Treatment: Adefovir Dipivoxil
Formulated as a pill taken once daily, adefovir dipivoxil has demonstrated antiviral activity against a broad spectrum of viruses, including HBV, human immunodeficiency virus (HIV), and herpes viruses. Adefovir dipivoxil is a nucleotide analogue from a class of antivirals shown to be long acting, potent inhibitors of viral replication with unique resistance profiles.

Data from Gilead's Phase II studies in 67 patients demonstrated that 12 weeks of treatment with adefovir dipivoxil at once-daily doses of 5 mg, 30 mg and 60 mg provided potent antiviral activity against the hepatitis B virus. Sixty-seven percent of patients, who received a 30 mg daily dose of adefovir dipivoxil exhibited viral suppression, fell below the detectable limits of the branched chain DNA assay. When quantified with a more sensitive assay (PCR), the median reduction of HBV DNA was found to be more than 99.99 percent or 4.0 log10. Similar results were observed in patients with chronic HBV infection.

Treatment with adefovir dipivoxil also was associated with seroconversion in the group of patients with chronic HBV infection and elevated ALTs. After 24 weeks of follow-up, 27 percent of patients in the 30 mg and 60 mg dose arms lost HBe-antigen, and 20 percent seroconverted. Rates of adverse events and changes in laboratory safety markers were similar in the placebo and treatment groups.

See: Gilead