BACKGROUND AND STUDY AIMS: To investigate the efficacy of the combined therapy of lamivudine (LAM) plus alpha interferon (IFN) and LAM monotherapy in HBeAg negative chronic hepatitis B (CHB) patients who were unresponsive to previous IFN monotherapy, and the incidence of YMDD mutations. PATIENTS- METHODS:Forty-fiveHBeAgnegative patients were enrolled in this study. 24 of these were treated with LAM (100 mg/day, PO, for 24 months) alone (group 1) and 21 with combined therapy (IFN-alpha-2b, 10 MU, tiw, SC, for 6 months plus LAM 100 mg/day, PO, for 24 months) (group 2). Normal alanine aminotransferase values and negativity of HBV DNA (molecular hybridization; Digene, USA) were accepted as treatment response. YMDD variants were analyzed at the end of treatment or when clinical breakthrough was observed (Inno-Lipa Innogenetic kit, Belgium). RESULTS: End of follow-up response rate was 29.2%, by ITT in group 1, 19% in group 2 (p > 0.05). Histological activity index was statistically decreased by LAM monotherapy as compared to combination therapy. YMDD mutation rates were 59% in group 1, 62.5% in group 2 (p > 0.05). CONCLUSIONS: Additional IFN-alpha therapy to LAM in HBeAg negative CHB not responding to previous IFN-alpha monotherapy does not increase the response rate compared to LAM monotherapy and does not also decrease the incidence of YMDD mutations.
RCT Entities:
BACKGROUND AND STUDY AIMS: To investigate the efficacy of the combined therapy of lamivudine (LAM) plus alpha interferon (IFN) and LAM monotherapy in HBeAg negative chronic hepatitis B (CHB) patients who were unresponsive to previous IFN monotherapy, and the incidence of YMDD mutations. PATIENTS- METHODS: Forty-five HBeAg negative patients were enrolled in this study. 24 of these were treated with LAM (100 mg/day, PO, for 24 months) alone (group 1) and 21 with combined therapy (IFN-alpha-2b, 10 MU, tiw, SC, for 6 months plus LAM 100 mg/day, PO, for 24 months) (group 2). Normal alanine aminotransferase values and negativity of HBV DNA (molecular hybridization; Digene, USA) were accepted as treatment response. YMDD variants were analyzed at the end of treatment or when clinical breakthrough was observed (Inno-Lipa Innogenetic kit, Belgium). RESULTS: End of follow-up response rate was 29.2%, by ITT in group 1, 19% in group 2 (p > 0.05). Histological activity index was statistically decreased by LAM monotherapy as compared to combination therapy. YMDD mutation rates were 59% in group 1, 62.5% in group 2 (p > 0.05). CONCLUSIONS: Additional IFN-alpha therapy to LAM in HBeAg negative CHB not responding to previous IFN-alpha monotherapy does not increase the response rate compared to LAM monotherapy and does not also decrease the incidence of YMDD mutations.
Authors: Tatyana A Shamliyan; James R Johnson; Roderick MacDonald; Aasma Shaukat; Jian-Min Yuan; Robert L Kane; Timothy J Wilt Journal: J Gen Intern Med Date: 2011-01-04 Impact factor: 5.128