Adefovir Proves Extremely Effective and As Safe As

liver411

Adefovir Proves Extremely Effective and As Safe As Placebo in the Treatment of HBV Infection



By Brian Boyle, MD



Chronic hepatitis B virus (HBV) infection is a leading cause of cirrhosis and hepatocellular carcinoma around the world. Adefovir dipivoxil (ADV) is a nucleotide analogue that was previously considered for the treatment of HIV, but at higher dosing levels was found to be associated with significant renal disease. At lower, and apparently safer, doses, ADV has proven to be an extremely effective agent in the treatment of wild-type and lamivudine-resistant HBV.



In a study presented at the 41st ICAAC, investigators evaluated the HBV antiviral activity of ADV (10 mg daily) compared to placebo. The week 48 results of the study were presented, including assessments of the changes in liver histology, HBV DNA, ALT and HBeAg seroconversion. Safety and tolerability were also assessed.



At baseline, the 515 enrolled patients were HBsAg and HBeAg positive, had an HBV DNA 106 copies/mL, and an elevated ALT. At the end of 48 weeks of therapy, 53% of ADV patients demonstrated an improvement in liver histology compared to 25% of the patients who received placebo (p<0.001).



Further, at week 48, the ADV patients had a median 3.52 log10 copies/mL reduction in HBV DNA levels compared to a 0.55 log10 copies/mL reduction in the placebo group (p<0.001) and 12% of ADV patients seroconverted compared to 6% in placebo group (p<0.05).



Finally, 48% of the ADV patients had a normal ALT level at week 48 compared to 16% of the placebo patients (p<0.001). Premature discontinuation of study medication and adverse events were similar between the ADV and placebo arms.



The authors conclude, "ADV 10 mg demonstrated significant antiviral activity, with liver histology improvements, increased HBeAg seroconversion rates, and decreases in HBV DNA and ALT levels. The safety profile was similar to placebo."



These are encouraging data regarding the use of ADV in the treatment of HBV, and follow on the heels of data presented at the AASLD meeting that were equally encouraging regarding long-term efficacy and safety.



1/09/02



Reference

S. Lim and others. Antiviral Activity of Adefovir Dipivoxil (ADV) in HBeAg+ Chronic Hepatitis B infection. Abstract LB-20. Abstracts of the 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (41st ICAAC).December 16-19, 2001.

medline

that's good.

I read only a few letters from listserv of HBV .

It seems that some people think adefovir is good

liver411

yes. you are right.