title: Effect of switching from treatment with nucleos(t)ide analogs to pegylated interferon α-2a on virological and serological responses in chronic hepatitis B patients.
abstract: OBJECTIVE
  To investigate the efficacy of switching to pegylated interferon-α-2a (PegIFNα-2a) treatment in nucleos(t)ide analog (NA)-treated chronic hepatitis B (CHB) responder patients.
  
  
  METHODS
  A 48-wk prospective and retrospective treatment trial of NA-treated CHB patients who had received entecavir (ETV) for at least 48 wk and had serum hepatitis B virus (HBV)-DNA < 500 IU/mL, serum hepatitis B envelope antigen (HBeAg) < 100 S/CO, serum alanine aminotransferase, and aspartate aminotransferase levels < 2 × the upper limit of normal of 40 IU/L was performed. The effects on virological and serological responses and adverse reactions to 0.5 mg daily ETV for 48 wkvsswitching to PegIFNα-2a were compared. Forty-four patients were randomized to be switched from NA treatment to the PegIFNα-2a group, and 44 patients were simultaneously randomized to the ETV group.
  
  
  RESULTS
  After 48 wk of therapy, the decrease in hepatitis B surface antigen (HBsAg) levels was greater in the PegIFNα-2a group than in the ETV group (3.1340 log10IU/mLvs3.6950 log10IU/mL,P= 0.00). Seven patients who were anti-HBs-positive at baseline achieved HBsAg loss when switched to PegIFNα-2a (15.91%vs0%,P= 0.018). The HBeAg serological conversion rate was higher in the PegIFNα-2a group than in the ETV group; however, the difference was not significant because of the small sample sizes (34.38%vs21.88%,P= 0.232). In the PegIFNα-2a group, patients with HBsAg levels < 1500 IU/mL at baseline had higher HBeAg seroconversion and HBsAg loss rates at week 48 than those with HBsAg levels ≥ 1500 IU/mL (HBeAg seroconversion: 17.86%vs62.5%,P= 0.007; HBsAg loss: 41.67%vs6.25%,P= 0.016). Moreover, patients with HBsAg levels < 1500 IU/mL at week 24 had higher HBsAg loss rates after therapy than those with HBsAg levels ≥ 1500 IU/mL (36.84%vs0%,P= 0.004). However, there were no statistically significant differences in HBeAg seroconversion rates (47.06%vs25.93%,P= 0.266).
  
  
  CONCLUSIONS
  NA-treated CHB patients switched to sequential PegIFNα-2a achieved highly potent treatment termination safely.
authors.affiliation: Li-Ting He, Xiao-Guang Ye, Xiao-Yuan Zhou, Department of Infectious Diseases, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong Province, China.
authors.forename: Li-Ting
authors.initials: LT
authors.lastname: He
authors.affiliation: Li-Ting He, Xiao-Guang Ye, Xiao-Yuan Zhou, Department of Infectious Diseases, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong Province, China.
authors.forename: Xiao-Guang
authors.initials: XG
authors.lastname: Ye
authors.affiliation: Li-Ting He, Xiao-Guang Ye, Xiao-Yuan Zhou, Department of Infectious Diseases, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou 510260, Guangdong Province, China.
authors.forename: Xiao-Yuan
authors.initials: XY
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D057915:Drug Substitution; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies; D000069078:Seroconversion; D000072230:Sustained Virologic Response; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C413685:entecavir; D006147:Guanine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; C100416:peginterferon alfa-2a
keywords: Chronic hepatitis B; Effect; Entecavir; Sequential therapy; pegylated interferon-α-2a