Marie Préau

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.).

Health-related quality of life and patient–provider relationships in HIV-infected patients during the first three years after starting PI-containing antiretroviral treatment

The aim of this study was to investigate factors associated with better health-related quality of life (HRQL) during the first three years after starting PI-containing antiretroviral treatment. Clinical, social and behavioural data from the APROCO cohort enabled us to analyze simultaneously the association between HRQL and patients’ relationships with their health care providers. A self-administered questionnaire collected information about HRQL (MOS-SF36) and relationships with medical staff (trust and satisfaction with information). Two aggregate scores, the physical (PCS) and mental (MCS) component summaries (adjusted for baseline HRQL), were used as dependent variables in the linear regressions to identify factors associated with HRQL. We had complete longitudinal data for 360 of the 611 patients followed through M36. Factors independently associated with a high MCS were (male) gender, no more than one change in treatment, (few) self-reported symptoms and trust in the physician. Factors independently associated with high PCS levels were employment, no children, (few) self-reported symptoms and satisfaction with the information and explanations provided by the medical staff. These results underline the need to improve patient–provider relationships to optimize long-term HRQL. Socio-behavioural interventions should focus on this goal.

Health-related quality of life in French people living with HIV in 2003 : results from the national ANRS-EN12-VESPA study

Objective:Since the advent of HAART, the assessment of health-related quality of life (HRQL) has become a major concern in the therapeutic follow-up of people living with HIV. Design:HRQL was evaluated for 2235 participants in the ANRS-EN12-VESPA Study. These participants completed the Medical Outcome Study 36-Item Short Form Health Survey (MOS SF-36) questionnaire. Anxiety and depression were assessed using the Hospital Anxiety and Depression (HAD) scale. Individuals were considered to have an ‘acceptable’ physical (and mental) HRQL if their MOS SF-36 scores were greater than the 25th percentile of the corresponding age-sex-specific distribution of scores in the French general population. Methods:Logistic regression models were used to identify factors associated with an ‘acceptable’ physical and mental HRQL among demographic, psychosocial and clinical characteristics. Potential selection bias caused by non-random missing responses to the MOS SF-36 questionnaire was statistically tested. Results:Physical and mental HRQL were ‘acceptable’ in 1176 (53%) and 1152 (51%) individuals, respectively. After adjusting for sociodemographic factors, HIV clinical status and hepatitis C co-infection, high HAD scores and the consumption of anxiolytic, antidepressant and hypnotic drugs were found to be negatively associated with normal physical and mental HRQL. Conclusion:The role of disclosure and discrimination is determinant in HRQL, and the various cultural and psychological dimensions require further research. The presence of other infections or co-morbidities requires a comprehensive care system including medical staff and social worker teams. HIV should increasingly be regarded as a chronic disease characterized by different pathological conditions requiring a comprehensive and multidisciplinary approach.

Self-Reported Fatigue and Depressive Symptoms as Main Indicators of the Quality of Life (QOL) of Patients Living with HIV and Hepatitis C: Implications for Clinical Management and Future Research

Abstract Purpose: To analyze the impact of self-reported fatigue and depressive symptoms on the quality of life (QOL) of patients co-infected with HIV and hepatitis C virus (HCV) not receiving anti-HCV therapy. Method: We used data from a cross-sectional survey conducted among 115 co-infected adults including an assessment of QOL (WHOQOL-HIV bref questionnaire), depressive symptomatology (Center for Epidemiological Studies Depression Scale [CES-D]), and fatigue (Fatigue Impact Scale [FIS]). Results: Eighty-four percent of patients had been infected through injecting drug use (IDU). Half reported a history of depression or other psychiatric co-morbidities, 57% presented depressive symptoms, and 69% reported fatigue. FIS and CES-D scores accounted for 54% and 66% of total variance in psychological QOL and level of independence-related QOL, respectively, in a multivariate analysis adjusted for sociodemographic and clinical characteristics and alcohol or drug use. High FIS scores were independently associated with impaired physical QOL and social relationships, whereas high CES-D scores were independently associated with lower environmental QOL. Conclusion: Self-reported fatigue and depressive symptoms are the best indicators of co-infected patients’ QOL. These two indicators could be more easily used for a better clinical management of co-infected patients and also introduced as patient outcome measures in clinical research.

Unprotected sex in regular partnerships among homosexual men living with HIV: a comparison between sero-nonconcordant and seroconcordant couples (ANRS-EN12-VESPA Study).

Objective:We investigated factors associated with unprotected sex in regular partnerships among homosexual men living with HIV. Method:We used data from a French national representative sample of people living with HIV (ANRS-EN12-VESPA survey). This analysis included men in a regular partnership with another man for at least twelve months. Unprotected sex was defined as reporting at least one episode of sexual intercourse without a condom with this regular partner in the previous 12 months. Separate analyses were conducted in sero-nonconcordant couples and in HIV-positive seroconcordant couples. Results:285 and 193 homosexual men respectively reported a regular sero-nonconcordant and seroconcordant partner. Unprotected sex was reported by a higher number of respondents within seroconcordant (46.7%) than within sero-nonconcordant couples (15.6%).In both seroconcordant and sero-nonconcordant partnerships, unprotected sex was significantly more frequent when episodes of unprotected sex with casual partners were reported. In seroconcordant couples, those who had more than four casual partners were also more likely to practise unprotected sex with their regular partner. Among sero-nonconcordant couples, binge drinking and absence of disclosure of ones HIV-positive status to the partner were also independently associated with unprotected sex. Conclusions:A limited number of sero-nonconcordant homosexual couples persist in reporting risky sexual behaviour. Prevention messages should encourage communication and HIV disclosure. The relationship between unprotected sex with both casual and regular partners also calls attention about the underlying psycho-social and interactional factors that may influence sexual behaviours of people living with HIV in regular relationships, independently of the status of the partner.

Unsafe sex in regular partnerships among heterosexual persons living with HIV : evidence from a large representative sample of individuals attending outpatients services in France (ANRS-EN12-VESPA Study)

Objective:Risky sexual behaviour remains frequent among people living with HIV. We analysed factors associated with unsafe sex within serodiscordant couples among heterosexual individuals living with HIV in France. Methods:In 2003, a face-to-face survey was conducted among individuals selected in a random stratified sample of 102 French hospital departments delivering HIV care. This analysis included adults heterosexual participants in a regular partnership for at least 12 months with a seronegative/unknown serostatus partner, HIV-diagnosed for at least 12 months. Unsafe sex was defined as reporting inconsistent condom use in the prior 12 months. Among men and women, participants who reported unsafe sex were compared with those who did not. Results:663 heterosexual adults reported being in a serodiscordant regular partnership. Women accounted for 41% of participants and 26% of the sample were immigrants. Unsafe sex with the steady partner was reported by 26% of men and 34% of women (p = 0.024).For men, factors independently associated with unsafe sex were being in a relationship for more than 10 years, being in a difficult financial situation and reporting regular consumption of alcohol to excess.Among women, having a history of drug use, not being aware of partners serostatus, and reporting a difficult financial situation were independently associated with unsafe sex. In addition, immigrant women were associated with safer sex. Conclusions:A high number of serodiscordant couples continue to report risky sexual behaviour, and related factors are gender-specific. Couple-level interventions are essential in order to prevent HIV-transmission and to encourage negotiation within couples.

Health-related quality of life in HIV-1 -infected patients on HAART: a five-years longitudinal analysis accounting for dropout in the APROCO-COPILOTE cohort (ANRS CO-8)

BackgroundThe long-term efficacy of Highly Active Antiretroviral Therapies (HAART) has enlightened the crucial role of health-related quality of life (HRQL) among HIV-infected patients. However, any analysis of such extensive longitudinal data necessitates a suitable handling of dropout which may correlate with patients–health status.MethodsWe analysed the HRQL evolution over 5 years for 1,000 patients initiating a protease inhibitor (PI)-containing therapy, using MOS SF-36 physical (PCS) and mental (MCS) scores. In parallel with a classical separate random effects model, we used a joint parameter-dependent selection model to account for non-ignorable dropout.ResultsHRQL evolved according to a two-phase pattern, characterized by an initial improvement during the year following HAART initiation and a relative stabilization thereafter. Immunodepression and self-reported side effects were found to be negative predictors of both PCS and MCS scores. Hepatitis C virus coinfection and AIDS clinical stage were found to affect physical HRQL. Results were not significantly altered when accounting for dropout.ConclusionSuch results, obtained on a large sample of HIV-infected patients with extensive follow-up, underline the need for a regular monitoring of patients–immunological status and for a better management of their experience with hepatitis C and HAART.

Suicide attempts among people living with HIV in France

Abstract This study examined the prevalence and characteristics of attempted suicide among a representative sample of French Human Immunodeficiency virus (HIV) infected individuals. In 2003, a face-to-face survey was conducted among people living with HIV/AIDS (PLWHA) selected in a random, stratified sample of French hospital departments. Among solicited individuals, 2,932 agreed to participate and were asked if they had ever AS. Among the respondents, 23% had AS. Female gender, younger age, native French citizenship, reporting household financial difficulties, having been HIV-contaminated through homosexual contact or through injection drug use and suffering from lipodystrophy-related symptoms were all independently associated with AS. HIV-discrimination and the lack of social support from family remained independently associated with AS. Our findings indicate a high level of AS among PLWHA and emphasize the multiple roles of factors associated with living with HIV, together with sociodemographic factors. The results enable the possibility for vulnerable groups to be targeted for specific future interventions in order to prevent attempted suicide.

Unsafe sex with casual partners and quality of life among HIV-infected gay men: evidence from a large representative sample of outpatients attending French hospitals (ANRS-EN12-VESPA).

Introduction: The introduction of highly active antiretroviral therapy has relaunched the debate on risky sexual behavior among HIV-infected gay men. It was proposed to study the influences of lifestyle characteristics and health-related quality of life (HRQL) on unsafe sex with casual partners in a representative sample of HIV-infected gay men. Methods: In 2003, a national survey based on face-to-face interviews was conducted among a representative sample of patients selected in a random stratified sample of 102 French hospital departments delivering HIV care. The patients selected for this analysis were gay men who reported having had sex with casual partners during the previous 12 months. Unsafe sex was defined as at least 1 episode of anal sexual intercourse without a condom with a casual partner during the previous 12 months. Health-related quality of life was assessed using the SF-36 Scale. Patients who declared that they had engaged in unsafe sex were compared with those who declared that they had not done so, using the &khgr;2 test and logistic regressions. Results: Among the 1117 gay men who participated in the study, 607 declared having had casual partners during the previous 12 months, and 140 (20%) of this latter group had engaged in unsafe sex. Poor mental HRQL was encountered in 68% of the patients and found to be independently associated with unsafe sex, even after multiple adjustment for number of partners, occurrences of binge drinking, use of anxiolytics, use of the Internet, and use of outdoor and commercial venues for sexual encounters. Conclusions: Risky sexual behavior with casual partners is frequent among HIV-infected gay men. In addition to other well-known factors, behavior of this kind was found in this study to be related to poor mental HRQL. A more comprehensive approach to care designed to improve mental quality of life might therefore make for more effective secondary prevention.

Time perspective and quality of life among HIV-infected patients in the context of HAART

Abstract We explored associations between time perspective (TP) and quality of life (QOL) among HIV-infected patients. With the French validated version of the Zimbardo Time Perspective Inventory, we evaluated the TP of patients. A self-administered questionnaire gathered information about QOL (WHOQOL-HIV), TP, relationship with medical staff and self-reported side effects of HAART. Six scores of QOL—physical, psychological, social relationship, environment, patient independence and spirituality were used as dependent variables in the linear regressions to identify factors associated with QOL. The sample (n=72) for this study was recruited from a hospital department specialising in HIV care and consisted of 48 (67%) HIV-infected women and 24 (33%) HIV-infected men with a mean age of 42 years. Using hierarchical regression analysis adjusted on socio-demographic characteristics, clinical characteristics and co-factors, significant relationships were observed between the several TP orientations and an impaired physical, environmental QOL as well as level-of-independence QOL. Specific dimensions of QOL are influenced by specific orientations of TP, which provides information on self-perception and subjective evaluation of QOL. The TP construct provides keys to managing HIV infection in order to improve QOL.