‘No justification’ for HIV exclusion from ICI trials
medwireNews: Researchers highlight the “almost universal exclusion” of people living with HIV (PLWH) from clinical trials of immune checkpoint inhibitor (ICI) therapies despite malignancy being the leading cause of morbidity and mortality in this population.
“[T]he exclusion of PLWH is unsupported by current data, denies patients the benefit of ICI therapy, and is ethically unjustifiable,” say Daniel Araujo (Princess Margaret Cancer Centre, Toronto, Ontario, Canada) and co-workers.
Between January 2016 and March 2019, just five of 107 ICI trials with PLWH inclusion criteria data allowed the enrolment of PLWH, with this group encompassing only 4.7% of participants.
As all five trials including PLWH were academic, studies including PLWH were a significant 259.77 times more likely to be academic than pharmaceutical company-sponsored trials, the team writes in JAMA Network Open.
“Whereas the reasons for PLWH exclusion are not disclosed in any protocols, we suspect this practice results from dogma rather than reasoned decision,” the authors comment.
They cite the 2017 ASCO task force recommendations for inclusion of PLWH in oncology trials, especially those with a T-cell CD4+ count of 350 cells/µL or above indicating normal immunologic function.
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