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Introduction: This study aims to provide a landscape of the global antiretroviral (ARV) market by analyzing the transactional data on donor-funded ARV procurement between 2003 and 2015, and the ARV price determinants., Design: The data were obtained from the Global Price Reporting Mechanism (GPRM) managed by the AIDS Medicines and Diagnostics Service of the WHO, and it consists of information that covers approximately 80% of the total donor-funded adult ARV transactions procurement., Methods: ExWorks prices and procured quantities were standardized according to the guidelines in terms of yearly doses. Descriptive statistics on quantities and prices show the main trends of the ARV market. Ordinary least squares estimation was carried out for the whole sample, then stratified according to the type of supplier (originator and generic) and controlled for time and geographical fixed-effects. Given that analyses were carried out on a public dataset on ARV transactional prices from the GPRM, ethics are respected and consent was not necessary., Results: Originator medicines are on average the least expensive in the sub-Saharan Africa region, where at the same time, generic medicines are on average the most expensive. By contrast, originator medicines are the most expensive in Europe and Central Asia, and generic medicines are the least expensive. In fact, the data suggest mixed strategies by ARV suppliers to exploit opportunities for profit maximization and to adapt to the specific conditions of market competition in each region. Our results also suggest that the expiration of patents is not sufficient to boost additional developments in generic competition (at least in the ARV market) and that formal or informal agreements between generic firms may de facto slow down or even reverse long-term trends towards price decreases., Conclusions: Our findings provide an improved understanding of the ARV market that can help countries strengthen policy measures to increase their bargaining power in price negotiations and the use of TRIPS flexibilities, with a special emphasis on negotiations with generic manufacturers., Competing Interests: Authors have no competing interests to declare.

Background: In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We aimed to evaluate the costs and cost-effectiveness of the ART monitoring approaches assessed in the Stratall trial., Methods: The randomised, controlled, non-inferiority Stratall trial was done in a decentralised setting in Cameroon. Between May 23, 2006, and Jan 31, 2008, ART-naive adults were randomly assigned (1:1) to clinical monitoring (CLIN) or viral load and CD4 cell count plus clinical monitoring (LAB) and followed up for 24 months. We calculated costs, number of life-years saved (LYS), and incremental cost-effectiveness ratios (ICERs) with data from patients who had been followed up for at least 6 months. We considered two cost scenarios in which viral load plus CD4 cell count tests cost either US$95 (scenario 1; Abbott RealTime HIV-1 assay) or $63 (scenario 2; generic assay). We compared ICERs with a WHO-recommended threshold of three times the per-person gross domestic product (GDP) for Cameroon ($3670-3800) and an alternative lower threshold of $2385 to determine cost-effectiveness. We assessed uncertainty with one-way sensitivity analyses and cost-effectiveness acceptability curves., Findings: 188 participants who underwent LAB and 197 who underwent CLIN were followed up for at least 6 months. In scenario 1, LAB increased costs by a mean of $489 (SD 430) per patient and saved 0·103 life-years compared with CLIN (ICER of $4768 [95% CI 3926-5613] per LYS). In scenario 2, the incremental mean cost of LAB was $343 (SD 425) -ie, an ICER of $3339 (2507-4173) per LYS. A combined strategy in which LAB would only be used in patients starting ART with a CD4 count of 200 cells per μL or fewer suggests that 0·120 life-years would be saved at an additional cost of $259 per patient in scenario 1 (ICER of $2167 [95% CI 1314-3020] per LYS) and $181 in scenario 2 (ICER of $1510 [692-2329] per LYS) when compared with CLIN., Interpretation: Laboratory monitoring was not cost effective in 2006-10 compared with clinical monitoring when the Abbott RealTime HIV-1 assay was used according to the $3670 cost-effectiveness threshold (three times per-person GDP in Cameroon), but it might be cost effective if a generic in-house assay is used., Funding: French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Ensemble pour une Solidarité Thérapeutique Hospitalière En Réseau (ESTHER)., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objectives: Using cohort data nested in a randomized trial conducted in Cameroon, this study aimed to investigate time trends and predictors of the susceptibility to transmitting HIV during the first 24 months of treatment., Methods: The outcome, susceptibility to transmitting HIV, was defined as reporting inconsistent condom use and experiencing incomplete virological suppression. Mixed logistic regressions were performed to identify predictors of this outcome among 250 patients reporting to have had sexual relationships either with HIV-negative or unknown HIV status partner(s)., Results: Despite an initial decrease from 76% at M0 to 50% at M6, the rate of inconsistent condom use significantly increased from M12 (59%) to M24 (66%) (p = 0.017). However, the proportion of patients susceptible to transmitting HIV significantly decreased over follow-up from 76% at M0, to 50% at M6, 31% at M12 and 27% at M24 (p<0.001). After controlling for age, gender and intervention group, we found that perceiving healthcare staff's readiness to listen as poor (adjusted odds ratios (AOR) [95% Confidence Interval (CI)] = 1.87 [1.01-3.46]), reporting to have sexual relationships more than once per week (AOR [95%CI] = 2.52 [1.29-4.93]), having more than one sexual partner (AOR [95%CI] = 2.53 [1.21-5.30]) and desiring a/another child (AOR [95%CI] = 2.07 [1.10-3.87]) were all associated with a higher risk of being susceptible to transmitting HIV. Conversely, time since ART initiation (AOR [95%CI] = 0.66 [0.53-0.83] for an extra 6 months and ART adherence (AOR [95%CI] = 0.33 [0.15-0.72]) were significantly associated with a lower risk of being susceptible to transmitting HIV., Conclusions: The decrease observed in the susceptibility to transmitting HIV suggests that fear of behavioural disinhibition should not be a barrier to universal access to ART. However, developing adequate preventive interventions matching patients' expectations -like the desire to have children- and strengthening healthcare staff's counselling skills are urgently needed to maximize the impact of ART in slowing the HIV epidemic.

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.

The continued scaling-up of antiretroviral therapy (ART) in Sub-Saharan Africa provides an opportunity to further study its impact on sexual behaviors among people living with HIV/AIDS (PLWHA). We explored time trend and correlates of sexual activity among PLWHA initiating ART in Cameroon and compared sexual risk behaviors between patients sexually active before and after initiating ART and those resuming sexual activity after ART initiation. Analyses were based on longitudinal data collected within the randomized trial (n=459) conducted in nine rural district hospitals in Cameroon. Sexual activity was defined as reporting at least one sexual partner during the previous 3 months. Inconsistent condom use (ICU) was defined as reporting to have "never," "sometimes," or "nearly always" used condoms at least once with a partner(s) either HIV-negative or of unknown HIV status during the same period. Mc Nemar tests were used to assess time trend, while mixed-effect logistic regressions were conducted to analyze the effect of time since ART initiation on sexual activity. The proportion of sexually active patients significantly increased over time: from 31.8% at baseline to 40.2 and 47.1% after 6 and 12 months of ART, respectively (p=0.001), to 55.9% after 24 months (p=0.02). After adjustment for behavioral and psychosocial factors, time since ART initiation was independently associated with reporting sexual activity (AOR [95% CI]=1.30 [1.17-1.46] per 6-month increase, p=0.001). ICU was more frequent among patients sexually active both before and after ART initiation than among those who resumed sexual activity after ART initiation (82 vs. 59%, p

Background: Although treatment adherence is a major challenge in sub-Saharan Africa, it is still unknown which longitudinal patterns of adherence are the most detrimental to long-term virological response to non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens. This analysis aimed to study the influence of different time patterns of adherence on virological failure after 24 months of treatment in Cameroon., Methods: Antiretroviral therapy (ART) adherence data were collected using face-to-face questionnaires administered at months 1, 3, 6, 12, 18 and 24. Virological failure was defined as viral load >40 copies/ml at month 18 and/or 24. Two combined indicators of early adherence (months 1, 3 and 6) and adherence during the maintenance phase (months 12, 18 and 24) were designed to classify patients as always adherent during the early or maintenance phase, non-adherent at least once and having interrupted ART for >2 days at least once at any visit during either of these two phases., Results: Virological failure occurred in 107 (42%) of the 254 patients included in the analysis. In the early and maintenance phases, 84% and 76%, respectively, were always adherent, 5% and 5% were non-adherent and 11% and 20% experienced ≥ 1 treatment interruption. Early non-adherence was independently associated with virological failure (adjusted OR 7.2 [95% CI 1.5, 34.6]), while only treatment interruptions had a significant impact on virological failure during the maintenance phase (adjusted OR 2.1 [95% CI 1.1, 4.4])., Conclusions: ART NNRTI-regimens used in sub-Saharan Africa seem to 'forgive' deviations from good adherence during the maintenance phase. Optimizing adherence in the early months of treatment remains crucial, especially in a setting of poor health care infrastructure and resources.

Objective: (i) To assess HIV care decentralization in Cameroon from the patients' point of view, in terms of health-related quality of life (HRQL) and perceived quality of services; (ii) to identify patient- and hospital-related factors undermining HRQL., Methods: Perceived quality of services was compared among 1985 HIV-infected patients treated with antiretroviral therapy (ART) for at least 6 months in 27 treatment centres at different levels of health care delivery (central, provincial and district) (EVAL-ANRS 12-116 survey, 2007) using chi-square and non-parametric tests. Correlates of the SF-12 physical (PCS) and mental (MCS) HRQL scores were identified using two-level linear models., Results: Patients followed-up at central and district levels had similar physical HRQL, while those followed-up at the more decentralized district level reported significantly better mental HRQL. Patients at district level also expressed better relationships with caregivers, easier access to consultations and more reliable drug supply. Financial barriers to access to HIV care and self-reported side-effects were independently associated with both lower PCS and lower MCS. Caregivers' heavy workload tended to impair both PCS and MCS, while availability of counselling by social workers in the hospital was independently associated with higher MCS., Conclusions: Despite limited resources, the decentralization of ART delivery can improve quality of care, providing a positive impact on HIV-infected patients' well-being. The development of psychosocial support interventions is necessary but not sufficient for improving quality of care in ART scaling-up programmes, and should be related to global strengthening of health human resources.

Background: It is well established that high adherence to HIV-infected patients on highly active antiretroviral treatment (HAART) is a major determinant of virological and immunologic success. Furthermore, psychosocial research has identified a wide range of adherence factors including patients' subjective beliefs about the effectiveness of HAART. Current statistical approaches, mainly based on the separate identification either of factors associated with treatment effectiveness or of those associated with adherence, fail to properly explore the true relationship between adherence and treatment effectiveness. Adherence behavior may be influenced not only by perceived benefits-which are usually the focus of related studies-but also by objective treatment benefits reflected in biological outcomes., Methods: Our objective was to assess the bidirectional relationship between adherence and response to treatment among patients enrolled in the ANRS CO8 APROCO-COPILOTE study. We compared a conventional statistical approach based on the separate estimations of an adherence and an effectiveness equation to an econometric approach using a 2-equation simultaneous system based on the same 2 equations., Results: Our results highlight a reciprocal relationship between adherence and treatment effectiveness. After controlling for endogeneity, adherence was positively associated with treatment effectiveness. Furthermore, CD4 count gain after baseline was found to have a positive significant effect on adherence at each observation period. This immunologic parameter was not significant when the adherence equation was estimated separately. In the 2-equation model, the covariances between disturbances of both equations were found to be significant, thus confirming the statistical appropriacy of studying adherence and treatment effectiveness jointly., Conclusions: Our results, which suggest that positive biological results arising as a result of high adherence levels, in turn reinforce continued adherence and strengthen the argument that patients who do not experience rapid improvement in their immunologic and clinical statuses after HAART initiation should be prioritized when developing adherence support interventions. Furthermore, they invalidate the hypothesis that HAART leads to "false reassurance" among HIV-infected patients.

Aim: Previous economic literature on the cost-effectiveness of antiretroviral treatment (ART) programs has been mainly focused on the microeconomic consequences of alternative use of resources devoted to the fight against the HIV pandemic. We rather aim at forecasting the consequences of alternative scenarios for the macroeconomic performance of countries., Methods: We used a micro-simulation model based on individuals aged 15-49 selected from nationally representative surveys (DHS for Cameroon, Tanzania and Swaziland) to compare alternative scenarios : 1-freezing of ART programs to current levels of access, 2- universal access (scaling up to 100% coverage by 2015, with two variants defining ART eligibility according to previous or current WHO guidelines). We introduced an "artificial" ageing process by programming methods. Individuals could evolve through different health states: HIV negative, HIV positive (with different stages of the syndrome). Scenarios of ART procurement determine this dynamics. The macroeconomic impact is obtained using sample weights that take into account the resulting age-structure of the population in each scenario and modeling of the consequences on total growth of the economy., Results: Increased levels of ART coverage result in decreasing HIV incidence and related mortality. Universal access to ART has a positive impact on workers' productivity; the evaluations performed for Swaziland and Cameroon show that universal access would imply net cost-savings at the scale of the society, when the full macroeconomic consequences are introduced in the calculations. In Tanzania, ART access programs imply a net cost for the economy, but 70% of costs are covered by GDP gains at the 2034 horizon, even in the extended coverage option promoted by WHO guidelines initiating ART at levels of 350 cc/mm(3) CD4 cell counts., Conclusion: Universal Access ART scaling-up strategies, which are more costly in the short term, remain the best economic choice in the long term. Renouncing or significantly delaying the achievement of this goal, due to "legitimate" short term budgetary constraints would be a misguided choice.

Objective: Scaling up antiretroviral treatment (ART) through decentralization of HIV care is increasingly recommended as a strategy toward ensuring equitable access to treatment. However, there have been hitherto few attempts to empirically examine the performance of this policy, and particularly its role in protecting against the risk of catastrophic health expenditures (CHE). This article therefore seeks to assess whether HIV care decentralization has a protective effect against the risk of CHE associated with HIV infection. DATA SOURCE AND STUDY DESIGN: We use primary data from the cross-sectional EVAL-ANRS 12-116 survey, conducted in 2006-2007 among a random sample of 3,151 HIV-infected outpatients followed up in 27 hospitals in Cameroon. DATA COLLECTION AND METHODS: Data collected contain sociodemographic, economic, and clinical information on patients as well as health care supply-related characteristics. We assess the determinants of CHE among the ART-treated patients using a hierarchical logistic model (n = 2,412), designed to adequately investigate the separate effects of patients and supply-related characteristics., Principal Findings: Expenditures for HIV care exceed 17 percent of household income for 50 percent of the study population. After adjusting for individual characteristics and technological level, decentralization of HIV services emerges as the main health system factor explaining interclass variance, with a protective effect on the risk of CHE., Conclusion: The findings suggest that HIV care decentralization is likely to enhance equity in access to ART. Decentralization appears, however, to be a necessary but insufficient condition to fully remove the risk of CHE, unless other innovative reforms in health financing are introduced., (© Health Research and Educational Trust.)

Purpose of Review: Given the lack of evidence on how to best design and implement antiretroviral therapy (ART) scaling-up policies, operational research has seen a surge in interest. There is, however, little published information on the contribution of operational research in ART programs' implementation or in improvement of associated outcomes. The article focuses therefore on how operational research may contribute to such improvements and what the key enabling factors are for its integration into program frameworks., Recent Findings: One of the most systematic operational research linked to a national ART program on the African continent was conducted in Cameroon between 2006 and 2010. Along with operational research carried out elsewhere in Africa, it helped demonstrate that a strategy of decentralizing HIV care can increase treatment coverage and improve early access to care, while maintaining good clinical outcomes. Multipartnership between local researchers, national authorities, healthcare professionals and the civil society is the key enabling factor for the relevance of operational research and the translation of its results into policy and practice., Summary: In spite of a dramatic increase in access to ART during recent years in low-income countries, the fight against HIV remains a failure in terms of the goal of breaking the pandemic dynamic. Operational research is needed more than ever to face this challenge.

Background: Brazil became the first developing country to guarantee free and universal access to HIV/AIDS treatment, with antiretroviral drugs (ARVs) being delivered to nearly 190,000 patients. The analysis of ARV price evolution and market dynamics in Brazil can help anticipate issues soon to afflict other developing countries, as the 2010 revision of the World Health Organization guidelines shifts demand towards more expensive treatments, and, at the same time, current evolution of international legislation and trade agreements on intellectual property rights may reduce availability of generic drugs for HIV care., Methods and Findings: Our analyses are based on effective prices paid for ARV procurement in Brazil between 1996 and 2009. Data panel structure was exploited to gather ex-ante and ex-post information and address various sources of statistical bias. In-difference estimation offered in-depth information on ARV market characteristics which significantly influence prices. Although overall ARV prices follow a declining trend, changing characteristics in the generic segment help explain recent increase in generic ARV prices. Our results show that generic suppliers are more likely to respond to factors influencing demand size and market competition, while originator suppliers tend to set prices strategically to offset compulsory licensing threats and generic competition., Significance: In order to guarantee the long term sustainability of access to antiretroviral treatment, our findings highlight the importance of preserving and stimulating generic market dynamics to sustain developing countries' bargaining power in price negotiations undertaken with originator companies.

Background: Good knowledge in HIV care among physicians is a necessary prerequisite to effective antiretroviral therapy (ART) scaling-up in Sub-Saharan Africa., Methods: Between September 2006 and March 2007, a 27-item knowledge questionnaire was proposed to all HIV physicians working in 27 hospitals throughout six provinces of Cameroon. Physicians' responses were compared between the three levels of decentralization of the Cameroonian healthcare delivery system (χ(2) and Fisher tests). Correct responses were summed to build a knowledge score. Factors significantly associated with a higher score were identified using linear regression., Results: In total, 93 physicians filled in the questionnaire. Level of knowledge was globally good (median score 23), with no significant difference between the three levels of decentralization. Gaps in knowledge were observed regarding the use of cotrimoxazole and the follow-up of ART-treated patients. Main factors independently associated with a higher knowledge score included training, involvement in therapeutic committees, satisfactory collaboration with other practitioners and establishment of strong relationships between patients and patients' associations., Conclusions: Overall knowledge in HIV care is good among HIV physicians working at all three levels of decentralization of healthcare in Cameroon. However, a national training policy should be set up to improve knowledge and practices in both ART follow-up and specific situations such as paediatric HIV. Collaboration between caregivers and external resources involved in HIV care should also be encouraged.

The majority of HIV-infected people in sub-Saharan Africa are women, many of reproductive age. Cameroon is severely hit by the AIDS epidemic and has developed a large national program for improving access to antiretroviral treatment (ART). The reproductive intentions of women living with HIV/AIDS (WLHA) who obtain access to ART in this country remain poorly documented. Our study aimed at exploring factors associated with the desire to have a child among 1433 ART-treated fertile WLHA aged <50. Analyses were based on data collected during the national cross-sectional survey EVAL (ANRS 12-116), which was conducted between September 2006 and March 2007 in 27 HIV care centers in Cameroon. Logistic regression was used to explore factors associated with women's desire to have a child, defined as reporting the wish to have a/another child. A total of 791 women (55%) reported the desire to have a child. After adjusting for age, matrimonial status, number of biological children, and sexual activity, the main factors independently associated with this desire in a multivariate analysis were having a good physical health-related quality of life (1.02 [1.01-1.03] for a one-point increment on the 12-item Short-Form Health Survey scale) and a CD4 count at ART initiation <200 cells/mm(3) (1.7 [1.2-2.4]). As a conclusion, the desire to have a child is frequent among ART-treated WLHA in Cameroon. HIV care and family planning programs should be integrated more thoroughly in order to support WLHA's reproductive choices.

Background: The independent evaluation of the Cameroonian antiretroviral therapy (ART) Programme, which reached one of the highest coverage in the eligible HIV-infected population (58%) in Sub-Saharan Africa, offered the opportunity to assess ART outcomes in the context of the decentralization of HIV care delivery., Materials and Methods: A cross-sectional survey (EVAL, ANRS 12-116, 2007) was carried out in a random sample of 3151 HIV-positive patients (response rate 90%) attending 27 treatment centres at the different level of the healthcare delivery (central, provincial and district), as well as in the exhaustive sample of doctors in charge of HIV care in these centres (response rate 92%, n = 97). Multivariate two-level analyses were conducted to assess the impact of the level of healthcare delivery on CD4 cell gains since initiation of treatment and adherence to treatment in the subsample of patients who were ART-treated for 6 months or more (n = 1985)., Results: District treatment centres were characterized by more limited technical and human resources but a lower workload. ART-treated patients followed up in these centres had significantly lower socioeconomic status. After adjustment for other explanatory factors, immunological improvement was similar in patients followed up at the central and district level, whereas adherence to ART was better both at provincial and district levels., Conclusion: Success in scaling-up access to ART in Cameroon has been facilitated by decentralization of the healthcare system. Long-term sustainability urgently implies better integration of this HIV-targeted programme in the global healthcare reform of financing mechanisms, management of human resources and drug procurement systems.

Context: The national antiretroviral treatment (ART) program in Cameroon has reached one of the highest rate of coverage in Western and Central Africa (58% of the estimated eligible HIV-infected population in June 2008)., Objectives: To assess the extent to which decentralized delivery of HIV care at the district level has contributed to increased access to ART., Methods: Comparison of ART-treated and non-ART-treated in the sub-sample of medically eligible HIV-positive patients (n=2566) in the cross-sectional ANRS-EVAL survey was carried out among patients seeking HIV care in 14 hospitals at central level (Yaoundé, Douala and capitals of 8 provinces) and 13 at district levels. Logistic regressions and multivariate analysis were carried out to identify factors related to non-access to ART at both levels of care., Results: Only 7% of eligible patients did not have access to ART. After adjustment for time since initial HIV diagnosis and CD4 counts (at initiation of treatment for those ART-treated and at time of survey for those who were not), younger and male patients, as well as those who only had a primary level education were less likely to be ART-treated at central but not at district level, whereas those who were unemployed were less likely to be treated at both levels. Patients were less likely to be treated in central hospitals with higher workload per medical staff member and absence of task shifting policy, and in district hospitals with non-availability of equipment for CD4 counts and larger size (150 beds or more)., Conclusion: Main persisting barriers in access to ART in Cameroon are rather due to insufficient access to HIV testing and difficulties in patients' referral to ART delivery centers after HIV diagnosis, since the overwhelming majority of eligible patients already seeking HIV care had effective access. However, health systems strengthening (HSS) is still needed to overcome some remaining barriers in access to ART and to guarantee its long-term sustainability.

Objectives: To study the impact of both decentralization of HIV care and individual factors on delayed first consultation (> or =6 months) after HIV diagnosis in Cameroon, in the context of the national antiretroviral treatment scale-up program., Design: The national cross-sectional multicenter survey EVAL (ANRS 12-116) was conducted from September 2006 to March 2007 in 27 HIV centers in Cameroon., Methods: : Logistic regression was used to characterize patients with delayed first consultation among 3151 HIV-infected adults., Results: Fifteen percent of patients reported a delay of at least 6 months before their first consultation after HIV diagnosis. In the multivariate analysis adjusted for the frequency of visits to the HIV center, independent correlates of reporting a delay of at least 6 months before consulting included the characteristics of the HIV centers (created before 2005 and located in small or medium-size hospitals) and the following individual patient characteristics: sex and matrimonial status (women living in a couple), the circumstances of the HIV diagnosis (test not performed in the hospital providing HIV care, test performed during a voluntary screening campaign) and patient's negative perception of antiretroviral treatment toxicity., Conclusion: Delays before first consultation for HIV care in Cameroon have been reduced, thanks to the full implementation of the national program of decentralization. Results underline the importance of coordinating diagnosis with treatment activities and the need to develop counseling actions, focusing on the balance between antiretroviral treatment effectiveness and its potential side effects. Counseling should also be part of patients' follow-up after diagnosis during voluntary screening campaigns.

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.

Objective: To identify correlates of self-reported antiretroviral therapies (ART) interruptions among people living with HIV and AIDS (PLWHA) in Cameroon., Methods: Analyses were based on data collected in the national survey EVAL (ANRS 12-116) among 533 ART-treated PLWHA in Yaoundé, the capital city of Cameroon, and its neighbourhood. Logistic regression models were used to identify factors associated with self-reported ART interruptions longer than two consecutive days during the previous 4 weeks., Results: ART interruptions were reported by 68 patients (12.8%). After adjustment for gender, education and household income, characteristics independently associated with interruptions were pharmacy stock shortages [OR (95%CI):3.25 (1.78-5.90)], binge drinking [2.87 (1.39-5.91)] and the number of self-reported slimming symptoms [1.23 (1.02-1.48)]., Conclusion: In poor-resource settings where access to second and third-line regimens is still limited, food supply programs and interventions to minimise ART shortage may reduce the risk of ART interruptions.

Background: User fees are a common feature of health system financing in low and middle-income countries. In the context of universal access to HIV/AIDS treatment and care, the advantages of user fees for funding at country and local level should be balanced with their clinical and public health impact., Methods: We reviewed the literature on user fees and the impact of user fees on HIV/AIDS service delivery., Results: Empirical evidence gathered since the 1980s shows that sustainability, efficiency and equity challenges faced by health systems have persisted with and have often been exacerbated by the introduction of user fees. The evidence on HIV/AIDS suggests that free care at the point of service fosters uptake and helps to extend access for the poorest users. User fees are currently the main barrier to adherence to antiretroviral therapy (ART). Their abolition is associated with better virological results and increased survival. Such abolition should be carried out in parallel with the implementation of financing mechanisms, such as prepayment and risk pooling, which are able to gather funds from the sectors of the population who are able to pay for healthcare and to promote equity towards the poorest., Conclusion: WHO has included free access to HIV/AIDS treatment at the point of service delivery as a component of its public health approach for reaching universal access. Implementation of free HIV/AIDS care should, however, be linked to efforts to strengthen healthcare systems, ensure long-term sustainability of funding and monitor equity of access to care.

Background: Economic cost-effectiveness analysis (CEA) has been proposed as the appropriate tool to set priorities for resource allocation among available health interventions. Controversy remains about the way CEA should be used in the field of HIV/AIDS., Methods and Objectives: This paper reviews the general literature in health economics and public economics about the use of CEA for priority setting in public health, in order better to inform current debates about resource allocation in the fight against HIV/AIDS., Results: Theoretical and practical limitations of CEA do not raise major problems when it is applied to compare alternatives for treating the same medical condition or public health problem. Using CEA to set priorities among different health interventions by ranking them from the lowest to the highest values of their cost per life-year saved is appropriate only under the very restrictive and unrealistic assumptions that all interventions compared are discrete and finite alternatives that cannot vary in terms of size and scale. In order for CEA to inform resource allocation compared across programmes to fight the AIDS epidemic, a pragmatic interpretation of this economic approach, like that proposed by the Commission on Macroeconomics and Health, is better suited. Interventions, like a number of preventive strategies and first-line antiretroviral treatments for HIV, whose marginal costs per additional life-year saved are less than three times the gross domestic product per capita, should be considered cost-effective., Conclusion: Because of their empirical and theoretical limitations, results of CEA should only be one element in priority setting among interventions for HIV/AIDS, which should also be informed by explicit debates about societal and ethical preferences.

French national guidelines for the management of HIV non-occupational post-exposure (nPEP) were issued in 1998 and updated in 2003. NPEP is available and free of charge in all emergency or AIDS care units of French hospitals. A regional survey was carried out to study physicians' adherence to national guidelines, and determinants of adherence to nPEP follow-up in individuals sexually exposed to HIV. The survey was based on retrospective data collection of all consultations for nPEP made in the three AIDS information centers in South-Eastern France (January 2001-December 2002). Information included personal data, type of exposure, and treatment at the first visit after exposure and during follow-up. Exposures were classified into high risk (treatment highly recommended), moderate risk (treatment possibly recommended) and negligible risk (treatment never recommended) categories, according to the level of HIV risk of sexual transmission as indicated by the French national nPEP guidelines. Among the 910 sexual exposures, 56%, 37%, and 4% were classified as cases with high, moderate, and no risk respectively. NPEP was prescribed to 85% of cases. HIV risk of sexual exposure was significantly associated with nPEP receipt though more than half of the cases with negligible risk received nPEP. Independent characteristics associated with non-adherence to nPEP follow-up were younger age, being referred to hospital by a physician, sexual exposure with a casual partner or sexual assault, and "moderate risk" exposure. Better information should be provided to physicians prescribing nPEP to limit over-prescription while new strategies should be implemented to improve follow-up of individuals receiving nPEP, especially those who are younger or survivors of sexual assault.

Background: Macroeconomic policy requirements may limit the capacity of national and international policy-makers to allocate sufficient resources for scaling-up access to HIV care and treatment in developing countries., Method: An endogenous growth model, which takes into account the evolution of society's human capital, was used to assess the macroeconomic impact of policies aimed at scaling-up access to HIV/AIDS treatment in six African countries (Angola, Benin, Cameroon, Central African Republic, Ivory Coast and Zimbabwe)., Results: The model results showed that scaling-up access to treatment in the affected population would limit gross domestic product losses due to AIDS although differently from country to country. In our simulated scenarios of access to antiretroviral therapy, only 10.3% of the AIDS shock is counterbalanced in Zimbabwe, against 85.2% in Angola and even 100.0% in Benin (a total recovery). For four out of the six countries (Angola, Benin, Cameroon, Ivory Coast), the macro-economic gains of scaling-up would become potentially superior to its associated costs in 2010., Conclusion: Despite the variability of HIV prevalence rates between countries, macro-economic estimates strongly suggest that a massive investment in scaling-up access to HIV treatment may efficiently counteract the detrimental long-term impact of the HIV pandemic on economic growth, to the extent that the AIDS shock has not already driven the economy beyond an irreversible 'no-development epidemiological trap'.

Background: The aim of this study was to assess the cost-effectiveness of HIV treatment alternatives - with and without highly active antiretroviral therapy (HAART) - within alternative strata based on the CD4+ T-cell count at the initiation of treatment in a low-resource setting., Methods: A retrospective observational study was conducted following 286 HIV-positive individuals admitted to the principal teaching hospital in Casablanca, Morocco, between 1995 and 2002. Patients were stratified by CD4+ T-cell count and regression models were fitted to determine risk of opportunistic infection. Data on healthcare resource use were derived from patient records and were evaluated from the hospital perspective., Results: HAART led to a significant reduction in the number of HIV-related opportunistic infections (P<0.0001), extended survival (61.3 versus 55.2 months; P<0.0001) and reduced hospital stays (P<0.0001) in comparison with care in the absence of HAART. When medical care and drug costs were considered together, HAART was more costly than providing treatment for opportunistic infections. The incremental cost-effectiveness ratio was lower than gross domestic product (GDP) per capita for patients starting HAART with a CD4+ T-cell count <200 cells/mm3, but this increased to nearly three times GDP per capita when HAART was initiated at CD4+ T-cell counts above this threshold., Conclusions: HAART is more cost-effective than treating HIV-related opportunistic infections and, contrary to conclusions drawn in developed countries, HAART is more cost-effective when the CD4+ T-cell count drops to <200 cells/mm3.

Background: Many people living with HIV/AIDS (PLWHA) suffer from stigma and discrimination. There is an ongoing debate, however, about whether stigma, fear and discrimination actually fuel the persisting spread of HIV, or slow it down by reducing contacts between the whole population and high-risk minorities. To contribute to this debate, we analysed the relationship between perceived discrimination and unsafe sex in a large sample of French PLWHAs., Methodology/principal Findings: In 2003, we conducted a national cross-sectional survey among a random sample of HIV-infected patients. The analysis was restricted to sexually active respondents (N = 2,136). Unsafe sex was defined as sexual intercourse without a condom with a seronegative/unknown serostatus partner during the prior 12 months. Separate analyses were performed for each transmission group (injecting drug use (IDU), homosexual contact, heterosexual contact). Overall, 24% of respondents reported experiences of discrimination in their close social environment (relatives, friends and colleagues) and 18% reported unsafe sex during the previous 12 months. Both prevalences were higher in the IDU group (32% for perceived discrimination, 23% for unsafe sex). In multivariate analyses, experience of discrimination in the close social environment was associated with an increase in unsafe sex for both PLWHAs infected through IDU and heterosexual contact (OR = 1.65 and 1.80 respectively)., Conclusions: Our study clearly confirms a relationship between discrimination and unsafe sex among PLWHAs infected through either IDU or heterosexual contact. This relationship was especially strong in the heterosexual group that has become the main vector of HIV transmission in France, and who is the more likely of sexual mixing with the general population. These results seriously question the hypothesis that HIV-stigma has no effect or could even reduce the infection spread of HIV.

Background: This study aimed to determine factors associated with higher levels of health related quality of life (HRQL) among individuals HIV-infected through drug injection and to evaluate the impact of injecting drug status and opiate substitution treatment (OST) on HRQL., Methods: Two hundred and forty-three patients, enrolled in the MANIF cohort of patients HIV-infected through IDUs, participated. They completed a self-administered questionnaire, which included an HRQL evaluation (SF-12) and socio-demographic/clinical characteristics at the 42-month visit. Injecting drug status, OST and experience of negative life events (NLE) were collected at any follow-up visit in order to reconstitute individual trajectories., Results: Among the 243 patients, 35% reported a normal mental HRQL and 37% a normal physical HRQL. Independent predictors of "normal" mental HRQL were social support from partner, being a former IDU, no experience of violence-related NLE and few self-reported HAART-related side effects. "Normal" physical HRQL was predicted by younger age, stable partner, being a former IDU (> or = 6 months), CD4 cell count > 500, no experience of financial-related NLE and few HAART self-reported side effects., Conclusions: As HRQL has been found to have a prognostic value on the survival of HIV patients infected through drug injection, then providing more comprehensive care (for example by paying more attention to patients' experience of stressful events, meeting their needs in psychosocial support and better management of perceived toxicity) could globally improve treatment outcomes in this vulnerable population.

Criteria for initiation of highly active antiretroviral treatments (HAART) in HIV-infected patients remain a matter of debate world-wide because short-term benefits have to be balanced with costs of these therapies, and restrictions placed on future treatment options if resistant viral strains develop. On the other hand, postponing the introduction of HAART may involve a therapeutic opportunity cost if a patient's health is allowed to deteriorate to such an extent of becoming unable to benefit from new treatments currently under development when they become available. We introduce a two period model where period one treatment adoption is an irreversible act with future, but uncertain, consequences. New information, both endogenous and exogenous, arises over time and shapes the conditions surrounding the second period therapeutic decision. A surprising result is that, under conditions that appear close to those surrounding the HAART debate, the magnitude of the feared resistance effect has no effect on leaves the optimal treatment decision as far as it is high enough.

This study aimed to identify factors associated with nonadherence during the maintenance phase of highly active antiretroviral therapy (months 12-60) in the Anti PROtease Cohort (APROCO) cohort after correcting for the bias due to missing outcome data. A Heckman 2-stage approach (generalized estimating equations probit model) was used to compare visits with moderate or poor adherence and visits with high adherence. Between months 12 and 60, at least 1 self-reported adherence measure was available for 970 of the 1110 patients with at least 12 months of follow-up (3889 visits with adherence assessments). Adherence was rated as high at 2466 visits, moderate at 1125, and poor at 298. After adjustment for "missingness," moderate and poor adherence were independently associated with age (younger), perceived treatment side effects, dosing frequency different from twice daily, and a protease inhibitor-based regimen. They were also associated with depression and lack of support from the main partner. High adherence was most likely among patients born outside the European Union. A comparison restricted to poor-adherence and high-adherence visits yielded a similar pattern of predictors. Adjusting for missing outcome data changed the predictor set. Reasons for nonadherence are multifactorial. Psychosocial interventions and the selection of the best-tolerated regimens are needed to improve long-term adherence of HIV-infected patients to their lifelong treatment.

Until now, the economic implications of nonadherence to drug therapies have been mostly assessed in a cost perspective and understood as the impact of nonadherence behaviours on the cost-effectiveness ratios of particular therapies. In HIV disease, some modelling approaches have suggested that high adherence levels might improve the cost-effectiveness of highly active antiretroviral treatment regimens. However, there is an urgent need for research directly observing and measuring the costs of nonadherence behaviours. In addition to this cost perspective, the authors argue that the economic impact of nonadherence should also be studied in a microeconomic--patient-oriented--perspective. Major implications of this microeconomic perspective are drawn. First, the microeconomic approach highlights that nonadherence may often be a rational choice of the patient, thus suggesting new ways for improving adherence. Second, it implies that the adherence behaviour can be interpreted as an indicator of patients' subjective valuation of highly active antiretroviral treatment therapies; in particular, higher levels of adherence are associated with higher patient well-being. Third, it shows that the adherence behaviour cannot be regarded as an exogenous variable when the impact of adherence on health outcome or on cost-effectiveness ratios is studied, thus requiring the use of specific statistical or econometric methods.

Background: In France non-occupational post-exposure prophylaxis (nPEP) is recommended in case of sexual assault and can be prescribed, after risk evaluation, in emergency or AIDS care units., Methods: A survey was carried out on retrospective data of individuals being consulted for nPEP in south-eastern France., Results: Of the 915 consultations for sexual exposures, 94 were sexual assaults concerning adults. Most were prescribed nPEP (91.5%), but half were lost to follow-up., Conclusions: During the study period throughout the same region, 623 survivors reported sexual assault to the police. The comparison of these figures shows that the number of victims who have no access to medical consultation for nPEP may be alarmingly high and strongly suggests the urgency to develop strategies for guaranteeing prompt HIV medical assessment for victims of sexual assault and assure adherence to medical follow-up.

Objective: To disentangle the impact of adherence from that of injecting drug status and depressive syndrome on HIV clinical progression in a cohort of highly active antiretroviral therapy (HAART)-treated HIV patients infected through drug use., Design: MANIF 2000 is a French cohort of HIV-infected drug users with scheduled medical visits every 6 months. Only patients enrolled in the MANIF 2000 cohort who had a CD4 cell count >200 cells/microl at HAART initiation were selected. The follow-up period included all post-HAART initiation visits., Methods: HIV clinical progression was defined as either AIDS-related death or reaching a CD4 level <200 cells/microl. Adherence was assessed using a self-administered questionnaire and a structured face-to-face interview. Depressive symptoms were evaluated by a Center for Epidemiologic Studies Depression Scale (CES-D) score at each visit. Cox proportional hazards model was used to calculate crude and adjusted relative hazards and 95% confidence intervals and thus identify independent predictors of clinical progression., Results: Of the 305 HAART-treated patients in the cohort, 243 had CD4 cell count >200 cells/microl at HAART initiation. At the first visit after HAART initiation, median CD4 cell count was 466 cells/microl and 45% had undetectable viral load. Injecting drug users accounted for 17% of the study group. Over the follow-up period, 32 patients experienced HIV clinical progression. Probable depression was encountered in 46% of patients and non-adherence in 31% of the sample. After adjustment on baseline CD4 cell count, predictors of clinical progression were: having a higher level of cumulative non-adherence over the follow-up period [HR (95% CI)=1.2 (1.1-1.3) per 10% increase] and having a high score of depressive symptoms following HAART initiation [HR (95% CI)=5.3 (2.21-3.0)]., Conclusions: Although depressive syndrome is known to influence non-adherence behaviours that are amongst the major reasons for clinical progression, it is also a predictor of clinical progression in HIV-infected intravenous drug users on HAART, independently of non-adherence behaviours. HIV care providers should be more sensitive to depressive symptoms in order to detect them early and supply HIV patients with specific care. Further research is needed to determine whether treating depressive symptoms may improve adherence and thus delay disease progression and mortality.

Objective: To investigate the impact of non-lipodystrophy HAART-related side effects on unprotected sexual behaviours among HIV-infected drug users. DESIGNAND PARTICIPANTS: HAART-treated patients who reported having occasional partners during the follow-up period after HAART initiation were selected among patients of the MANIF 2000 cohort of HIV-infected drug users., Methods: Visits where patients reported unsafe sexual behaviours with occasional partners were compared to visits where they reported safe sexual behaviours using a logistic model based on Generalized Estimating Equations., Results: One-hundred and ninety-two HAART-treated patients reported occasional sexual partners at least once during follow-up, accounting for a total of 464 visits. Among these 192 patients, 134 (70%) declared at least once unsafe sexual behaviours with occasional partners. During follow-up, three or more HAART-related side effects were reported in 273 of the 464 visits. When comparing visits where patients reported unsafe sexual behaviours with occasional partners (n = 249) with those where they reported safe sexual behaviours (n = 215), experiencing three or more HAART-related side effects was significantly associated with unsafe sex after adjustment for cofactors such as injecting drug status, reporting more than two sexual partners and having sex more than once a week., Conclusions: Perceived side effects play a role in determining unsafe sexual behaviours. HIV prevention interventions must consider the negative impact of HAART-related side effects on sexual risk-taking behaviours. Drug maintenance programs contribute to sexual risk reduction among drug injecting patients.

Here we review the available evidence on adherence to highly active antiretroviral therapy (HAART) and its relationship with the risk of the dissemination of HIV-resistant viral strains in both developed and developing countries. We argue that referring to these issues of resistance and adherence to withhold or delay access to HAART in developing countries implicitly imposes a double standard of thinking that is unacceptable. Scaling-up access to HAART to succeed in low-resource settings, however, requires the long-term monitoring of adherence as well as the clarification of the complex trade-offs between minimizing the costs of therapeutic regimens and minimizing the risks of non-adherence and resistance.

Objective: To compare socio-economic and health characteristics of HIV-infected patients in Côte d'Ivoire whether or not they had access to the Drug Access Initiative (DAI) and to antiretroviral drug (ARV) treatment., Design and Methods: Cross-sectional survey using medical files, blood sampling for CD4 cell counts and face-to-face interviews among all patients, informed of their HIV status, who attended during a 6-week period in the five DAI referral centres and three additional centres in charge of HIV care in Abidjan and Bouaké (participation rate = 65.4%). Multiple logistic regression using generalized estimating equations (GEE) to identify factors related to non-access to DAI and to ARV treatment., Results: Among the 711 respondents, 23.0% were ARV-treated, 14.2% had been included in the DAI but were still waiting for initiation of ARV, and 62.7% were neither part of the DAI nor ARV-treated. In this latter group, less than one-third (29.6%) declared that they knew about the existence of the DAI. Among the 164 ARV-treated patients, 59.1% had benefited from DAI public subsidies partially covering the costs of drugs. In the non-DAI-non-ARV-treated group, 86% could have qualified for ARV treatment according to the DAI medical criteria (CD4 cell counts < 500 x 10(6) cells/l), and only 32.9% of those medically eligible were prescribed cotrimoxazole prophylaxis. In multivariate analysis, not being in the DAI and not being ARV-treated was related to: being a male, not having health care insurance, having a low level of education, living in poor housing conditions (absence of refrigerator in the household, absence of ventilation in patient's bedroom), and not being under cotrimoxazole prophylaxis., Conclusion: The Ivoirian DAI has facilitated access to ARV treatment for a significant number of patients with limited ability to pay. The majority of HIV-infected patients seeking care however face persisting socio-economic and informational barriers to access to these treatments.

Objective: To compare sexual behaviours of HIV-infected patients in Côte d'Ivoire whether or not they had access to antiretroviral treatment (ARV)., Design and Methods: Cross-sectional survey using face-to-face interviews among all patients, informed of their HIV serostatus, attending the eight health centers in charge of HIV care in Abidjan and Bouaké. Univariate comparisons of declared sexual behaviours during the prior 6 months between the 164 ARV-treated and the 547 non-ARV-treated respondents. Multiple logistic regressions to identify factors related to sexual abstinence in the total sample and to unprotected sexual intercourse in the subsample of sexually active respondents during the same period were performed., Results: More than half of the 711 respondents (53.0%) declared an absence of sexual activity during the previous 6 months, with this proportion being significantly higher among women (60.6%), and among both men (85.7%) and women (92.4%) who were not living in a stable relationship. Among the 334 sexually active patients, 49.7% declared a low frequency of sexual intercourse ('once a month or less'), and 43.7% declared at least one episode of unprotected sexual intercourse. In multivariate analysis, recent diagnosis of HIV infection (< 9 months), having only one sexual partner and not knowing her/his serostatus, high alcohol consumption, absence of episodes of acute morbidity, not participating in household's expenditures and not being ARV-treated were significantly related to a higher likelihood of HIV-related risky sexual behaviours., Conclusion: Sexual abstinence is the preventive strategy of choice for a majority of HIV-infected patients aware of their serostatus and consulting for care in Côte d'Ivoire. In these patients, access to ARV is not associated with an increase in HIV-related risky sexual behaviours.

Purpose: The objective was to evaluate the impact of an intervention for improving adherence to antiretroviral therapies (HAART) in HIV-infected patients., Method: We designed a prospective, controlled, randomized trial to assess the impact of an educational and counseling intervention in addition to standard of care. At M0, the study enrolled 244 HAART-treated patients who attended a medical consultation between September and December 1999 who were not included in another protocol. Patients in the intervention group (IG) were offered three individual sessions by trained nurses. The proportions of adherent patients at 6 months followup (M6) and the change in HIV RNA between M0 and M6 were measured., Results: Between M0 and M6, HIV RNA significantly decreased in the 123 patients of the IG (mean difference = -0.22 log [+/-0.86], p =.013), while it increased (+0.12 log [+/-0.90], p =.14) in the 121 patients of the control group. However, the proportion of patients with HIV RNA <40 copies/mL remained similar in both groups. In an intent-to-treat analysis, the only significant predictor of 100% adherence at M6 was the intervention group (p =.05) after adjustment for baseline adherence (p =.001). Among the 202 patients with available data on adherence, the proportion of adherent patients was similar in both groups at M0 (58% vs. 63%, p =.59) but became higher in the IG at M6 (75% vs. 61%, p =.04)., Conclusion: The educational and counseling intervention was efficient for increasing adherence to HAART and could be implemented in most clinical settings.

Objective: We investigated the impact of the first year of highly active antiretroviral therapy (HAART) on health-related quality of life (HRQL)., Methods: Medical data for patients in the French APROCO cohort were collected at enrollment (M0) and month 12 (M12). A self-administered questionnaire gathered information about HRQL (Medical Outcome Study 36-Item Short Form Health Survey) and toxicity-related symptoms. Using the twenty-fifth percentile of HRQL scales in the French population as a threshold, patients with normal values in at least three mental and three physical scales were considered to have a "normal HRQL." RESULTS. Of the 1053 patients followed through M12, HRQL data at M0 and M12 were available for 654. Among the 233 patients with a normal baseline HRQL, 63 (27.0%) experienced a deterioration of HRQL at M12. Among the 421 patients with a low baseline HRQL, 121 achieved a normal HRQL at M12. Logistic regression showed that factors independently associated with a normal HRQL at M12 were normal baseline HRQL, baseline CD4 count <500 cells/mm, time since HIV diagnosis <8 years, undetectable HIV-RNA at M12, and lower number of self-reported symptoms at M12., Conclusion: An assessment of HRQL should be integrated to efficacy outcomes to evaluate and compare long-term strategies properly and to optimize the durability of response to antiretroviral therapy.

The authors tested the impact of social instability on adherence to highly active antiretroviral therapy (HAART) among patients infected with HIV through injection drug use (IDU; MANIF2000 cohort). In the study, they analyzed sociodemographic baseline characteristics to develop an indicator of social instability. Information concerning adherence to HAART was collected through questionnaires during a 2-year follow-up period. Factors associated with nonadherence were studied in two different groups: 1) patients who had stopped injection drug use (ex-IDUs) and who were not in drug maintenance programs (DMT) during the entire follow-up period, and 2) those who were still opiate dependent. Among the 210 eligible patients, 114 were classified as ex-IDUs and 96 as opiate dependent. Ex-IDUs reported nonadherence behaviors in 96 of 384 visits (25.0%), while opiate-dependent patients were nonadherent in 111 of 308 visits (36.0%; p = .02). Among ex-IDUs, the only factor associated with nonadherence was social instability, while among opiate-dependent patients, injection behavior was the only determinant of nonadherence behavior. For opiate-dependent patients, DMT may enhance adherence to HAART, but only if it is successful in reducing abuse of injection practices. For ex-IDUs, it is very important that the management of social difficulties be taken into account to increase adherence to HAART.

To-date, most socio-behavioural research about HTV-infected patients' adherence to highly active antiretroviral therapies (HAART) has been based on cross-sectional studies. The French APROCO cohort gave us the opportunity to conjointly analyse the relationships between short-term adherence to HAART and HIV-infected patients' characteristics before initiation of treatment on the one hand, factors related to patients' subjective experience with HAART on the other hand. At the fourth-month follow-up visit (M4) after first prescription of HAART (M0), 26.7% of our sample of 445 patients self-reported non-adherence behaviour. Some patients' characteristics at M0 (younger age, poor housing conditions, lack of social support, and problems of adherence with previous antiretroviral regimens) were related to non-adherence at M4 in multivariate analysis. Non-adherence at M4 was, however, also related to the evolutions that affected a number of factors between M0 and M4: levels of depression, symptoms associated with treatment side effects, perception of individual state of health, beliefs towards effectiveness and toxicity of HAART. increases in alcohol and tobacco consumption, as well as contacts with other physicians than hospital HAART prescribers. Our prospective study brings additional evidence that even short-term non-adherence cannot be reliably predicted on the sole basis of a few a priori patient characteristics that clinicians could easily identify before initiation of HAART. It suggests that a dynamic approach to adherence, continuously monitoring the impact of experience with HAART on patients' daily lives, is needed for improving management of HIV/AIDS care.

Objective: To study the predictors of virological rebound in patients having early virological response to protease inhibitor (PI)-containing regimen., Design and Methods: APROCO cohort study prospectively enrolled 1283 HIV-infected patients starting a PI-containing regimen in 1997-1999. Adherence to therapy was measured with self-administered questionnaires after 4 months of therapy (M4). Virological rebound was defined as a viral load (VL) > 500 copies/ml in patients having early virological response, defined as a VL < 500 copies/ml at M4. Predictors of time to virological rebound were studied with multivariate proportional hazards model., Results: During a median follow-up of 20 months, virological rebound was observed in 32% of the 830 patients with early virological response. Virological rebound was more frequent when patients had received previous antiretroviral treatment [adjusted hazards ratio (HR) = 2.4; P < 0.0001], were younger (HR = 1.4 per each 10 years younger; P < 0.0001), had baseline CD4 cell count < 500 x 106/l (HR = 2.3; P < 0.001), had higher baseline VL (HR = 1.4 per each log10 copies/ml higher; P < 0.001), reported low adherence to therapy at M4 (HR = 2.1; P < 0.001) or had stopped PI at M4 (HR = 1.7; P = 0.04)., Conclusion: Initiation of treatment at a stage of preserved immunity is associated with a more durable virological response under protease inhibitor. Every effort should be made to monitor and strengthen adherence to therapy, even in patients having early virological response.