Liver function tests, CD4⁺ counts, and viral load among people living with HIV on dolutegravir compared to efavirenz-based cART; a comparative cross-sectional study

Background: Recently, dolutegravir-based therapy has become the first-line treatment when compared to others. However, dolutegravir-associated side effects in the liver and levels of efficacy haven't been addressed yet in underdeveloped countries such as Ethiopia. Objective: The purpose of this study was to compare liver function tests, CD4⁺ counts, and viral load among people living with HIV on dolutegravir and efavirenz-based antiretroviral regimens at Debre Markos Comprehensive Specialized Hospital in Northwest Ethiopia. Methods: An institutional-based comparative cross-sectional study was carried out from May 20 to July 10, 2020. An equal number of dolutegravir and efavirenz-prescribed patients (n = 53 each) for 6 months and above were included, and a judgmental sampling technique was used. A comparison of categorical and continuous parameters was analyzed with chi-square and an independent t-test, respectively, using SPSS version 26. A multivariable logistic regression was conducted and considered statistically significant at a p-value of <0.05. Results: The magnitude of liver enzyme (AST/ALT) abnormalities was 22.4 % (12/53) and 30.2 % (16/53) among dolutegravir- and efavirenz-prescribed patients, respectively. The dolutegravir group had significantly higher mean CD4⁺ counts than the efavirenz group (589.40 ± 244.38 vs. 450.64 ± 203.54 cell/mm³; p = 0.002). The efavirenz group had a significantly higher mean viral load than the dolutegravir group (783.83 ± 476.82 vs. 997.98 ± 439.11 cp/ml; p = 0.032). There was a statistically insignificant difference in AST (p = 0.709) or ALT (p = 0.687) between dolutegravir and efavirenz-based regimens. The multivariable logistic regression analysis revealed that BMI ≥25 kg/m² was associated with liver enzyme abnormalities (AOR = 6.60, 95 % CI: 1.17, 42.82). Conclusion: A dolutegravir-based regimen was more likely to result in patients achieving higher efficacy for viral suppression and a CD4⁺ count increase. Although the differences were statistically insignificant, the mean AST and ALT levels were marginally higher in efavirenz-treated groups than in dolutegravir-treated groups.