FDA approves Gilead's Hepsera for the treatment of chronic hepatitis
FOSTER CITY, CA., Sept. 23, 2002 -- Gilead Sciences announced that it had received FDA approval on Friday, September 20 for its antiviral agent Hepsera (adefovir dipivoxil) for the treatment of chronic hepatitis B.
Hepsera, administered as an oral 10 mg tablet, is the first nucleotide analogue to receive FDA approval for the treatment of chronic hepatitis B. It works by blocking the replication of the hepatitis B virus (HBV) in the body.
In clinical studies, Hepsera treatment was associated with significant improvements in liver histology and fibrosis, reduction in serum HBV DNA levels, increased rates of seroconversion, and normalization of alanine aminotransferase (ALT) levels as compared to placebo in treatment-naive patients and in patients with prior interferon experience.
These pivotal studies included patients with compensated liver function and either "e" antigen-positive (HBeAg-positive) or "e" antigen-negative (HBeAg-negative, or precore mutant) chronic hepatitis B.
Hepsera is the first drug for which efficacy has been demonstrated in HBeAg-negative patients in a 48-week double-blind, placebo-controlled study. The drug was studied and proven effective in patients who were treated with and developed resistance to lamivudine, including patients wait-listed for or who had received a liver transplant. Mutations associated with resistance to Hepsera have not been identified through 48 weeks of treatment in pivotal studies (n=467).
"FDA approval of Hepsera gives physicians and their patients a new weapon in the fight against chronic hepatitis B," said Eugene Schiff, MD, Chief, Division of Hepatology and Director, Center for Liver Diseases, University of Miami, Florida. "Hepsera is an important development for people who have varying stages of active liver disease, including those with the HBeAg-negative or precore mutant strain of chronic hepatitis B.
"It is also an option for patients who aren't candidates for or have developed resistance to previously available therapies. With Hepsera, an unprecedented range of patients will have the potential to benefit from treatment."
Hepsera is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
This indication is based on histological, virological, biochemical and serological responses in adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
As is the case with other antiviral therapies for chronic hepatitis B, physicians need to monitor liver function for exacerbation of hepatitis following discontinuation of therapy. Additionally, HIV resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV infection who receive anti-hepatitis B therapies that may have activity against HIV. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.
Gilead has established a U.S. Patient Assistance Program for people who do not have insurance or cannot afford to pay for treatment. For more information about the Patient Assistance Program or the Early Access Program, call 1-800-GILEAD-5 or 1-650-574-3000.
For full prescribing information on Hepsera, visit www.hepsera.com
SOURCE Gilead Sciences
Posted: September 2002