2 The technology

2 The technology

Description of the technology

Sofosbuvir–velpatasvir (Epclusa, Gilead) is a fixed-dose combination drug. Sofosbuvir inhibits hepatitis C virus (HCV) non‑structural viral protein NS5B ribonucleic acid (RNA)-dependent RNA polymerase. Velpatasvir inhibits HCV non-structural protein NS5A.

Marketing authorisation

Sofosbuvir–velpatasvir has a marketing authorisation in the UK for treating chronic hepatitis C virus (HCV) infection in adults. This includes genotypes 1–6 HCV in people with or without compensated or decompensated cirrhosis.

Adverse reactions

The summary of product characteristics states that headache, fatigue and nausea are the most common adverse reactions (incidence of 10% or more). For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Sofosbuvir–velpatasvir is taken orally. The recommended dose is 1 tablet once daily, for 12 weeks. Each tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. The marketing authorisation states that decompensated cirrhosis should be treated with sofosbuvir–velpatasvir in combination with ribavirin, for 12 weeks. Ribavirin plus sofosbuvir–velpatasvir may also be considered for people with genotype 3 HCV who have compensated cirrhosis.

Price

Sofosbuvir–velpatasvir costs £12,993.33 per 28‑day pack. The total cost of a 12‑week treatment course is £38,980. Ribavirin costs £246.65 per 56-tablet pack. The total cost of a 12‑week treatment course of sofosbuvir–velpatasvir with ribavirin is £40,089.93.

The company has a simple discount agreement which provides a discount to the list price of sofosbuvir–velpatasvir at the point of purchase or invoice. The level of the discount is commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)