Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Gastroenterology | Immunology | Hepatology (Liver, Pancreatic, Gall Bladder) | Infections and Infectious Diseases | Vaccines
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved May 2001
Treatment Area: Hepatitis A and B
Twinrix is a combination hepatitis vaccine approved for the
prevention of hepatitis A and B in adults 18 years and older.
Populations likely to benefit from this new vaccine include chronic
liver disease patients and healthcare personnel. Furthermore,
hepatitis A and B are the most common vaccine-preventable diseases
in travelers. As a result, individuals who travel to areas such as
Africa, the Caribbean, South America, Central America, the Middle
East and eastern and southern Europe may also find Twinrix
According to the World Health Organization, there are more than
350 million chronic hepatitis B virus (HBV) infections worldwide.
Each year, approximately 125,000 to 200,000 Americans are infected
with hepatitis A. Hepatitis B can be spread through infected blood
or body fluids, sexual contact, intravenous drug use, body piercing
and tattooing. Hepatitis A can spread by the "fecal-oral"
route, or placing something in the mouth that has been contaminated
with the stool of a person with hepatitis A.
Data was analyzed from 1,551 subjects in 11 trials following
administration of three doses of Twinrix on a 0-, 1- and 6-month
schedule. In these trials, 99.9% of the subjects showed a response
against the hepatitis A component of Twinrix and 98.5% demonstrated
a response against the hepatitis B component.
One of the 11 trials was a randomized, multicenter comparative
trial conducted in the United States. In this trial, an
immunogenicity analysis was performed in 533 subjects who completed
the study according to protocol. Subjects received either Twinrix
on a 0-, 1-, 6-month schedule or Havrix (Hepatitis A Vaccine,
Inactivated) on a 0-, 6-month schedule and Engerix-B [Hepatitis B
Vaccine (Recombinant)] on a 0-, 1-, 6-month schedule, given
concurrently in opposite arms.
Results from the trial demonstrated that subjects receiving
three doses of Twinrix had antibody responses similar to those of
subjects receiving monovalent hepatitis A and B vaccines separately
over the same time period. The antibody responses to the hepatitis
A and B components in the Twinrix group were 99.6 and 95.1%,
respectively, and 99.3 and 92.2% in the Havrix and Engerix-B
Twinrix was generally well tolerated in clinical trials. The
most common adverse events associated with the drug included
soreness at the injection site, headache and fatigue.