Assessment of the Safety and Efficacy of Tenofovir- Lamivudine-Dolutegravir Combination Therapy a mong HIV-infected Patients in University of Uyo Teaching Hospital, Uyo, Nigeria

Abstract

Background: Clinical outcomes are measurable changes in health, function or quality of life that result from professional care. Examples of clinical outcomes are cure, clinical worsening and death. Due to life-threatening toxicity of Zidovudine, Lamivudine and Nevirapine combination and Tenofovir, Lamivudine and Efavirenz antiretroviral combination in Nigeria, a new therapy, Tenofovir,
Lamivudine and Dolutegravir (TLD) combination had become first-line drug regimen. Study aimed at assessing the safety and efficacy of TLD combination therapy.

Method: This was a longitudinal, multi-phase non-interventional study involving 194 asymptomatic HIV-infected patients attending antiretroviral clinic in University of Uyo Teaching Hospital. Data were collected through a purposive convenience sampling technique after obtaining ethical approval and informed consent were filled. Questionnaires were administered to the study participants for
demographic and medication information and clinical parameters such as viral load and CD4-count were collated from their case files. A 5mL venous blood sample was collected from participants for liver and kidney function tests at baseline (0 month), 3 months- and 6 months-post baseline respectively. Blood samples of study participants were stored in the freezer after separation and were
analyzed at the end of every week in the hospital laboratory. Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST) were biomarkers evaluated for liver functions while serum creatinine was evaluated for kidney function. The blood samples were properly disposed by the hospital laboratory scientist. Biochemical assays of liver enzymes ALT and AST and
creatinine test were carried out by using Randox® reagents. The results obtained were analyzed using SPSS version 25. ANOVA was used to compare data of biochemical parameters across the three phases of study while p ≤ 0.05 was considered significant.

Results: The results showed that 55 participants completed the three phases with CD4-counts 482.90±251.72, 486.67±172.28 and  17.0±180.60cells/mm3 at 0-, 3- and 6-month respectively. The Liver enzyme ALT was normal in all Phases while AST mean-values were elevated in all Phases. ALT, AST and AST/ALT ratio were significantly varied from the baseline at 3-month (0.001, 0.000 and 0.000) and 6-month (0.093, 0.000 and 0.000) respectively. The creatinine clearance was below normal limit and continued to fall with time for both males (67.79±20.96-, 65.26±18.76- and 64.70±19.62mL/min) and females (75.8±20.66-, 70.07±20.66- and 69.60±21.90mL/min)
respectively.

Conclusion: This study indicated that there was significantly decreased viral load of study participants while CD4 count was increased. The study also indicated that biochemical parameters of liver function, enzymes ALT and ALP were significantly increased in participants. The study also indicated that creatinine clearance of participants was significantly reduced in post-baseline follow-up. The
most common complaint by participants on TLD was insomnia. Six study participants on TLD were confirmed dead.