96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in the treatment of chronic hepatitis B☆

Background/Aims

In order to prevent the occurrence of drug-resistant mutants associated with treatment for chronic hepatitis B virus (HBV) infection, combination therapy is being developed. To determine the efficacy of adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy in chronic HBV infection.

Methods

Thirty treatment-naı¨ve, HBeAg-positive patients were randomized to combination ADV plus FTC (n=14) or ADV plus placebo monotherapy (n=16) for 96 weeks. HBV DNA was measured by polymerase chain reaction. Treatment was stopped in those with HBeAg seroconversion.

Results

The median decrease in HBV DNA at week 96 was higher in the combination group (−5.30 vs. −3.98log₁₀copies/ml, p=0.05). More patients in the combination group had normalization of alanine aminotransaminase and HBV DNA<300copies/ml at week 96 when compared with the monotherapy group [11 of the 14 patients (78.6%) vs. 6 of the 16 patients (37.5%), p=0.03]. However, HBeAg seroconversion at week 96 was similar in the 2 groups [2/14 (14.3%) vs. 4/16 (25.0%), p=NS]. No ADV or FTC resistance was detected at week 96. In those with HBeAg seroconversion, 50.0% had post-treatment relapse.

Conclusions

Combination ADV plus FTC resulted in more potent suppression of HBV DNA over 96 weeks of therapy.

Abbreviations: ADV, adefovir dipivoxil, FTC, emtricitabine, HBeAg, hepatitis B e antigen, anti-HBe, hepatitis B e antibody, ALT, alanine aminotransaminase, PCR, polymerase chain reaction, HBV, hepatitis B virus

Keywords: Combination therapy, Serum HBV DNA suppression, Normalization of serum alanine aminotransaminase, Adefovir dipivoxil plus emtricitabine, Adefovir dipivoxil