High acceptability and viral suppression rate for first-Line patients on a dolutegravir-based regimen: An early adopter study in Nigeria.

Nigeria adopted dolutegravir (DTG) as part of first line (1L) antiretroviral therapy (ART) in 2017. However, there is limited documented experience using DTG in sub-Saharan Africa. Our study assessed DTG acceptability from the patient's perspective as well as treatment outcomes at 3 high-volume facilities in Nigeria. This is a mixed method prospective cohort study with 12 months of follow-up between July 2017 and January 2019. Patients who had intolerance or contraindications to non-nucleoside reverse-transcriptase inhibitors were included. Patient acceptability was assessed through one-on-one interviews at 2, 6, and 12 months following DTG initiation. ART-experienced participants were asked about side effects and regimen preference compared to their previous regimen. Viral load (VL) and CD4+ cell count tests were assessed according to the national schedule. Data were analysed in MS Excel and SAS 9.4. A total of 271 participants were enrolled on the study, the median age of participants was 45 years, 62% were female. 229 (206 ART-experienced, 23 ART-naive) of enrolled participants were interviewed at 12 months. 99.5% of ART-experienced study participants preferred DTG to their previous regimen. 32% of particpants reported at least one side effect. "Increase in appetite" was most frequently reported (15%), followed by insomnia (10%) and bad dreams (10%). Average adherence as measured by drug pick-up was 99% and 3% reported a missed dose in the 3 days preceding their interview. Among participants with VL results (n = 199), 99% were virally suppressed (<1000 copies/ml), and 94% had VL <50 copies/ml at 12 months. This study is among the first to document self-reported patient experiences with DTG in sub-Saharan Africa and demonstrated high acceptability of DTG-based regimens among patients. The viral suppression rate was higher than the national average of 82%. Our findings support the recommendation of DTG-based regimen as the preferred 1L ART.

Subclinical atherosclerosis and associated risk factors among HIV-infected adults in Jos, North Central Nigeria: a cross-sectional study.

INTRODUCTION: human immunodeficiency virus (HIV) is evolving into a leading cause of cardiovascular diseases (CVD) in sub-Saharan Africa (SSA) where the burden of HIV remains high. Atherosclerosis underlie progression to CVD. We therefore examined the prevalence of subclinical atherosclerosis and its association with traditional and non-traditional risk factors for CVD in Nigerian HIV-infected adults. METHODS: this was a cross-sectional study involving randomly selected stable HIV-infected patients with undetectable viral load attending HIV clinics at the Jos University Teaching Hospital and Faith Alive Foundation in Jos, Nigeria. Demographic data, biophysical measurements, cardiovascular risk factors and information regarding HIV-related factors, fasting serum lipid profile, fasting plasma glucose, high-sensitivity C-reactive protein and Carotid-Intima-Media-Thickness (CIMT) were assessed. Subclinical atherosclerosis was defined using a cut-off value of mean CIMT ≥ 0.78 mm. Data were analyzed with the Statistical Package for Social Sciences® (SPSS) software version 23.0 (IBM Corp., Chicago, Illinois, USA). Bivariate analysis and multivariate logistic regression were used to examine the association between risk factors of CVD and subclinical atherosclerosis. The statistical significance level was set at p ≤ 0.05. RESULTS: a total of 148 HIV adults (70.9% being females) on Anti-Retroviral Therapy (ART) were included in this study. The prevalence of subclinical atherosclerosis was 7.4%. Among subjects with subclinical atherosclerosis (SCA), 63.6% were males and 81.8% were hypertensive. Elevated blood glucose, lipids and high-sensitivity C-reactive protein, body mass index (BMI), HIV-related parameters (duration of HIV infection, antiretroviral regimen, CD4+ cell count), current smoking status, alcohol use, were not significantly associated with subclinical atherosclerosis (p>0.05). Male gender [OR(95%CI=4.91(1.36-17.77)], age [OR(95%CI)=1.14(1.06-1.23)], hypertension [OR(95%CI=14.4(3.03-71.86)] and metabolic syndrome [OR(95%CI=8.34(1.73-40.18)] were significantly associated with SCA at bivariate analysis. After adjusting for age, sex and antiretroviral regimen, only increasing age [Adjusted Odds Ratio (AOR) (95% confidence interval (CI)] = 1.12(1.01-1.25)] and hypertension [AOR (95%CI)=10.67 (1.31-87.18)], remained as independent predictors of subclinical atherosclerosis (SCA). CONCLUSION: the prevalence of subclinical atherosclerosis among HIV-infected adults is high in Nigeria. It is significantly associated with increasing age and hypertension. Traditional CVD risk factors such as dyslipidaemia, diabetes mellitus and obesity were not associated with subclinical atherosclerosis in this population.

Incidence and predictors of adverse drug events in an African cohort of HIV-infected adults treated with efavirenz.

INTRODUCTION: Adverse drug reactions associated with efavirenz (EFV) therapy are poorly described beyond the first year of treatment. We aimed to describe the incidence and predictors of EFV-related adverse drug reactions (ADRs) in a cohort of adult Nigerian HIV-infected patients on antiretroviral therapy (ART). METHODS: This retrospective cohort study utilized clinical data of HIV-1 infected adults (aged ≥15 years), commenced on efavirenz containing-regimen between January 2004 and December 2011. The time-dependent occurrence of clinical adverse events as defined by the World Health Organization was analyzed by Cox regression analysis. RESULTS: A total of 2920 patients with baseline median (IQR) age of 39 (33-46) years, largely made up of men (78%) were included in the study. During 8834 person-years of follow up, 358 adverse drug events were reported; the incidence rate was 40.3 ADRs per 1000 person-years of treatment. Lipodystrophy and neuropsychiatric disorders were the most common ADRs with incidences of 63 and 30 per 1000 patients respectively. About one-third of the neuropsychiatric adverse events were within 12 months of commencement of ART. The risk of neuropsychiatric ADRs was independently predicted for women [adjusted hazard ratio (aHR) 9.05; 95% CI: 5.18-15.82], those aged <40 years (aHR 2.59; 95% CI: 1.50-4.45), advanced HIV disease (WHO stage 3 or 4) [aHR 2.26; 95% CI: 1.37-3.72], and zidovudine [aHR 2.21; 95% CI: 1.27-3.83] or stavudine [aHR 4.22; 95% CI: 1.99-8.92] containing regimen compared to tenofovir. CONCLUSION: Neuropsychiatric adverse drug events associated with efavirenz-based ART had both early and late onset in our clinical cohort of patients on chronic EFV therapy. Continuous neuropsychiatric assessment for improved detection and management of neuropsychiatric ADRs is recommended in resource-limited settings where the use of efavirenz-based regimens has been scaled up.