5.3.3.1 Chronic hepatitis B

Entecavir

• Tablets 500micrograms, 1mg
• Oral solution 50micrograms

Notes

1. NICE TA153: Entecavir (Baraclude), within its marketing authorisation, is recommended as an option for the treatment of people with chronic HBeAg-positive or HBeAg-negative hepatitis B in whom antiviral treatment is indicated (August 2008)
   1. This guidance does not apply for people with chronic hepatitis B who also have hepatitis C, hepatitis D or HIV.

Telbivudine

• NICE TA154: Telbivudine (Sebivo) is not recommended for the treatment of chronic hepatitis B (August 2008).

5.3.3.2 Acute and Chronic hepatitis C

NHS England (NSHE) will routinely commission antivirals for adults with acute hepatitis C (HCV), including the treatment of acute HCV infection in immunosuppressed adults (e.g. post transplantation patients) (see NHSE Commissioning Policy for more details).

MHRA Drug Safety Update (October 2018): Ritonavir-containing products: reports of interaction with levothyroxine leading to reduced thyroxine levels. Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after the start and end of ritonavir treatment

MHRA Drug Safety Update (December 2018): Direct-acting antivirals for chronic hepatitis C: risk of hypoglycaemia in patients with diabetes

Zepatier

(Elbasvir-grazoprevir)

• Tablets 50mg/100mg

Notes

1. NICE TA413: Elbasvir-grazoprevir (Zapatier) is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1 of guidance, only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit (October 2016)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Maviret

(Glecaprevir-pibrentasvir)

• Tablets modified-release 100mg/40mg

Notes

1. NICE TA499: Glecaprevir–pibrentasvir (Maviret) is recommended, within its marketing authorisation, as an option for treating chronic hepatitis C in adults, only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit (January 2018)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Harvoni

(Ledipasvir-sofosbuvir)

• Tablets 90mg/400mg

Notes

1. NICE TA363: Ledipasvir-sofosbuvir (Harvoni) is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1 of guidance (November 2015)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Sovaldi

(Sofosbuvir)

• Tablets 400mg

Notes

1. NICE TA330: Sofosbuvir (Solvaldi) is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1 of guidance (February 2015).
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Epclusa

(Sofosbuvir-velpatasvir)

• Tablets 400mg/100mg

Notes

1. NICE TA430: Sofosbuvir–velpatasvir (Epclusa) is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1 of guidance, only if the company provides it with the discount agreed in the simple discount agreement (January 2017)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Vosevi

(Sofosbuvir-velpatasvir-voxilaprevir)

• Tablets 400mg/100mg/100mg

Notes

1. NICE TA507: Sofosbuvir-velpatasvir-voxilaprevir (Vosevi) is recommended as an option for treating chronic hepatitis C in adults, as specified in table 1 of guidance, only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit (February 2018)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
2. For NHS England commissioned treatment of acute hepatitis C, see above.

Ribavirin

• Tablets 200mg
• Capsules 200mg

Notes

1. NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C (November 2013)
2. NICE TA106: Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C (November 2013)
3. NICE TA200: Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of TA75 and TA106) (September 2010)

Exviera

(Dasabuvir)

Notes

1. The marketing authorisation holder has discontinued this product.
2. NICE TA365: Ombitasvir-paritaprevir-ritonavir (Viekirax) with or without dasabuvir (Exviera) is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1 of guidance, only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit (November 2015)
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
3. For NHS England commissioned treatment of acute hepatitis C, see above.

Viekirax

(Ombitasvir-paritaprevir-ritonavir)

Notes

1. The marketing authorisation holder has discontinued this product.
   
2. NICE TA365: Ombitasvir-paritaprevir-ritonavir (Viekirax) with or without dasabuvir (Exviera) is recommended, within its marketing authorisation, as an option for treating genotype 1 or 4 chronic hepatitis C in adults, as specified in table 1 of guidance, only if the company provides it at the same price or lower than that agreed with the Commercial Medicines Unit (November 2015)
   
   1. It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.
3. For NHS England commissioned treatment of acute hepatitis C, see above.

5.3.3.3 Chronic hepatitis D

Bulevirtide

• Powder for solution for injection vial 2mg

Notes

1. NICE TA896: Bulevirtide (​Hepcludex​) ​is recommended​ as an option for treating chronic hepatitis D in adults with compensated liver disease (June 2023), only if:
   1. there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) ​and​
   2. their hepatitis has not responded to peginterferon alfa-2a (PEG-IFN) or they cannot have interferon-based therapy ​and​
   3. the company provides it according to the commercial arrangement.