DiagnosticsNICE Recommends VIREAD (tenofovir Disoproxil Fumarate) For The Treatment Of Chronic Hepatitis B, UK
The National Institute for Health and Clinical Excellence
(NICE) has issued final guidance recommending the use of VIREAD (tenofovir) for the treatment
of chronic hepatitis B virus infection in adults.1 VIREAD is an oral antiviral medication which
inhibits the replication of the hepatitis B virus and has shown to be at least as effective as other
currently recommended options and a cost-effective antiviral strategy.1 In both treatment-naç¯ve
and treatment-experienced patients, tenofovir has demonstrated consistent efficacy for up to two
years.2,3 Drug resistance is a common barrier to successful long-term therapy and tenofovir is the
only antiviral agent for hepatitis B treatment that, in its registrational trials, shows no resistance
after two years.2,3,4
"The NICE final guidance recommending VIREAD is a significant advancement for the
management of hepatitis B. Chronic hepatitis B is a major health problem and a life-threatening
disease. Many patients require long-term therapy and it is important that treatments demonstrate
consistent efficacy, established long-term safety profile and robust drug resistance, all of which
VIREAD is able to offer", commented Professor Graham Foster, Queen Marys, University of
London and Consultant Hepatologist at Barts and The London NHS Trust in East London.
Tenofovir received approval in the European Union for the treatment of chronic hepatitis B
infection in adults in April 2008, and has already been approved for use in Scotland and Wales
by two independent healthcare technology assessment groups.5,6 The decision by NICE will now
allow patients in England to have the same access that those in Scotland and Wales have had
for nearly a year. The drug has a well established safety profile, gained from more than 2 million
patient years of safety data provided from extensive clinical experience in the treatment of HIV.7
There is no cure for hepatitis B infection but it is entirely preventable by vaccination, and many
people remain vulnerable to infection with the hepatitis B virus, which is up to 100 times more
easily transmitted than HIV-1.8 The virus is transmitted in blood and other body fluids, and not
through casual contact. In the UK, it is estimated that more than 325,000 people are living with
chronic hepatitis B, and are at risk of developing scarring of the liver (cirrhosis) and potentially
cancer.9
Professor Arie Zuckerman, Chairman of the Hepatitis B Foundation UK said: "The Hepatitis
B Foundation is pleased with the decision reached by NICE. Hepatitis B is frequently
undiagnosed and undermanaged. We are confident that there will be further advances in
treatment of this common and important infection, which will lead to decrease in viral load without
evident drug resistance, while enabling patients to continue with their lives".
In 90 percent of HBeAg-negative patients and 76 percent of HBeAg-positive patients, tenofovir
achieved a reduction in viral load to less than 400 copies/mL within two years.7 In addition, 23
percent of HBeAg-positive patients had achieved seroconversion, meaning that the loss of the
"e" antigen and the emergence of the "e" antibody demonstrated that the replication of the virus
had diminished.7
References:
1. National Institute for Health and Clinical Excellence. Single Technology Appraisal TA173, July
2009: Tenofovir disoproxil for the treatment of chronic hepatitis B. http://www.nice.org.uk.
2. Marcellin et al., American Association for the Study of Liver Diseases 2008, Oral #146.
3. Heathcote et al., American Association for the Study of Liver Diseases 2008, Oral #158.
4. Snow-Lampart et al., American Association for the Study of Liver Diseases 2008, Poster #977.
5. Scottish Medicines Consortium. Advice from New Drugs Committee tenofovir disoproxil (as
fumarate), 245 mg film-coated tablet (VIREAD). 7 July 2008.
http://www.scottishmedicines.org.uk. Accessed 1 June 2009.
6. AWMSG: Appraisal report on Tenofovir disoproxil fumarate (VIREAD) for the treatment of
hepatitis B. 13th August. http://www.wales.nhs.uk. Accessed 1 June 2009.
7. Gilead data on file HIV004.
8. World Health Organization. Hepatitis B: Fact Sheet. 2000. Available at:
http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed 1 June 2009.
9. Stella Pendleton and Penny Wilson-Webb. 2007. Rising Curve: Chronic Hepatitis B Infection
in the UK. Hepatitis B Foundation UK. Available here. Accessed 1 June 2009.
About VIREAD
VIREAD (245 mg of tenofovir disoproxil as fumarate) is a once-daily oral antiviral medication
developed by Gilead Sciences. It belongs to a class of antiviral drugs known as nucleotide
analogues. VIREAD works by blocking HBV DNA polymerase, the enzyme that is necessary for
the hepatitis B virus to reproduce itself in liver cells.
VIREAD received approval in the European Union (EU) for the treatment of chronic hepatitis B
infection in adults in April 2008. It is indicated for use in patients with compensated liver disease,
with evidence of active viral replication, persistently elevated serum alanine aminotransferase
(ALT) levels and histological evidence of active inflammation and/or fibrosis.
Refer to the Viread Summary of Product Characteristics for full details, available at:
http://www.emc.medicines.org.uk.
NICE