The National Institute for Health and Clinical Excellence has reached a milestone with the publication of its 200^th technology appraisal guidance, on the use of peginterferon alfa and ribavirin for the treatment of chronic hepatitis C.

The new guidance updates existing recommendations on the use of these drugs on the National Health Service to reflect changes in their marketing authorisations, allowing for wider use and, if appropriate, shorter treatment regimens for patients with the disease.

NICE has now recommended combination therapy with either Roche’s Pegasys (peginterferon alfa 2a) or Schering-Plough’s ViraferonPeg (peginterferon alfa 2b) and ribavirin as an option for adults with chronic hepatitis C who have failed to respond to earlier treatment with them, when the disease has relapsed, or in patients also infected with HIV. 

In addition, the Institute has also approved shorter courses of combination therapy with either of these drugs – which are associated with less severe side effects - in patients who have a rapid virological response to treatment at week four (as identified by a highly sensitive test) and are considered suitable for the regimen.

The cost of treatment with Pegasys plus ribavirin (Roche’s Copegus) is around £3,215 for 16 weeks, £4,824 for 24 weeks and £11,425 for 48 weeks of therapy, while ViraferonPeg plus ribavirin (S-P’s Rebetol) will set the NHS back £5,540 for 24 weeks or £11,081 for 48 weeks of therapy, but both options have been deemed a cost-effective use of resources.

Sir Andrew Dillon, NICE chief executive, noted that widening access to Pegasys and ViraferonPeg will give “clinicians and people living with hepatitis C more treatment options,” a critical factor in the fight against the disease, which many experts fear is somewhat of a ticking time bomb in the UK.

Ticking time bomb?

It is estimated that as many as 466,000 people are living with hepatitis C in the country, but as the disease can essentially lie dormant without symptoms for years, by the time patients are diagnosed – sometimes up to 50 years after infection – damage to the liver has already occurred. In fact, around 80% of those infected with the virus go on to develop chronic hepatitis, which can lead to liver cirrhosis and, in worst cases, liver cancer.

In the meantime, as undiagnosed patients are unaware that they carry the disease there is a significant risk of infecting others, even through simple activities like sharing toothbrushes, although injecting drug use and practices involving percutaneous exposure are more common routes of transmission, and so its prevalence continues to grow.

The guidance, which is now final, marks the 200^th published by NICE since 2000, when cost regulator first advice was on the removal of wisdom teeth. The Institute has since published an average of 20 appraisals a year, with altogether 399 recommendations on the use of treatments, of which – perhaps surprising to some – 83% were positive.

“The guidance we have issued today, like the 199 that have preceded it, was developed by means of a transparent and consultative process that is held up as an example of excellence worldwide,” said Dillon.