title: Telbivudine therapy for chronic hepatitis B: A journey to identify super-responders and to optimize treatment using the roadmap model.
abstract: Hepatitis B virus (HBV) infection is one of the most serious health problems worldwide with a high risk for cirrhosis and liver cancer. Several antiviral agents have been approved for the treatment of chronic hepatitis B, leading to a rapid reduction in HBV DNA and normalization of serum alanine aminotransferase levels. Telbivudine, a potent inhibitor of HBV replication, has been shown to be well tolerated. Because of the emergence of drug resistance, optimization strategies for telbivudine therapy have been shown to improve patient responses. Optimal baseline characteristics in so-called super-responders have been used to predict the virological response. Baseline HBV DNA levels < 9 log10copies/mL (2 × 108IU/mL) or alanine aminotransferase levels of more than or equal to twofold the upper limit of normal in HBeAg-positive patients and HBV DNA < 7 log10copies/mL (2 × 106IU/mL) in HBeAg-negative patients were strong predictors for virological response. In addition, the roadmap model, based on early virological response at week 24 of therapy, is considered as a powerful tool to identify patients at risk of treatment failure (HBV DNA ≥ 300 copies/mL, i.e. 60 IU/mL) and to reduce the risk of antiviral resistance. When considering pre-treatment characteristics and on-treatment responses, telbivudine may provide physicians with a wide choice of options to effectively treat patients with chronic hepatitis B, especially those with or at risk of renal impairment, or women of childbearing age.
authors: Graduate Institute of Clinical Medicine and Hepatitis Research Center, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors: Jia-Horng
authors: JH
authors: Kao
authors: Hepatology Department, AP-HP, Beaujon Hospital, University Paris Diderot and INSERM UMR1149, Centre de Recherche sur l'inflammation, Labex INFLAMEX, Clichy, France.
authors: Tarik
authors: T
authors: Asselah
authors: Department of Infectious Disease, Shengjing Hospital, China Medical University, Shenyang, China.
authors: Xiao-Guang
authors: XG
authors: Dou
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Kamal
authors: http://orcid.org/0000-0003-1896-9736
authors: K
authors: Hamed
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D011237:Predictive Value of Tests; D012306:Risk; D000077712:Telbivudine; D013936:Thymidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D000077712:Telbivudine; D000410:Alanine Transaminase; D013936:Thymidine
keywords: hepatitis B virus infection; nucleos(t)ides analogs; prediction; treatment response; viral load