Abstract 3230: Safety and efficacy of immune checkpoint inhibitors (ICIs) in patients with HIV, hepatitis B, or hepatitis C viral infections
Authors: Shah Neil J. , AL-Shbool Ghassan , Blackburn Matthew , Cook Michael , Kelly William J. , Belouali Anas , Ochoa Sebastian , Colton Bradley S. , Puthiamadathil Jeevan , Serzan Michael T. , Knoedler Alice R. , Liu Stephen V. , Pishvaian Michael J. , Mohebtash Mahsa , Madhavan Subha , He Aiwu R. , Atkins Michael B. , Gibney Geoffrey T. , Kim Chul 
Published: August 2019

Abstract
Background: Immune checkpoint inhibitors (ICIs) have become standard of care for many malignancies. However, patients (pts) with human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) were excluded from many clinical trials. Therefore, the safety and efficacy of ICI therapy in these patient populations is not well characterized.
Methods: We performed a retrospective analysis of pts with HIV, HBV, or HCV treated with ICI therapy at five MedStar Health hospitals from January 2011 to April 2018. The incidence of immune-related adverse events (irAEs) per CTCAE4.03, objective response rate (ORR) per RECIST v1.1, changes in viral status and CD4 T-cell counts during treatment were analyzed.
Results: A total of 50 pts were identified; (21 HIV, 4 HIV/HCV, 1 HIV/HBV, 15 HBV, 22 HCV, and 3 HBV/HCV) treated with anti-PD-(L)1 monotherapy (43) or in combination with ipilimumab (1) or chemotherapy (6). In the HIV group (21), the median age was 62 (29-85), 52% were male, 33% white, and 67% African American (AA). Tumor types included non-small-cell lung carcinoma (NSCLC; n=12), Hodgkin’s lymphoma and anal carcinoma (2 each), head and neck cancer, colorectal cancer, renal cell carcinoma (RCC), Burkitt’s lymphoma, and hepatocellular carcinoma (HCC) (one each). Any grade irAEs was 24% (5), and grade ≥ 3 irAEs was 10% (hepatitis and pneumonitis). Four pts had elevated HIV viral loads at baseline; 2 of 2 assessed had decreased levels after starting ICI therapy without changes in their antiretroviral therapy. Nine pts maintained an undetectable HIV viral load during ICI therapy. CD4 T-cell counts improved in 5 pts and decreased in 6 pts during ICI therapy. The ORR in response-evaluable pts for the entire group (16) was 25% (1 CR, 3 PR, 4 SD, and 8 PD). In the HBV/HCV cohort (34), median age was 62 (37-77), 71% were male, 24% white, and 50% AA. Tumor types included HCC (16), NSCLC (10), RCC (3), and head & neck, gastric and small cell lung cancer, one each. Any grade irAEs were noted in 50% (17) and grade ≥3 in 26% [colitis (2), hepatitis (3), pneumonitis, diabetic ketoacidosis, neurological weakness and rash, one each]. Of 15 HBV pts, 4 pts had detectable, and 8 pts had undetectable viral load before initiation of ICI. Among 4 pts with detectable viral load, no transaminitis was observed. Of 22 HCV pts, 9 were previously treated, 11 were untreated and no data available in 2. Among 4 pts with pre- and post-viral loads, 2 untreated pts’ viral loads showed small improvement and other 2 previously treated pts’ viral loads remained undetectable. The ORR in response-evaluable pts for the entire group (27) was 22% (6 PR, 7 SD, and 14 PD) and HCC pts (13) treated with anti-PD-(L)1 monotherapy was 23% (3 PR, 3 SD, and 7 PD).
Conclusion: ICI therapy was not associated with any new safety signal in pts with HIV, HBV, or HCV infection with no evidence of viral reactivation. Prospective trials are needed to validate the above findings.
Citation Format: Neil J. Shah, Ghassan AL-Shbool, Matthew Blackburn, Michael Cook, William J. Kelly, Anas Belouali, Sebastian Ochoa, Bradley S. Colton, Jeevan Puthiamadathil, Michael T. Serzan, Alice R. Knoedler, Stephen V. Liu, Michael J. Pishvaian, Mahsa Mohebtash, Subha Madhavan, Aiwu R. He, Michael B. Atkins, Geoffrey T. Gibney, Chul Kim. Safety and efficacy of immune checkpoint inhibitors (ICIs) in patients with HIV, hepatitis B, or hepatitis C viral infections [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3230.