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NICE set to approve raft of new hepatitis C drugs

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The National Institute for Health and Care Excellence is set to recommend three new treatments for some adults with hepatitis C, following preliminary positive recommendations in July.

NICE has published final draft guidance on the following three drugs for treating hepatitis C:

  • Daclatasvir (Daklinza)
  • Ledipasvir-sofosbuvir (Harvoni)
  • Ombitasvir-paritaprevir-ritonavir (Viekirax) with or without dasabuvir (Exviera)

Daclatasvir, manufactured by Bristol-Myers Squibb, is an oral inhibitor of non-structural protein 5A, a multifunctional protein that is a component of the hepatitis C virus replication complex. It inhibits both viral replication and assembly.

The drug is approved for treating hepatitis C genotypes 1, 3 or 4, with or without cirrhosis in different treatment durations and in combination with other drugs depending on various stages of the disease.

The recommended dose of daclatasvir is 60 mg once daily, said the final draft guidance from NICE.

Ledipasvir–sofosbuvir, manufactured by Gilead Sciences, prevents hepatitis C virus replication by inhibiting both non-structural protein 5A and also 5B proteins.

In common with daclatasvir, the drug’s marketing authorisation recommends specific treatment durations for hepatitis C genotypes 1, 3 and 4. It should not be used in people with genotypes 2, 5 and 6, said NICE in its final draft guidance on the drug.

The recommended dose is one daily tablet containing a fixed-dose combination of 90mg ledipasvir and 400mg sofosbuvir. It is taken orally for eight, 12 or 24 weeks, with or without ribavirin.

Meanwhile, ombitasvir-paritaprevir-ritonavir is a fixed-dose combination of two direct-acting anti-hepatitis C virus drugs – ombitasvir and paritaprevir – and ritonavir.

Each tablet contains 12.5mg ombitasvir, 75mg paritaprevir, and 50mg ritonavir.

“In the past there have been limited treatment options available and therefore this decision is an important milestone”

Anna Maria Geretti

Ombitasvir inhibits non-structural viral protein 5A, paritaprevir inhibits 3/4A serine protease, and ritonavir increases the bioavailability of paritaprevir.

The recommended dose is two tablets once daily, according to the final draft guidance. It is taken orally for 12 or 24, weeks with or without dasabuvir, and with or without ribavirin.

Dasabuvir is a direct-acting anti-hepatitis C virus drug which inhibits a viral enzyme (NS5B) that has a role in viral genome replication.

The recommended dose is one 250mg tablet twice daily. It is taken orally for 12 or 24 weeks with ombitasvir-paritaprevir-ritonavir and with or without ribavirin.

Both ombitasvir-paritaprevir-ritonavir and dasabuvir are manufactured by AbbVie.

The marketing authorisation recommends specific treatment combinations and durations for genotypes 1 and 4 depending on genotype, subtype and whether or not the person has cirrhosis.

A consultation on the final draft version of the three guidelines will run until 29 October, after which they are likely to be approved – subject to any appeal against NICE’s decision.

It follows initial approval in initial draft guidance published in July.

Access to the three drugs will be managed through the specialised commissioning programme put in place by NHS England.

This means prescribing decisions made by multidisciplinary teams to ensure that treatment is prioritised for patients with the highest unmet clinical need.

Anna Maria Geretti, professor of virology and infectious diseases at the University of Liverpool, said: “It is a challenge to treat patients with hepatitis C virus infection, including the significant number of patients with genotype 3, whose condition tends to progress rapidly.

“In the past there have been limited treatment options available and therefore this decision is an important milestone,” she said.

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