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. 2025 Jul 31;15(1):28013.
doi: 10.1038/s41598-025-13504-3.

Drug induced liver injury in HIV patients on dolutegravir based antiretroviral therapy regimens in Wolaita Sodo comprehensive specialized hospital

Firew Abraham  1 , Alemayehu Toma  2   3 , Tamrat Balcha  4 , Bereket Molla Tigabu  5
Affiliations

Drug induced liver injury in HIV patients on dolutegravir based antiretroviral therapy regimens in Wolaita Sodo comprehensive specialized hospital

Firew Abraham et al. Sci Rep. .

Abstract

Drug induced liver injury is the most common and life-threatening condition associated with antiretroviral therapy. Dolutegravir (DTG) based combination antiretroviral therapy (ART) is currently first line treatment for HIV infected patients in Ethiopia. However, its effect on liver is not addressed. Therefore, this study aimed to assess the incidence of DTG based ART induced liver injury as first-line HIV treatment among peoples living with HIV. Hospital based retrospective cohort study was conducted in Wolaita Sodo Comprehensive Specialized Hospital ART unit, in South Ethiopia. Data was extracted from patient medical recording card. Non parametric Mann-Whitney U test was used to compare the medians between groups for continuous variables and Fisher's exact test was employed for categorical variables. Univariate and multivariate survival Cox regression was employed to assess predictor variables for drug induced liver injury. The effect of the dolutegravir based regimen on liver enzymes were assessed with paired sample t-test. Kaplan Maier survival analysis was used to estimate mean survival function. A statistical significance was considered at p-value ≤ 0.05. Out of 234 patients on dolutegravir based combination therapy, 68 (29.1%) had drug induced liver injury (DILI). Predictors for DILI were higher baseline alkaline phosphatase (ALP) and experience with other ART. Among DILI cases, 67 (98.5) were associated with cholestatic type of drug induced liver injury. Only 1.5% had both cholestatic and hepatocellular type of DILI. There was significant increment in alanine aminotransferases (ALT), aspartate aminotransferases (AST), and alkaline phosphatase (ALP), body weight and blood glucose level (p < 0.001). However, there is no significant change in creatinine level (p > 0.05). The study demonstrated a significant elevation in liver enzymes, body weight and blood glucose levels in patients taking DTG based combination therapy. The most common drug induced liver injury was cholestatic type. Predictor variables for drug induced liver injury were increased baseline ALP and treatment history with other antiretroviral therapy.

Keywords: Antiretroviral therapy; Dolutegravir; Drug induced liver injury; Human immunodeficiency virus.

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Conflict of interest statement

Declarations. Competing interests: The authors declare no competing interests. Ethical approval: The data was collected for this research after approval from the Ethics Committee of Wolaita Sodo University of Science. The need for informed consent was waived by Wolaita Sodo University Institutional Review Board CHSM/ERC/06/16.

Figures

Fig. 1
Fig. 1
Prevalence of drug induced liver injury after initiating dolutegravir based ART regimen in the study participants, 2025 (N = 234).
Fig. 2
Fig. 2
Change in ALP level after initiating dolutegravir based ART regimen in the study participants, 2025 (N = 234).
Fig. 3
Fig. 3
Mean survival time in patients with dolutegravir based ART regimen in the study participants, 2025 (N = 234).
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