מתוך medicontext.co.il
NEW YORK (Reuters Health) – Gilead Sciences on Friday released preliminary data from a phase III trial suggesting that its investigational nucleotide analogue adefovir dipivoxil is able to lower levels of serum hepatitis B virus (HBV) DNA in lamivudine-resistant chronic hepatitis B patients with compensated liver disease.
In the trial, 59 patients were randomized to receive either 10 mg of adefovir dipivoxil in combination with placebo, 100 mg of lamivudine with placebo, or 10 mg of adefovir dipivoxil with 100 mg of lamivudine.
According to Gilead, patients in both the adefovir dipivoxil groups experienced significantly greater reductions in serum HBV levels at 16 weeks than those who received lamivudine with placebo.
No patients withdrew from the study, and frequency and types of adverse events were similar in all treatment arms. Additionally, no adefovir dipivoxil-treated patients had meaningful increases in serum creatinine or serum phosphorus, which are markers of renal function.
Aside from this trial, Gilead has thus far initiated two phase III studies of adefovir dipivoxil as a treatment for hepatitis B. Preliminary data from both these pivotal trials–expected to be used in first-half 2002 US and European regulatory filings–indicate the drug is safe and effective in improving liver histology in patients with chronic or precore mutant hepatitis B.
During mid-afternoon trading on the NASDAQ, shares of Foster City, California-based Gilead were down 1.77 at 64.45.
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