Abstract
Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), however this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials. Our study aimed to characterize the current rate of exclusion and conditional inclusion of PLWH in cancer ICI trials by tumor type, trial phase, and year. ClinicalTrials.gov cancer ICI trials with planned starts between 1/1/2019 and 10/20/2020 were identified. Based on trial eligibility criteria, trials were categorized as “excluded” if PLWH could not enroll, “conditionally included” if only PLWH with adequate immune function were allowed, or “included/not specified” if HIV was not mentioned in the eligibility criteria. Trials from 2014 were separately collected for comparison over time. The number of trials excluding PLWH were compared to the included/not specified group using Fisher’s exact test. Of 809 trials analyzed from 2019 to 2020, 74.4% excluded, 6.9% conditionally included, and 18.7% included/did not specify PLWH. Early phase trials excluded PLWH more frequently than late phase trials. The 2019–2020 trial cohort showed no significant change in exclusion of PLWH compared to 2014. Despite increasing evidence for safe and effective ICI use for PLWH, most cancer ICI trials exclude PLWH and few studies permit PLWH to participate, even if HIV is well-controlled.
Highlights
Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials
PLWH often do not receive the same level of care as their non-human immunodeficiency virus (HIV)-infected counterparts, even if their illness has been well-controlled with antiretroviral therapy (ART) and they have normal CD4+ T cell counts
Of the 809 ICI trials analyzed with 2019–2020 start dates, 602 (74.4%) excluded PLWH, 56 (6.9%) trials conditionally included PLWH, and the remaining 151 (18.7%) trials belonged to the included/not specified category (Table 1)
Summary
Emerging retrospective and prospective studies indicate that immune checkpoint inhibitors (ICIs) can be safe and effective cancer treatments among people living with human immunodeficiency virus (PLWH), this high-cancer-risk population has often been excluded from groundbreaking cancer ICI trials. One example of inadequate access to care for PLWH is the exclusion of this population from potentially lifeextending clinical trials This was the case for several groundbreaking immune checkpoint inhibitor (ICI) cancer trials despite the fact that PLWH are at increased risk of developing and dying from cancer, both AIDS-defining and non-AIDS-defining[4,5,6,7,8,9]. With improvements in ART efficacy, the population of PLWH has aged, increasing the risk of PLWH developing cancers that affect non-HIV-infected aging p opulations[11]. Several other studies found clinical benefit of immunotherapy for PLWH and cancer[12,13,14]
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