Clin Mol Hepatol.  2016 Sep;22(3):350-358. 10.3350/cmh.2016.0019.

Comparison of the clinical outcomes between antiviral-naïve patients treated with entecavir and lamivudine-resistant patients receiving adefovir add-on lamivudine combination treatment

• Kim HJ
• Park SK
• Yang HJ
• Jung YS
• Park JH
• Park DI
• Cho YK
• Sohn CI
• Jeon WK
• Kim BI
• Choi KY

• KMID: 2373135
• DOI: http://doi.org/10.3350/cmh.2016.0019

Abstract

BACKGROUND/AIMS
To analyze the effects of preexisting lamivudine (LAM) resistance and applying antiviral treatment (adefovir [ADV] add-on LAM combination treatment) on long-term treatment outcomes, and comparing the clinical outcomes of antiviral-naïve chronic hepatitis B patients receiving entecavir (ETV) monotherapy.
METHODS
This study enrolled 73 antiviral-naïve patients who received 0.5-mg ETV as an initial therapy and 54 patients who received ADV add-on LAM combination treatment as a rescue therapy from July 2006 to July 2010.
RESULTS
During 24-month treatments, the decreases in serum log10HBV-DNA values (copies/mL) were significantly greater in the antiviral-naïve patients treated with ETV than the patients receiving ADV add-on LAM combination treatment. The biochemical response rates for alanine aminotransferase normalization at 6 months (ETV) and 12 months (ADV add-on LAM) were 90.4% (66/73) and 77.8% (42/54), respectively (P=0.048). A Kaplan-Meier analysis indicated that the rates of serologic response, viral breakthrough, and emergence of genotypic resistance did not differ significantly between the two patient groups. There were also no significant intergroup differences in the rates of disease progression (PD) and new development of hepatocellular carcinoma (HCC).
CONCLUSION
The long-term clinical outcomes of antiviral-naïve patients treated with ETV and LAM-resistant patients receiving ADV add-on LAM combination treatment were comparable in terms of the emergence of HCC and disease progression.

Keyword

Entecavir; Adefovir; Chronic hepatitis B; Disease progression; Cirrhosis

MeSH Terms

Adenine/*analogs & derivatives/pharmacology/therapeutic use
Adult
Alanine Transaminase/blood
Antibodies, Viral/blood
Antiviral Agents/*therapeutic use
DNA, Viral/blood
Disease Progression
Drug Resistance, Viral/drug effects
Drug Therapy, Combination
Female
Follow-Up Studies
Genotype
Guanine/analogs & derivatives/pharmacology/therapeutic use
Hepatitis B e Antigens/blood
Hepatitis B virus/drug effects/genetics/isolation & purification
Hepatitis B, Chronic/*drug therapy
Humans
Lamivudine/pharmacology/therapeutic use
Male
Middle Aged
Organophosphonates/pharmacology/*therapeutic use
Treatment Outcome
Adenine
Alanine Transaminase
Antibodies, Viral
Antiviral Agents
DNA, Viral
Hepatitis B e Antigens
Organophosphonates
Lamivudine
Guanine