2 The technology

2 The technology

Description of the technology

Elbasvir–grazoprevir (Zepatier, Merck Sharp & Dohme) is a fixed-dose combination drug. Elbasvir inhibits hepatitis C virus (HCV) non‑structural viral protein NS5A and grazoprevir inhibits HCV NS3/4A protease.

Marketing authorisation

Elbasvir–grazoprevir has a marketing authorisation in the UK for treating chronic hepatitis C in adults.

The recommendations in the marketing authorisation for the specific genotypes are listed below:

  • genotype 1a: 12 weeks (16 weeks plus ribavirin should be considered in patients with baseline HCV RNA level >800,000 IU/ml or the presence of specific NS5A polymorphisms causing at least a 5‑fold reduction in activity of elbasvir to minimise the risk of treatment failure)

  • genotype 1b: 12 weeks

  • genotype 4: 12 weeks (16 weeks plus ribavirin should be considered in patients with baseline HCV RNA level >800,000 IU/ml to minimise the risk of treatment failure).

Adverse reactions

The summary of product characteristics includes headache and fatigue as very common adverse reactions, and nausea as a common reaction. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

It is taken orally. The recommended dose of elbasvir–grazoprevir is 1 tablet once daily. Each tablet contains 50 mg elbasvir and 100 mg grazoprevir.

Price

Elbasvir–grazoprevir costs £12,166.67 per 28‑day pack. The total cost of a 12‑week treatment course is £36,500.

The company has agreed a nationally available price reduction for elbasvir–grazoprevir with the Commercial Medicines Unit. The contract prices agreed through the framework are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)