Efficacy and safety of eltrombopag in the treatment of immune thrombocytopenia patients with hepatitis B virus infection: A prospective, multicenter, single arm, phase II trial

Abstract

Hepatitis B virus (HBV) infection is the most common chronic viral infection worldwide. Epidemiological data showed that the hepatitis virus surface antigen carrier rate among those aged 1-59 was 7.2% in China, ranking at the intermediate prevalence level. 1 Although there is no epidemiological data report on immune thrombocytopenia patients with HBV infection (ITP-HBV), previous small sample studies showed that the detection rate of anti-hepatitis B core antigen (anti-HBc) in ITP patients was 30.3%. 2 For ITP-HBV, immunosuppressive agents increase the risk of HBV reactivation. Elevating platelet counts while controlling HBV replication is the key to a good prognosis for these patients.Thrombopoietin receptor agonists (TPO-RAs) can promote bone marrow megakaryocytes to produce mature platelets but have weak regulatory effects on the immune system. 3 Studies have shown that the overall response rate of TPO-RAs in the treatment of adult ITP is approximately 80%. 4 The advent of the era of TPO-RAs has changed the pattern of second-line treatment of ITP and provides new possibilities for disease management of ITP-HBV. Therefore, to evaluate the efficacy and safety of TPO-RAs in the treatment of ITP-HBV, we conducted a prospective, multicenter, single-arm clinical study on eltrombopag in the treatment of ITP-HBV (ClinicalTrials.gov Identifier: NCT03664518). Methods are detailed in the Supplementary Methods.Between December 2018 and December 2021, 48 patients from six sites in China were enrolled in the study and subsequently included in the safety analysis set (SS). In total, 46 patients completed the stage I study and were considered as the full analysis set (FAS) and perprotocol analysis set (PPS) (Figure S1). The demographics and baseline characteristics of patients were summarized in Tables S1 and S2. The median age of total patients was 49 years (interquartile range [IQR] 34-57), and 58.7% of patients were female. The median baseline platelet count was 13 Â 10 9 /L (IQR 7-23). Thirty-seven percentage (17/46) of patients were treated with glucocorticoids at baseline, 80.4% (37/46) received antiviral drugs, and 80.4% (37/46) had a history of steroid therapy. The difference of baseline characteristics was not statistically significant among the newly diagnosed, persistent, and chronic groups (all p > .05, Table S1). Additionally, we found that no baseline characteristic was correlated with treatment response (Table S3).