Efficacy and safety of three antiretroviral therapy regimens for treatment-naive African adults living with HIV-2 (FIT-2): a pilot, phase 2, non-comparative, open-label, randomised controlled trial.

BACKGROUND: Due to the low number of individuals with HIV-2, no randomised trials of HIV-2 treatment have ever been done. We hypothesised that a non-comparative study describing the outcomes of several antiretroviral therapy (ART) regimens in parallel groups would improve understanding of how differences between HIV-1 and HIV-2 might lead to different therapeutic approaches. METHODS: This pilot, phase 2, non-comparative, open-label, randomised controlled trial was done in Burkina Faso, Côte d'Ivoire, Senegal, and Togo. Adults with HIV-2 who were ART naive with CD4 counts of 200 cells per µL or greater were randomly assigned 1:1:1 to one of three treatment groups. A computer-generated sequentially numbered block randomisation list stratified by country was used for online allocation to the next available treatment group. In all groups, tenofovir disoproxil fumarate (henceforth tenofovir) was dosed at 245 mg once daily with either emtricitabine at 200 mg once daily or lamivudine at 300 mg once daily. The triple nucleoside reverse transcriptase inhibitor (NRTI) group received zidovudine at 250 mg twice daily. The ritonavir-boosted lopinavir group received lopinavir at 400 mg twice daily boosted with ritonavir at 100 mg twice daily. The raltegravir group received raltegravir at 400 mg twice daily. The primary outcome was the rate of treatment success at week 96, defined as an absence of serious morbidity event during follow-up, plasma HIV-2 RNA less than 50 copies per mL at week 96, and a substantial increase in CD4 cells between baseline and week 96. This trial is registered at ClinicalTrials.gov, NCT02150993, and is closed to new participants. FINDINGS: Between Jan 26, 2016, and June 29, 2017, 210 participants were randomly assigned to treatment groups. Five participants died during the 96 weeks of follow-up (triple NRTI group, n=2; ritonavir-boosted lopinavir group, n=2; and raltegravir group, n=1), eight had a serious morbidity event (triple NRTI group, n=4; ritonavir-boosted lopinavir group, n=3; and raltegravir group, n=1), 17 had plasma HIV-2 RNA of 50 copies per mL or greater at least once (triple NRTI group, n=11; ritonavir-boosted lopinavir group, n=4; and raltegravir group, n=2), 32 (all in the triple NRTI group) switched to another ART regimen, and 18 permanently discontinued ART (triple NRTI group, n=5; ritonavir-boosted lopinavir group, n=7; and raltegravir group, n=6). The Data Safety Monitoring Board recommended premature termination of the triple NRTI regimen for safety reasons. The overall treatment success rate was 57% (95% CI 47-66) in the ritonavir-boosted lopinavir group and 59% (49-68) in the raltegravir group. INTERPRETATION: The raltegravir and ritonavir-boosted lopinavir regimens were efficient and safe in adults with HIV-2. Both regimens could be compared in future phase 3 trials. The results of this pilot study suggest a trend towards better virological and immunological efficacy in the raltegravir-based regimen. FUNDING: ANRS MIE.

Prevalence of hypertension and other cardiovascular disease risk factors among university students from the National Polytechnic Institute of Côte d'Ivoire: A cross-sectional study.

BACKGROUND: Cardiovascular diseases (CVD) are the leading causes of death in the world, mainly occurring in low-and-middle income countries. The aim of this study was to estimate the prevalence of hypertension and other cardiovascular risk factors among university students at a National Polytechnic Institute in Côte d'Ivoire. METHODS: A cross-sectional study was conducted among students of the National Polytechnic Institute of Côte d'Ivoire. Sample was selected using a non-probabilistic convenient sampling method. Anthropometric measurements, blood pressure and capillary blood glucose were measured. A logistic regression model allowed to determine factors associated with hypertension. RESULTS: A total of 2,030 students, 79.7% males and 20.3% females, with a median age of 20 years (IQR = [19-22]) participated in the study. On hypertension knowledge, 96.9% (n = 1,968) of students reported having heard of hypertension; salty foods were reported by more than a third as a cause of hypertension (n = 734; 37.3%), while 114 (5.8%) and 157 (8.0%) selected tobacco and alcohol as causes of hypertension, respectively. The overall prevalence of hypertension was 6.0%, higher in males (6.8%) compared to females (2.7%) (p < 0.001). As for CVD risk factors, 148 (7.3%) were overweight or obese; 44.0% of males and 36.6% of females reported alcohol consumption. In multivariate analysis, being a female (OR = 4.16; CI 95% = [1.96-9.09]; p<0.001), being 25 years old and older (OR = 3.34; CI 95% = [2.01-5.55]; p = 0.001), tobacco use (OR = 2.65; CI 95% = [1.41-4.96]; p = 0.002), being overweight or obese (OR = 3.75; CI 95% = [2.13-6.59]; p<0,001) and having abnormal waist circumference (OR = 6.24; CI 95% = [1.99-19.51]; p = 0.002) were significantly associated with high blood pressure. CONCLUSION: CVD risk factors are prominent among young adults in Côte d'Ivoire. Appropriate behavioural health interventions promoting a healthy lifestyle for young adults should be urgently implemented for CVD burden reduction.