Overview

Ledipasvir-sofosbuvir (Harvoni) is recommended as a possible treatment for adults with some types (called genotypes) of chronic hepatitis C. See tables 1 and 2.

Table 1 If your hepatitis C has not been treated before

Type of hepatitis C Ledipasvir–sofosbuvir treatment recommended by NICE
1, without cirrhosis 8 weeks’ treatment
1 or 4, with cirrhosis 12 weeks’ treatment

 

Table 2 If your hepatitis C has been treated before, but has not responded well enough 

Type of hepatitis C Ledipasvir–sofosbuvir treatment recommended by NICE
1 or 4, without cirrhosis 12 weeks’ treatment
1 or 4, with cirrhosis 12 weeks’ treatment, only if the person has a low risk of the disease getting worse

What does this mean for me? 

If you have genotype 1 or 4 chronic hepatitis C that fits the criteria in tables 1 or 2, and your healthcare team think that ledipasvir–sofosbuvir is the right treatment, you should be able to have the treatment on the NHS.

The treatment should be available on the NHS within 3 months of the guidance being issued.

If you are not eligible for treatment as described above, you should be able to continue taking ledipasvir–sofosbuvir until you and your healthcare team decide it is the right time to stop.

Your responsibility

The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.

Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

  • National Institute for Health and Care Excellence (NICE)