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BACKGROUND: The decision about whether to switch to third-line antiretroviral therapy (ART) in patients with treatment failure on second-line therapy is difficult in settings with little access to genotypic resistance testing. In this study, we used a standardised algorithm including a wide range of adherence-enhancing interventions followed by a new viral load measurement to decide whether to switch to third-line therapy in this situation. The decision, made on the basis of effectiveness of the adherence reinforcement to drive viral resuppression, did not use genotypic resistance testing. METHODS: In this prospective cohort study, adults in four west African countries with treatment failure of a boosted protease inhibitor ART regimen were offered nine adherence reinforcement interventions, and followed up for 64 weeks. We measured viral load at week 12 and used the results to decide ART treatment at week 16: if successful resuppression (plasma HIV-1 RNA /=2 log10 copies per mL compared with baseline), patients continued the same second-line regimen; otherwise they switched to a third-line regimen based on ritonavir-boosted darunavir and raltegravir. The primary endpoint was virological success at week 64 (plasma HIV-1 RNA

objective To investigate the relationship between unsafe sexual behaviours and poor self-perceived health among people living with HIV and AIDS (PLWHA) in western Africa. methods In March 2006, a survey was conducted among patients continuing their participation in the TRIVACAN trial (ANRS 1269) in Coˆ te d’Ivoire, in which patients had been randomized to either continuous or interrupted antiretroviral therapy (ART) (2-months-off ⁄ 4-months-on cycles [2 ⁄ 4-ART]) after 6–18 months of continuous ART (C-ART). Socio-demographic and psychosocial information, including data on sexual behaviours during the previous 6 months, was collected using face-to-face interviews. Sexually active patients with either a steady partner (serodiscordant or of unknown HIV status) or casual partners were considered to have unsafe sexual behaviours if they reported inconsistent condom use (ICU). results Seventy-seven of the 192 patients reported ICU. In multivariate logistic regression, men were significantly less likely to report ICU than women (OR [95% CI] = 0.45 [0.20–0.98]). After adjustment for educational level and reduced sexual activity since ART initiation, concealment of HIV status (2.08 [1.02– 4.25]) and poor self-perceived health (2.32 [0.97–5.52]) were independently associated with ICU. conclusion HIV prevention strategies in resource-limited settings should take into account self-perceived health and difficulties to disclose HIV status. Counselling interventions need to be developed to help PLWHA to adopt or negotiate safe behaviours respecting their individual cultures.

To estimate the incidence and risk factors of mortality and severe morbidity during the first months following antiretroviral therapy (ART) initiation in West African adults.A cohort study in Abidjan in which 792 adults started ART with a median CD4 cell count of 252 cells/mul and were followed for a median of 8 months. Severe morbidity was defined as all World Health Organization stage 3 or 4-defining morbidity events other than oral candidiasis.In patients with pre-ART CD4 cell count200, at 200-350 and350 cells/mul, incidence of mortality was 5.0 [95% confidence interval (CI), 2.6-8.7], 1.7 (95% CI, 0.6-3.8) and 0.0 (95% CI, 0.0-3.4]/100 person-years, and incidence of severe morbidity was 13.3 (95% CI, 9.0-19.1), 9.5 (95% CI, 6.2-12.9) and 7.9 (95% CI, 3.4-15.5)/100 person-years, respectively. The most frequent diseases were invasive bacterial diseases (32/65 episodes, 49%) and tuberculosis (25/65 episodes, 38%). Both diseases followed the same curve of decreasing incidence over time. Patients who experienced severe morbidity had higher risks of mortality, virological failure and immunological failure. Other independent risk factors for mortality and/or severe morbidity were: at baseline, high viral load, advanced clinical stage, past history of tuberculosis, low BMI, low haemoglobin and low CD4 cell count; during follow-up: low CD4 cell count and persistently detectable viral load.These data give new arguments to reinforce the hypothesis that, in this region, ART should be started before the CD4 cell count drops below 350 cells/mul. Further studies should assess whether patients with low BMI, low haemoglobin, high viral load or past history of tuberculosis should start ART earlier.

To report the tolerance of indinavir combined with ritonavir (IDV/r 800/100 mg) twice daily (bid) in sub-Saharan African HIV-infected adults. HAART-naives patients started zidovudine plus lamivudine plus IDV/r 800/100 mg bid. Follow-up included standardized documentation of morbidity, CD4+ cell count, creatininemia, plasma HIV-1 RNA, and IDV minimal plasma concentration (Cmin) measurements at month 1 (M1), M3, and M6. Seventy HIV-1-infected adults (68 women, median CD4 235/mm3) started HAART. At M6, 63% had undetectable viral load, and the median gain in CD4 since baseline was +128/mm3. During the first 6 months, 21 patients experimented with 23 treatment modifications (reduction in IDV/r 400/100 mg bid, n = 11; switch to efavirenz, n = 11; zidovudine replaced by stavudine, n = 1), including 22 for digestive intolerance and 1 for severe anemia. At M1, M3, and M6, 67, 59, and 48 patients were still receiving IDV/r 800/100 mg bid, of whom 70%, 72%, and 60% had IDV Cmin above 5 ng/ml, respectively. In these ...

In sub-Saharan Africa, the position of efavirenz as a first-line nonnucleoside reverse transcriptase inhibitor remains to be discussed. We report here the 6-month efficacy and tolerance of an efavirenz-containing highly active antiretroviral therapy in a large cohort of HIV-1-infected adults. Seven hundred forty highly active antiretroviral therapy-naive adults (74% women; 14% with positive serum HBs antigen and 21% with abnormal baseline transaminase value) started zidovudine + lamivudine + efavirenz. At month 6, 1.2% of them were dead, 87% had undetectable viral load, and 7% had abnormal transaminase value. From months 1 to 6, the percentage of women who were actually using a contraceptive method increased from 58% to 80% (65% intramuscular progesterone and 35% oral estrogen/progesterone combination). The incidence of pregnancy was 2.6/100 woman-years (95% confidence interval, 0.67-4.51), and 86% of pregnant women voluntarily interrupted the pregnancy with no intervention on our part. Before month 6, only 0.8% of patients permanently discontinued efavirenz for severe adverse effects (neurologic, 0.6%; cutaneous, 0.1%; and hepatic, 0.1%). The leading cause of severe morbidity was tuberculosis. Considering the very high hepatic and cutaneous tolerance, efavirenz could be considered as a valuable first-line drug for women of childbearing age who agree to use contraception in sub-Saharan Africa, provided that the risk of teratogenicity should be closely monitored.

BACKGROUND: In antiretroviral therapy (ART) programs decreasing loss to follow up (LTFU) is a major priority. METHODS: We conducted a prospective study in Abidjan. Adults who started ART between June 2005 and May 2008 and were still in care 6 months later had monthly visits biannual CD4 counts computerized data collection and home visits (routine follow-up). A subset of patients also had biannual plasma HIV-1 RNA measurements with a physician and a research assistant hired to pay particular attention to their visits (enhanced follow-up). We analyzed the association between 18-month outcomes and pre-ART characteristics medication possession ratio (MPR) and type of follow-up. Patients were LTFU if their last visit was before month-18 and they had not returned to care by month-24. RESULTS: 2074 patients started ART of whom 1636 (79%) were still in care at month-6. The routine (n = 999) and enhanced (n = 637) groups had similar baseline characteristics. From month-6 to month-18 they had similar death rates (routine 3.6% enhanced 3.9% P = 0.74) but the enhanced group had significantly less LTFU (routine 11.3% enhanced 5.8% P < 0.001). In multivariate analysis the risk of LTFU from month-6 to month-18 was 46% lower with enhanced follow-up 56% higher in patients living outside the centre area and 4.0 fold higher in patients with a low MPR (

To investigate the relationship between unsafe sexual behaviours and poor self-perceived health among people living with HIV and AIDS (PLWHA) in western Africa.In March 2006, a survey was conducted among patients continuing their participation in the TRIVACAN trial (ANRS 1269) in Côte d'Ivoire, in which patients had been randomized to either continuous or interrupted antiretroviral therapy (ART) (2-months-off/4-months-on cycles [2/4-ART]) after 6-18 months of continuous ART (C-ART). Socio-demographic and psychosocial information, including data on sexual behaviours during the previous 6 months, was collected using face-to-face interviews. Sexually active patients with either a steady partner (serodiscordant or of unknown HIV status) or casual partners were considered to have unsafe sexual behaviours if they reported inconsistent condom use (ICU).Seventy-seven of the 192 patients reported ICU. In multivariate logistic regression, men were significantly less likely to report ICU than women (OR [95% CI] = 0.45 [0.20-0.98]). After adjustment for educational level and reduced sexual activity since ART initiation, concealment of HIV status (2.08 [1.02-4.25]) and poor self-perceived health (2.32 [0.97-5.52]) were independently associated with ICU.HIV prevention strategies in resource-limited settings should take into account self-perceived health and difficulties to disclose HIV status. Counselling interventions need to be developed to help PLWHA to adopt or negotiate safe behaviours respecting their individual cultures.

International audience; To report the tolerance of indinavir combined with ritonavir (IDV/r 800/100 mg) twice daily (bid) in sub-Saharan African HIV-infected adults. HAART-naives patients started zidovudine plus lamivudine plus IDV/r 800/100 mg bid. Follow-up included standardized documentation of morbidity, CD4(+) cell count, creatininemia, plasma HIV-1 RNA, and IDV minimal plasma concentration (C(min)) measurements at month 1 (M1), M3, and M6. Seventy HIV-1-infected adults (68 women, median CD4 235/mm(3)) started HAART. At M6, 63% had undetectable viral load, and the median gain in CD4 since baseline was +128/mm(3). During the first 6 months, 21 patients experimented with 23 treatment modifications (reduction in IDV/r 400/100 mg bid, n = 11; switch to efavirenz, n = 11; zidovudine replaced by stavudine, n = 1), including 22 for digestive intolerance and 1 for severe anemia. At M1, M3, and M6, 67, 59, and 48 patients were still receiving IDV/r 800/100 mg bid, of whom 70%, 72%, and 60% had IDV Cmin above 5 ng/ml, respectively. In these patients, at M1, M3, and M6, the mean (+/- SD) IDV C(min) were 3431 +/- 3835 ng/ml, 2288 +/- 2116 ng/ml, and 1543 +/- 2398 ng/ml, respectively. There was no renal insufficiency of any grade, and no symptoms of urinary stones. The IDV/r 800/100 mg bid-containing regimen led to high IDV Cmin and a high rate of digestive intolerance. There was a surprising lack of nephrological side effects during the 6 months of follow-up, supporting the hypothesis that nephrological tolerance of IDV might be higher in sub-Saharan African individuals than in Americans or Europeans.

Summary Background Structured treatment interruptions of highly-active antiretroviral therapy (HAART) might be particularly relevant for sub-Saharan Africa, where cost-saving strategies could help to increase the number of patients on HAART. We did a randomised trial of structured treatment interruption in Abidjan, Cote d'Ivoire. Methods HIV-infected adults were randomised to receive continuous HAART (CT), CD4-guided HAART (CD4GT) with interruption and reintroduction thresholds at 350 and 250 cells per mm 3 , respectively, or 2-months-off, 4-months-on HAART. Primary endpoints were death and severe morbidity (any WHO stage 3 or 4 events and any events leading to death) at month 24. We report data from the CT and CD4GT groups until Oct 31, 2005, when the data safety monitoring board recommended to prematurely stop the CD4GT arm. Analyses were intention-to-treat. This study is registered at ClinicalTrials.gov, number NCT00158405. Results 326 adults (median CD4 count nadir 272 per mm 3 ) were randomised to the CT or CD4GT groups and followed up for median of 20 months. Incidence of mortality (per 100 person-years) was not different between groups (CT 0·6, CD4GT 1·2; p=0·57). Incidence of severe morbidity (per 100 person-years) was higher in the CDG4T group (17·6) than in the CT group (6·7; p=0·001). The most frequent severe events were invasive bacterial diseases. 79% of severe morbidity episodes occurred in patients with CD4 count 200–500 per mm 3 . Conclusion Patients on CD4GT had severe morbidity rates 2·5-fold higher than those on CT. This difference was mainly due to high rates of common diseases in patients with CD4 count 200–500 per mm 3 . This CD4-guided structured treatment interruption strategy should not be recommended in Abidjan.