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.

Future of HIV2 and HIV2 + 1 Infected Patients Treated with Antiretrovirals Followed at the Day Hospital HIV Care Unit from 2011 to 2015.

Introduction: HIV2 is endemic in West Africa. In Burkina Faso, its prevalence was estimated at 2%. The aim of this work was to evaluate the follow-up of patients and also to contribute to the availability of data. Methods: We involved 18 years or older. Infection was screened according to the national algorithm. A cross- sectional study from first June 2017 to 31 December 2017 was performed. For each patient, sociodemographic, clinical, biological, therapeutic and evolution data were collected and analyzed. Results: The proportion of patients infected with HIV2 (n = 48; 1.7%) and HIV2 + 1 (n = 67; 2.4%) was 4.3%. The sex rat mean age was 50.3 ± 8.5 years. The combination of 2INTI + LPV/r was the most prescribed (n = 73; 63.5%). The average gain of LTCD4 has evolved from + 236 cells/mm3 in 2011 to + 364 cells/mm3 in 2015. The retention rate at grade 5 was about 70%. Conclusion: The immunological and clinic response of the patients was satisfactory. More than half of the patients remained in the continuum of care after five years of follow-up.

Risk Factors for Early Mortality on Antiretroviral Treatment of Elderly People Infected with HIV in Burkina Faso.

BACKGROUND: Age is a key determinant of mortality due to diseases including HIV infection. METHODS: A retrospective and descriptive cohort study used a computerized database to compare HIV-infected patients diagnosed in late adulthood to a group of patients diagnosed before their 49 years of age, without matching the characteristics of HIV infection. The study included patients who visited the day hospital (outpatient clinic) of the Sanou Souro Teaching Hospital of Bobo-Dioulasso, in Burkina Faso, from January 2007 to December 2011. Older adults were defined as those aged 50 years and more. RESULTS: Participants in the study consisted of 2572 patients (265 older adults and 2307 young patients living with HIV. Based on Markov chain method, 32.1% of the older adults living with HIV were found to be seroconvert at 50 years or older. The median follow-up time on antiretroviral treatment (ART) was 32.7 months (range 0.03-65.4 months). Two hundred and ninety-five (11.5%) patients died, including 21.1% of older adults and 10.4% of young (P < .01). World Health Organization stage 3 or 4 and the lowest CD4 count reached <200 cells/mm(3) were the factors associated with early mortality of older adults on ART. CONCLUSION: Mortality rate of older adult patients living with HIV in Burkina Faso is high. Early diagnosis, early treatment, and primary prevention of HIV infection in the older adults are the main keys that could help reduce such mortality.

Characteristics and follow-up of newly managed HIV-infected patients in the national referral center in Ouagadougou, Burkina Faso.

BACKGROUND: In sub-Saharan countries, HIV testing and treatment facilities are available, especially at subsidized rates for the past few years. METHODS: A prospective and descriptive review was conducted at Yalgado Ouédraogo Teaching Hospital Internal Medicine department in Ouagadougou, using personal case report forms, between June 2009 and August 2010 in all newly diagnosed adults with positive HIV antibody. RESULTS: The study participants consisted of 191 patients at a median age of 37 years (range, 18-65 years) and sex ratio (men/women): 0.66. In all, 110 (57.6%) patients were symptomatic. Fourteen patients were lost to follow-up. Of the 177 patients, 144 had CD4 count <350 cells/mm(3) and all have been treated. At the ninth month, weight gain and immune restoration were significant (P < .01); only 79 of the 144 patients had viral load measurement, and 76 of the 79 were undetectable. Mortality rate of treated patients was 6.25%. CONCLUSION: Laboratory tests and highly active antiretroviral therapy make the management of patients easier, but a majority of them still presented late and were still lost to follow-up. Nevertheless, we have excellent treatment success.

Rheumatoid arthritis in Burkina Faso: clinical and serological profiles.

The objective of this work was to study the clinical and serological profiles of rheumatoid arthritis in Burkina Faso (West Africa). It is a cross-sectional study conducted from March 2006 to February 2009 in the Internal Medicine Department of the University Hospital Yalgado Ouedraogo. All patients seen in the rheumatologic consultation unit during this period, with rheumatoid arthritis fulfilling the ACR criteria, were routinely selected. The determination of anticyclic citrullinated peptide antibodies (ACPA) was carried out with a computerized method (Elia CCP, Phadia AB, Uppsala, Sweden). Values higher than 10 IU/l were considered positive. Forty-eight cases of rheumatoid arthritis (RA) were recruited throughout the study period among 2,194 (2.2 %) patients. Forty-two files were subjected to the study. There were 34 women and 8 men. The average age was 41.70 ± 13 years with extremes of 22 and 71 years. The average duration of the disease was 86.17 ± 82.01 months with extremes of 8 and 360 months. Rheumatoid factors (RF) were positive in 21 out of 30 patients (70.0%). The determination of ACPA carried out in all the patients was positive in 34 (81%) patients; their average value was 217 IU/l with extremes of 38 and 1,170. RF and ACPA were associated to bones erosions (p = 0.0001). Twenty-two patients were placed on methotrexate, eight on hydroxychloroquine, and three on salazopyrine. Nine were given only NSAIDs or prednisolone. No patients had had a biotherapy agent. The frequency of RA was low in our study compared to other African studies published so far. The particularity of RA cases reported in African series, including ours, is the rarity of extra-articular manifestations of the disease. The severity of the disease at presentation in the rheumatology clinic may be due to their late consultation among other causes.