Lamivudine/Adefovir Has Similar Efficacy to Entecavir, but Issues With Renal and Bone Safety Arise: Presented at EASL

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Source: DGNews | Posted 5 days ago

Lamivudine/Adefovir Has Similar Efficacy to Entecavir, but Issues With Renal and

Bone Safety Arise

: Presented at EASL

By Berrie

BERLIN -- April 5, 2011 -- Although de novo combination treatment with

lamivudine plus adefovir (LAM/ADV) achieves similar virological response rates

to entecavir in patients with chronic hepatitis B virus (HBV), the effects of

LAM/ADV indicate problems with long-term renal and bone safety.

Findings were presented here on April 1 at the 46th Annual Meeting of the

European Association of the Study of the Liver (EASL), by Ivana Carey, MD,

King’s College London School of Medicine, and King’s College Hospital, London,

United Kingdom.

For the study, patients with chronic HBV who were naïve to nucleoside/nucleotide

analogue therapy were randomised to combination LAM/ADV 10 mg/day (n = 192) or

entecavir 0.5 mg/day (n = 154), for a median of 30 months treatment duration.

At 3 months, there were no significant differences in complete virologic

response -- defined as HBV DNA <12 IU/mL -- between patients receiving LAM/ADV

(48%) and those receiving entecavir (54%), nor was there any significant

difference at 30 months (79% and 78%, respectively).

Significantly more patients treated with LAM/ADV than entecavir achieved

hepatitis B e antigen (HBeAg) seroconversion (21% vs 6%; P =.02) and decreases

in HBV DNA from month 24 (P =.05).

There were no differences between groups for viral mutations associated with

drug resistance, serum creatinine levels, or estimated glomerular filtration

rate (eGFR), although eGFR significantly decreased from baseline to month 18

onwards in the LAM/ADV group (P =.04).

Serum phosphate levels decreased significantly during treatment in the LAM/ADV

group compared with the entecavir group at month 12 (P <.05) and month 24 (P

<.05).

Dr. Carey said that to counterbalance the phosphate loss seen with LAM/ADV

treatment, vitamin D was given to all patients. Alternatively, should patients

already have renal issues, such as diabetes, high blood pressure, or family

history of renal problems, they can be given entecavir rather than LAM/ADV.

[Presentation title: Long-Term De-Novo Lamivudine + Adefovir Combination Therapy

in Chronic Hepatitis B Is Efficient, but Has Negative Impact on Renal/ Bone

Safety in Comparison to Entecavir Monotherapy. Abstract 707]