Fabienne Marcellin

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.

Financial barriers to HIV treatment in Yaoundé, Cameroon: first results of a national cross-sectional survey

OBJECTIVE To assess the extent to which user fees for antiretroviral therapy (ART) represent a financial barrier to access to ART among HIV-positive patients in Yaoundé, Cameroon. METHODS Sociodemographic, economic and clinical data were collected from a random sample of 707 HIV-positive patients followed up in six public hospitals of the capital city (Yaoundé) and its surroundings through face-to-face interviews carried out by trained interviewers independently from medical staff and medical questionnaires filled out by prescribing physicians. Logistic regression models were used to identify factors associated with self-reported financial difficulties in purchasing ART during the previous 3 months. FINDINGS Of the 532 patients treated with ART at the time of the survey, 20% reported financial difficulty in purchasing their antiretroviral drugs during the previous 3 months. After adjustment for socioeconomic and clinical factors, reports of financial difficulties were significantly associated with lower adherence to ART (odds ratio, OR: 0.24; 95% confidence interval, CI: 0.15-0.40; P < 0.0001) and with lower CD4+ lymphocyte (CD4) counts after 6 months of treatment (OR: 2.14; 95% CI: 1.15-3.96 for CD4 counts < 200 cells/microl; P = 0.04). CONCLUSION Removing a financial barrier to treatment with ART by eliminating user fees at the point of care delivery, as recommended by WHO, could lead to increased adherence to ART and to improved clinical results. New health financing mechanisms based on the public resources of national governments and international donors are needed to attain universal access to drugs and treatment for HIV infection.

Determinants of unplanned antiretroviral treatment interruptions among people living with HIV in Yaoundé, Cameroon (EVAL survey, ANRS 12-116)

Objective  To identify correlates of self‐reported antiretroviral therapies (ART) interruptions among people living with HIV and AIDS (PLWHA) in Cameroon.

Absence of association between MDR1 genetic polymorphisms, indinavir pharmacokinetics and response to highly active antiretroviral therapy.

Objective:The relationship between MDR1 single nucleotide polymorphisms (SNP) and the pharmacokinetic or pharmacodynamic responses to protease inhibitors has been recently challenged. Aim:The objective of the present study was to determine whether MDR1 genetic polymorphisms in exons 21 and 26 (G2677T/A and C3435T) are in association with indinavir (IDV) plasma concentrations and/or therapeutic response to highly active antiretroviral therapy (HAART) in HIV-infected patients treated with unboosted IDV containing regimens. Methods:MDR1 genotyping was performed in a population of 139 HIV-1-positive patients followed during 72 weeks, as part of the previous study called ANRS 081 ‘Trianon’. The primary study was a randomized trial comparing over 72 weeks the efficacy of two antiretroviral drug combinations in a population of adult HIV-1-infected patients: group 1, [lamivudine (3TC) – stavudine (d4T) – IDV (800 mg three times daily)] and group 2, [Nevirapine (NVP) – d4T – IDV (1000 mg three times daily)]. Results:MDR1 SNPs analyzed separately or combined into haplotypes did not show any significant association with IDV pharmacokinetics nor response to HAART. Mean modelled IDV peak and trough concentrations, as well as clearance modelled from pharmacokinetic model, after 8 weeks of therapy were not significantly different between patients carrying the wild-type haplotype GG-CC (at position 2677 and 3435 respectively) and others. Conclusions:Our results do not support an association between MDR1 genetic polymorphisms and modelled IDV clearance or clinical response to HAART.

Factors associated with unprotected anal intercourse among men who have sex with men in Douala, Cameroon.

Objectives Research on men who have sex with men (MSM) in sub-Saharan Africa was neglected for a long time. The objective of this study was to understand factors associated with unprotected anal intercourse (UAI) with male partners among a group of MSM living in the city of Douala, Cameroon. Methods In 2008, a survey on the sexual activity and practices of MSM was set up in Douala in collaboration with a local community-based organisation. Data were collected among a convenience sample of 168 MSM during face-to-face interviews with trained interviewers. Results A total of 142 individuals reported sexual activity during the previous 6 months, among whom 80 (57%) reported UAI with male partners. In a multivariate logistic regression model adjusted for the frequency of sexual intercourse, not having had access to prevention interventions and not knowing any HIV-infected person were both independently associated with a higher risk of UAI. Other factors associated with this higher risk included having had a stable male partnership at some point in ones life and not having been out of Douala for more than 4 weeks during the previous year. Conclusions This community-based research is the first study of MSM in Cameroon and the HIV transmission risks they face. Results show the importance of HIV prevention interventions from peers, and underline the need to maintain efforts to develop specific interventions targeting MSM more efficiently in the African context.

Adherence to antiretroviral treatment in HIV-positive patients in the Cameroon context: promoting the use of medication reminder methods.

Objectives: Antiretroviral treatment (ART) scale-up in sub-Saharan Africa has made it possible to investigate the maintenance of adherence to HIV medications. We describe here adherence to ART and identify its correlates in the Cameroonian context. Design: Prospective cohort study in 9 rural district hospitals. Methods: A mixed logistic regression model was used to identify factors associated with adherence to ART in 401 patients with data prospectively collected on adherence. Results: Although 73% of patients were adherent after the first month on ART, this proportion decreased to 61% after 24 months. After adjustment for known factors of adherence to ART (such as knowledge, motivation and side-effects), patients who reported willingness to start ART before initiation, those who were satisfied with information provided by their physicians, and those who implemented reminder methods for ART intake {eg, using an alarm clock, mobile phone, or watch [odds ratio (95% confidence interval)] = 2.45 (1.58 to 3.79), but also the help of a relative to remind them or other methods} were more likely to be adherent to ART. Conclusions: Besides highlighting some correlates already known to have an impact on adherence to ART, our findings also underline the need to reinforce the counseling component of follow-up through innovative methods. Accordingly, training and implementation research should encourage the use of medication reminder methods, such as mobile phones, to assure adherence over time and improve long-term response to ART.

Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)

Objective Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC. Methods In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively. Results In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively). Conclusions Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence. Trial registration Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511

Assessing adherence to antiretroviral therapy in randomized HIV clinical trials: a review of currently used methods

Antiretroviral therapy for the treatment of HIV infection requires high levels of adherence to both maintain plasma HIV RNA at undetectable levels and prevent the emergence of drug resistance. As adherence to treatment is a major criterion for the evaluation of therapeutic outcomes, randomized clinical trials (RCTs) conducted among HIV-infected patients commonly include an assessment of adherence. However, there is still no gold-standard tool for assessing adherence behaviors in HIV RCTs. The methods currently used to collect and analyze adherence data are varied, which makes the comparison of results between studies difficult. The scope of this article is to review and discuss the range of adherence measures currently used in RCTs conducted among HIV-infected adults.

Satisfaction with care in HIV-infected patients treated with long-term follow-up antiretroviral therapy: the role of social vulnerability

Abstract The aim of this study was to determine factors associated with complete satisfaction with the care provided (satisfaction with physicians and satisfaction with services and organization) among HIV-infected patients followed up in the French ANRS CO8 APROCO-COPILOTE cohort. Analyses focused on cross-sectional data collected during the ninth year of cohort follow-up. Satisfaction with care, sociodemographic characteristics, and behavioral data were collected using self-administered questionnaires, while clinical data were derived from medical records. Complete satisfaction with care was defined as being 100% satisfied. Two logistic regression models were used to identify predictors of (1) complete satisfaction with physicians (n=404) and (2) complete satisfaction with services and organization (n=396). Sixteen percent of patients were completely satisfied with physicians, while 15.9% were completely satisfied with services and organization. Being older and reporting fewer discomforting antiretroviral therapy (ART) side effects were factors independently associated with complete satisfaction with both physicians and services and organization. Strong support from friends and absence of hepatitis C (HCV) co-infection were independently associated with complete satisfaction with physicians, while strong support from ones family and comfortable housing conditions were independently associated with complete satisfaction with services and organization. Even after nine years of follow-up, social vulnerabilities still strongly influence HIV-infected patients’ interactions with the health care system. Day-to-day experience with the disease, including perceived treatment side effects, appears to play a key role in the quality of these interactions. More attention should be given to patient satisfaction, especially for socially vulnerable patients, in order to avoid potentially detrimental consequences such as poor adherence to ART.

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.