Treatment of chronic hepatitis D with the entry inhibitor myrcludex B: First results of a phase Ib/IIa study

摘要: Background & Aims The therapeutic option for patients with chronic hepatitis delta virus infection (CHD) is limited to interferon alpha rare curative outcome. Myrcludex B a first-in-class entry inhibitor inactivating the (HBV) and D (HDV) receptor sodium taurocholate co-transporting polypeptide. We report interim results of pilot trial on chronically infected HDV treated myrcludex B, or pegylated (PegIFNα-2a) their combination. Methods Twenty-four CHD were equally randomized (1:1:1) receive PegIFNα-2a Patients evaluated virological biochemical response tolerability study drugs at weeks 12 24. Results was well tolerated no serious adverse event occurred. Although surface antigen levels remained unchanged, RNA significantly declined week 24 in all cohorts. became negative two each cohorts, five B+PegIFNα-2a cohort. ALT decreased cohort (six eight patients), HBV DNA reduced Virus kinetic modeling suggested strong synergistic effect both HBV. Conclusions showed serum induced normalization under monotherapy. Synergistic antiviral effects Myr-IFN indicated benefit combination inhibition treat patients. Lay summary new drug infection. After 24weeks treatment and/or α-2a, R NA, relevant marker infection, D. Two which received either RNA, seven who same time negative. tolerated.