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1. High Prevalence and High Rate of Antibiotic Resistance of Mycoplasma genitalium Infections in Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Pre-exposure Prophylaxis Trial

Author

C. Chapolard, L. Larmet, A. Becker, I. Madelaine, Rémy Choquet, M. Danet, Stéphane Morel, S. Parlier, N. Hall, E. Dalle, M Saouzanet, F. Clement, Y Saïdi, E. Rosenthal, M. Meunier, L. Zarka, C. Etienne, S. Rouby, Péchenot, J. Delgado, N. Dumon, S. Cousseau, M. Cavellec, M Suzan, Catherine Capitant, D. Ponscarme, B. Boissavy, S. Pailhes, Claire Pintado, Chloé Le Roy, C. Bernaud, J. Koffi, A. Djessima, P M Roger, A. Adda, Cécile Bébéar, B. Bonnet, F. Bonnet, H. Hue, Emmanuelle Netzer, Baptiste Demoulin, N Leturque, C. Gatey, Nadège Bourgeois-Nicolaos, F Euphrasie, Béatrice Berçot, C. Adouard-groslafeige, P. Penot, François Raffi, M. Godinot, R. Biekre, C. Monfort, Naoufel Mzoughi, F. Jeanblanc, A Cheret, Armelle Pasquet, Laurence Meyer, B Guillon, T. Huleux, Constance Delaugerre, J. Lambec, O. Leclanche, S. Bagge, R. Veron, Gilles Pialoux, G. Conort, B. Loze, S. le Nagat, F. Tolonin, Christian Chidiac, Sabine Pereyre, Nicolas Lorente, Berrebi, N. Mezreb, T. Cepitelli, A. Decouty, H. Melliez, S. Vandamme, A. Pansu, Michel Besnier, M. Colas, H. Bazus, Isabelle Charreau, W. Rozenbaum, X. Teruin, S. Huon, K. Moudachirou, Eric Senneville, J. Foucoin, L. Gilly, Foubert, P. Cornavin, Clotilde Rousseau, F. Lorho, J. Berdougo, S Fouéré, S. Breaud, C. Brochier, N. Mahjoub, G Cattin, J Binesse, and Jean-Michel Molina

Subjects
Microbiology (medical), Male, medicine.medical_specialty, HIV Infections, Mycoplasma genitalium, Azithromycin, Emtricitabine, Men who have sex with men, Pre-exposure prophylaxis, Sexual and Gender Minorities, Antibiotic resistance, Internal medicine, RNA, Ribosomal, 16S, medicine, Prevalence, Humans, Mycoplasma Infections, Homosexuality, Male, Doxycycline, biology, business.industry, Incidence (epidemiology), Drug Resistance, Microbial, biology.organism_classification, Infectious Diseases, Pre-Exposure Prophylaxis, business, medicine.drug
Abstract

Background Mycoplasma genitalium (MG) is an emerging pathogen among men who have sex with men (MSM) with raising rates of antibiotic resistance. This study assessed the prevalence and incidence of MG infection in MSM enrolled in the open-label phase of the ANRS IPERGAY trial with on-demand tenofovir disoproxil fumarate/emtricitabine for human immunodeficiency virus prevention and the impact of doxycycline post-exposure prophylaxis (PEP). Methods 210 subjects were tested at baseline and at 6 months by real-time PCR assays for MG detection in urine samples and oropharyngeal and anal swabs. Resistance to azithromycin (AZM), to fluoroquinolones (FQs), and to doxycycline was investigated in the French National Reference Center of Bacterial Sexually Transmitted Infections (STIs). Results The all-site prevalence of MG at baseline was 10.5% (6.3% in urine samples, 4.3% in anal swabs, 0.5% in throat swabs) and remained unchanged at 6 months whether or not PEP was used: 9.9% overall, 10.2% with PEP, 9.6% without. The overall rate of MG resistance (prevalent and incident cases) to AZM and FQs was 67.6% and 9.1%, respectively, with no difference between arms. An in vivo mutation of the MG 16S rRNA, which could be associated with tetracycline resistance, was observed in 12.5% of specimens tested. Conclusions The prevalence of MG infection among MSM on pre-exposure prophylaxis was high and its incidence was not decreased by doxycycline prophylaxis with a similar high rate of AZM and FQ resistance, raising challenging issues for the treatment of this STI and supporting current recommendations to avoid testing or treatment of asymptomatic MG infection.

Published
2020

2. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study

Author

Jean-Michel Molina, Isabelle Charreau, Bruno Spire, Laurent Cotte, Julie Chas, Catherine Capitant, Cecile Tremblay, Daniela Rojas-Castro, Eric Cua, Armelle Pasquet, Camille Bernaud, Claire Pintado, Constance Delaugerre, Luis Sagaon-Teyssier, Soizic Le Mestre, Christian Chidiac, Gilles Pialoux, Diane Ponscarme, Julien Fonsart, David Thompson, Mark A Wainberg, Veronique Doré, Laurence Meyer, L Meyer, C Capitant, I Charreau, E Netzer, N Leturque, J Binesse, V Foubert, M Saouzanet, F Euphrasie, D Carette, B Guillon, Y Saïdi, J P Aboulker, B Spire, M Suzan, G Cattin, B Demoulin, L Sagaon-Teyssier, N Lorente, V Doré, E Choucair, S Le Mestre, A Mennecier, N Etien, M C Simon, A Diallo, S Gibowski, J F Delfraissy, D Thompson, J Sas, J Pankovitch, M Klein, A Anis, Benoit Trottier, Cécile Tremblay, Jean-Guy Baril, Antoine Chéret, Michel Besnier, Willy Rozenbaum, Nathalie Bajos, Julie Timsit, Gilles Peytavin, Isabelle Durand-Zaleski, Jean-Pierre Aboulker, Marie Suzan-Monti, Gabriel Girard, Daniela Rojas Castro, Marie Préau, Michel Morin, Anaïs Mennecier, Elias Choucair, Véronique Doré, Marie-Christine Simon, Joanne Otis, France Lert, Alpha Diallo, Séverine Gibowski, Cecile Rabian, Génétique et Ecologie des Virus, Génétique des Virus et Pathogénèse des Maladies Virales, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), and Greps, Laboratoire

Subjects
0301 basic medicine, Male, Epidemiology, [SHS.PSY]Humanities and Social Sciences/Psychology, HIV Infections, Men who have sex with men, law.invention, Cohort Studies, Condoms, Pre-exposure prophylaxis, 0302 clinical medicine, law, Emtricitabine, 030212 general & internal medicine, Young adult, ComputingMilieux_MISCELLANEOUS, Randomized Controlled Trials as Topic, Incidence (epidemiology), Middle Aged, Infectious Diseases, France, Cohort study, medicine.drug, Adult, medicine.medical_specialty, Canada, Adolescent, Anti-HIV Agents, Sexual Behavior, Immunology, Medication Adherence, [SHS.PSY] Humanities and Social Sciences/Psychology, 03 medical and health sciences, Young Adult, Condom, Virology, Internal medicine, medicine, Humans, Homosexuality, Male, Tenofovir, Gynecology, business.industry, 030112 virology, Sexual intercourse, HIV-1, Pre-Exposure Prophylaxis, business, Follow-Up Studies
Abstract

Summary Background Data for on-demand pre-exposure prophylaxis (PrEP) are scarce. We implemented a cohort study to assess its efficacy, safety, and effect on sexual behaviour. Methods We invited men and transgender women who have sex with men, previously enrolled in the randomised placebo-controlled ANRS IPERGAY trial at seven sites (six in France and one in Canada), to participate in an open-label extension with on-demand tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) to be taken before and after sexual intercourse. We assessed the incidence of HIV and other sexually transmitted infections (STIs), PrEP adherence, safety, and sexual behaviour. Statistical analyses included comparisons of proportions and incidence between the randomised phase of the ANRS IPERGAY trial and the open-label phase, and all participants were included in safety analyses. ANRS IPERGAY is registered with ClinicalTrials.gov, number NCT01473472. Findings Between Nov 4, 2014, and Jan 27, 2015, we enrolled 361 participants. Median follow-up was 18·4 months (IQR 17·7–19·1). One participant who discontinued PrEP acquired HIV infection. HIV incidence was 0·19 per 100 person-years (95% CI 0·01–1·08), compared with 6·60 per 100 person-years (3·60–11·05) in the placebo group of the randomised study, indicating a relative reduction of 97% (95% CI 81–100) in the incidence of HIV with on-demand PrEP. Participants used a median of 18 pills of study drugs per month (IQR 11–25), and at the 6 month visit 240 (71%) of 336 participants had tenofovir detected in plasma. Drug-related gastrointestinal events were reported in 49 participants (14%) but were self-limited. Only four participants (1%) discontinued PrEP, three because of an increase in plasma creatinine. The proportion of participants reporting condomless sex at their last receptive anal intercourse significantly increased from 77% (136 of 176 participants) at baseline to 86% (66 of 77 participants) at 18 months' follow-up (p for trend=0·0004). The incidence of a first bacterial STI during this open-label phase did not change significantly compared with the randomised phase (59·0 vs 49·1 per 100 person-years, respectively; p=0·11). Interpretation On-demand oral PrEP is highly effective at preventing HIV infection among high-risk men who have sex with men and therefore represents an alternative to daily PrEP, expanding choices for HIV prevention. High rates of STIs resulting from low condom use did not undermine PrEP efficacy, but warrant frequent testing. Funding ANRS (France Recherche Nord and Sud Sida-HIV Hepatites), the Canadian HIV Trials Network, Fonds Pierre Berge—Sidaction, Gilead Sciences, and the Bill & Melinda Gates Foundation.

3. Prevalence, Risk factors, and Shedding of Human Herpes Virus-8 among Men Having Sex With Men Enrolled in a Pre-exposure Prophylaxis Study.

Author

Gras J, Helary M, Carette D, Minier M, Salmona M, Gabassi A, Saouzanet M, Charreau I, Meyer L, Molina JM, and Delaugerre C

Abstract

Background: Seroprevalence and risk factors for Human Herpesvirus-8 (HHV-8) infection among HIV-negative men who have sex with men (MSM) on pre-exposure prophylaxis (PrEP) have not been well characterized. Our objectives were to assess the prevalence and incidence of HHV-8 infection in MSM enrolled on PrEP and assess viral shedding in seropositive participants., Methods: The ANRS IPERGAY study enrolled 429 participants in France and Canada to evaluate oral PrEP for HIV-1 prevention. Stored sera samples at day 0 (D0) and last visit were tested for the detection of HHV-8 antibodies using an indirect immunofluorescence assay. Baseline characteristics were analyzed to identify risk factors associated with HHV-8 seropositivity. Among seropositive participants, HHV-8 DNA was quantified on available oral and anal swabs, and ORF-K1 typing performed on HHV-8 positive samples., Results: One hundred participants were seropositive at D0 (prevalence of 24%, 95% Confidence Interval (95%CI): 20·0-28·4) and 18/329 seroconverted during the study (incidence rate of 2·66 per 100 person-years, 95%CI: 1·57-4·20). Risk factors independently associated with baseline HHV-8 seropositivity included older age, high number of sexual partners, chemsex use and HSV-2 seropositivity. Among HHV-8 seropositive participants with available swab(s) for virological analysis, 37/115 (32%) displayed HHV-8 oral shedding, and 5/113 (4.4%) anal shedding at least once. Four patients had positive viral load before seroconversion., Conclusion: Prevalence and incidence of HHV-8 infection were high in HIV-negative PrEP users. Among seropositive participants, HHV-8 DNA is mainly detected in saliva, which may play a major role in viral transmission in this population., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2023
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4. Costs of intermittent versus continuous antiretroviral therapy in patients with controlled HIV infection: a substudy of the ANRS 106 Window Trial.

Author

Charreau I, Jeanblanc G, Tangre P, Boyer L, Saouzanet M, Marchou B, Molina JM, Aboulker JP, and Durand-Zaleski I

Subjects
Adult, Anti-Retroviral Agents therapeutic use, Antiretroviral Therapy, Highly Active economics, HIV Infections economics, Health Care Costs, Humans, Anti-Retroviral Agents administration & dosage, Anti-Retroviral Agents economics, Antiretroviral Therapy, Highly Active methods, HIV Infections drug therapy, HIV-1
Abstract

Background: Structured treatment interruptions in chronic HIV infection have been explored as a drug-sparing strategy to reduce drug-related adverse events and costs while maintaining CD4 cell counts at a level high enough to prevent the risk of disease progression., Objectives: To test the hypothesis and put a figure on the reduction in total medical costs, we conducted a cost study analysis in the setting of a randomized open-label study comparing an intermittent to a continuous antiretroviral regimen., Patients and Methods: Four hundred three HIV-1-infected adults who were tolerating highly active antiretroviral therapy (HAART), with a nadir CD4 count of 100 cells per microliter or more and a CD4 count above 450 cells per microliter at screening, were randomly assigned to switch to a fixed 8-week off, 8-week on intermittent treatment (IT) or to maintain their current treatment (CT) strategy. The proportions of patients who reached a CD4 cell count below 300 cells per microliter through 96 weeks (primary end point) were not significantly different between arms. Costs were estimated from the viewpoint of the payer over the 96-week study period. Unit costs were provided from the national reimbursement schedules for hospital inpatient and outpatient admissions and ambulatory visits and the national selling price for medications. All analyses were performed on an intention-to-treat basis., Results: Complete cost data were available for 391 patients (197 patients in the IT and 194 in the CT arms). The mean cost in euros (Euro) per patient over the 96 weeks of follow-up (excluding protocol-driven costs) was 9738 in the IT arm vs. 16,162 in the CT arm, a 6424 difference almost entirely due to the difference in HAART cost. Mean protocol-driven costs represented Euro290 in the IT vs. Euro280 in the CT arm. The use of IT achieved a 40% reduction in the total cost of HAART., Conclusions: Reducing by 40% the cost ofHAART medications in a treatment interruption strategy did not increase the costs related to adverse events or consultations.

Published
2008
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