Safety and efficacy of immune checkpoint inhibitors (ICIs) in cancer patients with HIV, hepatitis B, or hepatitis C viral infection

• Published in: Journal for immunotherapy of cancer Vol. 7; no. 1; pp. 353 - 8
• Main Authors: Shah, Neil J., Al-Shbool, Ghassan, Blackburn, Matthew, Cook, Michael, Belouali, Anas, Liu, Stephen V., Madhavan, Subha, He, Aiwu Ruth, Atkins, Michael B., Gibney, Geoffrey T., Kim, Chul
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd 17.12.2019; BioMed Central Ltd; BMJ Publishing Group LTD; BioMed Central; BMJ Publishing Group
• Subjects: Adult; Aged; Aged, 80 and over; Analysis; Anti-HIV agents; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Atezolizumab; Avelumab; Bictegravir; Biomarkers; Biopsy; Cancer; Cancer patients; Cancer therapies; Carboplatin; Care and treatment; Chemotherapy; Clinical trials; Clinical/Translational Cancer Immunotherapy; Cobicistat; Darunavir; Dolutegravir; Durvalumab; Elvitegravir; Emtricitabine; Female; Health aspects; Hepatitis B; Hepatitis B (HBV); Hepatitis B - complications; Hepatitis B - diagnosis; Hepatitis C; Hepatitis C (HCV); Hepatitis C - complications; Hepatitis C - diagnosis; Hepatitis C virus; HIV; HIV infections; HIV Infections - complications; HIV Infections - diagnosis; HIV patients; Hospitals; Human immunodeficiency virus; Human immunodeficiency virus (HIV); Humans; Immune checkpoint inhibitors; Immune checkpoint inhibitors (ICI); Immune related adverse events (irAEs); Immunotherapy; Infection; Infections; Ipilimumab; Liver cancer; Lung cancer; Lymphoma; Male; Middle Aged; Molecular Targeted Therapy - adverse effects; Molecular Targeted Therapy - methods; Neoplasm Staging; Neoplasms - complications; Neoplasms - diagnosis; Neoplasms - drug therapy; Neoplasms - etiology; Nivolumab; Odds Ratio; Patients; Pembrolizumab; Pemetrexed; Raltegravir; Research Article; Retrospective Studies; Rilpivirine; T cells; Tomography, X-Ray Computed; Toxicity; Treatment Outcome; Tumors; Viral infections; Hepatitis C (HCV); Hepatitis B (HBV); Immune checkpoint inhibitors (ICI); Immune related adverse events (irAEs); Human immunodeficiency virus (HIV)
• ISSN: 2051-1426; 2051-1426
• DOI: 10.1186/s40425-019-0771-1

BackgroundPatients with chronic viral infections including human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) are at increased risk of developing malignancies. The safety and efficacy of ICI therapy in patients with both cancer and chronic viral infections is not well established as most clinical trials of ICIs excluded these patient populations.MethodsWe performed a retrospective analysis of patients with advanced-stage cancers and HIV, HBV, or HCV infection treated with ICI therapy at 5 MedStar Health hospitals from January 2011 to April 2018.ResultsWe identified 50 patients including 16 HIV, 29 HBV/HCV, and 5 with concurrent HIV and either HBV or HCV. In the HIV cohort (n = 21), any grade immune-related adverse events (irAEs) were 24% with grade ≥ 3 irAEs 14%. Among 5 patients with matched pre/post-treatment results, no significant changes in HIV viral load and CD4+ T-cell counts were observed. RECIST confirmed (n = 18) overall response rate (ORR) was 28% with 2 complete responses (CR) and 3 partial responses (PR). Responders included 2 patients with low baseline CD4+ T-cell counts (40 and 77 cells/ul, respectively). In the HBV/HCV cohort (n = 34), any grade irAEs were 44% with grade ≥ 3 irAEs 29%. RECIST confirmed ORR was 21% (6 PR). Among the 6 patients with known pre/post-treatment viral titers (2 HCV and 4 HBV), there was no evidence of viral reactivation.ConclusionsOur retrospective series is one of the largest case series to report clinical outcomes among HIV, HBV and HCV patients treated with ICI therapy. Toxicity and efficacy rates were similar to those observed in patients without chronic viral infections. Viral reactivation was not observed. Tumor responses occurred in HIV patients with low CD4 T-cell counts. While prospective studies are needed to validate above findings, these data support not excluding such patients from ICI–based clinical trials or treatment.