title: Preemptive adefovir versus lamivudine for prevention of hepatitis B reactivation in chronic hepatitis B patients undergoing chemotherapy.
abstract: BACKGROUND
  This proof-of-concept study compared lamivudine (LAM) with a newer antiviral agent, adefovir dipivoxil (ADF), in preventing hepatitis B virus (HBV) reactivation in chronic HBV patients undergoing chemotherapy.
  
  
  METHODS
  Hepatitis B surface antigen (HBsAg) positive patients intended to undergo chemotherapy were randomized to receive either LAM 100 mg daily or ADF 10 mg daily. Anti-viral therapy was started 1 week prior to chemotherapy and until 6 months after completing chemotherapy. The primary outcome was HBV reactivation rate. All patients with viral breakthrough were screened for resistance mutations by direct sequencing.
  
  
  RESULTS
  Seventy treatment-naïve patients were consecutively randomized 1:1 to LAM or ADF. The median baseline HBV DNA levels were similar (LAM 3.36 vs. ADF 3.17 log10 copies/mL, p = 0.860). The median duration was 8.3 months on LAM and 10.6 months on ADF (p = 0.220). HBV reactivation was observed in 13/35 (37.1%) on LAM compared with 10/35 (28.6%) on ADF (p = 0.611). The median time to HBV reactivation was 4.6 and 8.1 months, on LAM and ADF respectively. Among these 13 patients, 8/13 (61.5%) on LAM had developed drug resistance mutations but none on ADF had developed drug resistance mutations to ADF (p = 0.003). Both drugs were well tolerated and no severe drug-related toxicities were reported.
  
  
  CONCLUSIONS
  In this randomized clinical study, adefovir and lamivudine demonstrated similar efficacy in preventing hepatitis B reactivation in HBsAg-positive patients undergoing chemotherapy. In patients whose hepatitis B reactivated, adefovir was associated with a lower resistance profile.
authors: Division of Gastroenterology, Case Western Reserve University / University Hospital Case Medical Center / Louis Stokes Cleveland Veterans Affairs Medical Center, 10701 East Blvd, GI Section 111E (W), Cleveland, OH, 44106, USA, edith.ho@case.edu.
authors: Edith Y
authors: EY
authors: Ho
authors: Thomas
authors: T
authors: Yau
authors: Franck
authors: F
authors: Rousseau
authors: E Jenny
authors: EJ
authors: Heathcote
authors: George K K
authors: GK
authors: Lau
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics / Q000502:physiology*; D019694:Hepatitis B, Chronic / Q000097:blood / Q000517:prevention & control*; D006801:Humans; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009369:Neoplasms / Q000188:drug therapy; D063065:Organophosphonates / Q000627:therapeutic use*; D014775:Virus Activation / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D063065:Organophosphonates; D019259:Lamivudine; D000225:Adenine; C106812:adefovir dipivoxil