PLoS One

INTRODUCTION: The Temprano and START trials provided evidence to support early ART initiation recommendations. We projected long-term clinical and economic outcomes of immediate ART initiation in Cote d'Ivoire. METHODS: We used a mathematical model to compare three potential ART initiation criteria: 1) CD4 <350/muL (ART<350/muL); 2) CD4 <500/muL (ART<500/muL); and 3) ART at presentation (Immediate ART). Outcomes from the model included life expectancy, 10-year medical resource use, incremental cost-effectiveness ratios (ICERs) in $/year of life saved (YLS), and 5-year budget impact. We simulated people with HIV (PWH) in care (mean CD4: 259/muL, SD 198/muL) and transmitted cases. Key input parameters to the analysis included first-line ART efficacy (80$90/person-year). We assessed cost-effectiveness relative to Cote d'Ivoire's 2017 per capita annual gross domestic product ($1,600). RESULTS: Immediate ART increased life expectancy by 0.34 years compared to ART<350/muL and 0.17 years compared to ART<500/muL. Immediate ART resulted in 4,500 fewer 10-year transmissions per 170,000 PWH compared to ART<350/muL. In cost-effectiveness analysis, Immediate ART had a 10-year ICER of$680/YLS compared to ART<350/muL, ranging from cost-saving to an ICER of $1,440/YLS as transmission rates varied. ART<500/muL was "dominated" (an inefficient use of resources), compared with Immediate ART. Immediate ART increased the 5-year HIV care budget from$801.9M to $812.6M compared to ART<350/muL. CONCLUSIONS: In Cote d'Ivoire, immediate compared to later ART initiation will increase life expectancy, decrease HIV transmission, and be cost-effective over the long-term, with modest budget impact. Immediate ART initiation is an appropriate, high-value standard of care in Cote d'Ivoire and similar settings

Dissection aortique anevrismale chez un adulte infecte par le VIH-1 dans le cadre d'un syndrome de reconstitution immune avec tuberculose

We here report the case of a 35-year old man with HIV-1 but with no previous medical-surgical history hospitalized in Abidjan, Cote d'Ivoire, due to fever, cough, dyspnea, chest pain and unfolding of the aortic arch observed on chest x-ray a week after having started antiretroviral therapy (ART). CT angiography of the thoracic aorta showed overall, extended aortic ectasia with mural thrombus. Transesophageal echocardiography objectified type A ascending aortic dissection (Stanford classification). The diagnosis of tuberculosis was confirmed based on Mycobacterium tuberculosis culture isolation. Eight years after, the patient was still alive without surgical treatment and complained of intermittent chest pain. Blood pressure was stable with moderate renal failure. We here report a rare case of aortic aneurism dissection in an adult patient with tuberculosis infected with HIV-1 during immune reconstitution inflammatory syndrome

EBioMedicine

Background High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa. Methods In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality

Interest of early antiretroviral therapy in adults infected with HIV in sub-Saharan Africa

Les pays africains au sud du Sahara ont vu leur nombre de patients sous traitement antirétroviral (ARV) croître de façon rapide depuis 2005. Si l’impact individuel et collectif de cette montée en puissance des traitements est positif dans l’ensemble, les défis demeurent nombreux en termes de dépistage, d’observance, d’adhésion aux soins, de résistance aux ARV, de dépendance vis-à-vis des bailleurs de fonds, et de disponibilité des personnels. Dans ce contexte, la question du moment idéal pour proposer le début du traitement ARV doit être abordée de façon médicale individuelle (quel est le rapport bénéfices/risques individuel à débuter à des seuils différents ?), mais également de façon collective en terme de bénéfices et risques pour la communauté, d’organisation des soins, d’analyse médico-économique, de prioritisation et d’équité. Cette thèse, qui est une thèse de recherche clinique, aborde le premier volet de la question, celui des bénéfices et des risques pour l’individu à débuter un traitement plus tôt. Sur ce sujet, le raisonnement a beaucoup évolué au cours des 15 dernières années. Après l’arrivée des multithérapies ARV à la fin des années 1990, la crainte de la toxicité des médicaments a d’abord incité à une approche prudente, et à recommander le seuil de début à 200 CD4/mm3 chez les personnes asymptomatiques. Cette crainte de la toxicité a conduit au début des années 2000 à essayer de pratiquer des « interruptions programmées » d’ARV, pour tenter d’obtenir le maintien au dessus d’un seuil de 200 CD4/mm3, tout en limitant l’exposition aux médicaments. Nous avons participé à un de ces essais d’interruptions programmées en Côte d’Ivoire, au cours duquel nous avons contribué à affiner les connaissances sur la toxicité des ARV (Moh, Antivir Ther 2005). Les essais d’interruptions programmées ont conduit à constater que : (i) les personnes qui interrompaient entre 350 et 250 CD4/mm3 avaient plus de risque de morbidité sévère que celles qui n’interrompaient pas, (ii) les personnes qui débutaient leur premier traitement avant 350 CD4/mm3 avaient moins de risque de morbidité que celles qui débutaient plus tard (Moh, AIDS 2007), et (iii) dans l’essai d’interruption Trivacan réalisé en Côte d’Ivoire, cette morbidité sévère intermédiaire était plus fréquente que dans l’essai SMART réalisé sur d’autres continents, et avait un spectre différent, dominé par la tuberculose et les maladies bactériennes sévères. Les conclusions de ces essais ont donc été que le traitement ARV devait être débuté beaucoup plus tôt que ce qui était auparavant recommandé, et que ceci était probablement encore plus vrai en Afrique sub-Saharienne que dans le reste du monde. En 2008, nous avons lancé en Côte d’Ivoire l’essai Temprano ANRS 12136, dont l’objectif est d’évaluer les bénéfices et risques d’un traitement ARV précoce avec ou sans 6 mois de prophylaxie par isoniazide (INH) chez des adultes infectés par le VIH-1 ayant entre 250 et 800 CD4/mm3. De Mars 2008 à Juillet 2012, 2076 adultes ont été inclus dans l’essai Temprano, dont le suivi se terminera en décembre 2014. L’état du suivi est bon, et les incidences de morbidité et mortalité actuellement constatées sont conformes aux hypothèses du protocole. La pratique de la prophylaxie par INH s’avère bien tolérée, et la procédure choisie par notre équipe (radiographie de thorax systématique et période tampon d’observation de un mois avant le début de l’INH) apporte une grande sécurité de prescription (Moh, Plos One, manuscrit en révision). Notre équipe a traversé une crise politico-militaire au 1er semestre 2011, qui n’a pas eu de retentissement sur la qualité de l’essai en cours. Cette crise a par contre eu des effets délétères pour les patients sous traitement ARV, puisque les échecs virologiques retardés sont significativement associés au fait d’avoir été sous traitement pendant cette période (Moh, manuscrit soumis). .The African countries situated in the South of the Sahara have seen their number of patients under antiretroviral therapy (ART) grow rapidly since 2005. If the individual and collective impact of this rise of the treatments is positive overall, challenges remain in terms of screening, compliance, accession to care, resistance to ARTs, dependence on donors, and availability of the staff. In this context, the question of the ideal time to propose initiation of ART must be addressed in the individually medical way (what is the individual benefit-harm ratio to start at different thresholds?) but also collectively in terms of benefits and risks for the community, organization of care, medico-economic analysis, prioritization and equity. This thesis, which is a clinical research thesis, addresses the first part of the question, the benefits and risks for the individual to start treatment earlier. On this subject, the rationale has changed considerably over the past 15 years. After the arrival of ART multitherapy at the end of the 1990s, the fear of drug toxicity first prompted a cautious approach, and to recommend the threshold from beginning to 200 CD4/mm3 in the asymptomatic people. This fear of toxicity led in the early 2000s to try to practice "scheduled interruptions" of ARTs, to try to get the maintenance above a threshold of 200 CD4/mm3, in limiting exposure to the drug. We have participated in one of these trials of interruptions programmed in Côte d'Ivoire, in which we have helped to refine the knowledge on the toxicity of ARTs (Moh, Antivir Ther 2005). Testing scheduled interruptions led to see that: (i) persons who interrupted between 350 and 250 CD4/mm3 had greater risk of severe diseases than those who didn’t interrupt, (ii) persons who started their first treatment prior to 350 CD4/mm3 had less risk of morbidity than those who started later (Moh, 2007 AIDS), and (iii) in trial interruption Trivacan launched in Côte d'Ivoire, this intermediate severe morbidity was more frequent than in the SMART trial carried out on other continents, and had a different spectrum dominated by tuberculosis and severe bacterial diseases. The findings of these trials were that the ART should be started much earlier than was previously recommended, and that this was probably even truer in sub-Saharan Africa than in the rest of the world. In 2008, we launched in Ivory Coast the clinical trial, Temprano ANRS 12136, whose objective is to assess the benefits and risks of early ART with or without 6 months of prophylactic isoniazid (INH) in HIV-1 infected adults with CD4 250 and 800/mm3. From March 2008 to July 2012, 2076 adults were included in the trial Temprano, which follow-up will be completed by December 2014. The state of the follow-up is good, and the impact of morbidity and mortality currently observed are consistent with the assumptions of the Protocol. The practice of INH prophylaxis is well tolerated, and the procedure chosen by our team (systematic chest x-ray and period buffer observation of one month before the beginning of the INH) brings a prescription safety (Moh, Plos One manuscript in review). Our team went through a crisis politico-military 1St half 2011, which had no impact on the quality of the ongoing trial. This crisis has however had deleterious effects for patients under ART, since delayed virological failure are significantly related to the fact of having been under treatment during this period (Moh, submitted manuscript)

Interest of early antiretroviral therapy in adults infected with HIV in sub-Saharan Africa

Les pays africains au sud du Sahara ont vu leur nombre de patients sous traitement antirétroviral (ARV) croître de façon rapide depuis 2005. Si l’impact individuel et collectif de cette montée en puissance des traitements est positif dans l’ensemble, les défis demeurent nombreux en termes de dépistage, d’observance, d’adhésion aux soins, de résistance aux ARV, de dépendance vis-à-vis des bailleurs de fonds, et de disponibilité des personnels. Dans ce contexte, la question du moment idéal pour proposer le début du traitement ARV doit être abordée de façon médicale individuelle (quel est le rapport bénéfices/risques individuel à débuter à des seuils différents ?), mais également de façon collective en terme de bénéfices et risques pour la communauté, d’organisation des soins, d’analyse médico-économique, de prioritisation et d’équité. Cette thèse, qui est une thèse de recherche clinique, aborde le premier volet de la question, celui des bénéfices et des risques pour l’individu à débuter un traitement plus tôt. Sur ce sujet, le raisonnement a beaucoup évolué au cours des 15 dernières années. Après l’arrivée des multithérapies ARV à la fin des années 1990, la crainte de la toxicité des médicaments a d’abord incité à une approche prudente, et à recommander le seuil de début à 200 CD4/mm3 chez les personnes asymptomatiques. Cette crainte de la toxicité a conduit au début des années 2000 à essayer de pratiquer des « interruptions programmées » d’ARV, pour tenter d’obtenir le maintien au dessus d’un seuil de 200 CD4/mm3, tout en limitant l’exposition aux médicaments. Nous avons participé à un de ces essais d’interruptions programmées en Côte d’Ivoire, au cours duquel nous avons contribué à affiner les connaissances sur la toxicité des ARV (Moh, Antivir Ther 2005). Les essais d’interruptions programmées ont conduit à constater que : (i) les personnes qui interrompaient entre 350 et 250 CD4/mm3 avaient plus de risque de morbidité sévère que celles qui n’interrompaient pas, (ii) les personnes qui débutaient leur premier traitement avant 350 CD4/mm3 avaient moins de risque de morbidité que celles qui débutaient plus tard (Moh, AIDS 2007), et (iii) dans l’essai d’interruption Trivacan réalisé en Côte d’Ivoire, cette morbidité sévère intermédiaire était plus fréquente que dans l’essai SMART réalisé sur d’autres continents, et avait un spectre différent, dominé par la tuberculose et les maladies bactériennes sévères. Les conclusions de ces essais ont donc été que le traitement ARV devait être débuté beaucoup plus tôt que ce qui était auparavant recommandé, et que ceci était probablement encore plus vrai en Afrique sub-Saharienne que dans le reste du monde. En 2008, nous avons lancé en Côte d’Ivoire l’essai Temprano ANRS 12136, dont l’objectif est d’évaluer les bénéfices et risques d’un traitement ARV précoce avec ou sans 6 mois de prophylaxie par isoniazide (INH) chez des adultes infectés par le VIH-1 ayant entre 250 et 800 CD4/mm3. De Mars 2008 à Juillet 2012, 2076 adultes ont été inclus dans l’essai Temprano, dont le suivi se terminera en décembre 2014. L’état du suivi est bon, et les incidences de morbidité et mortalité actuellement constatées sont conformes aux hypothèses du protocole. La pratique de la prophylaxie par INH s’avère bien tolérée, et la procédure choisie par notre équipe (radiographie de thorax systématique et période tampon d’observation de un mois avant le début de l’INH) apporte une grande sécurité de prescription (Moh, Plos One, manuscrit en révision). Notre équipe a traversé une crise politico-militaire au 1er semestre 2011, qui n’a pas eu de retentissement sur la qualité de l’essai en cours. Cette crise a par contre eu des effets délétères pour les patients sous traitement ARV, puisque les échecs virologiques retardés sont significativement associés au fait d’avoir été sous traitement pendant cette période (Moh, manuscrit soumis). .The African countries situated in the South of the Sahara have seen their number of patients under antiretroviral therapy (ART) grow rapidly since 2005. If the individual and collective impact of this rise of the treatments is positive overall, challenges remain in terms of screening, compliance, accession to care, resistance to ARTs, dependence on donors, and availability of the staff. In this context, the question of the ideal time to propose initiation of ART must be addressed in the individually medical way (what is the individual benefit-harm ratio to start at different thresholds?) but also collectively in terms of benefits and risks for the community, organization of care, medico-economic analysis, prioritization and equity. This thesis, which is a clinical research thesis, addresses the first part of the question, the benefits and risks for the individual to start treatment earlier. On this subject, the rationale has changed considerably over the past 15 years. After the arrival of ART multitherapy at the end of the 1990s, the fear of drug toxicity first prompted a cautious approach, and to recommend the threshold from beginning to 200 CD4/mm3 in the asymptomatic people. This fear of toxicity led in the early 2000s to try to practice "scheduled interruptions" of ARTs, to try to get the maintenance above a threshold of 200 CD4/mm3, in limiting exposure to the drug. We have participated in one of these trials of interruptions programmed in Côte d'Ivoire, in which we have helped to refine the knowledge on the toxicity of ARTs (Moh, Antivir Ther 2005). Testing scheduled interruptions led to see that: (i) persons who interrupted between 350 and 250 CD4/mm3 had greater risk of severe diseases than those who didn’t interrupt, (ii) persons who started their first treatment prior to 350 CD4/mm3 had less risk of morbidity than those who started later (Moh, 2007 AIDS), and (iii) in trial interruption Trivacan launched in Côte d'Ivoire, this intermediate severe morbidity was more frequent than in the SMART trial carried out on other continents, and had a different spectrum dominated by tuberculosis and severe bacterial diseases. The findings of these trials were that the ART should be started much earlier than was previously recommended, and that this was probably even truer in sub-Saharan Africa than in the rest of the world. In 2008, we launched in Ivory Coast the clinical trial, Temprano ANRS 12136, whose objective is to assess the benefits and risks of early ART with or without 6 months of prophylactic isoniazid (INH) in HIV-1 infected adults with CD4 250 and 800/mm3. From March 2008 to July 2012, 2076 adults were included in the trial Temprano, which follow-up will be completed by December 2014. The state of the follow-up is good, and the impact of morbidity and mortality currently observed are consistent with the assumptions of the Protocol. The practice of INH prophylaxis is well tolerated, and the procedure chosen by our team (systematic chest x-ray and period buffer observation of one month before the beginning of the INH) brings a prescription safety (Moh, Plos One manuscript in review). Our team went through a crisis politico-military 1St half 2011, which had no impact on the quality of the ongoing trial. This crisis has however had deleterious effects for patients under ART, since delayed virological failure are significantly related to the fact of having been under treatment during this period (Moh, submitted manuscript)

Community Health Workers. Reinforcement of an Outreach Strategy in Rural Areas Aimed at Improving the Integration of HIV, Tuberculosis and Malaria Prevention, Screening and Care Into the Health Systems. "Proxy-Sante" Study

International audienceBACKGROUND: In Côte d'Ivoire, the health system remains poorly accessible and inefficient, particularly in rural areas. Malaria, tuberculosis and HIV remain a major concern. Tasks shifting to Community Health Workers (CHWs) in rural areas has been proposed in terms of responses and has shown encouraging results with some limitations. Objective is therefore to develop and implement, in a health district, at the level of a neighborhood, a sub-prefecture, two villages and two camps, innovative strategies aimed at improving the integration of HIV, malaria and tuberculosis prevention and care into the health system at the community level through CHWs.METHODS: Introduce innovations to be integrated into the national system: (i) Selection and strengthening of the capacities of CHWs to provide care for the three diseases through home visits [Information Education and Counseling/Communication for Behavior Change (IEC/CBC)], simple malaria screening and management, referral of suspected tuberculosis cases and Directly Observed Treatment, short-course (DOTS), screening, prophylaxis and distribution of antiretrovirals (ARVs) to HIV-infected patients; (ii) monthly animation of village health committees by target groups (women of childbearing age, children under 5 years old, young adolescents); (iii) use of an application and tablets for data collection.DISCUSSION: This innovative project integrates new activities such as ARV distribution by CHWs, management of pre-exposure prophylaxis in rural areas and electronic data capture by communities. Several lessons can be learned on the relevance of the role and activities to be carried out by these CHWs in the fight against these three diseases

Chimioprophylaxie antituberculeuse primaire à l'isoniazide : une stratégie d'actualité à l’ère du tester et traiter ; revue de la littérature

Position du problème : La tuberculose demeure une menace de santé publique responsable de plus d'un million de décès en 2018. La chimioprophylaxie à l'isoniazide est une des stratégies permettant le contrôle de cette maladie. Encore peu prescrite, son intérêt suscite encore plus de questions à l’ère du « tester et traiter » concernant les antirétroviraux. L'objectif de cette étude est donc de réaliser une revue des essais randomisés de chimioprophylaxie antituberculeuse primaire à l'isoniazide (« thérapie préventive à l'isoniazide », TPI), en distinguant les « essais d'efficacité (EE) » comparant la TPI à un placebo ou à l'absence de chimioprophylaxie ; et les « essais de régime » (ER), comparant la TPI à un ou plusieurs autres régimes. Méthodes : Recherche bibliographique (mots-clés sur les bases de données des articles publiés Medline, Scopus : « tuberculosis », « prophylaxis », « HIV », « randomized controlled trial ») et lecture standardisée d'articles sélectionnés rapportant des résultats d'essais randomisés de TPI chez les personnes infectées par le VIH. Résultats : Au total, 18 essais retenus (11 EE et 7 ER), incluant 19 725 participants. Les régimes étudiés étaient 3H, 6H, 9H, 12H, 36H/2RZ, 3RH, 3RZ, 3RHZ, et 3HP [H : Isoniazide, R : Rifampicine, Z : Pyrazinamide, P : Rifapentine]. Localisation : dix en Afrique, trois à Haïti, un en Inde, un aux USA, un aux Amériques et deux multi continentaux. Dans les EE avec ou sans ARV, la TPI réduit significativement le risque de tuberculose de 32 % à 71 %. Dans les EE avant les ARV, on ne retrouve aucune tendance à une réduction de la mortalité par la TPI. Dans les EE sous ARV, la TPI réduit la mortalité. Dans les ER, on ne trouve aucun argument pour préférer un autre régime à la TPI. La tolérance est bonne. La TPI diminue possiblement le risque de sélection de bacilles multirésistants, au lieu de l'aggraver, par la baisse du nombre d'épisodes de tuberculose et donc de l'utilisation des traitements antituberculeux curatifs. Conclusion : Loin d'avoir été rendue obsolète par le traitement ARV, la TPI reste une intervention d'actualité.BACKGROUND: Tuberculosis remains a public health threat responsible as recently as 2018 for more than one million deaths. Chemoprophylaxis with isoniazid is one of the strategies implemented to control the disease. Although it is not yet widely prescribed, its utilization raises additional questions in the "test and treat" era of for anti-retroviral therapy. The objective of this study is to review the different randomized controlled trials of antitubercular Isoniazid Preventive Therapy (IPT). We have distinguished (a) "efficacy trials" (ET) comparing IPT to a placebo or the absence of chemoprophylaxis and (b) "IPT regimen trials" (RT) comparing IPT to one or several other regimens. METHODS: Literature search (keywords from published articles found in the Medline and Scopus data bases: "tuberculosis", "prophylaxis", "HIV", "randomized controlled trial") and standardized reading of selected articles reporting results from randomized trials of IPT in HIV-infected people. RESULTS: Eighteen selected trials (11 ET and 7 RT), including 19,725 participants. The regimens studied were 3H, 6H, 9H, 12H, 12H, 36H/2RZ, 3RH, 3RZ, 3RHZ, and 3HP [H: Isoniazid, R: Rifampicin, Z: Pyrazinamide, P: Rifapentine]. LOCATIONS: Ten in Africa, three in Haiti, one in India, one in the USA, one in the Americas and two multi-continental trials. In ET with or without antiretrovirals (ART), IPT significantly reduces the risk of tuberculosis, by 32 to 71%. In ET prior to ART, IPT does not appear to reduce mortality. In ET in patients receiving ART, on the other hand, IPT reduces mortality. As regards RT, there seems to be no reason to prefer other regimens to IPT. Tolerance is good. Importantly, IPT may reduce (rather than worsen) the risk of multidrug-resistant bacilli selection by decreasing the number of TB episodes and, consequently, the number of curative tuberculosis treatments. CONCLUSION: Far from becoming obsolete due to ARV treatment, IPT has remained a timely and relevant intervention

Plasma sVCAM-1, antiretroviral therapy and mortality in HIV-1-infected West African adults

OBJECTIVES: We report the association between pre-antiretroviral therapy (pre-ART) soluble vascular cell adhesion molecule-1 (sVCAM-1) levels and long-term mortality in HIV-infected West African adults participating in a trial of early ART in West Africa (Temprano ANRS 12136 trial). METHODS: The ART-naïve HIV-infected adults were randomly assigned to start ART immediately or defer ART until the WHO criteria were met. Participants who completed the trial follow-up were invited to participate in a post-trial phase (PTP). The PTP end-point was all-cause death. We used multivariable Cox proportional models to analyse the association between baseline sVCAM-1 and all-cause death, adjusting for ART strategy, sex, CD4 count, plasma HIV-1 RNA and peripheral blood mononuclear cell HIV-1 DNA levels. RESULTS: In all, 954 adults (77% women, median CD4 count of 387 cells/μL) were randomly assigned to start ART immediately (n = 477) or to defer initiation of ART (n = 477). They were followed for a median of 5.8 years [interquartile range (IQR): 5.2-6.3]. In multivariable analysis, the risk of death was significantly associated with baseline sVCAM-1 [≥1458 vs. < 1458 ng/mL; adjusted hazard ratio = 2.86, 95% confidence interval (CI): 1.60-5.11]. The 6-year probability of death rates were 14.4% (95%CI: 9.1-22.6) and 9.4% (5.4-16.1) in patients with baseline sVCAM-1 ≥ 1458 ng/mL randomized to deferred and immediate ART, respectively, and 3.8% (2.2-6.5) and 3.5% (1.9-6.3) in patients with baseline sVCAM-1 < 1458 ng/mL randomized to deferred and immediate ART. The median difference between pre-ART and 12-month sVCAM-1 levels in patients randomized to immediate ART was -252 (IQR: -587 to -61). CONCLUSIONS: Pre-ART sVCAM-1 levels were significantly associated with mortality, independently of whether ART was started immediately or deferred, but they significantly decreased after 12 months of ART

Association of cellular HIV-1 DNA and virological success of antiretroviral treatment in HIV-infected sub-Saharan African adults

BACKGROUND: HIV-1 DNA persists in infected cells, forming viral reservoirs. Pre-antiretroviral treatment (ART) HIV-1 DNA load was reported to predict ART success in European severely immunocompromised patients. The aim of this study was to determine whether HIV-1 DNA levels are associated with virological success in less severely immunocompromised patients who receive early ART in sub-Saharan Africa. METHODS: The association between pre-ART HIV-1 DNA and the virological response after 30 months on ART was studied in multivariate logistic regression in patients randomised to immediate ART groups in the Temprano trial, which assessed the benefits of early ART in HIV-infected adults in Côte d'Ivoire. HIV-1 DNA was quantified in peripheral blood mononuclear cell (PBMC) using real-time PCR. RESULTS: HIV-1 DNA levels were measured in 1013 patients. Their medians [IQR] of pre-ART CD4 count, HIV-1 RNA and HIV-1 DNA levels were 465 [379-578]/mm(3), 4.7 [4.0-5.3] log(10) copies/ml and 2.9 [2.5-3.2] log(10) copies/million PBMC, respectively. Pre-ART HIV-1 DNA was significantly correlated with pre-ART HIV-1 RNA (R = 0.59, p < 0.0001). In multivariate analysis, HIV-1 DNA < 3 log(10) copies/million PBMC was significantly associated with virological success at M30 after adjustment for other key variables (ART regimen, IPT, sex, age, WHO clinical stage, CD4 and HIV-1 RNA; aOR 1.57; 95% CI 1.08-2.30; p = 0.02). CONCLUSION: Low HIV-1 DNA was statistically associated with virological success in this population of sub-Saharan African adults who started treatment with a median pre-ART CD4 count at 465/mm(3). HIV-1 DNA could become a useful tool for guiding some therapeutic decisions in the test-and-treat era. Trial registration TEMPRANO ANRS 12136 ClinicalTrials.gov, number NCT00495651, date of registration 03/07/2007