Marie Suzan-Monti

On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection

BACKGROUND Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen. METHODS We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections. RESULTS Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03). CONCLUSIONS The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [ANRS] and others; ClinicalTrials.gov number, NCT01473472.).

HIV-1 DNA Levels in Peripheral Blood Mononuclear Cells and Cannabis Use are Associated With Intermittent HIV Shedding in Semen of Men Who Have Sex With Men on Successful Antiretroviral Regimens

BACKGROUND Few data exist on the efficacy of combined antiretroviral therapy (cART) in semen of human immunodeficiency virus type 1 (HIV-1) infected men who have sex with men (MSM) with sustained control of HIV replication in blood. METHODS HIV-1 infected MSM on successful cART for >6 months were enrolled. HIV-RNA was quantified in seminal plasma (spVL) and in blood plasma (bpVL) from 2 paired samples collected 4 weeks apart. Relationship between spVL and bpVL (measured by an ultrasensitive assay, LOQ 10 copies/mL), total peripheral blood mononuclear cells (PBMC)-associated HIV-DNA, sexually transmitted infections (STIs), and self-reported socio-behavioral characteristics was assessed using GEE logistic regression. RESULTS In total, 157 patients were included. Median time with bpVL <50 copies/mL was 3.3 years. spVL was detectable in 23/304 samples (prevalence 7.6%). Median spVL was 145 cp/mL (100-1475). spVL was detectable on the first, on the second, and on both samples in 5, 14, and 2 men, respectively. In sum, 33 individuals (21%) had STIs (asymptomatic in 24/33). Residual bpVL was undetectable by ultrasensitive assay in 225/300 samples (75%). After multivariable adjustments, PBMC-associated HIV-DNA (OR 2.6[1.2; 6.0], for HIV-DNA > 2.5 log10 cp/10(6) PBMC, P = .02), and cannabis use during sexual intercourse (OR 2.8[1.2; 6.7], P = .02) were the only factors associated significantly with spVL. CONCLUSION We show that HIV-RNA can be detected intermittently in semen of HIV-1 infected MSM despite successful cART. The size of blood HIV-1 reservoir predicted spVL detection. Our results indicated also that the possible effect of cannabis should be taken into account when developing prevention interventions targeted toward HIV-infected MSM on successful cART.

Expanding access to non-medicalized community-based rapid testing to men who have sex with men: an urgent HIV prevention intervention (the ANRS-DRAG study).

Background Little is known about the public health benefits of community-based, non-medicalized rapid HIV testing offers (CBOffer) specifically targeting men who have sex with men (MSM), compared with the standard medicalized HIV testing offer (SMOffer) in France. This study aimed to verify whether such a CBOffer, implemented in voluntary counselling and testing centres, could improve access to less recently HIV-tested MSM who present a risk behaviour profile similar to or higher than MSM tested with the SMOffer. Method This multisite study enrolled MSM attending voluntary counselling and testing centres’ during opening hours in the SMOffer. CBOffer enrolees voluntarily came to the centres outside of opening hours, following a communication campaign in gay venues. A self-administered questionnaire was used to investigate HIV testing history and sexual behaviours including inconsistent condom use and risk reduction behaviours (in particular, a score of “intentional avoidance” for various at-risk situations was calculated). A mixed logistic regression identified factors associated with access to the CBOffer. Results Among the 330 participants, 64% attended the CBOffer. Percentages of inconsistent condom use in both offers were similar (51% CBOffer, 50% SMOffer). In multivariate analyses, those attending the CBOffer had only one or no test in the previous two years, had a lower intentional avoidance score, and met more casual partners in saunas and backrooms than SMOffer enrolees. Conclusion This specific rapid CBOffer attracted MSM less recently HIV-tested, who presented similar inconsistent condom use rates to SMOffer enrolees but who exposed themselves more to HIV-associated risks. Increasing entry points for HIV testing using community and non-medicalized tests is a priority to reach MSM who are still excluded.

Uptake of PrEP and condom and sexual risk behavior among MSM during the ANRS IPERGAY trial

ABSTRACT The double-blind phase of the randomized ANRS IPERGAY trial, evaluating sexual activity-based oral HIV pre-exposure prophylaxis (PrEP), was conducted among high-risk men who have sex with men (MSM). Results showed an 86% (95% CI: 40–98) relative reduction in HIV incidence among participants with tenofovir disoproxil fumarate–emtricitabine vs. placebo. The present pooled analysis aimed to analyze (i) participants’ adherence to the prescribed treatment and/or condom use during sexual intercourse and (ii) sexual behavior during the double-blind phase of the study. Four hundred MSM were enrolled in the trial. Every 2 months they completed online questionnaires collecting sexual behavior and PrEP adherence data regarding their most recent sexual intercourse. A total of 2232 questionnaires (M0–M24) were analyzed. Changes over time were evaluated using a mixed model accounting for multiple measures. Irrespective of sexual partner and practice type, on average, 42.6% (min: 32.1–max: 45.8%) reported PrEP use only during their most recent episode of sexual intercourse; 29% (22.9–35.6%) reported both PrEP and condom use; 11.7% (7.2–18.9%) reported condom-use only, and 16.7% (10.8–29.6%) reported no PrEP or condom use with no significant change during the study. Scheduled (i.e., correct) PrEP use was reported on average by 59.0% (47.2–68.5%) of those reporting PrEP use during their most recent sexual intercourse. Overall, 70.3% (65.3–79.4%) and 69.3% (58.3–75.4%) of participants reported, respectively, condomless anal and condomless receptive anal intercourse during their most recent sexual encounter without significant change during follow-up. Overall, on average 83.3% (min: 70.4–max: 89.2%) of participants protected themselves by PrEP intake or condom use or both during the trial, and no increase in at-risk sexual practices was observed. None of these indicators showed significant trend during the follow-up, although we found a tendency toward decrease (p = .19) of the median number of sexual partners strengthening the absence of behavioral disinhibition. On-demand PrEP within a comprehensive HIV prevention package could improve prevention in MSM.

Patterns of adherence to antiretroviral therapy and HIV drug resistance over time in the Stratall ANRS 12110/ESTHER trial in Cameroon

The emergence of HIV drug resistance is a crucial issue in Africa, where second‐line antiretroviral therapy (ART) is limited, expensive and complex. We assessed the association between adherence patterns and resistance emergence over time, using an adherence measure that distinguishes low adherence from treatment interruptions, in rural Cameroon.

Comparison of risk factors in HIV-infected men who have sex with men, coinfected or not with hepatitis C virus (ANRS VESPA2 French cross-sectional national survey)

Objectives HIV-infected men who have sex with men (HIV-MSM) are at high risk of hepatitis C virus (HCV) infection. This study aimed to compare risk factors between HIV-MSM coinfected with HCV and those who are not, in a national representative survey conducted in France. Methods The ANRS VESPA2 survey (April 2011–January 2012) collected sociodemographic and behavioural data (through face-to-face administered questionnaires) as well as medical data (physician questionnaire) among 3022 HIV-infected adults recruited in 73 French HIV hospital departments. We identified behavioural correlates of HCV coinfection among sexually active HIV-MSM who participated in VESPA2 (logistic regression models). Results Ninety-three of the 1037 HIV-MSM of the study population (8.9%) were coinfected with HCV. The following risk factors were independently associated with HCV coinfection, after adjustment for age and time since HIV diagnosis: current or past injecting drug use, having had at least 20 male sexual partners during the previous 12 months, reporting inconsistent condom use during anal sex with casual partners, and attending sex parties. Individuals reporting at least three sexual risk factors were at the highest risk of being coinfected with HCV (OR (95% CI): 22.86 (9.74; 53.62), p<0.0001). Conclusions HIV-MSM reporting several sexual risk factors should be sensitised to risk-reduction behaviours to avoid HCV transmission to sexual partners, and infection or reinfection with HCV.

Health-related quality of life of people living with HIV followed up in hospitals in France: comparing trends and correlates between 2003 and 2011 (ANRS-VESPA and VESPA2 national surveys)

In recent years, France has witnessed both structural changes in the population of people living with HIV and a relative improvement in the social representation of HIV infection. However, potential changes in peoples day-to-day experience with HIV have not been documented. We used data from the national surveys ANRS-VESPA (2003) and VESPA2 (2011) to compare the levels and patterns of correlates of health-related quality of life (HRQL) in adult HIV-infected patients followed up in French hospitals over a period of eight years. Mean physical and mental SF-12 scores were compared (VESPA, n = 2072; and VESPA2, n = 2267) using analysis of variance (ANOVA) F tests. Heckman regression models were then used to identify independent correlates of physical and mental quality of life in the two surveys, while accounting for possible bias due to missing score values. A common set of potential socio-demographic, clinical, behavioral, and psychosocial correlates was tested. Individuals reported a decrease in physical quality of life in VESPA2 compared with VESPA (mean score (standard error): 47.5 (0.2) versus 49.6 (0.2), p < .0001), and better mental HRQL (44.3 (0.3) versus 42.3 (0.3), p < 0.0001). In both surveys, financial difficulties and patient-perceived experience of rejection behaviors by medical staff were independently associated with impaired physical and mental quality of life. Older age and unemployment were independently associated with impaired physical quality of life. Immigrants from Sub-Saharan Africa reported better mental quality of life. Findings show that quality of life levels in adult HIV-infected patients followed up at hospital in France has significantly, yet modestly, changed in recent years. However, the pattern of quality of life correlates has remained relatively stable. The impact of patient–provider relationships on self-reported outcomes is confirmed. Further research is needed to identify potential differences in quality of life correlates in specific subgroups of patients, such as men who have sex with men, women, immigrants, and injecting drug users.

Empowering HIV testing as a prevention tool: Targeting interventions for high-risk men who have sex with men

Abstract In France, HIV testing can be easily performed in free and anonymous voluntary counselling testing (VCT) centres. The recent national study among French men who have sex with men (MSM) showed that 73% of those already tested for HIV had been tested in the previous two years. Nothing is known about the risk behaviours of MSM attending VCT centres. This study aimed to characterize sexual risk behaviours of MSM tested for HIV in such centres and identify factors associated with inconsistent condom use (ICU). A cross-sectional study was conducted from March to December 2009 in four VCT centres where a self-administered questionnaire was proposed to all MSM about to have a HIV test. ICU was defined as reporting non-systematic condom use during anal intercourse with casual male partners. Among the 287 MSM who fully completed their questionnaire, 44% reported ICU in the previous six months. Among those who had been already tested, 63% had had their test in the previous two years. Factors independently associated with ICU included: never avoiding one-night stands, not having been recently HIV tested, experiencing difficulty in using condoms when with a HIV negative partner or when under the influence of drugs or alcohol and finally, reporting to have had a large number of casual male partners in the previous six months. The rate of recently tested MSM was high in our study. Nevertheless, this rate was lower than that found in the last national study. Furthermore those not recently tested were significantly more likely to report high risk behaviours. We therefore recommend that further efforts be made to adapt the offer of both HIV testing and counselling to meet the specific needs of hard-to-reach MSM. Accordingly, an additional community-based offer of HIV testing to reach most-at-risk MSM is forthcoming in France.

Impact of HIV Comprehensive Care and Treatment on Serostatus Disclosure among Cameroonian Patients in Rural District Hospitals

This work aimed to analyze the rate of disclosure to relatives and friends over time and to identify factors affecting disclosure among seropositive adults initiating antiretroviral therapy (ART) in rural district hospitals in the context of decentralized, integrated HIV care and task-shifting to nurses in Cameroon. Stratall was a 24-month, randomized, open-label trial comparing the effectiveness of clinical monitoring alone with laboratory plus clinical monitoring on treatment outcomes. It enrolled 459 HIV-infected ART-naive adults in 9 rural district hospitals in Cameroon. Participants in both groups were sometimes visited by nurses instead of physicians. Patients with complete data both at enrolment (M0) and at least at one follow-up visit were included in the present analysis. A mixed Poisson regression was used to estimate predictors of the evolution of disclosure index over 24 months (M24).The study population included 385 patients, accounting for 1733 face-to-face interviews at follow-up visits from M0 to M24. The median [IQR] number of categories of relatives and friends to whom patients had disclosed was 2 [1]–[3] and 3 [2]–[5] at M0 and M24 (p-trend<0.001), respectively. After multiple adjustments, factors associated with disclosure to a higher number of categories of relatives and friends were as follows: having revealed one’s status to one’s main partner, time on ART, HIV diagnosis during hospitalization, knowledge on ART and positive ratio of follow-up nurse-led to physician-led visits measuring task-shifting. ART delivered in the context of decentralized, integrated HIV care including task-shifting was associated with increased HIV serological status disclosure.

Informal pre‐exposure prophylaxis use in France: results from the Flash PrEP survey (2014)

D Rojas Castro, G Quatremere, L Sagaon-Teyssier, J-M Le Gall, M Preau, M Suzan-Monti and B Spire Innovation and Research Unit, AIDES, Pantin, France, GRePS EA4163, University of Lyon, Lyon, France, INSERM, UMR912 “Economics and Social Sciences Applied to Health & Analysis of Medical Information” (SESSTIM), Marseille, France, Aix Marseille University, UMR_S912, IRD, Marseille, France and ORS PACA, Southeastern Health Regional Observatory, Marseille, France