Safety and Efficacy of Immune Checkpoint Inhibitors in Patients with Cancer and Viral Hepatitis: The MD Anderson Cancer Center Experience

Abstract

Background Despite the clinical benefit of immune checkpoint inhibitors (ICIs), patients with a viral hepatitis have been excluded from clinical trials because of safety concerns. The purpose of this study was to determine the incidence rate of adverse events (AEs) in patients with viral hepatitis who received ICIs for cancer treatment. Materials and Methods We conducted a retrospective study in patients with cancer and concurrent hepatitis B or C, who had undergone treatment with ICI at MD Anderson Cancer Center from January 1, 2010 to December 31, 2019. Results Of the 1076 patients screened, we identified 33 with concurrent hepatitis. All 10 patients with HBV underwent concomitant antiviral therapy during ICI treatment. Sixteen of the 23 patients with HCV received it before the initiation of ICI. The median follow-up time was 33 months (95% CI, 23-45) and the median duration of ICI therapy was 3 months (IQR, 1.9-6.6). Of the 33 patients, 12 (39%) experienced irAEs (immune-related adverse events) of any grade, with 2 (6%) having grade 3 or higher. None of the patients developed hepatitis toxicities. Conclusion ICIs may be a therapeutic option with an acceptable safety profile in patients with cancer and advanced liver disease.

Management of Hepatitis B Virus and Hepatitis C Virus Infections in Patients with Cancer Receiving Immune Checkpoint Inhibitors

“…[ 19 , 22 ] HBV reactivation after ICIs can be fatal, but recent studies have not resulted in any cases of HBV-related liver failure or death. [ 7 ] In our search of the literature, we found 28 studies that evaluated the safety of ICI therapy in patients with HBV infection and cancer: 3 prospective clinical trials, 7 retrospective cohort studies, 9 retrospective case series, and 9 case reports ( Table 2 ). [ 7 , 8 , 20 , 23–45 ] We also found two systematic reviews on this topic.…”

“…As of Jul 7, 2023, a total of 2799 patients with cancer with chronic or past HBV infection receiving ICIs had been reported in the literature. [ 7 , 8 , 20 , 23–35 , 37–40 , 44–47 ] Of these, 1.4% (38/2799) had HBV reactivation, of whom 35 (92%) had chronic HBV infection ( Fig. 1 ).…”

“… HBV reactivation rates in HBV-infected patients with cancer receiving ICIs based on studies published as of July 2023. [ 7 , 8 , 20 , 23–35 , 37–40 , 44–47 ] The ICI regimens most commonly linked to HBV reactivation were PD-1 inhibitors (camrelizumab, nivolumab, pembrolizumab, sintilimab, and toripalimab). HBV: hepatitis B virus; ICI: immune checkpoint inhibitor; PD-1: programmed cell death protein-1.…”

“…Oncologic professional societies recommend universal HCV screening for all patients with cancer. [ 59 , 60 ] Published data [ 6 , 7 , 14 , 23 , 24 , 31 , 32 , 45 , 57 , 61 , 62 ] support that HCV-infected patients with cancer can be safely enrolled in cancer clinical trials of ICIs; however, these patients should be monitored for hepatitis flare and reactivation (or enhanced HCV replication). The management of HCV in patients with cancer receiving ICIs should be individualized on the basis of the patient’s viral hepatitis status, liver function, cancer treatment plan, and cancer status.…”

“…[ 6 ] Many cancer clinical trials of ICIs exclude patients with HBV infection or HCV infection because of safety concerns regarding hepatitis flare and viral reactivation. [ 7 ]…”