J Korean Med Sci.  2005 Oct;20(5):821-828. 10.3346/jkms.2005.20.5.821.

Adefovir Dipivoxil Alone or in Combination with Ongoing Lamivudine in Patients with Decompensated Liver Disease and Lamivudine-resistant Hepatitis B Virus

• Kim KM
• Choi WB
• Lim YS
• Lee HC
• Chung YH
• Lee YS
• Suh DJ

• KMID: 1781766
• DOI: http://doi.org/10.3346/jkms.2005.20.5.821

Abstract

The purpose of this prospective study was to evaluate the efficacy and safety of adefovir dipivoxil with or without ongoing lamivudine in decompensated lamivudine-resistant chronic hepatitis B patients. Forty-six hepatitis B e antigen (HBeAg)-positive patients with decompensated liver function and lamivudine-resistant hepatitis B virus (HBV) were assigned to adefovir dipivoxil monotherapy (n=18) or combination therapy with ongoing lamivudine (n=28) according to their own preference. After 24 weeks of treatment, 83% of monotherapy and 86% of combination therapy showed serum HBV DNA below detection limit (<0.5 pg/mL). Alanine aminotransferase (ALT) normalized in 78% and 82% respectively. Median Child-Pugh-Turcotte (CPT) score or Model for End-Stage Liver Disease (MELD) score reduced significantly by 3 or 5 point in monotherapy and 2 or 2 point in combination therapy respectively. There were no significant differences in rate of undetectable serum HBV DNA, median change of ALT and median reduction of CPT or MELD scores between the two groups. In conclusion, both adefovir dipivoxil monotherapy and combination therapy with ongoing lamivudine result in comparable virologic, biochemical, and clinical improvements in HBeAg-positive patients with decompensated liver function and lamivudine-resistant HBV. Combination with lamivudine showed no additional benefit over monotherapy during 24 weeks of treatment in these patients.

Keyword

Hepatitis B, Chronic; Hepatitis B virus; adefovir Dipivoxil; Lamivudine; Liver Diseases

MeSH Terms

Adenine/administration and dosage/*analogs and derivatives
Adolescent
Adult
Anti-HIV Agents/administration and dosage
Antiviral Agents/administration and dosage
Drug Combinations
Drug Resistance, Viral/drug effects
Female
Hepatitis B/*complications/*drug therapy
Humans
Lamivudine/*administration and dosage
Liver Cirrhosis/*etiology/*prevention and control
Male
Middle Aged
Phosphonic Acids/*administration and dosage
Research Support, Non-U.S. Gov't
Treatment Outcome

Figure

• 

  Fig. 1 Median values of HBV DNA levels in adefovir dipivoxil monotherapy and adefovir dipivoxil/lamivudine combination therapy group over 24 weeks of treatment. Median serum HBV DNA levels decreased rapidly within 8 weeks and remained low throughout the 24 weeks in both groups. The 0 marker on Y axis more accurately represents a value of <0.5 pg/mL HBV DNA because the lower limit of detection of Digene Hybrid Capture II assay used for measurement of HBV DNA was 0.5 pg/mL. The horizontal lines in the box mark the 25th, 50th, and 75th percentiles of the data. Error bars extend from the quartiles to the farthest observation.

• 

  Fig. 2 Median values of ALT levels in adefovir dipivoxil monotherapy and adefovir dipivoxil/lamivudine combination therapy group over 24 weeks of treatment. Median ALT levels decreased rapidly within 8 weeks and remained lower than the baseline levels throughout the 24 weeks in both groups. The horizontal lines in the box mark the 25th, 50th, and 75th percentiles of the data. Error bars extend from the quartiles to the farthest observation.

• 

  Fig. 3 Changes of MELD score at baseline and at week 24 in adefovir dipivoxil monotherapy and adefovir dipivoxil/lamivudine combination therapy group. There was a significant reduction of median values of MELD score at week 24 compared with baseline in both groups.

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