For the treatment of chronic hepatitis C, the NICE drafts recommend:

• Daclatasvir (Daklinza, Bristol-Myers Squibb)
• Ledipasvir-sofosbuvir (Harvoni, Gilead Sciences)
• Ombitasvir-paritaprevir-ritonavir with or without dasabuvir (Viekirax with or without Exviera, Abbvie)

Hepatitis C is a virus that infects the liver. It is spread by contact with infected blood, for instance by using contaminated needles for injecting drugs or sharing razors or toothbrushes. The virus can cause inflammation of, and damage to the liver, preventing it from working properly.

About a third of people infected with the hepatitis C virus will eventually develop liver cirrhosis, where normal liver tissue is replaced by scar tissue. A small number of people with chronic hepatitis C and cirrhosis also go on to develop liver cancer.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Hepatitis C is a major public health challenge. It is difficult to diagnose, with estimates suggesting around 50% of people with the condition in England remain undiagnosed.

"Even when people are diagnosed, the long duration and potentially unpleasant side-effects of current interferon-based treatments can discourage people with the disease from completing the full course, or even from seeking treatment in the first place.

"We are very pleased to recommend not only one, but three new treatment options for chronic hepatitis C. This is good news, not just for people with chronic hepatitis C, but also because having more effective treatments for the condition could reduce the spread of the virus.”

It is recommended that access to the drugs used to treat hepatitis C is managed through the specialised commissioning programme put in place by NHS England with prescribing decisions made by multidisciplinary teams/centres to ensure that treatment is prioritised for patients with the highest unmet clinical need.

People whose treatment with daclatasvir, ledipasvir-sofosbuvir, or ombitasvir-paritaprevir-ritonavir with or without dasabuvir, is not recommended in the respective NICE guidance, but was started within the NHS before this guidance was published, should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

Ends

For further information, please contact the NICE press office on 0300 323 0142 / pressoffice@nice.org.uk or out of hours on 07775 583 813. 

Notes to Editors

Daclatasvir (Daklinza, Bristol-Myers Squibb)

Daclatasvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1.

Table 1 Daclatasvir for treating chronic hepatitis C

• Daclatasvir (Daklinza, Bristol-Myers Squibb) is an oral inhibitor of non-structural protein 5A, a multifunctional protein that is a component of the hepatitis C virus (HCV) replication complex. It inhibits both viral replication and assembly.
• Daclatasvir, in combination with other medicinal products, has a marketing authorisation in the UK for treating chronic hepatitis C virus infection in adults. The marketing authorisation recommends specific treatment combinations and durations, as follows:
• For genotype 1 or 4 HCV without cirrhosis: daclatasvir plus sofosbuvir for 12 weeks.
• Prolonging treatment to 24 weeks may be considered for people who have had previous treatment including a NS3/4A protease inhibitor.
• For genotype 1 or 4 HCV with compensated cirrhosis: daclatasvir plus sofosbuvir for 24 weeks.
• Shortening treatment to 12 weeks may be considered for untreated people with cirrhosis and positive prognostic factors.
• Adding ribavirin may be considered for people with very advanced liver disease or with other negative prognostic factors.
• For genotype 3 HCV with compensated cirrhosis and/or previous treatment: daclatasvir plus sofosbuvir and ribavirin for 24 weeks.
• For genotype 4 HCV: daclatasvir for 24 weeks plus peginterferon alfa and ribavirin for 24–48 weeks.
• The recommended dose of daclatasvir is 60 mg once daily.
• The price of daclatasvir is £8172.61 per 28 tablet pack of 60 mg daclatasvir (excluding VAT; ‘British national formulary’ [BNF] March 2015). The average cost of daclatasvir plus sofosbuvir is £59,501 for a 12 week course and £119,002 for a 24 week course; when ribavirin is added these costs increase to £60,304 and £120,608 respectively. The average cost of a course of treatment with daclatasvir in combination with peginterferon alfa and ribavirin ranges from £53,628 to £58,221 (depending on whether peginterferon alfa and ribavirin are taken for 24 or 48 weeks; daclatasvir may only be taken for 24 weeks). Costs may vary in different settings because of negotiated procurement discounts.

Ledipasvir-sofosbuvir (Harvoni, Gilead Sciences)

Ledipasvir–sofosbuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 2.

Table 2 Ledipasvir–sofosbuvir for treating adults with chronic hepatitis C

• Ledipasvir–sofosbuvir (Harvoni, Gilead Sciences) has a marketing authorisation in the UK for treating chronic hepatitis C in adults. However, the marketing authorisation recommends specific treatment durations for HCV genotypes 1, 3 and 4 only, and states that ledipasvir–sofosbuvir should not be used in people with HCV genotypes 2, 5 and 6.
• The recommended dose is 1 daily tablet containing a fixed-dose combination of 90 mg ledipasvir and 400 mg sofosbuvir. It is taken orally for 8, 12 or 24 weeks, with or without ribavirin. The recommended treatment duration and whether ribavirin is co-administered depends on genotype, treatment history and presence of cirrhosis.
• The cost of ledipasvir–sofosbuvir is £12,993.33 per 28 tablet pack (excluding VAT; company’s evidence submission). The cost of an 8 week course of treatment is £25,986.66 and a12 week course is £38,979.99 (both excluding VAT), not including the cost for ribavirin. Costs may vary in different settings because of negotiated procurement discounts.

Ombitasvir-paritaprevir-ritonavir with or without dasabuvir (Viekirax with or without Exviera , Abbvie)

Ombitasvir–paritaprevir–ritonavir with or without dasabuvir is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1.

Table 1 Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C

• Ombitasvir–paritaprevir–ritonavir (Viekirax, Abbvie) is a fixed-dose combination of 2 direct-acting anti-hepatitis C virus drugs (ombitasvir and paritaprevir) and ritonavir. The recommended dose is 2 tablets once daily, taken orally.
• Ombitasvir–paritaprevir–ritonavir has a marketing authorisation in the UK for the treatment of chronic hepatitis C in adults in combination with other medicinal products. The marketing authorisation recommends specific treatment combinations and durations for genotypes 1 and 4 hepatitis  C virus (HCV) depending on genotype, subtype and whether or not the person has cirrhosis
• Ombitasvir–paritaprevir–ritonavir costs £10733.33 excluding VAT for 28 days’ supply. The total costs of a 12-week and a 24-week course are £32200 and £64400 respectively (both excluding VAT: MIMS, February 2015). Costs may vary in different settings because of negotiated procurement discounts.
• Dasabuvir (Exviera, Abbvie) 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 1 tablet twice daily. It is taken orally for 12 or 24 weeks with ombitasvir–paritaprevir–ritonavir and with or without ribavirin. The recommended treatment duration and whether ribavirin is co-administered depends on the subtype of genotype 1 HCV and the presence of cirrhosis.
• Dasabuvir costs £933.33 excluding VAT for 28 days’ supply. The total cost of a 12-week and a 24-week course of dasabuvir are £3100 and £6200 respectively (both excluding VAT: MIMS, February 2015). Costs may vary in different settings because of negotiated procurement discounts.