Clinical Outcomes Experienced by Seropositive Ambulatory Patients Receiving Tenofovir, Lamivudine and Dolutegravir Combination Therapy in University of Uyo Teaching Hospital, Uyo, Nigeria
M. O. Ajulo
*
Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Uyo, Uyo, Akwa-Ibom State, Nigeria.
R. E. Udoh
Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Uyo, Uyo, Akwa-Ibom State, Nigeria.
E. O. Olorunsola
Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Uyo, Uyo, Akwa-Ibom State, Nigeria.
H. O. Ajulo
Department of Animal Science, Faculty of Agriculture, University of Uyo, Uyo, Akwa-Ibom State, Nigeria.
*Author to whom correspondence should be addressed.
Abstract
Background: Due to life-threatening toxicity of Zidovudine, Lamivudine & Nevirapine (ZLN) and Tenofovir, Lamivudine & Efavirenz (TLE) antiretroviral combinations in Nigeria, a new therapy, Tenofovir +Lamivudine +Dolutegravir (TLD) had become first-line drug regimen.
Objectives: Study aimed to access the safety and efficacy of the newly approved combination therapy.
Method: The study recruited 194 asymptomatic patients by purposive convenience sampling after ethical approval was granted and informed consent were filled. Participants’ viral load and CD4-count were collated from their folders. Questionnaires were administered to study participants. Fifty-five participants were dropped due to medication-adherence issues. A 5mL blood sample was collected from participants for liver and kidney function tests at 0 month, 3 months and 6 months respectively. The results obtained were analyzed by using SPSS version 25. Statistical analytical tool, ANOVA was used while p≤0.05 was considered significant.
Results: There were 139 participants consisting of 95 (68.35%) females and a mean age 39.22±9.45years in Phase 1. Only 55 participants completed the three phases consisting of 36 (65.45%) females and a mean age 40.61±10.10years. Their CD4-counts were 482.90±251.72, 486.67±172.28 and 617.0±180.60cells/mm3 at 0-, 3- and 6-month respectively. The Liver enzyme ALT mean-values were 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).
Conclusion: This study indicated that TLD was significantly associated with increased CD4-count, ALT, AST and ALP while creatinine clearance of study participants was significantly reduced. Six study participants were confirmed dead due to intake of TLD.
Keywords: Antiretroviral, drug toxicity, HIV, AIDS, hepatotoxicity, renotoxicity