New funding could help avoid health ‘time bomb’

Experts say new PHARMAC funding could help avert potential public health ‘time bomb’

News release
Tuesday, 31 March 2009
For immediate release

Health experts believe that new access to Pegasys® (peginterferon alfa-2a (40KD)), an effective antiviral treatment for two diseases, chronic hepatitis B and C, today announced by PHARMAC, will save thousands of lives and hundreds of millions of taxpayer dollars over the next twenty years.1,2,3

Together, health experts consider hepatitis B & C to be among the largest public health threats facing New Zealand in the near future. More than 140,000 New Zealanders are estimated to be suffering from Hepatitis B & C, progressive acting viral diseases that, if left untreated can eventually lead to cirrhosis of the liver, liver failure or even liver cancer.3-8

Associate Professor Ed Gane, Hepatologist at Auckland City Hospital, says that both hepatitis B & C were, until as recently as a decade ago, considered to be incurable.9-12

“Up to 20 per cent of patients with chronic hepatitis C or chronic hepatitis B will progress to, and eventually die from cirrhosis of the liver, liver failure or liver cancer.”

“As a result, hepatitis B and C infections together now account for more than half of referrals for liver transplantation and more than 95 per cent of new cases of liver cancer in New Zealand. These two diseases represent a potential time bomb for the health system – the projected numbers of HCV-related liver cancers are projected to treble over the next 20 years and untreated hepatitis C alone could cost the health system $400 million over the next 10-15 years.”

Clinical trials have shown that up to 52 per cent of patients with the difficult to treat genotype 1, and 84 per cent with genotypes 2 and 3 hepatitis C can be virus free following treatment with Pegasys in combination with ribavirin. Up to one third of patients with hepatitis B can also enter lasting remission after treatment with Pegasys, where levels of the hepatitis B virus fall below detectable levels.9-12

John Hornell, Chief Executive of the Hepatitis Foundation of New Zealand, estimates that 90,000 – 110,000 New Zealanders are suffering from chronic hepatitis B infection, and another 50,000 suffering from chronic hepatitis C infection. However, Mr Hornell says fewer than 30,000 of these are aware of their condition and able to seek treatment.4,5,6

“The best treatment outcomes are seen in those people who are diagnosed and receive treatment early. Unfortunately, the treatment rate in New Zealand is low because many people with chronic hepatitis B and C simply have not been diagnosed.”

Mr Hornell said the difficulty was that many people with chronic hepatitis B & C did not experience symptoms, or if they did, the symptoms were mild or non-specific.13

“It’s important that people in the highest risk categories* get tested for hepatitis B and C when they visit their GP. The message we’re spreading is that advancements in treatment like Pegasys mean that hepatitis B and C have higher success rates than were previously achievable.”

“That is why we encourage anyone who maybe at risk of carrying either of these viruses to get the diagnostic blood test, whether or not they experience symptoms, so they can receive any necessary treatment before the liver is irreversibly impaired or before they unwittingly transmit these infectious diseases to anyone else.”

Associate Professor Gane agrees, saying testing will enable earlier diagnosis of chronic hepatitis B and C. By doing so, patients will be able to adopt precautions to avoid spreading the virus further, to adopt lifestyle modifications which may prevent the progression of their liver disease to cirrhosis and to receive treatment that may help them become virus free.

* Risk factors for hepatitis B and C

Hepatitis B13 Hepatitis C14
• New Zealanders who are of Maori, Pacific or Asian ethnicity
• Born outside of New Zealand, particularly in sub-Saharan Africa, Southeast Asia, the Amazon Basin, the Pacific Islands or the Middle East
• Travel to regions with high infection rates of HBV, such as sub-Saharan Africa, Southeast Asia, the Amazon Basin, the Pacific Islands or the Middle East
• Unprotected/unsafe sex with more than one partner
• Recreational/exposure to blood (through sport or work)
• Family member with hepatitis B
• Sexual partner with hepatitis B
• Intravenous drug use – past & present
• Received blood transfusions or blood products prior to the introduction of screening in 1992
• Born in areas of high prevalence particularly in Egypt, the Middle East, Eastern Europe, Cambodia or Vietnam
• Unsafe/unsanitary body piercing or tattooing procedures (suspected, but as yet unproven links)
• Previous incarceration in prison

About Pegasys

Pegasys® (peginterferon alfa-2a) is a Prescription Medicine used to treat chronic hepatitis B and chronic hepatitis C, which are viral infections of the liver. In hepatitis B, Pegasys is usually used alone. In hepatitis C, Pegasys is recommended to be used in combination with ribavirin (Copegus®) tablets.

Pegasys should not be used if: you have autoimmune hepatitis, decompensated cirrhosis (severe liver disease), the patient is under 3 years of age, or if you have had an allergic reaction to alfa interferons, products derived from the bacteria Escherichia coli (E. coli) or other ingredients in Pegasys. Pegasys is not recommended for pregnant women; effective contraception is recommended for females while they are taking Pegasys. Tell your doctor if: you are pregnant or plan to become pregnant, you are breast-feeding or plan to breast-feed, or you have any other health problems including: mental illness or history of mental illness (including depression), liver, kidney, heart or thyroid disease, breathing difficulties, autoimmune disorders, psoriasis (a skin disease), low levels of red or white blood cells or platelets, HIV or AIDS, diabetes, or eye or vision problems.

Possible unwanted effects include: Common: flu-like symptoms, loss of appetite or weight, nausea, diarrhoea or stomach pain, hair loss, itching, rash or dry skin, reactions at the site of injection, headache or dizziness, muscle or joint aches, pain, breathlessness, cough or sore throat, tiredness, weakness, fever, chills or shaking, trouble concentrating or sleeping, feeling anxious or nervous, irritability, depression, blurred vision, eye inflammation, dryness or pain of the eye, blocked, runny or bleeding nose, bleeding or bruising more easily, impotence, ringing or noise in the ears. Rare (serious): chest pain or difficulty breathing, fast or irregular heart beats, severe changes in emotions or mood, seeing, feeling or hearing things that are not there, suicidal thoughts or attempt, strange or disturbing thoughts or moods, anaemia (e.g. feeling tired, headaches, looking pale), a red, itchy, blistery rash, loss of consciousness, blood in stools.
TAPS CH2294/30 MAR 2009

References
1. Pegasys® (peginterferon alfa-2a (40KD) Data Sheet, 7 October 2008
2. PHARMAC. Access widened to pegylated interferon for hepatitis B and C genotypes 2 and 3. Available at www.pharmac.co.nz. [Accessed March 2009].
3. Sheerin IG, Green FT, Sellman JD, et al. The costs of not treating hepatitis C virus infection in injecting drug users in New Zealand. Drug Alcohol Rev. 2003;22(2):159-67.
4. Roche Data on File (PEG003).
5. Roche Data on File (PEG004).
6. Roche Data on File (PEG005).
7. O’Shea R. Hepatitis C. Cleveland Clinic Center for Continuing Education. Available at [www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/hepatology/hepatitis-C]. Accessed March 2009.
8. Lavanchy D. Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures. J Viral Hepat 2004. 11(2): 97-107.
9. Hadziyannis SJ, Sette Jr H, Morgan TR, et al. Peginterferon-alfa2a and Ribavirin Combination Therapy in Chronic Hepatitis C. Ann Intern Med 2004;140:346-355.
10. Lau GKK, Piratvisuth T, Luo KX, et al. Peginterferon Alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med, 2005. 352(26):2682-95.
11. Marcellin P, Bonino F, Lau KK, et al. The majority of patients with HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a (40KD) [Pegasys®] 2 years post-treatment. Abstract #743. Presented at 41st Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, April 27, 2006.
12. Marcellin P et al. HBsAg clearance continues to increase after the end of treatment with PEGASYS ± lamivudine: 5-year follow-up study in patients with HBeAg-negative disease. Abstract #PE086. Presented at: Asian Pacific Association for the Study of the Liver (APASL); February 13-16, 2009; Hong Kong, China.
13. MayoClinic.com. Hepatitis B. Available at http://www.mayoclinic.com [Accessed March 2009].
14. Hepatitis C Resource Centre. Hepatitis C FAQ. Available at http://hepc.org.nz. [Accessed March 2009].

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