PATIENTS in Scotland with the deadliest form of hepatitis will be the first in the UK to get access to a new drug treatment on the NHS.
The Scottish Medicines Consortium (SMC) ruled that bulevirtide can be prescribed to patients with chronic hepatitis delta virus (HDV) infection where there is also evidence of significant fibrosis of the liver and other interferon-based drugs have either failed or are unsuitable.
Hepatitis D, also known as “delta hepatitis,” is a liver infection caused by the hepatitis D virus (HDV). It can only occur in people who are also infected with Hepatitis B.
In some patients it causes an acute, short-term infection, but others will go on to develop chronic HDV, which is life-threatening.
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Without treatment, chronic HDV can accelerate the onset of cirrhosis, liver cancer, and death - killing sufferers within five to 10 years.
Chronic HDV infection has the highest mortality rate of any of form of viral hepatitis and is thought to sicken millions of people across the globe.
Bulevirtide - also known by the brand name Hepcludex - is the first treatment available on NHS Scotland for patients with HDV infection.
John Dillon, professor of Hepatology and gastroenterology at the University of Dundee said: “Hepatitis delta virus may be less well known that hepatitis B or C, but it is highly aggressive and chronic infection carries potentially life-threatening consequences.
"[The SMC decision] is encouraging but it is also a reminder that more needs to be done across Scotland to find those affected so that we can ensure they receive the care and support they need.”
Experts believe that the rollout of the first treatment for HDV could also result in increased in testing and diagnosis rates for the infection.
Bulevirtide can be self-administered at home with a once-daily injection.
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Dr Véronique Walsh, vice president and general manager for the drug's manufacturer, Gilead Sciences UK & Ireland, said: “For years, chronic hepatitis delta virus infection has proven to be a notoriously difficult challenge to treat, with no licensed therapy options in the UK.
"This recommendation is a vitally important turning point, providing the option of bulevirtide across the NHS in Scotland.”
The SMC’s recommendation is the first of its kind in the UK.
A decision from the National Institute of Health and Care Excellence (NICE), which will provide guidance on its use across the rest of the UK, is scheduled to be made in the near future.
In its latest round of medicine decisions, the SMC also accepted pralsetinib (brand name Gavreto) on an interim basis for the treatment of a rare type of advanced non-small cell lung cancer.
The medicine, which can be taken as a pill once a day, will be made available while further information is gathered.
Following this SMC will review the evidence and make a decision on routine availability in NHS Scotland.
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In one study, with 211 participants, pralsetinib was shown to shrink or eliminate tumours in 72 per cent of the patients who were being treated for the cancer for the first time.
Among those who had previously received platinum-based chemotherapy, 59% had a partial or complete response to treatment - where a complete response meant there were no remaining signs of cancer.
SMC chair, Mark MacGregor, said: "The clinical evidence is promising but highly uncertain.
"The committee look forward to reviewing the updated evidence when available to ensure that this treatment offers good value to patients in NHSScotland.”
Muriel De Vos, of manufactuer Roche Products Ltd, said: "This is fantastic news for patients in Scotland with this type of advanced non-small cell lung cancer as they will now have access to a much needed treatment that targets their specific tumour type.
"Due to the lack of targeted treatment options, this condition is difficult to treat and this gives them hope for a better outcome."
In addition, nintedanib (brand name Ofev) can now be made available at an earlier stage in disease progression for patients suffering from idiopathic pulmonary fibrosis (IPF), a chronic and fatal lung condition.
Previously, the SMC advice restricted nintedanib to use only in patients with more advanced disease.
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