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NICE is currently updating part of its guidance on the use of peginterferon alfa and ribavirin for the treatment of chronic hepatitis C. Reflecting changes in the licensed indications for peginterferon alfa, today’s draft guidance reaffirms the previous draft issued for public consultation in recommending wider use of these drugs, and, where appropriate, shorter treatment durations, for people with chronic hepatitis C.

Hepatitis C, which is primarily acquired as a result of exposure through the skin to contaminated blood (for example, through injecting drug use), can be a debilitating condition, and, if left untreated can lead to serious life-long health consequences. In 2007, the number of confirmed new hepatitis C infections in England and Wales was 7540. The prevalence of the infection varies by sex and age, and it is most common in men and in people aged 25 to 44 years.

Today’s draft guidance, which is now with consultees who have the opportunity to appeal against the proposed guidance, states that:

• combination therapy with peginterferon alfa (2a or 2b) and ribavirin is recommended as a treatment option for adults with chronic hepatitis C who have been treated previously with peginterferon alfa (2a or 2b) and ribavirin in combination, or with peginterferon alfa monotherapy, and whose condition either did not respond to treatment, or responded initially to treatment but then relapsed, or who are also infected with HIV
• shortened courses of combination therapy with peginterferon alfa (2a or 2b) and ribavirin are recommended for the treatment of adults with chronic hepatitis C who have a rapid virological response to treatment at week 4 that is identified by a highly sensitive test, and who are considered suitable for a shortened course of treatment.

Dr Gillian Leng, NICE Deputy Chief Executive, said: “NICE reviews all its guidance to ensure that we take account of any new research or changes in clinical practice. In this case our review considered the extensions to the licensed indications for peginterferon alfa. Hepatitis C is a potentially debilitating condition and the treatments available have some side effects. Therefore, recommending shorter treatment durations is obviously good news for some people with this condition. The draft guidance also widens access to these drugs, giving clinicians and people living with hepatitis C more treatment options.”

NICE has not yet issued final guidance to the NHS. Final guidance is expected to be published in September 2010. Until NICE issues final guidance, NHS bodies should continue to follow existing NICE guidance on the use of these drugs.

Notes to Editors

About the draft guidance

1. Read the draft guidance on Hepatitis C - peginterferon alfa and ribavirin.

About hepatitis C

2. Hepatitis C is a disease of the liver caused by infection with the hepatitis C virus (HCV). Generally the virus is primarily acquired through percutaneous exposure through the skin (eg through injecting drug use) to contaminated blood.

3. Since the viral inactivation programme was implemented in the mid-1980s and blood donor screening started in 1991, the transmission of HCV in the UK, via transfusion of blood, blood products or organ transplantation, has all but ceased. However, injecting drug use, and cosmetic and other practices involving percutaneous exposure remain common routes of transmission.

4. Estimates from the Health Protection Agency suggest that approximately 142,000 people between the ages of 15-59 years had chronic HCV in England and Wales in 2003; a prevalence rate of 0.44% in this age group. More than 90% of all newly diagnosed infections in the UK occur in injecting drug users.

5. People infected with HCV are often asymptomatic, but about 20% will develop acute hepatitis and will experience non-specific symptoms including malaise, weakness and anorexia. About 80% of those exposed go on to develop chronic hepatitis. The rate of progression of the disease is slow but variable, usually taking about 20-50 years from the time of infection. About 30% of those who are infected develop cirrhosis within 20-30 years, and a small percentage of these people are at a high risk of developing hepatocellular carcinoma. A third may never progress to cirrhosis or will not progress for at least 50 years. Some people with end-stage liver disease or hepatocellular carcinoma may require liver transplantation.

6. For the majority of people with hepatitis C (regardless of disease severity), the standard treatment is combination therapy with ribavirin and either peginterferon alfa-2a or peginterferon alfa-2b. Monotherapy with peginterferon alfa is used only for people unable to tolerate ribavirin (in line with NICE guidance TA75 and TA106).

7. Peginterferon alfa-2a (Pegasys, Roche Products) has a UK marketing authorisation for ‘the treatment of chronic hepatitis C in adult patients who are positive for serum HCV-RNA, including patients with compensated cirrhosis and/or who are co-infected with clinically stable HIV’. The preferred treatment regimen is in combination with ribavirin, but monotherapy is indicated in cases of intolerance or contraindication to ribavirin.

8. A weekly course of treatment with peginterferon alfa-2a (180 micrograms) costs £126.91

9. Peginterferon alfa-2b (ViraferonPeg, Merck Sharpe & Dohme) has a UK marketing authorisation for ‘the treatment of adult patients with chronic hepatitis C who are positive for HCV-RNA, including patients with compensated cirrhosis and/or co-infected with clinically stable HIV’. The preferred treatment regimen is in combination with ribavirin, but monotherapy with peginterferon alfa-2b is indicated in cases of intolerance or contraindication to ribavirin. Patients may not have been treated previously or their condition may have not responded to previous treatment with interferon alpha (pegylated or non-pegylated) in combination with ribavirin or interferon alfa monotherapy.

10. A weekly course of peginterferon alfa-2b (average of 120 micrograms) costs £162.60.

11. Two forms of ribavirin (Copegus, Roche Products; Rebetol, Merck Sharpe & Dohme) are currently available. Each product is indicated for the treatment of chronic hepatitis C and must be used only as part of a combination regimen with peginterferon alfa or interferon alfa. Ribavirin monotherapy must not be used. Each product is licensed for use only in combination with the interferon products made by the same manufacturer.

12. The cost of treatment with peginterferon alfa-2a plus ribavirin (Copegus) is estimated to be £3215 for 16 weeks, £4824 for 24 weeks and £11,425 for 48 weeks of therapy. For people treated with peginterferon alfa-2b plus ribavirin (Rebetol), the cost is £5540 for 24 weeks or £11,081 for 48 weeks of therapy.

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, procedures and medical technologies within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.