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ZADAXIN®: The Power to Fight Hepatitis
B
The hepatitis B virus (HBV): a DNA virus affecting more than 350 million
people worldwide. An active immune response is fundamental to the ultimate
goal of viral clearance.
ZADAXIN provides the power to energize immune response. |
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ZADAXIN Monotherapy in HBV
Powering the Response
Four times the number of ZADAXIN patients achieved complete sustained
response — HBV DNA and HBeAg clearance — after 12 months
of follow-up. (1) |
HBV Sustained Viral Clearance (1)
32 patients treated with ZADAXIN for
6 months (1.6 mg BIW) with
12-month follow-up; 32 control patients observed for 18 months.
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ZADAXIN vs IFN:
Up to 170% greater sustained response rate.
ZADAXIN vs lamivudine:
Up to 5 times greater sustained response rate.
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Comparative Sustained Response Ranges *
*Loss of HBV DNA and HBeAg. |
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ZADAXIN Treatment Combinations in HBV
More Power – More Safety – More Success
ZADAXIN has not been shown to add to the side effects of other drugs.
ZADAXIN is more than an antiviral. Because it is principally an Immune
System Enhancer, ZADAXIN can be used in combination with interferon or
nucleoside analogs like lamivudine.
ZADAXIN combined with lamivudine provided an HBV DNA sustained clearance
rate more than 5 times greater than lamivudine alone (70% response
rate 12 months post therapy). (5,6)
ZADAXIN combined with IFN provided a 76% sustained response rate
— almost 2 times the sustained response rate to IFN alone.
ZADAXIN plus low-dose IFN resulted in a 55% response rate in previous
IFN failures. (8) |
Sustained Response
Rate* (4-7)
*Normal ALT; HBV DNA negative. |
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Improving Quality of Life
Because of its exemplary safety profile, ZADAXIN is ideal for patients
who are unable to tolerate IFN or lamivudine treatment.
ZADAXIN: Virtually no incidence of adverse events.
Other HBV therapies: Adverse events associated with lamivudine
or IFN include malaise/fatigue, depression, flu-like symptoms, headache,
nausea, abdominal discomfort, diarrhea, YMDD mutations, myalgia,
and insomnia.
Of more than 3,000 patients treated in all ZADAXIN clinical trials
worldwide, less than 1% experienced ZADAXIN-related adverse events.* |
Comparative Adverse-Event Incidence |
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Energy for Special Patient Populations
ZADAXIN has been tested and proven safe, effective, and easy to tolerate
in numerous patient populations, including the elderly, previous treatment
failures, and patients with depressed immune systems.
Reaching the World
Approved in more than 25 countries.
*Adverse experiences have been infrequent and mild, consisting primarily
of local discomfort at the injection site and rare instances of erythema,
transient muscle atrophy, polyarthralgia combined with hand edema, and
rash.
References: 1. Chien RN, et al. Hepatology. 1998;27:1383-1387.
2.Meta-analysis. Data on file. 3. Schiff. Diseases of the Liver, 1999.
4. Dienstag. Clinics in Liver Diseases, 1999. 5. Chan, et al. Data on
file, 1999. 6. Dienstag JL, et al. N Engl J Med. 1999;341:1256-1263. 7.
Saruc M, et al. In: Program and abstracts of Digestive Disease Week; May
20-23, 2001; Atlanta, Georgia. Abstract 1949. 8. Rasi G, et al. J Viral
Hepat. 1996;3:191-196. 9. Food and Drug Administration Medical Officers
Review. EPIVIR-HBV New Drug Application. 1998;26. 10. INTRON A [package
insert]. Kenilworth, NJ: Schering Corporation; 1999.
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