Case Report For reprint orders, please contact: reprints@futuremedicine.com Nivolumab treatment in advanced lung cancer patient with chronic active hepatitis C and systemic lupus erythematosus Marco Tagliamento* ,1 , Francesco Grossi 2 , Sabrina Paolino 3 , Erika Rijavec 2 , Carlo Genova 1 , Giovanni Rossi 1 , Federica Biello 4 & Andrea De Maria 5,6 1 IRCCS Ospedale Policlinico San Martino, Lung Cancer Unit, Medical Oncology 2, Genoa, Italy 2 Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Medical Oncology, Milan, Italy 3 Research Laboratory & Academic Division of Clinical Rheumatology, Department of Internal Medicine & Medical Specialties (Di.M.I.), University of Genoa, Genoa, Italy 4 AOU Maggiore della Carit ` a, Medical Oncology, Novara, Italy 5 IRCCS Ospedale Policlinico San Martino, Infectious Diseases Unit, Genoa, Italy 6 Department of Health Sciences (DISSAL) & Centre of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy *Author for correspondence: tagliamento.marco@gmail.com The proportion of cancer patients candidate to receive immune checkpoint inhibitors (ICI) as part of the therapeutic approach is increasing in all settings, from the early to the advanced stage of disease. The management of ICI in special populations of patients with viral hepatitis or autoimmune disease still lacks strong evidence-based recommendations. Patients having one of these two clinical conditions are generally excluded from clinical trials testing immunotherapic compounds. We present the experience of a patient with heavily pretreated advanced non-small-cell lung cancer affected by both chronic active hepatitis C and systemic lupus erythematosus, treated with nivolumab. We give a report of long-term effcacy and safety data, and we provide an insight on this important topic. First draft submitted: 28 January 2017; Accepted for publication: 20 May 2018; Published online: 3 June 2019 Keywords: autoimmune disease • HCV • hepatitis C • immune checkpoint inhibitors • nivolumab • non-small cell lung cancer • systemic lupus erythematosus • viral hepatitis Since the first introduction of immune checkpoint inhibitors (ICI) in the treatment of non-small cell lung cancer (NSCLC), the attention was placed on two aspects concerning the safety of these compounds: the presence of infection by hepatitic viruses or human immunodeficiency virus (HIV) and a positive anamnesis for autoimmune disease (AD). To date, most phase II and III clinical trials of immunotherapy involving lung cancer and other cancer types have excluded patients with acute or chronic HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) infection. Similarly, patients with AD have been excluded from enrollment, with minor exceptions [1–5]. Exclusion of these patients occurred predominantly for registrative purposes in view of the potential for the so-called immune reconstitution inflammatory syndrome (IRIS, i.e. the paradoxical clinical worsening of the preexisting disease mediated by the restored immunity). Accordingly, few patients with lung cancer and coinfection or AD have so far been treated. At present, data about the safety of ICI in the treatment of patients with autoimmune disorders are poor and principally derive from small case series and from retrospective studies, particularly focused on melanoma. Among 19 patients with AD who received an anti-programmed death-1 (PD-1) for advanced melanoma, the 42% developed a flare of the preexisting disorder, and were treated with immunosuppressive and/or symptomatic therapy. No ICI discontinuation was required [6]. In another retrospective study, 20 out of 52 melanoma patients treated with anti-PD-1 had a flare of the AD (rheumatoid arthritis, polymyalgia rheumatica, Sjogren’s syndrome, immune thrombocytopaenic purpura, psoriasis) that required immunosuppressive therapy. Two patients discontinued the treatment [7]. Regarding lung cancer, in a retrospective evaluation of 56 cases of NSCLC with coexisting AD the exacerbation rate was around 23%, with a minority of patients requiring corticosteroids [8]. Immunotherapy (2019) 11(10), 873–879 ISSN 1750-743X 873 10.2217/imt-2019-0025 C  2019 Future Medicine Ltd