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NICE backs hepatitis C drug in draft guidance

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A new anti-viral drug has been provisionally approved as an option to treat certain types of hepatitis C in draft guidance from the National Institute for Health and Care Excellence.

Elbasvir-grazoprevir (Zepatier) is licensed to treat chronic hepatitis C in adults with genotypes 1a, 1b or 4.

“As these types of anti-viral drugs are more effective, the spread of the virus can be reduced”

Carole Longson

It comes in the form of a tablet which is taken once daily. Around 4,000 patients will be eligible for elbasvir-grazoprevir alongside other options already available on the NHS.

The drug works by blocking two proteins that cause the virus to multiply and infect new cells. In trials, it had cure rates above 90% for people with hepatitis C genotypes 1 and 4.

NICE has concluded that it should be routinely available on the NHS, as elbasvir-grazoprevir was considered just as effective as similar treatments that are already available.

Elbasvir-grazoprevir, manufactured by Merck Sharp & Dohme, costs £36,500 per patient for a 12-week course of treatment, but the NHS has been offered a confidential discounted price by the company.

The draft guidance is now with consultees, who have the opportunity to appeal against it.

Professor Carole Longson

Professor Carole Longson

Professor Carole Longson

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment.

“Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin,” she said.

She added: “Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced.”

NICE has previously published guidance recommending the following direct acting anti-viral treatments for hepatitis C:

  • Daclastavir with sofosbuvir or peginterferon alfa, and sometimes with ribavirin to treat genotypes 1, 3, and 4 (November 2015)
  • Ombitasvir-paritaprevir-ritonavir with or without dasubuvir to treat genotypes 1a, 1b and 4 (November 2015)
  • Ledipasvir-sofosbuvir to treat genotypes 1 and 4 (November 2015)
  • Sofosbuvir with peginterferon alfa and/or ribavirin to treat all genotypes (February 2015)
  • Simeprevir with peginterferon alfa and ribavirin to treat genotypes 1 and 4 (February 2015)
  • Boceprevir with peginterferon alfa and ribavirin to treat genotype 1 – with compensated liver disease (April 2012)
  • Telaprevir with peginterferon alfa and ribavirin to treat genotype 1 – with compensated liver disease (April 2012)
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