8th Conference on Retroviruses and Opportunistic Infections Chicago, IL - February 4 - 8, 2001

Conf Retroviruses Opportunistic Infect 2001 Feb 4-8; 8:54 (abstract no. 36)

Y. Benhamou¹, M. Bochet¹, V. Thibault¹, V. Calvez¹, P. Vig², C. Brosgart², J. Fry², T. Poynard¹, and C. Katlama¹

BACKGROUND: Lamivudine resistance (LAM^R) to HBV occurs in approximately 15%-32% of both immunocompetent HBV- and HIV-infected patients after one year of lamivudine (LAM) therapy. The four year incidence of LAM^R HBV is 90% in HIV/HBV co-infected patients treated with antiretroviral therapy containing LAM. Adefovir dipivoxil (ADV) has potent in vivo and in vitro activity against both wild-type and LAM^R HBV. The objective of this study was to evaluate the safety and efficacy of ADV 10 mg once daily in the treatment of LAM^R HBV infection in HIV- infected patients.

METHODS: Thirty five HIV/HBV co-infected patients receiving LAM (150 mg bid) as a part of their current anti-retroviral therapy were enrolled in this 12 month study. Patients had controlled HIV RNA (≥ 2.60 log₁₀ copies/mL) at screening. All patients had detectable serum HBV DNA despite LAM therapy (median 21.3 ± 10 months) and documented M550V or M550I mutations in the HBV DNA polymerase gene. ADV 10 mg daily was added to the patients' existing anti-HIV therapy. Patients were seen monthly for safety and efficacy evaluations.

RESULTS: Thirty- four males and 1 female, with a mean age of 41.2 ± 1.6 years were enrolled. Two patients discontinued early for reasons not related to ADV toxicity. The median time on ADV was 28 ± 5.7 weeks. Mean decrease in HBV DNA serum levels from baseline (8.64 ± 0.08 log₁₀ copies/mL) was -2.27 ± 0.10 log₁₀ copies/ mL at week 4, -2.61 ± 0.12 log₁₀ copies/mL at week 8, -2.90 ± 0.11 log₁₀ copies/mL at week 12, -3.0 ± 0.12 log₁₀ copies/mL at week 16, -3.16 ± 0.13 log₁₀ copies/mL at week 20, -3.40 ± 0.14 log₁₀ copies/mL at week 24, -3.5 ± 0.19 log₁₀ copies/mL at week 28 and -4.27 ± 0.16 log₁₀ copies/mL at week 32 (p<0.0001). Three patients became HBeAg negative at week 8, 16 and 32, respectively. There were no significant changes in mean serum ALT from baseline (p=0.16); also no significant changes in serum electrolytes, renal function, HIV RNA and CD4 cell count were observed. Adefovir dipivoxil was generally well tolerated.

CONCLUSIONS: These results indicate that 7 months dosing of ADV 10 mg daily when added to LAM is well tolerated and has significant activity against LAM^R HBV in HIV/HBV co-infected patients.

2001-02-04
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Copyright © 2001 - Foundation for Retrovirology and Human Health. Reproduction of this abstract (other than one copy for personal reference) must be cleared through the Foundation for Retrovirology and Human Health. Licensed (AIDSLINE) from National Library of Medicine.