Details

Autor(en) / Beteiligte

• Marcellin, Patrick
• Chang, Ting‐Tsung
• Lim, Seng G. Lee
• Sievert, William
• Tong, Myron
• Arterburn, Sarah
• Borroto‐Esoda, Katyna
• Frederick, David
• Rousseau, Franck

Titel

Long‐term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen–positive chronic hepatitis B

Ist Teil von

• Hepatology (Baltimore, Md.), 2008-09, Vol.48 (3), p.750-758

Ort / Verlag

Hoboken: Wiley Subscription Services, Inc., A Wiley Company

Erscheinungsjahr

2008

Quelle

Wiley-Blackwell Journals

Beschreibungen/Notizen

• Treatment of 171 patients with hepatitis B e antigen (HBeAg)‐positive chronic hepatitis B (CHB) with adefovir dipivoxil (ADV) 10 mg over 48 weeks resulted in significant histological, virological, serological, and biochemical improvement compared with placebo. The long‐term efficacy and safety of ADV in a subset of these patients was investigated for up to 5 years. Sixty‐five patients given ADV 10 mg in year 1 elected to continue in a long‐term safety and efficacy study (LTSES). At enrollment, the 65 LTSES patients were a median 34 years old, 83% male, 74% Asian, 23% Caucasian, median baseline serum hepatitis B virus (HBV) DNA 8.45 log10 copies/mL, and median baseline alanine aminotransferase (ALT) 2.0 × upper limit of normal. At 5 years on study, the median changes from baseline in serum HBV DNA and ALT for the 41 patients still on ADV were 4.05 log10 copies/mL and −50 U/L, respectively. HBeAg loss and seroconversion were observed in 58% and 48% of patients by end of study, respectively. Fifteen patients had baseline and end of follow‐up liver biopsies; improvements in necroinflammation and fibrosis were seen in 67% and 60% of these patients, respectively. Adefovir resistance mutations A181V or N236T developed in 13 LTSES patients; the first observation was at study week 195. There were no serious adverse events related to ADV. Conclusion: Treatment with ADV beyond 48 weeks was well tolerated and produced long‐term virological, biochemical, serological, and histological improvement. (HEPATOLOGY 2008;48:750–758.)