A double-blind, randomized, lamivudine-controlled clinical trial of DAIDING (adefovir dipivoxil) for lamivudine-resistant patients with chronic hepatitis B / 中华肝脏病杂志
Chinese Journal of Hepatology
;
(12): 803-805, 2006.
Artigo
em Chinês
| WPRIM
| ID: wpr-260588
ABSTRACT
<p><b>OBJECTIVE</b>To investigate the efficacy and safety of adefovir dipivoxil (ADV, DAIDING) for Chinese chronic hepatitis B patients with lamivudine (LAM) resistance.</p><p><b>METHODS</b>This study was a multicenter, double-blind clinical trial. 209 chronic hepatitis B patients with LAM resistance were randomly put in an ADV, DAIDING or a LAM group. After 24 and 48-weeks of treatment, serum HBV DNA levels were measured by quantitative PCR and liver function tests; HBV serology and safety assessments were also conducted.</p><p><b>RESULTS</b>The mean reduction of HBV DNA from baseline at 24 and 48 weeks was significantly greater in the ADV group compared with that in the LAM group (2.40 log10 vs 0.94 log10, P < 0.01; 2.71 log10 vs 1.07 log10, P < 0.01). In the ADV group, the virological response and ALT normalization at 24 and 48 weeks were significantly higher than those in the LAM group. There was no significant difference between the two groups in the portion of HBeAg reduction, HBeAg seroconversion and incidence of adverse events. There was no severe adverse event related to the investigational product, DAIDING, in this trial.</p><p><b>CONCLUSION</b>DAIDING (ADV) is effective and safe for the treatment of chronic hepatitis B patients with LAM resistance.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Antivirais
/
Farmacologia
/
Adenina
/
Método Duplo-Cego
/
Lamivudina
/
Hepatite B Crônica
/
Farmacorresistência Viral
/
Usos Terapêuticos
/
Tratamento Farmacológico
/
Organofosfonatos
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Adolescente
/
Adulto
/
Idoso
/
Feminino
/
Humanos
/
Masculino
Idioma:
Chinês
Revista:
Chinese Journal of Hepatology
Ano de publicação:
2006
Tipo de documento:
Artigo
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