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发表于 2002-11-10 00:00
| New Data on Use of Hepsera (Adefovir Dipivoxil) in Patients with Epivir-HBV- (Lamivudine) Resistant Hepatitis B
Chronic hepatitis B is a serious, debilitating illness that can cause cirrhosis of the liver, liver cancer and death. Approximately 1.25 million people are infected with HCV in the US, where approximately 100,000 new HBV infections occur annually. Chronic hepatitis B is the main cause of liver cancer and the tenth leading cause of death worldwide, with 400,000,000 infected with the virus. Every year on the planet, one million people are expected to die from this infection.
Until recently, there were only two available treatments for chronic HCV: Epivir-HBV and Intron A (standard interferon alfa-2b). In September 2002, the FDA approved a new drug, Hepsera (adefovir dipivoxil), for the treatment of chronic HBV. Hepsera is a welcome and effective addition to the small armamentarium of HBV treatments now available. At the 10mg recommended dose, Hepsera produces efficacious anti-HBV activity, works against Epivir-HBV-resistant virus and is well tolerated.
At the 53rd AASLD meeting in Boston (November 1-5, 2002), Gilead Sciences presented 48-week results from a clinical trial (study 461) evaluating the antiviral activity and safety of Hepsera (adefovir dipivoxil 10 mg) when used as monotherapy or in combination with ongoing lamivudine compared to continued lamivudine monotherapy in chronic hepatitis B patients with lamivudine-resistant virus and compensated liver function.
The data were presented by Marion Peters, MD, principal investigator and Chief of Hepatology Research, University of California, San Francisco Medical Center. This presentation is one of ten abstracts at 53 AASLD meeting that describes the antiviral activity, safety and resistance profile of Hepsera. HIV and Hepatitis.com will review more of this data in the coming week.
Results of the current study (461) show that patients with lamivudine-resistant virus who switched to Hepsera monotherapy or added Hepsera to ongoing lamivudine treatment experienced significant virological, biochemical and serological improvements through 48 weeks. Patients receiving Hepsera alone or in combination with lamivudine experienced statistically significant reductions in both serum hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT), a measure of liver damage, compared with patients who received lamivudine only.
Patients treated with lamivudine alone did not show significant virological, biochemical or serological benefit compared with their baseline values. The results in the two Hepsera treatment arms shows switching to monotherapy with Hepsera achieved similar results to combination therapy (when Hepsera was added to lamivudine) in patients with lamivudine-resistant HBV.
“These data extend the results seen at 16 weeks through 48 weeks of therapy, indicating that adefovir dipivoxil (Hepsera), whether used alone or in combination with lamivudine, significantly reduces HBV DNA and normalizes ALT levels in chronic hepatitis B patients with lamivudine-resistant virus,” said Dr. Peters.
“Resistance to lamivudine has been shown to develop in approximately two thirds of patients after four years of therapy. The results of this study are particularly important as physicians consider the best approach to selecting treatment for their patients and for managing those who have developed resistance to lamivudine.”
Study 461 Results
At week 48, the median decrease from baseline in serum HBV DNA was 4.0 log10 copies/mL and 3.6 log10 copies/mL in patients switching to Hepsera monotherapy and adding Hepsera in combination with lamivudine, respectively, compared to a median change of 0.0 log10 copies/mL for patients continuing on lamivudine monotherapy. In addition, ALT levels normalized in 53 percent of patients receiving Hepsera in combination with lamivudine and in 47 percent of patients who switched to Hepsera monotherapy compared to five percent of patients who continued lamivudine monotherapy.
Eleven and six percent of patients switching to Hepsera monotherapy and adding Hepsera in combination with lamivudine seroconverted by week 48, respectively, compared to zero percent of patients on lamivudine monotherapy. Seroconversion is defined as both the disappearance of the hepatitis B "e" antigen (HBe-antigen negative), a marker of HBV replication, and the appearance of antibodies specific for this antigen (HBe-antibody positive).
Summary of Results
Lamivudine
(n=19)
Lamivudine+Hepsera
(n=20)
Hepsera
(n=19)
HBV DNA (log10 copies/mL) DAVG48
(p-value)
0.05
-2.93 (p<0.001)
-3.06 (p<0.001)
Median change from baseline for serum HBV DNA at week 48 (log10 copies/mL) (p-value) 0.0
-3.6 (p<0.001)
-4.0 (p<0.001)
Proportion of patients with ALT normalization at week 48 (p-value)
5 percent
53 percent (p<0.01)
47 percent (p<0.01)
Seroconversion
0 percent
6 percent
11 percent
“The data from this and nine other presentations at AASLD underscore the strength and versatility of Hepsera across a range of patients with varying stages of active liver disease,” said John C. Martin, PhD, President and CEO, Gilead Sciences.
11/06/02
Sources
Gilead Sciences www.hepsera.com.
M Peters and others. ADEFOVIR DIPIVOXIL (ADV) ALONE AND IN COMBINATION WITH LAMIVUDINE (LAM) SUPPRESSES YMDD MUTANT HEPATITIS B VIRUS REPLICATION: 48 WEEK PRELIMINARY ANALYSIS. Abstract 101440. Hepatology ID 845 (poster).
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