Although the researchers state that more studies are needed to validate their findings, they found that patients who also had HIV, HBV, or HCV who were being treated with ICI therapy had similar rates of efficacy and toxicity to patients without chronic viral infections.
Patients with cancer who also have viral infections, such as HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) should not be excluded from immune checkpoint inhibitor (ICI) studies, according to a new study published in the Journal for ImmunoTherapy of Cancer.
Although the researchers state that more studies are needed to validate their findings, they found that patients who also had HIV, HBV, or HCV who were being treated with ICI therapy had similar rates of efficacy and toxicity to patients without chronic viral infections. Additionally, found no viral reactivation. Tumor responses occurred in patients with HIV with low CD4 T-cell counts.
This retrospective analysis looked at 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.
Previously, patients with chronic viral infections were excluded from ICI therapy, a type of cancer immunotherapy that works through suppression of immune inhibitory pathways such as the programmed cell death protein-1 (PD-1)/programmed death-ligand-1 (PD-L1) axis and the cytotoxic lymphocytes antigen proteins (CTLA-4) pathway.
From the MedStar database, researchers identified 50 patients who fit the study criteria. Of that group, 16 were living with HIV, 29 with HBV/HCV, and 5 with concurrent HIV and either HBV or HCV. The median age was 62 years, and most of the patients were treated with anti-PD-(L)1 monotherapy while 1 was treated with a combination of ipilimumab and nivolumab; another 6 patients were treated with anti-PD-(L)1/chemotherapy/targeted therapy combination. The most common type of cancer in the HIV cohort was non-small cell lung cancer. In the HBV/HCV cohort, hepatocellular carcinoma was the most common cancer.
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.
Among RECIST evaluable patients, (n = 18) the 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.
In the HBV/HCV cohort (n = 34), any grade irAEs were 44% with grade ≥ 3 irAEs in 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.
The study had 2 limitations-viral parameters were not collected and tumor assessment was not performed consistently.
However, the authors concluded that “toxicity and efficacy rates were similar to those observed in patients without chronic viral infections, supporting the use of ICI therapy in this patient population and the inclusion of such patients’ in future ICI-based trials.”
Additional studies are needed, they said.
Shah NJ, Al-Shbook G, Blackburn M, et al. Safety and efficacy of immune checkpoint inhibitors (ICIs) in cancer patients with HIV, hepatitis B, or hepatitis C viral infection. J Immunother Cancer. 2019;7(1):353. doi: 10.1186/s40425-019-0771-1.