Immune checkpoint inhibitor therapy in patients with advanced cancer and chronic viral infections: Real-world clinical experience.

Abstract

e20589 Background: Patients with chronic viral infections, including human immunodeficiency virus (HIV) and viral hepatitis, have historically been excluded from pivotal immune checkpoint inhibitor (ICI) trials due to concerns regarding safety and efficacy. As ICIs are widely used in non–small cell lung cancer (NSCLC) and melanoma, real-world evidence is needed to better understand outcomes in this underrepresented population. Methods: We conducted a retrospective cohort study using the TriNetX Global Collaborative Network, comprising de-identified electronic health records from 170 healthcare organizations. Adult patients with NSCLC or melanoma treated with ICIs, including pembrolizumab, nivolumab, ipilimumab, atezolizumab, or durvalumab, were identified. Among patients eligible for propensity score matching, 4,153 patients with documented HIV and/or viral hepatitis (Cohort A) and 98,495 patients without viral infection (Cohort B) were included. Propensity score matching was performed in a 1:1 ratio based on demographics and baseline clinical characteristics, resulting in 4,153 matched patients in each cohort. All outcome analyses were conducted in the matched population. Outcomes were assessed beginning one day after the index event, defined as the first qualifying cancer diagnosis with ICI exposure. The primary outcome was overall survival. Secondary outcomes included inpatient hospitalization and emergency department visits. Kaplan–Meier survival analysis and measures of association were performed. Results: After propensity score matching, baseline characteristics were well balanced between cohorts, including age, sex, race, ethnicity, and liver-related comorbidities. Kaplan–Meier analysis demonstrated no statistically significant difference in OS between viral and non-viral cohorts (HR 1.05; 95% CI, 0.99-1.12; p = 0.83). The cumulative risk of death was comparable (44.9% vs. 45.8%), with no significant differences in risk ratio (RR 0.98; 95% CI, 0.94-1.03) or odds ratio (OR 0.96; 95% CI, 0.88-1.05). Median OS was 723 days in the viral cohort vs 818 days in the non-viral cohort (log-rank p = 0.12). Furthermore, healthcare utilization was comparable, with no significant differences in the risk of inpatient hospitalization (39.6% vs. 39.4%; p = 0.45) or emergency department utilization. Conclusions: In this large real-world analysis, patients with NSCLC or melanoma and concomitant HIV or viral hepatitis treated with ICs did not demonstrate a statistically significant difference in OS healthcare utilization compared with matched patients without viral infection, suggesting that chronic viral infections should not necessarily preclude the use of ICs in patients with solid tumors. Prospective studies are warranted to further characterize safety and efficacy in this historically underrepresented population.