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.