Evaluation of protease inhibitors based anti-retroviral regimen induced liver injury at Zewditu memorial hospital.

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Addis Abeba University


Background: The inclusion of protease inhibitors (PIs) in therapeutic regimens has a significant impact on the success of the treatment; these classes have been associated with liver-related injury in some individuals. Rates of hepatotoxicity from registration trials of various PIs have ranged from 1% to 9.5%, of which few patients had serious liver-related outcomes. Objective: To evaluate the incidence, severity, patterns, time dependent and risk factors of PIs based anti-retroviral regimens induced liver injury. Methods: An observational cohort prospective study was conducted at anti-retroviral treatment clinic of Zewditu memorial hospital. All patients that were HIV positive and candidate for PI based regimens, and fulfilling other eligibility criteria were included in the study. The study was conducted from March 1, 2018 to December 30, 2018 (including follow up period for total of 6 months). Results: Out of 142 study participants, overall, liver injury of any grade was observed in 25 (17.6%) participants. From 35 PI based naïve participants, 3 patients developed liver injury during the study period. Majority of the participants 21 (84%) developed cholestatic pattern of liver injury. Overall incidence of grade 1, 2 and 3 were 16 (64%), 6 (24%) and 3 (12%) respectively. The incidence of liver injury was high (57.1%; 4/7) within 25-48 weeks from the starting PI based regimens. Cotrimoxazole prophylactic therapy and previous first line on AZT/3TC/NVP were significantly associated with liver injury. Conclusion: Overall, liver injury of any grade was observed in 25 (17.6%) participants while only 3 (12%) participants developed grade-3 liver injury. None of the participants developed grade-4 liver injury and no liver related death was reported during the study period. Recommendation: Regular follow up of liver function tests is important to monitor liver toxicities in HIV positive patients, particularly with PIs-based regimen. Further study need to be conducted with large sample size and long term follow up to identify the mechanism and risk factors associated with PIs.



Incidence, Severity, Protease enzyme inhibitor, Drug induced liver injury, Liver injury.