title: 52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B.
abstract: OBJECTIVE
  The Roadmap concept is a therapeutic framework in chronic hepatitis B for the intensification of nucleoside analogue monotherapy based on early virologic response. The efficacy and safety of this approach applied to telbivudine treatment has not been investigated.
  
  
  METHODS
  A multinational, phase IV, single-arm open-label study (ClinicalTrials.gov ID NCT00651209) was undertaken in HBeAg-positive, nucleoside-naive adult patients with chronic hepatitis B. Patients received telbivudine (600 mg once-daily) for 24 weeks, after which those with undetectable serum HBV DNA (<300 copies/mL) continued to receive telbivudine alone while those with detectable DNA received telbivudine plus tenofovir (300 mg once-daily). Outcomes were assessed at Week 52.
  
  
  RESULTS
  105 patients commenced telbivudine monotherapy, of whom 100 were included in the efficacy analysis. Fifty-five (55%) had undetectable HBV DNA at Week 24 and continued telbivudine monotherapy; 45 (45%) received tenofovir intensification. At Week 52, the overall proportion of undetectable HBV DNA was 93% (93/100) by last-observation-carried-forward analysis (100% monotherapy group, 84% intensification group) and no virologic breakthroughs had occurred. ALT normalization occurred in 77% (87% monotherapy, 64% intensification), HBeAg clearance in 43% (65% monotherapy, 16% intensification), and HBeAg seroconversion in 39% (62% monotherapy, 11% intensification). Six patients had HBsAg clearance. Myalgia was more common in the monotherapy group (19% versus 7%). No decrease in the mean glomerular filtration rate occurred in either treatment group at Week 52.
  
  
  CONCLUSIONS
  Telbivudine therapy with tenofovir intensification at Week 24, where indicated by the Roadmap strategy, appears effective and well tolerated for the treatment of chronic hepatitis B.
authors: NKC Institute of Gastroenterology and Hepatology, Prince of Songkla University, Songklanagarind Hospital, Hat-Yai, Songkhla, Thailand. teerha.p@psu.ac.th
authors: Teerha
authors: T
authors: Piratvisuth
authors: Piyawat
authors: P
authors: Komolmit
authors: Tawesak
authors: T
authors: Tanwandee
authors: Wattana
authors: W
authors: Sukeepaisarnjaroen
authors: Henry L Y
authors: HL
authors: Chan
authors: Mário G
authors: MG
authors: Pessôa
authors: Eduardo
authors: E
authors: Fassio
authors: Suzane K
authors: SK
authors: Ono
authors: Fernando
authors: F
authors: Bessone
authors: Jorge
authors: J
authors: Daruich
authors: Stefan
authors: S
authors: Zeuzem
authors: Hugo
authors: H
authors: Cheinquer
authors: Rashidkhan
authors: R
authors: Pathan
authors: Yuhong
authors: Y
authors: Dong
authors: Aldo
authors: A
authors: Trylesinski
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects* / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D000077712:Telbivudine; D000068698:Tenofovir; D013936:Thymidine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome; D014779:Virus Replication / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D000077712:Telbivudine; D000068698:Tenofovir; D000410:Alanine Transaminase; D000225:Adenine; D013936:Thymidine
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