Source

Department of Gastroenterology and Hepatology, NHO, Osaka National Hospital, Osaka Department of the Clinical Research Center, NHO, Nagasaki Medical Center, Nagasaki Department of Gastroenterology, NHO, Kyushu Medical Center, Kyushu Department of Gastroenterology, NHO, Nagoya Medical Center, Nagoya Department of Gastroenterology, NHO, Kanazawa Medical Center, Kanazawa Center for Liver Disease, NHO, Kokura Medical Center, Kokura Department of Hepatology, NHO, Minamiwakayama Medical Center, Minamiwakayama Department of Gastroenterology, NHO, Osaka Minami Medical Center, Osaka Department of Gastroenterology, NHO, Kure Medical Center, Kure Department of Gastroenterology, NHO, Kyoto Medical Center, Kyoto Department of Gastroenterology, NHO, Tokyo National Hospital, Tokyo Department of Gastroenterology, NHO, Sendai Medical Center, Sendai Department of Gastroenterology, NHO, Sagamihara National Hospital, Sagamihara Department of Gastroenterology, NHO, Matsumoto Medical Center, Matsumoto, Japan.

Abstract

Aim:  Add-on adefovir dipivoxil (ADV) therapy has been a standard rescue treatment for patients with lamivudine (LAM)-resistant chronic hepatitis B, but the overall benefits of long-term add-on ADV therapy are still limited. The aim of this study was to evaluate the long-term efficiency of add-on ADV treatment and to explore predictive factors associated with it. Methods:  A total of 158 patients with LAM-resistant chronic hepatitis B were included in this retrospective, multicenter, nationwide study in Japan. After confirming LAM resistance, ADV was added to LAM treatment. Three types of events were considered as outcomes: virological response, hepatitis B e antigen (HBeAg) clearance and alanine aminotransferase (ALT) normalization. Virological response was defined as serum hepatitis B virus (HBV) DNA levels of less than 3 log copies/mL. Baseline factors contributing to these outcomes were examined by univariate and multivariate analyses. Results:  The median total duration of ADV treatment was 41 months (range, 6-84). The rate of virological response was 90.8% at 4 years of treatment; HBeAg clearance and ALT normalization were achieved by 34.0% and 82.7%, respectively, at the end of follow up. Each outcome had different predictive factors: baseline HBV DNA and albumin level were predictive factors for virological response, history of interferon therapy and ALT level for HBeAg clearance, and sex and baseline albumin level for ALT normalization. Conclusion:  Long-term add-on ADV treatment was highly effective in LAM-resistant chronic hepatitis B patients in terms of virological and biochemical responses. Lower HBV replication and lower albumin level at baseline led to better outcomes.