Clinical outcomes and renal safety in HIV/AIDS patients on tenofovir-containing regimens in Lesotho

Abstract

Tenofovir (TDF)-containing highly active antiretroviral therapy (HAART) regimens are the most preferred first-line regimens in the treatment of Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome (HIV/AIDS) in Lesotho. Although these regimens have proven efficacious, their use is associated with progressive deterioration of renal function. The benefits and risks associated with the use TDF-containing HAART regimens varies with determining factors such as sex, body weight, treatment duration and age at antiretroviral therapy initiation. The aim of this study was to evaluate the clinical outcomes [body weight and Cluster of differentiation-4 (CD4) cell count] and renal safety (serum creatinine concentration, creatinine clearance and estimated glomerular filtration rate (eGFR)) in HIV/AIDS patients taking TDF-containing HAART regimens in Lesotho. An observational, descriptive, retrospective, longitudinal study design was implemented in Paballong HIV/AIDS care centre located in Berea district, Lesotho. Two hundred fifty-five participants were enrolled in the study (56.10% females, n=143); with the mean age of 39.76±11.93 years and 59.00±12.87 kg mean baseline body weight. Most participants were initiated antiretroviral treatment at World Health Organization (WHO) clinical stage II (69.80%, n= 178). Most patients were initiated with TDF/Lamivudine (3TC)/Efavirenz (EFV) (84.70%, n=216) HAART regimen. The baseline mean CD4 cell count and serum creatinine concentration were 328.16±167.25 cells/mm3 and 83.39±37.50 μmol/l respectively. Seventy-three participants (28.60%) were on antiretroviral therapy for > 42 months. The results for clinical outcomes analysis revealed that upon treatment initiation at any age, patients gained an estimated body weight of to 0.10 kg from baseline over one year of treatment period (p<0.05). The female sex had greater weight gain, estimated at 2.49 kg over the treatment period, than males (p<0.05). The results for CD4 cell count unveiled an estimated increase in CD4 cell count of 0.02 cells/mm3 in patients initiated on treatment at any age over one year treatment duration. In contrast to males, being female was associated with an estimated additional increase in CD4 cell count of 69.13 cells/mm3 over the treatment duration (p=0.02). The results entail that clinical outcomes improve following treatment and females were at more advantage to experience better clinical improvements over treatment period than males. The results for renal safety analysis from baseline levels over treatment duration showed an increase in serum creatinine concentration, estimated at 0.23 μmol/l at any age (p=0.004). Females also had more elevations in serum creatinine concentration over males, estimated at 12.14 μmol/l over treatment duration (p<0.05). Creatinine clearance results portrayed significant decline in glomerular filtration rate by 1.10 ml/min per day over treatment duration at any age (p<0.05). Although not statistically significant, females had an additional decline in glomerular filtration rate by 1.86 ml/min when compared to males (p=0.30). However, the body weight predicted statistically significant increase in glomerular filtration rate estimated at 1.49 ml/min over the treatment duration (p<0.05). The estimated glomerular filtration rate results contended that sex, age at antiretroviral therapy initiation and body weight are risk factors to developing renal toxicity over treatment duration. The estimated glomerular filtration rate declined significantly by 0.78 ml/min/1.73m2 per day at any age (p<0.05) while females were significantly more compromised in renal function by 13.05 ml/min/1.73m2 daily when compared to males (p<0.05). Although not statistically significant, body weight predicted a daily decline of 0.02 ml/min/1.73m2 (p=0.80) over treatment duration. The results reveal an underlying renal insufficiency due to treatment and females appeared to be more at risk to developing kidney disease than males over treatment period. In conclusion, clinical outcomes manifesting by weight gain and CD4 cell count elevation improve upon initiation of antiretroviral therapy at any age. Females are far more at advantage to experience better clinical outcomes than males over the treatment duration. The renal function is progressively deteriorated following initiation of antiretroviral therapy at any age. Females experience more renal compromise than males