Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection

• Published in: The New England journal of medicine Vol. 387; no. 21; pp. 1957 - 1968
• Main Authors: Yuen, Man-Fung, Lim, Seng-Gee, Plesniak, Robert, Tsuji, Keiji, Janssen, Harry L.A., Pojoga, Cristina, Gadano, Adrian, Popescu, Corneliu P., Stepanova, Tatyana, Asselah, Tarik, Diaconescu, Gheorghe, Yim, Hyung Joon, Heo, Jeong, Janczewska, Ewa, Wong, Alexander, Idriz, Nevin, Imamura, Michio, Rizzardini, Giuliano, Takaguchi, Koichi, Andreone, Pietro, Arbune, Manuela, Hou, Jinlin, Park, Sung Jae, Vata, Andrei, Cremer, Jennifer, Elston, Robert, Lukić, Tamara, Quinn, Geoff, Maynard, Lauren, Kendrick, Stuart, Plein, Helene, Campbell, Fiona, Paff, Melanie, Theodore, Dickens
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 24.11.2022
• Subjects: Alanine transaminase; Antigens; Antisense oligonucleotides; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Antiviral drugs; Chronic infection; DNA, Viral - blood; Fever; Gastroenterology; Gastroenterology General; Genetics; Hepatitis; Hepatitis B; Hepatitis B e Antigens - blood; Hepatitis B surface antigen; Hepatitis B Surface Antigens - blood; Hepatitis B virus - genetics; Hepatitis B, Chronic - drug therapy; Hepatitis B, Chronic - virology; Humans; Hypothesis testing; Infections; Infectious Disease; Injections, Subcutaneous; International organizations; Laboratories; Liver cancer; Liver Disease; Liver diseases; Nucleoside analogs; Nucleotide analogs; Oligonucleotides, Antisense - administration & dosage; Oligonucleotides, Antisense - adverse effects; Oligonucleotides, Antisense - therapeutic use; Placebos; Response rates; RNA Therapeutics; RNA, Messenger - drug effects; RNA, Viral - drug effects; Treatment Outcome; Viral Infections

In a phase 2 trial, bepirovirsen, an antisense oligonucleotide that targets all hepatitis B virus mRNAs, resulted in sustained loss of hepatitis B surface antigen and HBV DNA in 9 to 10% of participants with chronic HBV infection.