Skip navigation |

Sofosbuvir: draft guidelines from NICE by genotype

About the draft guidance

  1. The draft guidance states that:

Sofosbuvir in combination with peginterferon alfa and ribavirin

1.1 Sofosbuvir, in combination with peginterferon alfa and ribavirin, is recommended as an option for treating genotype 1 chronic hepatitis C in adults.

1.2 Sofosbuvir, in combination with peginterferon and ribavirin, is recommended as an option for treating genotype 3 chronic hepatitis C in adults with cirrhosis.

1.3 Sofosbuvir, in combination with peginterferon alfa and ribavirin, is recommended as an option for treating genotype 3 chronic hepatitis C in adults without cirrhosis, only if they had treatment for hepatitis C before.

1.4 Sofosbuvir, in combination with peginterferon alfa and ribavirin, is not recommended for treating genotype 4, 5 and 6 chronic hepatitis C in adults.

Sofosbuvir in combination with ribavirin alone

1.5 Sofosbuvir, in combination with ribavirin alone is not recommended for treating adults with genotype 1, 4, 5 and 6 chronic hepatitis C.

1.6 Sofosbuvir, in combination with ribavirin, is recommended as an option for treating genotype 2 chronic hepatitis C in adults only if they:

  • have not had treatment for chronic hepatitis C before and are intolerant to or ineligible for interferon therapy or
  • have had treatment for chronic hepatitis C before, regardless of interferon eligibility.

1.7 Sofosbuvir, in combination with ribavirin, is recommended as an option for treating genotype 3 chronic hepatitis C only in adults with cirrhosis.

1.8 People currently receiving treatment initiated within the NHS with sofosbuvir that is not recommended for them by NICE in this guidance should be able to continue treatment until they and their NHS clinician consider it appropriate to stop.

About chronic hepatitis C

  1. There are 6 major genotypes and several subtypes of the hepatitis C virus, the prevalence of each vary geographically.
  2. Genotypes 1 and 3 account for the majority of chronic hepatitis C cases in England (46% and 43% respectively).
  3. People with genotype 2 hepatitis C generally respond to treatment better than those with genotype 1, 3, 4, 5 or 6.
  4. For people with mild disease, a ‘watchful waiting’ approach may be agreed, on an individual basis, between the patient and clinician.
  5. Current NICE guidance (NICE technology appraisal 75 and NICE technology appraisal 106) recommends that standard treatment for the majority of people with chronic hepatitis C is peginterferon alfa and ribavirin combination therapy. Monotherapy with peginterferon alfa-2a or peginterferon alfa-2b is recommended for patients who are unable to tolerate ribavirin or for whom ribavirin is contraindicated.
  6. Other NICE guidance on hepatitis C (NICE technology appraisal 200) also recommends that people who have been previously treated with peginterferon alfa and ribavirin or with peginterferon alfa monotherapy have an option to receive further courses of peginterferon alfa and ribavirin.
  7. Shortened courses of peginterferon alfa and ribavirin are also recommended as an option for certain patient subgroups (NICE technology appraisal 200).
  8. For people with genotype 1 chronic hepatitis C, who have not been previously treated or who have been previously treated, NICE guidance also recommends telaprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 252) or boceprevir in combination with peginterferon alfa and ribavirin (NICE technology appraisal 253).

About sofosbuvir

  1. Sofosbuvir (Sovaldi, Gilead Sciences) is an antiviral drug used to prevent hepatitis C viral replication in infected cells. It is administered orally.
  2. Sofosbuvir has a UK marketing authorisation for use ‘in combination with other medicinal products for treating chronic hepatitis C in adults’. The recommended dose is one 400mg tablet daily. The summary of product characteristics for sofosbuvir states that peginterferon alfa and ribavirin, or ribavirin only, are the recommended co-administered medicinal products for use with sofosbuvir.
  3. The duration of treatment is 12 or 24 weeks depending on the patient’s hepatitis C virus genotype and history of prior treatment with interferon.
    1. The cost of sofosbuvir is £11,660.98 per 28-tablet pack of 400 mg tablets (excluding VAT, ‘British national formulary’ [BNF] May 2014). The cost of a 12-week course of treatment is £34,982.94 and a 24-week course is £69,965.88 (both excluding VAT), not including the cost for ribavirin and peginterferon alfa. Costs may vary in different settings because of negotiated procurement discounts.

Summary of Appraisal Committee’s key conclusions on cost effectiveness

Genotype 1

  1. The ICER for treatment with sofosbuvir plus peginterferon and ribavirin compared with peginterferon and ribavirin was £17,500 per QALY gained in treatment naïve patients.
  2. The Committee also considered sofosbuvir plus peginterferon and ribavirin to be cost effective compared with boceprevir plus peginterferon and ribavirin, and telaprevir in combination with peginterferon and ribavirin (ICERS of approximately £10,300 and £15,400 per QALY gained respectively).
  3. The Committee considered sofosbuvir plus peginterferon and ribavirin to be cost effective in treatment experienced patients compared with peginterferon and ribavirin, boceprevir and ribavirin and telaprevir and ribavirin with ICERs of approximately £12,600, £700 and £8200 per QALY gained respectively.
  4. Sofosbuvir plus ribavirin was not recommended in people for whom interferon was unsuitable (regardless of previous treatment) because of the higher ICER compared with standard care (no treatment) which was in excess of £47,500 per QALY gained in the combined cirrhotic and non-cirrhotic cohort.


Genotype 2

  1. Sofosbuvir plus ribavirin compared with peginterferon and ribavirin in people who were treatment experienced had an ICER of £12,500 per QALY gained. However, in the treatment naïve group the treatment was not recommended because of the high ICER of £46,300 per QALY gained.
  2. The Committee considered sofosbuvir plus ribavirin to be clinically effective and cost effective compared with no treatment in people for whom treatment with interferon was unsuitable regardless of treatment experience (with ICERs of approximately £12,500 and £8500 per QALY gained respectively).


Genotype 3

  1. The Committee considered the extended treatment duration (24 weeks) of sofosbuvir plus with ribavirin to be clinically effective compared with peginterferon alfa and ribavirin. The Committee considered sofosbuvir plus peginterferon alfa and ribavirin to be cost effective in people who were treatment naive with cirrhosis (with an ICER of approximately £6600 per QALY gained) but not in people who were treatment naive without cirrhosis (with a high ICER of approximately £40,600 per QALY gained). Treatment was recommended in treatment-experienced patients regardless or cirrhotic status with ICERs of below approximately £19,000 per QALY gained
  2. The Committee considered the cost effectiveness of sofosbuvir plus ribavirin to be acceptable in people who were not eligible for peginterferon alfa regardless of previous treatment in people who had cirrhosis with ICERs of approximately £10,500 per QALY gained in treatment naive and £19,200 per QALY gained treatment experienced patients. The Committee did not consider sofosbuvir in combination with ribavirin to be cost effective in non-cirrhotic patients with ICERs of approximately £28,000 and £31,400 per QALY gained in treatment-naive and experienced patients respectively.


Genotypes 4, 5 and 6

The Committee considered sofosbuvir in combination with ribavirin with or without peginterferon alpha to be clinically effective compared with peginterferon and ribavirin in people with treatment naïve and experienced HCV genotypes 4, 5 and 6.

13. The Committee did not consider sofosbuvir in combination with peginterferon alpha and ribavirin in people who were eligible for interferon to be cost effective in the treatment naive or experienced populations given the high degree of uncertainty in ICERs in excess of approximately £26,800 per QALY gained. In addition the Committee did not consider sofosbuvir plus ribavirin in people who were not eligible for interferon to be cost effective given the high degree of uncertainty in ICERs of approximately £26,800 per QALY gained.

This is draft guidance; NICE has not yet issued final guidance to the NHS. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Source: https://www.nice.org.uk/news/press-and-media/NICE-consults-on-draft-guidance-on-the-drug-sofosbuvir-for-treating-hepatitis-C