2 The technology
2.1 Ombitasvir–paritaprevir–ritonavir (Viekirax, AbbVie) is a fixed‑dose combination of 2 direct‑acting anti‑hepatitis C virus drugs (ombitasvir and paritaprevir) and ritonavir. Each tablet contains 12.5 mg ombitasvir, 75 mg paritaprevir, and 50 mg ritonavir. Ombitasvir inhibits non‑structural viral protein NS5A; paritaprevir inhibits NS3/4A serine protease; and ritonavir increases the bioavailability of paritaprevir. The recommended dose is 2 tablets once daily. It is taken orally for 12 or 24 weeks with or without dasabuvir, with or without ribavirin.
2.2 Dasabuvir (Exviera, AbbVie) is a direct‑acting anti‑hepatitis C virus drug which inhibits a viral enzyme (NS5B) that has a role in viral genome replication. The recommended dose is 1 tablet (250 mg) twice daily. It is taken orally for 12 or 24 weeks with ombitasvir–paritaprevir–ritonavir and with or without ribavirin. The recommended treatment duration and whether ribavirin is co‑administered depends on the subtype of genotype 1 hepatitis C virus (HCV) and the presence of cirrhosis.
2.3 Ombitasvir–paritaprevir–ritonavir has a marketing authorisation in the UK for the treatment of chronic hepatitis C in adults in combination with other medicinal products. The marketing authorisation recommends specific treatment combinations and durations for genotypes 1 and 4 HCV depending on genotype, subtype and whether or not the person has cirrhosis (see table 2). Dasabuvir has a marketing authorisation in the UK for the treatment of chronic hepatitis C in adults in combination with other medicinal products. However, the marketing authorisation recommends specific treatment durations for subtypes of genotype 1 HCV only. For full details of the recommended treatment durations with ombitasvir–paritaprevir–ritonavir with and without dasabuvir, see the summary of product characteristics. For a summary, see table 2.
2.4 The summary of product characteristics lists the following adverse reactions as common with ombitasvir–paritaprevir–ritonavir with or without dasabuvir and ribavirin: insomnia, nausea, pruritus (itching), asthenia (weakness), fatigue and anaemia. For full details of adverse reactions and contraindications, see the summaries of product characteristics.
2.5 Ombitasvir–paritaprevir–ritonavir costs £10,733.33 excluding VAT for 28 days' supply. The total costs of a 12‑week and a 24‑week course of ombitasvir–paritaprevir–ritonavir are £32,200 and £64,400 respectively (both excluding VAT: MIMS, February 2015). Dasabuvir costs £933.33 excluding VAT for 28 days' supply. The total costs of a 12‑week and a 24‑week course of dasabuvir are £2800 and £5600 respectively (both excluding VAT: MIMS, February 2015). The company has agreed a nationally available price reduction for ombitasvir–paritaprevir–ritonavir with or without dasabuvir with the Commercial Medicines Unit. The contract prices agreed through the framework are commercial in confidence.
Table 2 Marketing authorisation treatment schedule for ombitasvir–paritaprevir–ritonavir by HCV genotype
|
HCV genotype, liver disease stage |
Treatment |
Duration (weeks) |
|
1b, without cirrhosis |
Ombitasvir–paritaprevir–ritonavir with dasabuvir |
12 |
|
1b, with compensated cirrhosis |
Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin |
12 |
|
1a, without cirrhosis |
Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin |
12 |
|
1a, with compensated cirrhosis |
Ombitasvir–paritaprevir–ritonavir with dasabuvir and ribavirin |
24 |
|
4, without cirrhosis |
Ombitasvir–paritaprevir–ritonavir without dasabuvir and with ribavirin |
12 |
|
4, with compensated cirrhosis |
Ombitasvir–paritaprevir–ritonavir without dasabuvir and with ribavirin |
24 |
|
Abbreviation: HCV; hepatitis C virus. Follow the genotype 1a dosing recommendation in people with an unknown genotype 1 subtype or with mixed genotype 1 infection. Follow the same dosing recommendations in people with HIV‑1 co‑infection. |
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