3:34pm Saturday 18th January 2014
© Press Association 2014
A treatment for hepatitis C which is potentially more effective and quicker than other therapies has been given the green light by the European Commission.
With the EC's approval for marketing of the drug sofosbuvir, a once daily inhibitor, "many more patients are offered the opportunity of a cure", according to the makers Gilead Sciences.
"It is a game changer," said Professor Mark Thursz, a professor of hepatology at Imperial College and consultant in hepatology.
"We have been following the development of this drug for the past few years, looking at the trial data and getting very excited. For me the excitement is about what it can do for patients.
"There are patients we can now treat."
The approval means sofosbuvir 400mg tablets can be marketed in all 28 EU countries. Sofosbuvir is described as a nucleotide analogue inhibitor.
The National Institute for Health and Care Excellence (Nice) in Britain is reviewing the product for its cost effectiveness, which could pave the way for it to be used for both private and NHS patients.
Tests have shown that sofosbuvir, when used with established treatments such as the peg-interferon (peg-IFN) injection and the Ribavirin (RBV) tablet, offers high cure rates of up to 90% in previously untreated adult patients.
It can be used on adults who are suffering from any of the six variations "without adding any significant side effects but adding to the efficacy and shortening the time of treatment", Prof Thursz said. Previous treatments and how developed the illness has become would be key factors that have to be taken into account.
Patients can suffer flu-like symptoms when taking peg-IFN along with aches and pains, temperatures, suppression of bone marrow, rashes, diarrhoea and abdominal discomfort while tiredness and anaemia are possible side effects of RBV.
This second generation of direct acting antivirals is "in a different class because of its incredible potency", according to Prof Thursz.
He said that "the success rates we are expecting is about 80-90%" whereas just two years ago it was about 40% for some forms of the disease meaning "we have doubled the success rate, in two steps in two years".
Hepatitis C is estimated to affect 215,000 adults in the UK, according to Health Protection Agency figures from 2013, and it is a major cause of liver cancer and liver transplantation.
The current standard of care for hepatitis C involves up to 48 weeks of therapy using a peg-IFN/RBV regime, which may not be suitable for certain types of patient.
Many patients are ineligible, unwilling or intolerant to standard treatments to try and cure hepatitis C but there may be hope for more patients with the proposed shorter 12 week course of new treatment that may offer 90% efficacy, according to Gilead Sciences.
Dr Graham Foster, professor of hepatology, Queen Mary University of London, said: "Unlike many chronic diseases, hepatitis C can be cured. For many hepatitis C patients, however, for a number of reasons, many hepatitis C patients have not currently achieved a cure and often progress to end-stage liver disease or liver cancer.
"With high cure rates across a broad range of patients and a short duration of therapy, sofosbuvir is a very welcome therapeutic advance that will increase the number of patients who can be treated and ultimately cured."
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