Liver Disease

Is ART Linked to ESLD Risk?

Certain antiretroviral therapy (ART) drugs could be associated with an increased risk of end-stage liver disease (ESLD) in patients with HIV.

“[P]ast analyses have studied prevalent users exposed to old hepatotoxic drugs and used inadequate methods for detecting risk signals in complex data. We sought to detect which components of modern ART might contribute to ESLD risk,” the researchers wrote.

They examined data from 10,564 patients from 12 cohorts from the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD).Of the 10,564, 62 patients experienced validated ESLD events (42 ascites, 10 hepatic encephalopathy, 7 variceal hemorrhage, 3 hepatocellular carcinoma), and incidence rates were 0.4 per 1000 patients years in HIV-monoinfected patients, 2.8 per 1000 patient years in patients with HIV/HBV, 7.2 per 1000 patient years in patients with HIV/HCV, and 13.1 per 1000 person years in patients with HIV/HBV/HCV.

“We show how new user cohort designs can be used to detect toxicity signals even with relatively few events. While modern ART poses less risk for ESLD than hepatitis coinfection, some drugs showed toxicity signals. Confirming whether these drugs contribute to ESLD risk requires designs that focus on causality.”

—Michael Potts


Klein MB, Young J, Althoff KN, et al. Are modern antiretrovirals hepatotoxic? signals in patients starting art in NA-accord. Paper presented at Virtual CROI 2021. March 6-10, 2021.