Hepatitis C combination from AbbVie licensed in the UK: ombitasvir/paritaprevir/ritonavir (Viekirax) and dasabuvir (Exviera)

On 19 January 2015, AbbVie announced that its direct acting antiviral (DAA) hepatitis C drugs are now available in the UK, following EU marketing authorisation. [1]

The approvals were for the combination tablet of ombitasvir/paritaprevir/ritonavir (brand name Viekirax) and single compound dasabuvir (brand name Exviera).

The indication for both drugs is for use with or without ribavirin in patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

The combination tablet ombitasvir/paritaprevir/ritonavir is also licensed for use with ribavirin in non-cirrhotic, genotype 4 (GT4) chronic HCV patients.

The combined formulation contains ombitasvir 12.5 mg (NS5a inhibitor, previously ABT-450), paritaprevir 75 mg (NS4/4A protease inhibitor) and ritonavir 50 mg (pharmacokinetic booster). The recommended oral dose is two tablets taken once daily with food.

Dasabuvir 250mg is a non-nucleoside NS5B polymerase inhibitor. The recommended oral dose is one tablet, twice daily (morning and evening). Dasabuvir must always be administered together with ombitasvir/paritaprevir/ritonavir.

The efficacy of Viekirax has not been established in patients with HCV genotypes 2, 3, 5 and 6; therefore Viekirax should not be used to treat patients infected with these genotypes.

There are no data on the use of Viekirax and ribavirin in patients with HCV genotype 4 infection, with compensated cirrhosis and therefore the optimal treatment duration has not been established. Based on in vitro antiviral activity and available clinical data in HCV genotype 1, for people with HCV genotype 4 and compensated cirrhosis, a conservative treatment duration of 24 weeks is recommended.

Comment

This press release from AbbVie of UK availability is perhaps premature given the protracted NHS process to decide on access to new drugs and that a price has yet to be announced.

It seems likely that AbbVie will be interested setting comparable drug prices to Gilead rather than using the opportunity to bring competition to this market.