HIV In France Research Articles

Empowerment-based intervention and immigrant awareness of biomedical HIV prevention tools in France

Abstract Background Sub-Saharan African immigrants are particularly affected by HIV in France and social hardship is an indirect factor of HIV acquisition. While biomedical HIV prevention tools are available for HIV prevention, evidence suggests a lack of knowledge of these tools among immigrants from Sub-Saharan Africa. We analysed the impact of an empowerment-based intervention on the knowledge of treatment as prevention (TasP), Pre Exposure Prophylaxis (PrEP) and Post Exposure Prophylaxis (PEP) among a population of precarious sub-Saharan African immigrants. Methods Data were collected in the Makasi research project. Participants were recruited in public places based on their precarious situations, they were randomised into two groups (intervention and control) followed during six months between 2018 and 2021. We described the knowledge of biomedical HIV prevention tools at each follow-up time (0, 3, 6 months) and used random-effects logistic regression models to analyse the intervention effect on the level of knowledge of these tools. Results The majority of the participants were men (77.5%) and almost half of them arrived in France within 2 years prior to inclusion (49.3%). At the time of inclusion, 56% of participants knew about TasP, 6% knew about PEP and 4% knew about PrEP. Receiving the intervention increased the odds of knowing PEP (aOR=2.02 [1.09-3.75]; p < 0.026). Intervention effect were observed for TasP and PrEP only after 6 six months. We observed significant time effect for PEP (at 3 months aOR=4.26 [2.33-7.80]; p < 0.001; at 6 months aOR=18.28 [7.39-45.24]; p < 0.001) and PrEP (at 3 months aOR=4.02 [2.10-7.72]; p < 0.001; at 6 months aOR=28.33 [11.16-71.91]; p < 0.001). This time effect is linked to the associations outreach activities. Conclusions Our results suggest that exposure to the Makasi intervention combined with associations activities contributed to increase knowledge of biomedical HIV prevention tools among precarious sub-Saharan African immigrants. Key messages • The Makasi intervention improved the knowledge of biomedical HIV prevention tools. • One-shot empowerment-based intervention shows encouraging result for HIV prevention.

Drastic Reduction in Time to Controlled Viral Load in People With Human Immunodeficiency Virus in France, 2009-2019: A Longitudinal Cohort Study.

Aspirational targets to end AIDS by 2030 include having 95% of people with human immunodeficiency virus (HIV; PWH) diagnosed, 95% treated, and 95% with controlled viral load (VL). Our objective was to describe, using a large French prospective cohort, the median transition times through the cascade of care between 2009 and 2019. We analyzed patients whose first HIV diagnosis was made between 1 January 2009 and 31 December 2019. Using the Kaplan-Meier method, we estimated the time to linkage to care (from HIV diagnosis to first biological assessment), to treatment (date of first antiretroviral therapy [ART] prescription), and to controlled VL (first value <200 copies/mL). Analyses were disaggregated by time periods and patients' characteristics. Censoring date was 31 December 2021. Among the 16 864 patients linked to care since 2009, the median [Q1; Q3] time from HIV diagnosis to controlled VL decreased from 254 [127-745] to 73 [48-132] days in 2009-2011 and 2018-2019, respectively. Transition times from linkage to care to first ART decreased from 67 [17; 414] in 2009-2011 to 13 [5; 26] days in 2018-2019, and from ART to controlled VL from 83 [35; 130] in 2009-2011 to 38 [28; 90] days in 2018-2019. Differences were observed depending on patients' characteristics. We describe drastic reductions in transition time through the cascade of care, allowing reduction in the transmission period following each new infection. Delayed diagnosis remains the main obstacle to ending AIDS in the next decade.

Monkeypox Vaccine Hesitancy in French Men Having Sex with Men with PrEP or Living with HIV in France.

People with pre-exposure prophylaxis (PrEP) or living with HIV are a high-risk population for monkeypox virus (MPXV) infection. It is important to achieve high MPXV vaccination coverage rates in this group. This project used self-reporting to assess vaccine hesitancy for the smallpox vaccine and acceptance among men having sex with men with PrEP or living with HIV. In total, 52 (33.6%) participants among the 155 declared their hesitancy to be vaccinated against MPXV. Moreover, 20.7% patients with PrEP declared a hesitant attitude towards the smallpox vaccine compared to 40.2% of the HIV patients, p = 0.013. This difference remained not significant after adjustment for age (p = 0.119) and after adjustment for both age and number of different sexual partners (p = 0.406). Among PrEP people, those who expressed concerns about people getting more vaccines than needed (p = 0.012) were less likely to accept vaccination, whereas an increased number of different sexual partners during the previous month was significantly associated with acceptance of vaccination (p = 0.034). Among HIV people, those who expressed concerns about being infected by MPXV (p < 0.001), those who expressed that the smallpox vaccine should be compulsory for people at risk (p < 0.001) and those with an increased the number of different sexual partners the previous month (p = 0.018) were significantly associated with higher acceptance of MPXV vaccination. Our results suggest that vaccine strategy would be efficient in France with a communication strategy emphasizing the benefits of vaccination and the potential MPXV risk infection for health in PrEP and HIV people. Other preventive actions should be implemented, including reduction in sexual partners.

A comprehensive analysis of excess depressive disorder in women and men living with HIV in France\xa0compared to the general population

We aimed to estimate the prevalence of depressive disorder in people living with HIV (PLWH) and evaluate its association with non-HIV-specific and HIV-specific factors in PLWH and in PLWH compared to the general population (GP). We used cross-sectional data from the QuAliV study, conducted within the ANRS-CO3 Aquitaine-AQUIVIH-NA cohort of PLWH in Nouvelle-Aquitaine (2018–2020), and a nationally-representative survey in the GP (EHIS-ESPS, 2014–2015), we included all participants aged ≥ 18 years old who had completed the Patient Health Questionnaire-8 (PHQ-8). Depressive disorder was defined as Patient Health Questionnaire-8 score greater or equal to 10. Its association with non-HIV-specific (demographic, socio-economic, behavioral, health status), HIV-specific factors (immuno-viral markers, antiretrovirals, level of perceived HIV-stigma), and HIV-status was assessed using Poisson regression models with robust variance in women and men separately. We included 914 PLWH (683 men/231 women). More than one in five PLWH had depressive disorder. It was strongly associated with being younger and experiencing severe pain in both sexes. Unemployment in women, being single, and lack of family ties in men were also associated with depressive disorder. More than 30% of our sample reported HIV-stigma, with a dose–response relationship between level of perceived HIV-stigma and depressive disorder. The crude prevalence of depressive disorder was 2.49 (95%CI 1.92–3.22) and 4.20 (95%CI 3.48–5.05) times higher in women and men living with HIV respectively compared to GP counterparts and 1.46 (95%CI 1.09–1.95) and 2.45 (95%CI 1.93–3.09) times higher after adjustment for non-HIV specific factors. The adjusted prevalence ratio of depressive disorder was not significantly different in HIV-stigma free women, but remained twice as high in HIV-stigma free men. The prevalence of depressive disorder compared to the GP tended to decrease with age in PLWH. Excess depressive disorder remains a major concern in PLWH. Our findings reaffirm the importance of regular screening. Tackling social inequalities and HIV-stigma should be prioritized to ensure that PLWH achieve good mental as well as physical health outcomes.

Incidence of cervical, breast and colorectal cancers between 2010 and 2015 in people living with HIV in France.

We aimed to evaluate the incidence rates between 2010 and 2015 for invasive cervical cancer (ICC), breast cancer (BC), and colorectal cancer (CRC) in people living with HIV (PLWH) in France, and to compare them with those in the French general population. These cancers are targeted by the national cancer-screening program. This is a retrospective study based on the longitudinal data of the French Dat'AIDS cohort. Standardized incidence ratios (SIR) for ICC and BC, and incidence rates for all three cancers were calculated overall and for specific sub-populations according to nadir CD4 cell count, HIV transmission category, HIV diagnosis period, and HCV coinfection. The 2010-2015 CRC incidence rate was 25.0 [95% confidence interval (CI): 18.6-33.4] per 100,000 person-years, in 44,642 PLWH (both men and women). Compared with the general population, the ICC incidence rate was significantly higher in HIV-infected women both overall (SIR = 1.93, 95% CI: 1.18-3.14) and in the following sub-populations: nadir CD4 ≤ 200 cells/mm3 (SIR = 2.62, 95% CI: 1.45-4.74), HIV transmission through intravenous drug use (SIR = 5.14, 95% CI: 1.93-13.70), HCV coinfection (SIR = 3.52, 95% CI: 1.47-8.47) and HIV diagnosis before 2000 (SIR = 2.06, 95% CI: 1.07-3.97). Conversely, the BC incidence rate was significantly lower in the study sample than in the general population (SIR = 0.56, 95% CI: 0.42-0.73). The present study showed no significant linear trend between 2010 and 2015 in the incidence rates of the three cancers explored in the PLWH study sample. Specific recommendations for ICC screening are still required for HIV-infected women and should focus on sub-populations at greatest risk.

Hepatitis C virus (HCV) incidence among men who have sex with men (MSM) living with HIV: results from the French Hospital Database on HIV (ANRS CO4-FHDH) cohort study, 2014 to 2017.

BackgroundDespite the availability of highly effective direct-acting antivirals (DAAs) and the expected treatment as prevention (TasP) effect, transmission of hepatitis C virus (HCV) persists in men who have sex with men (MSM) who engage in high-risk sexual behaviours.AimWe aimed to estimate the incidence of primary HCV infection among MSM living with HIV in France when DAA was readily available.MethodsWe used data from a large French hospital cohort of persons living with HIV (ANRS CO4-FHDH) prospectively collected between 2014 and 2017. HCV incidence rates were calculated using person-time methods for HCV-negative MSM at inclusion who had serological follow-up from 1 January 2014 to 31 December 2017. Sensitivity analyses were performed by varying the main assumptions to assess their impact on the results.ResultsOf 14,273 MSM living with HIV who were initially HCV-seronegative, 330 acquired HCV during follow-up over 45,866 person-years (py), resulting in an overall estimated incidence rate of 0.72/100 py (95% CI: 0.65–0.80). HCV incidence significantly decreased from 0.98/100 py (95% CI: 0.81–1.19) in 2014 to 0.45/100 py (95% CI: 0.35–0.59) in 2017 (54% decrease; 95% CI: 36–67). This trend was confirmed by most of the sensitivity analyses.ConclusionThe primary incidence of HCV was halved for MSM living with HIV between 2014 and 2017. This decrease may be related to unrestricted DAA availability in France for individuals living with HIV. Further interventions, including risk reduction, are needed to reach HCV micro-elimination in MSM living with HIV.

“Sick but active, tired but healthy”. Narratives of body and self living with HIV

ABSTRACT Although studies have suggested that physical activity may diminish HIV-related fatigue, little is known about the physical experience or meanings attributed to either. We considered chronic fatigue and physical activity in terms of how they were experienced, interpreted and interrelated within narratives about living with HIV. Thematic analysis of 35 semi-structured interviews with people living with HIV in France led to the creation of four ideal-type narratives. The ideal types illustrated relations between diverse physical and social experiences of fatigue and physical activity. These dimensions of the HIV experience were part of larger identity narratives about the body and self, revealing tensions between the latter as healthy or ill, tired or active, vulnerable or robust, needing or heeding expected health behaviours. Illness narratives – and the meanings attributed to body and self – emerged as faceted by both physical experiences of the body and social experiences, and as situated within larger socio-political contexts and biopedagogies.

Impact of test-and-treat and risk reduction strategies on HCV transmission among MSM living with HIV in France: a modelling approach

ObjectiveSince the early 2000s, there has been an epidemic of HCV occurring among men who have sex with men (MSM) living with HIV, mainly associated with high-risk sexual and drug-related...

Barriers for the MSM Population to Access Testing for HIV in France, Poland, the UK and Across Europe: a Qualitative Study

Barriers for the MSM Population to Access Testing for HIV in France, Poland, the UK and Across Europe: a Qualitative Study

Prevalence and incidence of kidney diseases leading to hospital admission in people living with HIV in France: an observational nationwide study

ObjectivesTo describe hospitalisations for kidney disease (KD) among people living with HIV (PLHIV) in France and to identify the factors associated with such hospitalisations since data on the epidemiology of...

Perceived HIV‐related physical fatigue, sociodemographic characteristics and physical activity: A cross‐sectional study

To get a deeper understanding of correlates of perceived HIV-related fatigue by exploring its associations with sociodemographic characteristics and physical activity level of HIV-infected people. Previous studies on HIV-related fatigue have mainly focused on physiological and psychological characteristics, but few have considered its associations with sociodemographic variables. In addition, while physical activity has been found to reduce acute fatigue among HIV-infected people, its links with chronic HIV-related fatigue remain to be explored. The study employed an observational and cross-sectional survey design. The manuscript was organised according to STROBE guidelines. A total of 560 people living with HIV in France completed a measure of perceived physical fatigue using the Fatigue Intensity Scale. The predictors targeted sociodemographic characteristics and two measures of individuals' reported level of physical activity. Data were analysed by a stepwise multiple regression model. The results showed that lower age, higher physical activity level and socio-economic status were significantly associated with reduced perceived physical fatigue, explaining 25% of the variance. The results highlighted the importance of considering sociodemographic and lifestyle characteristics to better characterise HIV-related fatigue, in particular in an era where HIV as a chronic illness challenges questions of quality of life throughout increasingly longer lifespans. The results of this study have implications for HIV care professionals in terms of improving strategies for managing chronic fatigue or promoting physical activity according to more specific profiles of HIV-infected people.

PRM55 - A NEW ANALYSIS METHODOLOGY TO FIND ATYPICAL COST PROFILES IN PATIENTS LIVING WITH HIV FROM A NATIONAL CLAIM INSURANCE DATA (SNIIRAM)

This study is a large-scale extension of a published study on the economic burden of HIV in France that was solely focused on hospital costs. Through the application of a new analytical methodology, the objective is to find the profiles of patients living with HIV (PLHIV) who overexpress the cost of care, using all reimbursement data of the French health insurance (SNIIRAM database). We performed a retrospective cohort study. The SNIIRAM contains individualized data on all reimbursed health expenses for the entire French population. PLHIV were included between 01/01/2013 and 31/12/2013 by the presence of a care related to HIV. Each patient was followed one year after his inclusion. The annual cost per patient was assessed for the economic burden. The search for patient profiles overexpressing these costs is based on an innovative methodology with a machine learning algorithm. A Boosted Decision Tree regression model was customized to match the size and complexity of health data and to find meaningful profiles (a profile is a combination of dozens of variables). A medical reading of the data identified tens of variables of interest to describe the 98 000 PLHIV included in the study: sociodemographic information, hospital admissions, presence of opportunistic infections, comorbidities, frequency of viral load testing, consultations, and the cost of care. The dedicated machine learning algorithm identified more than ten relevant profiles. An interactive data-visualization tool allowed the restitution of these complex results in a clear way. This study shows that in-depth uses of large healthcare databases require innovative analysis methods. We combined a standard epidemiological study methodology (cohort definition and monitoring, medical review, economic burden) with an innovative mathematical model (Machine Learning) to obtain accurate results regarding patient profiles. These profiles are usable to objectify action plans to improve care policies.

Costs associated with hospitalization in HIV-positive patients in France.

To estimate the number of patients hospitalized for HIV-related reasons in France, to describe their characteristics and to estimate hospitalization-associated costs. A retrospective analysis of the French hospital medical information database (Programme de médicalisation des systèmes d'information en médecine, chirurgie, obstétrique et odontologie database). Patients hospitalized with HIV in France in 2013 and 2014 were identified in the database through International Classification of Diseases, 10th revision diagnostic codes as well as comorbidities and opportunistic infections. Hospital stays for each patient were extracted over a 12-month period following the initial index hospitalization. Costing was performed from the perspective of national health insurance. Direct costs were attributed from national tariffs for medical acts and expressed in 2016 Euros. During the study period, 70 180 stays, including day (80%) and overnight (20%) hospitalization, of patients with HIV were identified, of which 37 477 stays (by 20 126 patients) were directly related to HIV. In patients with overnight hospitalization, an opportunistic infection was documented in 50% of patients and at least one comorbidity were identified in 85% of patients. The overall estimated total annual cost of hospital stays was &OV0556; 64 126 616 (median annual cost per patient: &OV0556; 545). The median annual per capita cost was &OV0556; 541 for day hospitalization, &OV0556; 7664 for overnight stay with comorbidities and &OV0556; 9059 for overnight stay with opportunistic infections. Most patients hospitalized with HIV in France presented an opportunistic infection or at least one comorbidity that contributed to costs of hospitalization. The organization of interfaces between different healthcare providers in hospital and community practice needs to be organized so that comorbidities are identified and managed optimally.

Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study.

BackgroundEffective antiretroviral therapy has greatly reduced HIV-related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV. The majority of people living with HIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and other patient-reported outcomes of relevance in the current treatment era.ObjectiveWe aim to describe the development of a Web-based electronic patient-reported outcomes system for people living with HIV linked to the ANRS CO3 Aquitaine cohort’s data capture and visualization system (ARPEGE) and designed to facilitate the electronic collection of patient-reported data and ultimately promote better patient-physician communication and quality of care (both patient satisfaction and health outcomes).MethodsParticipants who meet the eligibility criteria will be invited to engage with the Web-based electronic patient-reported outcomes system and provided with the information necessary to create a personal patient account. They will then be able to access the electronic patient-reported outcomes system and complete a set of standardized validated questionnaires covering health-related quality of life (World Health Organization's Quality of Life Instrument in HIV infection, named WHOQOL-HIV BREF) and other patient-reported outcomes. The information provided via questionnaires will ultimately be presented in a summary format for clinicians, together with the patient’s HIV care history.ResultsThe prototype of the Web-based electronic patient-reported outcome system will be finalized and the first 2 formative research phases of the study (prototyping and usability testing) will be conducted from December 2017 to May 2018. We describe the sequential processes planned to ensure that the proposed electronic patient-reported outcome system is ready for formal pilot testing, referred to herein as phases 1a and 1b. We also describe the planned pilot-testing designed to evaluate the acceptability and use of the system from the patient’s perspective (phase 2).ConclusionsAs the underlying information technology solution, ARPEGE, has being developed in-house, should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment with health-promoting interventions in aging people living with HIV in hospital-based care or adapted for use in other patient populations.Trial RegistrationClinicalTrials.gov NCT03296202; https://clinicaltrials.gov/ct2/show/NCT03296202 (Archived by WebCite at http://www.webcitation.org/6zgOBArps)Registered Report IdentifierRR1-10.2196/9439

Head and neck squamous cell carcinoma in people living with HIV in France

ObjectivesHead and neck squamous cell carcinoma (HNSCC), mainly due to smoking, is one of the leading causes of cancer deaths. However, an increasing number of tumors – especially oropharyngeal cancer – are reported in non-smokers in association with the human papillomavirus (HPV). As HIV-infected individuals are particularly at risk of HPV-related disease, we aimed to describe the burden of HNSCC in this population. MethodsRetrospective chart review of patients from HIV clinics diagnosed with HNSCC between 2004 and 2014. Case patients were defined using the International Classification of Disease for Oncology (3rd edition). Age at HIV diagnosis and time from HIV diagnosis to HNSCC diagnosis were collected. Oropharyngeal cancers were considered as potentially HPV-related cancers, and their prevalence was compared with other HNSCCs over time. ResultsThe 286 patients enrolled in the study had a median age at HNSCC diagnosis of 52 years; 84% were males and 68% had a history of smoking. The oropharynx was the most frequent site (41%), followed by cancer of the oral cavity (31%), larynx (22%), and hypopharynx (7%). The prevalence (and proportion) of potentially HPV-related cancers increased significantly over time with a mean of 0.78 additional case patient per year. ConclusionThe prevalence of HNSCC is modest compared with other cancers in HIV-infected individuals. The prevalence of oropharynx carcinoma, a potentially HPV-related carcinoma, seems to increase over time. Even if tobacco may be an important contributor, the role of HPV in HIV-infected individuals presenting with HNSCC should be investigated.

Prevalence of drug resistance in children recently diagnosed with HIV-1 infection in France (2006-17): impact on susceptibility to first-line strategies.

To describe the prevalence of transmitted drug resistance (TDR) among 84 children newly diagnosed with HIV in France in 2006-17. HIV-1 resistance-associated mutations (RAMs) were characterized using both the 2009 Stanford list of mutations and the 2017 French National Agency for AIDS Research (ANRS) algorithm. A genotypic susceptibility score (GSS) was estimated for each first-line recommended ART combination. Patients were mainly infected through mother-to-child transmission (MTCT) (73/84; 86.9%), but only 18 children (24.7% of vertically infected patients) were previously exposed to antiretroviral prophylaxis from MTCT. Non-B variants were identified in 90.5% (76/84) of patients. The frequency of TDR was 8.3% (7/84) using the 2009 Stanford list and 16.7% (14/84) using both the Stanford list and the 2017 ANRS algorithm. The prevalence of PI-, NRTI-, efavirenz/nevirapine-, etravirine/rilpivirine- and doravirine-associated RAMs was 0%, 3.6%, 6.0%, 11.9% and 2.4%, respectively. Single-, dual- and triple-class resistance was present in 15.5%, 1.2% and 0% of cases, respectively. Additionally, 3/60 (5%) strains had integrase inhibitor (INI)-related RAMs (an isolated E157Q mutation, which could mostly affect the susceptibility to raltegravir/elvitegravir rather than that to dolutegravir). Among the 18 children exposed to MTCT prophylaxis, RAMs were identified in only 1 case (5.6%). The proportion of fully active combinations (GSS = 3) was ≥97.6%, ≥94.1%, ≥92.9% and ≥89.3% for PI-, INI-, efavirenz/nevirapine- and rilpivirine-based regimens, respectively. The proportion of NRTI- and NNRTI-related TDR in children is lower in France than in low- and middle-income countries. However, we suggest favouring PI- or dolutegravir- over NNRTI-based combinations to treat newly diagnosed HIV-infected children, even in the absence of previous exposure to antiretroviral prophylaxis of MTCT.

Smoking and HIV: confronting the epidemic

Although the global prevalence of cigarette smoking has declined, the proportion of people living with HIV who are smokers remains high and is about double that in the general population. 1 Mdodo R Frazier EL Dube SR et al. Cigarette smoking prevalence among adults with HIV compared with the general adult population in the United States: cross-sectional surveys. Ann Intern Med. 2015; 162: 335-344 Crossref PubMed Scopus (302) Google Scholar Despite the high prevalence, the research examining smoking cessation in people living with HIV is surprisingly sparse. 2 Pool ER Dogar O Lindsay RP Weatherburn P Siddiqi K Interventions for tobacco use cessation in people living with HIV and AIDS. Cochrane Database Syst Rev. 2016; 6 (CD011120) Google Scholar Thus, the study by Mercié and colleagues, 3 Mercié P Arsandaux J Katlama C et al. Efficacy and safety of varenicline for smoking cessation among people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Lancet HIV. 2018; (published online Jan 9. http://dx.doi.org/10.1016/S2352-3018(18)30002-X) Summary Full Text Full Text PDF PubMed Scopus (36) Google Scholar reported in The Lancet HIV, is a notable contribution. This double-blind, placebo-controlled phase 3 clinical trial showed that a 3 month course of varenicline combined with smoking cessation counselling was associated with a significantly higher proportion of participants who were biochemically confirmed as abstinent at 48 weeks compared with placebo and counselling (18 [15%, 95% CI 8–21] of 123 patients in the varenicline group vs eight [6%, 95% CI 2–11] of 124 patients in the placebo group; p=0·036). The study is the first high-quality investigation showing a long-term benefit of a smoking cessation intervention in HIV. 2 Pool ER Dogar O Lindsay RP Weatherburn P Siddiqi K Interventions for tobacco use cessation in people living with HIV and AIDS. Cochrane Database Syst Rev. 2016; 6 (CD011120) Google Scholar 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 trialVarenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care. Full-Text PDF

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

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. 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. 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. Varenicline is safe and efficacious for smoking cessation in people living with HIV and should be recommended as the standard of care. The French National Institute for Health and Medical Research (INSERM)-French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Pfizer.

Intimate ties of people living with HIV in France resulted both from social status and the experience of being HIV-infected: results from the ANRS-Vespa2 study, France

ABSTRACTBased on data from the ANRS-Vespa2 study, conducted among a representative sample of PLWHIV (France, 2011), we studied intimate ties with relatives and friends and their determinants. Six social network profiles were identified, with a clear association with socioepidemiological groups: the most surrounded individuals were MSM, and the most isolated ones were sub-Saharan African migrants (especially women). Social networks were shaped both by material socioeconomic status and HIV experience: involvement in PLWHIV organizations, disclosure of HIV infection, and the experience of discrimination. Among PLWHIV, intimate ties appeared to be shaped by both their multifaceted social position rooted in power relationships and by HIV-related stigma. Such a process nurtures social inequality in coping with HIV infection, since the most disadvantaged individuals appear to be the most isolated ones. A holistic approach to HIV care is still required to overcome the marginalization of PLWHIV.

Modeling HIV-HCV coinfection epidemiology in the direct-acting antiviral era: the road to elimination

BackgroundHCV treatment uptake has drastically increased in HIV-HCV coinfected patients in France since direct-acting antiviral (DAA) treatment approval, resulting in HCV cure in 63% of all HIV-HCV patients by the end of 2015. We investigated the impact of scaling-up DAA on HCV prevalence in the whole HIV population and in various risk groups over the next 10 years in France using a transmission dynamic compartmental model.MethodsThe model was based on epidemiological data from the French Dat’AIDS cohort. Eight risk groups were considered, including high-risk (HR) and low-risk (LR) men who have sex with men (MSM) and male/female heterosexuals, intra-venous drug users, or patients from other risk groups. The model was calibrated on prevalence and incidence data observed in the cohort between 2012 and 2015.ResultsOn January 1, 2016, 156,811 patients were registered as infected with HIV in France (24,900 undiagnosed patients) of whom 7938 (5.1%) had detectable HCV-RNA (722 undiagnosed patients). Assuming a treatment coverage (TC) rate of 30%/year (i.e., the observed rate in 2015), model projections showed that HCV prevalence among HIV patients is expected to drop to 0.81% in 2026. Sub-analyses showed a similar decrease of HIV-HCV prevalence in most risk groups, including LR MSM. Due to higher infection and reinfection rates, predicted prevalence in HR MSM remained stable from 6.96% in 2016 to 6.34% in 2026. Increasing annual TC rate in HR MSM to 50/70% would decrease HCV prevalence in this group to 2.35/1.25% in 2026. With a 30% TC rate, undiagnosed patients would account for 34% of HCV infections in 2026.ConclusionsOur model suggests that DAA could nearly eliminate coinfection in France within 10 years for most risk groups, including LR MSM. Elimination in HR MSM will require increased TC.