Anti-PD-1
monoclonal antibodies have shown durable long-term survival benefit in patients with metastatic
melanoma. Limited evidence exists on the safety and efficacy of
PD-1 inhibitors in patients with hepatitis B virus (HBV) and hepatitis C virus (HCV)
infections as these patients have traditionally been excluded from clinical trials because of a theoretical risk of
immune reconstitution inflammatory syndrome. We aim to determine the safety and efficacy of treatment with
PD-1 inhibitors in seven patients with HBV/HCV
infection and concurrent metastatic
melanoma or
non-small-cell lung cancer (NSCLC). We describe seven patients treated with
PD-1 inhibitors nivolumab and
pembrolizumab for either metastatic
melanoma or metastatic NSCLC in the setting of chronic or past HBV/HCV
infection. The safety and efficacy of treatment were analysed retrospectively by examining response to treatment,
alanine transaminase (ALT) trends and viral load trends. One patient showed an increase in ALT of Common Terminology Criteria for Adverse Events (CTCAE) grade 2 severity that returned to the normal range following treatment of his HCV
infection with
ledipasvir 90 mg/
sofosbuvir 400 mg. An additional four patients showed an increase in ALT of CTCAE grade 1 severity. The remaining two patients experienced no hepatic toxicity, with stable disease continuing after more than 24 cycles of
nivolumab. Efficacy was similar to the data of published trials. Our results indicate that patients with metastatic
melanoma and NSCLC can be treated safely with
PD-1 inhibitors in the context of HBV/HCV
infection. However, we recommend that those with active viral
hepatitis be monitored closely in consultation with a hepatologist and treated with
antiviral therapy if indicated.