Infectious Diseases, HIV-1, Drug Therapy, Combination, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Viral hepatitis, Viral load, Algorithms
Abstract

BACKGROUND: The decision about whether to switch to third-line antiretroviral therapy (ART) in patients with treatment failure on second-line therapy is difficult in settings with little access to genotypic resistance testing. In this study, we used a standardised algorithm including a wide range of adherence-enhancing interventions followed by a new viral load measurement to decide whether to switch to third-line therapy in this situation. The decision, made on the basis of effectiveness of the adherence reinforcement to drive viral resuppression, did not use genotypic resistance testing. METHODS: In this prospective cohort study, adults in four west African countries with treatment failure of a boosted protease inhibitor ART regimen were offered nine adherence reinforcement interventions, and followed up for 64 weeks. We measured viral load at week 12 and used the results to decide ART treatment at week 16: if successful resuppression (plasma HIV-1 RNA /=2 log10 copies per mL compared with baseline), patients continued the same second-line regimen; otherwise they switched to a third-line regimen based on ritonavir-boosted darunavir and raltegravir. The primary endpoint was virological success at week 64 (plasma HIV-1 RNA

Published
2019

2. Week 96 efficacy of lopinavir/ritonavir monotherapy in virologically suppressed patients with HIV: a randomized non-inferiority trial (ANRS 140 DREAM)

Author

Valérie Boilet, Catherine Fagard, Cécile Rabian, Sybilla Peron, Caroline Roussillon, Françoise Couturier, Isabelle Cohen-Codar, Pierre-Marie Girard, Monique Termote, Eric Bellissant, Olivier Bouchaud, Karine Amat, Babacar Sylla, Aïda Benalycherif, O. Patey, Jean-Marie Poirier, Anne-Marie Taburet, Yazdan Yazdanpanah, Isabelle Poizot, Laetitia Moinot, Elisabeth Rouveix, Patrick Mercié, Eve Todesco, Amel Besseghir, Stéphane De Wit, Isabelle Pellegrin, Bruno Spire, Geneviève Chêne, Adélaïde Perrier, Laurence Morand-Joubert, Sandrine Couffin-Cadiergues, Roland Landman, Jean-Luc Meynard, S. Kolta, Vincent Bouteloup, Dupuis, Christine, Services des Maladies Infectieuses et Tropicales [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), 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), Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard] (IMEA), 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), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), 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), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), 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), Observatoire régional de la santé Provence-Alpes-Côte d'Azur [Marseille] (ORS PACA), Service des maladies infectieuses et tropicales, Université Paris 13 (UP13)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Avicenne [AP-HP], Service d’information Médicale [CHU de Bordeaux] (Pôle de Santé Publique), CHU Bordeaux [Bordeaux], ANRS 140 DREAM Study Group : Girard PM, Meynard JL, Chêne G, Kolta S, Landman R, Mercié P, Moinot L, Morand-Joubert L, Cohen-Codar I, Couffin-Cadiergues S, Poirier JM, Poizot I, Rabian C, Spire B, Taburet AM, Yazdanpanah Y, Bellissant E, Pellegrin I, Peron S, De Wit S, Patey O, Rouveix E, Yazdanpanah Y, Amat K, Benalycherif A, Sylla B, Boilet V, Bouteloup V, Couturier F, Perrier A, Roussillon C, Termote M., 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), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service des maladies infectieuses et tropicales [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Saint-Antoine [APHP], Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Cochin [AP-HP], and Hôpital Avicenne-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris 13 (UP13)

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Efavirenz, 030106 microbiology, Lopinavir/ritonavir, HIV Infections, Emtricitabine, Lopinavir, Hospitals, University, 03 medical and health sciences, chemistry.chemical_compound, immune system diseases, Internal medicine, medicine, Clinical endpoint, Humans, Pharmacology (medical), Pharmacology, Ritonavir, business.industry, virus diseases, Middle Aged, Viral Load, 3. Good health, Regimen, Infectious Diseases, Anti-Retroviral Agents, chemistry, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, HIV-1, RNA, Viral, Reverse Transcriptase Inhibitors, Female, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, France, business, Viral load, medicine.drug
Abstract

Background: Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection. Objectives: To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years. Methods: Adults on stable ART with plasma HIV-1 RNA viral load

Published
2018

3. Evaluation of Four Tenofovir-Containing Regimens as First-Line Treatments in Cameroon and Senegal: The Anrs 12115 Dayana Trial

Author

Sinata Koulla-Shiro, Aïda Benalycherif, Gilles Peytavin, Ndeye Fatou Ngom Gueye, Sabrina Eymard-Duvernay, Pierre-Marie Girard, Charlotte Charpentier, Roland Landman, Vincent Le Moing, Eric Delaporte, Maguy Ngolle, Mahamadou-Baila Diallo, and Papa Salif Sow

Subjects
Adult, Male, medicine.medical_specialty, Genotype, Tenofovir, Anti-HIV Agents, First line, Organophosphonates, MEDLINE, HIV Infections, Medication Adherence, law.invention, Young Adult, Pharmacotherapy, Randomized controlled trial, immune system diseases, law, Antiretroviral Therapy, Highly Active, Internal medicine, medicine, Humans, Pharmacology (medical), Cameroon, Young adult, Pharmacology, business.industry, Adenine, virus diseases, Middle Aged, Viral Load, Senegal, CD4 Lymphocyte Count, Clinical trial, Treatment Outcome, Infectious Diseases, HIV-1, Drug Therapy, Combination, Female, business, Viral load, Follow-Up Studies, medicine.drug
Abstract

Background The aim of the present study was to determine appropriate tenofovir-based regimens meriting evaluation in large-scale randomized trials among sub-Saharan African patients. Methods This was a randomized open-label 96-week prospective pilot study evaluating four first-line regimens: tenofovir/emtricitabine/nevirapine (group 1), tenofovir/ lopinavir/ritonavir (group 2), tenofovir/emtricitabine/zidovudine (group 3) and tenofovir/emtricitabine/efavirenz (group 4) in antiretroviral-naive, HIV-1-infected patients in Senegal and Cameroon. The primary end point was defined as an HIV-1 RNA viral load Results At baseline, 119 patients included were 34% male, had a median plasma viral load of 5.4 log10 copies/ml and median CD4+ T-cell count of 200 cells/mm3 (range 53–358). The primary end point was achieved for groups 1, 3 and 4 (58% [ n=31], 62% [ n=29] and 53% [ n=30], respectively), but not for group 2 (38% [ n=29]). At week 96, undetectable HIV-1 RNA had been achieved in 74% of patients in group 1, 38% in group 2, 72% in group 3 and 73% in group 4. Patients with detectable HIV-1 RNA at week 16 were more likely to have baseline HIV-1 RNA≥100,000 copies/ml (adjusted OR 5.56, 95% CI 1.72, 16.67). HIV mutations associated with protease inhibitor resistance emerged in three patients, all of whom were in group 2. Anaemia occurred in two group 3 patients and was the only serious treatment-related adverse event. Conclusions Three efficient and safe tenofovir-based triple regimens were identified; the two-drug regimen (tenofovir/lopinavir/ritonavir) did not achieve the protocol-defined virological threshold of efficacy.

Published
2014

4. Tenofovir-Emtricitabine-Efavirenz in HIV-I-Infected Adults in Senegal: A 96-Week Pilot Trial in Treatment-Naive Patients

Author

M B Koita Fall, N F Ngom Gueye, Mboup S, Roland Landman, Halimatou Diop, M Poupard, Eric Delaporte, A. Trylesinski, M. Diallo, Ndella Diakhaté, P.S. Sow, Aïda Benalycherif, B Ndiaye, P M Girard, and C. Touré Kane

Subjects
Adult, Cyclopropanes, Male, medicine.medical_specialty, Efavirenz, Tenofovir, Anti-HIV Agents, Immunology, Organophosphonates, Human immunodeficiency virus (HIV), Renal function, HIV Infections, Pilot Projects, Dermatology, Pharmacology, medicine.disease_cause, Emtricitabine, Deoxycytidine, Medication Adherence, Therapy naive, chemistry.chemical_compound, Internal medicine, medicine, Humans, business.industry, Adenine, Pilot trial, Middle Aged, Senegal, Benzoxazines, CD4 Lymphocyte Count, Infectious Diseases, Tolerability, chemistry, Alkynes, HIV-1, Quality of Life, RNA, Viral, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

We report the results of a pilot open-label trial of a tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) combination conducted in Dakar, Senegal. Forty HIV-1-infected patients, naive of antiretroviral treatment and without active opportunistic disease, were included and followed through 96 weeks. At weeks 48 and 96, respectively, 82.5% and 85% of patients had HIV-1 RNA 3. The mean (SD) creatinine clearance decreased from 92 (36) to 73 (19) mL/min (P = .001). Treatment adherence was at least 94% at all scheduled visits. The efficacy and tolerability of a TDF/FTC/EFV combination were high and similar to those observed in Northern countries. This drug combination can be recommended in limited-resource countries, as did the World Health Organization (WHO) and should be made readily available as a fixed-dose combination.

Published
2009

5. Tenofovir plasma concentrations related to estimated glomerular filtration rate changes in first-line regimens in African HIV-infected patients: ANRS 12115 DAYANA substudy

Author

A. Benalycherif, Maryvonne Maynart, Mamadou-Baila Diallo, Sinata Koulla-Shiro, A. Ouattara, Charles Kouanfack, F. Ngom Gueye, Mireille Mpoudi Ngolle, S. Koulla-Shiro, Halimatou Diop, P.S. Sow, Aïda Benalycherif, Roland Landman, B. Ndiaye, R. Landman, Moussa Diallo, Ndeye Fatou Ngom Gueye, O. Elad, V. Le Moing, Maguy Ngolle, A. Sock, Claudine Ntsama Essomba, Papa-Salif Sow, Charlotte Charpentier, Sabrina Eymard-Duvernay, M B Koita Fall, E. Simen, P. M. Girard, C. Charpentier, C. Touré Kane, Gilles Peytavin, B. Ymele, Minh Patrick Lê, Avelin F. Aghokeng, S. Eymard-Duvernay, G. Peytavin, Sylvie Legac, Eric Delaporte, A. Thiam, Vincent Le Moing, Pierre-Marie Girard, E. Delaporte, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut de médecine et d'épidémiologie appliquée [AP-HP Hôpital Bichat-Claude Bernard] (IMEA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), 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), Hôpital Central de Yaoundé [Yaoundé], Service de Virologie [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Centre Hospitalier National et Universitaire de Fann-Dakar, 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), Services des Maladies Infectieuses et Tropicales [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), 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), 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), and Herrada, Anthony

Subjects
Male, HIV Infections, urologic and male genital diseases, chemistry.chemical_compound, Plasma, immune system diseases, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Tandem Mass Spectrometry, Antiretroviral Therapy, Highly Active, Medicine, Pharmacology (medical), drug monitoring, education.field_of_study, medicine.diagnostic_test, virus diseases, Lopinavir, Middle Aged, 3. Good health, Infectious Diseases, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Female, ART, medicine.drug, Glomerular Filtration Rate, Microbiology (medical), Adult, medicine.medical_specialty, Nevirapine, Efavirenz, Adolescent, Anti-HIV Agents, Population, antiretroviral therapy, Urology, Renal function, Emtricitabine, Young Adult, Humans, education, Tenofovir, [SDV.MP] Life Sciences [q-bio]/Microbiology and Parasitology, Africa South of the Sahara, Pharmacology, business.industry, chemistry, Therapeutic drug monitoring, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, HIV-1, Ritonavir, business, Chromatography, Liquid
Abstract

Objectives An open-label randomized trial (DAYANA) was conducted in sub-Saharan settings to evaluate four different regimens containing tenofovir disoproxil fumarate as first-line treatment for HIV infection. The objectives of the present substudy were to assess the relationship between trough concentrations of tenofovir in plasma collected after 24 h (C24) and estimated glomerular filtration rates (eGFR) calculated by the different formulae that are available. Methods The criteria for eligibility were those of the DAYANA trial, recruiting naive patients. The four tenofovir regimens were: Group 1, tenofovir/emtricitabine/nevirapine; Group 2, tenofovir/lopinavir/ritonavir; Group 3, tenofovir/emtricitabine/zidovudine; and Group 4, tenofovir/emtricitabine/efavirenz. The C24 of tenofovir was determined using LC-MS/MS. The eGFR was calculated using the Cockcroft–Gault, Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulae. Results The median C24 of tenofovir was 42 ng/mL. The C24 of tenofovir was higher with lopinavir/ritonavir than with the other three regimens: at Week 4, 84 ng/mL versus 25 ng/mL; and at Week 48, 81 ng/mL versus 52 ng/mL. The baseline merged eGFR was 98.2 mL/min/1.73 m2 with the CKD-EPI equation. Only the mean changes in eGFR in Group 2 differed from the absolute value of zero (−8.2 mL/min/1.73 m2) with the CKD-EPI equation between baseline and Week 48. The Cockcroft–Gault formula is inappropriate for these African patients because it underestimated the baseline eGFR and overestimated the changes in eGFR between baseline and Week 48. Conclusions In this population of mostly female HIV-1-infected African patients, tenofovir plasma overexposure was associated with PI/ritonavir and a time-dependent decrease in eGFR, probably via an inhibition of MRP2/MRP4 efflux transporters. The close monitoring over time of the eGFR using MDRD or CKD-EPI calculations and by using other biomarkers of renal disorder should be proposed as an alternative to therapeutic drug monitoring in resource-limited countries.

Published
2014

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