Adefovir Dipivoxil Plus Lamivudine Combination Treatment Is Superior to Adefovir Dipivoxil Monothera

November 7, 2007

AASLD 2007

956.Adefovir Dipivoxil Plus Lamivudine Combination Treatment Is Superior to

Adefovir Dipivoxil Monotherapy in Lamivudine-resistant Hepatitis B e

Antigen-negative Chronic Hepatitis B Patients

K. Tziomalos; T. Vassiliadis; O. Giouleme; G. Koumerkeridis; C. Koumaras; K.

Patsiaoura; A. Mpoumponaris; D. Gkisakis; K. Theodoropoulos; N. Grammatikos; A.

Panderi; N. Nikolaidis; N. Evgenidis

The aim of this study was to evaluate the long-term efficacy of adefovir

dipivoxil (ADV) in patients with hepatitis B e antigen (HBeAg)-negative chronic

hepatitis B (CHB) who have developed resistance to lamivudine (LAM) treatment.

In addition, we aimed to assess whether LAM should be discontinued in these

patients.

Methods

Sixty patients with lamivudine-resistant HBeAg-negative CHB were randomized in a

3:1 ratio to receive either ADV + LAM combination treatment (Group A; n = 45) or

ADV monotherapy (Group B; n = 15). Baseline characteristics did not differ

between groups. After a median follow-up time of 43 months (range, 10 to 63

months), hepatitis B virus (HBV) DNA became undetectable (< 400 copies/ml;

virological response) in 37/45 patients in Group A (82.2%) and in 11/15 patients

in Group B (73.3%)(p = 0.709). During follow-up, transaminases’ levels

normalized in 40/44 patients in Group A (90.9%) and in 8/14 patients in Group B

(57.1%)(p = 0.012). ADV-resistant mutations were identified in 2/45 patients in

Group A (4.4%) and in 5/15 patients in Group B (33.3%)(p = 0.011).

The two patients with ADV-resistance (group A) were suboptimal responders and in

one of two (50%) the duplication of ADV dose to 20 mg per day resulted in

disappearance of HBV DNA (< 6 IU/ml) six months later. Virological breakthrough

(reappearance of HBV DNA after its initial disappearance) did not develop in any

of the 37 Group A patients with virological response. In contrast, 3/11 Group B

patients with virological response (27.3%) developed virological breakthrough

(p=0.011). Treatment was well-tolerated and no adverse effects occurred.

Conclusion

In conclusion, ADV + LAM combination treatment is superior to ADV monotherapy in

patients with lamivudine-resistant HBeAg-negative CHB, in terms of both efficacy

and development of resistance to ADV. Increase of ADV dose to 20mg/day may be

effective in suboptimal response patients or even ADV-resistant patients.

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November 7, 2007