96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir dipivoxil monotherapy in

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Journal of Hepatology

Volume 48, Issue 5, May 2008, Pages 714-720

doi:10.1016/j.jhep.2007.10.013

96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir

dipivoxil monotherapy in the treatment of chronic hepatitis B

Chee-Kin Hui1, 2, 3, Hai-Ying Zhang4, Bowden5, Locarnini5,

M. Luk6, Kar-Wai Leung1, 2, 3, Yui-Hung Yueng4, April Wong4, Rousseau7,

Kwok-Yung Yuen1, 2, 3, Nikolai N. Naoumov8 and K.K. Lau

1Department of Microbiology, Queen Hospital, The University of Hong Kong,

Hong Kong SAR, China

2Research Centre of Infection and Immunology, The University of Hong Kong, Hong

Kong SAR, China

3State Key Laboratory of Emerging Infectious Diseases, The University of Hong

Kong, Hong Kong SAR, China

4Department of Medicine, Queen Hospital, The University of Hong Kong, 102

Pokfulam Road, Hong Kong SAR, China

5n Infectious Diseases Reference Laboratory, Vic., Australia

6Department of Surgery, Queen Hospital, The University of Hong Kong, Hong

Kong SAR, China

7Gilead Sciences Inc., Durham, NC, USA

8Institute of Hepatology, University College London, London, UK

Received 23 July 2007; revised 8 October 2007; accepted 11 October 2007.

Associate Editor: F. Zoulim. Available online 31 December 2007.

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. −3.98 log10 copies/ml, p = 0.05). More patients in the

combination group had normalization of alanine aminotransaminase and HBV DNA <

300 copies/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.

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Journal of Hepatology

Volume 48, Issue 5, May 2008, Pages 714-720

doi:10.1016/j.jhep.2007.10.013

96 weeks combination of adefovir dipivoxil plus emtricitabine vs. adefovir

dipivoxil monotherapy in the treatment of chronic hepatitis B

Chee-Kin Hui1, 2, 3, Hai-Ying Zhang4, Bowden5, Locarnini5,

M. Luk6, Kar-Wai Leung1, 2, 3, Yui-Hung Yueng4, April Wong4, Rousseau7,

Kwok-Yung Yuen1, 2, 3, Nikolai N. Naoumov8 and K.K. Lau

1Department of Microbiology, Queen Hospital, The University of Hong Kong,

Hong Kong SAR, China

2Research Centre of Infection and Immunology, The University of Hong Kong, Hong

Kong SAR, China

3State Key Laboratory of Emerging Infectious Diseases, The University of Hong

Kong, Hong Kong SAR, China

4Department of Medicine, Queen Hospital, The University of Hong Kong, 102

Pokfulam Road, Hong Kong SAR, China

5n Infectious Diseases Reference Laboratory, Vic., Australia

6Department of Surgery, Queen Hospital, The University of Hong Kong, Hong

Kong SAR, China

7Gilead Sciences Inc., Durham, NC, USA

8Institute of Hepatology, University College London, London, UK

Received 23 July 2007; revised 8 October 2007; accepted 11 October 2007.

Associate Editor: F. Zoulim. Available online 31 December 2007.

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. −3.98 log10 copies/ml, p = 0.05). More patients in the

combination group had normalization of alanine aminotransaminase and HBV DNA <

300 copies/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.

_________________________________________________________________

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