Abacavir/dolutegravir/lamivudine

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 37-year-old man developed delayed hepatotoxicity and drug-induced liver injury (DILI) during treatment with abacavir/dolutegravir/lamivudine for HIV-1 infection.

The man, who had been diagnosed with HIV-1 in November 2018, subsequently started receiving abacavir/dolutegravir/lamivudine [Triumeq; route and dosage not stated], resulting in complete suppression 4 weeks later. His ALT at baseline had been 54 IU/L, which was felt to have been related to the recent seroconversion. Throughout 2019, his ALT ranged from 40−150 IU/L, accompanied by occasional elevations in AST to about 80 IU/L. Notably, his ALP, GGT and bilirubin remained within normal limits. Subsequent analyses were found to be unremarkable. Eventually, the transaminitis worsened. By November 2020, laboratory analyses revealed ALT 501 IU/L/ and AST 200 IU/L; hence, urgent liver biopsy was scheduled. By December 2020, analyses revealed ALT 997 IU/L and AST 316 IU/L, consistent with hepatotoxicity.

Given no other triggers for the liver inflammation, the man's treatment with abacavir/dolutegravir/lamivudine was discontinued. He later admitted using anabolic steroids (unspecified) in 2020 due to Covid-19 gym closures; however, he claimed to have stopped them in November. His transaminase levels quickly improved following cessation of abacavir/dolutegravir/lamivudine, and within 14 days, his ALT was 354, while his and AST was 130 [units not stated]. Liver biopsy histopathology demonstrated changes consistent with DILI, which was not compatible with typical patterns seen with the use of anabolic steroids. Therefore, the antiretroviral therapy (ART) with abacavir/dolutegravir/lamivudine was thought to have resulted in delayed hepatotoxicity and DILI, two years after its initiation. Thereafter, he started receiving ART with doravirine/lamivudine/tenofovir disoproxil fumarate. He continued using anabolic steroids, with a continued decrease in ALT and AST levels.