AbbVie’s glecaprevir/pibrentasvir (G/P) has become the first treatment for chronic hepatitis C to be included in the UK’s Early Access to Medicines Scheme (EAMS).
G/P is a once-daily regimen that combines two distinct antiviral agents - the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) - dosed once-daily as three oral tablets.
The ribavirin-free treatment is currently being assessed by European regulators as a treatment for all genotypes (GT) of the virus after showing high cure rates in clinical trials, but will now become available to certain patients in the UK before a decision is reached.
The positive scientific opinion by the Medicines and Healthcare Products Regulatory Agency enables the regimen to be accessed by adults with compensated cirrhosis and at least one of the following: GT 1, 4, 5 or 6 infection and prior treatment with an NS5A inhibitor; GT 2, 3, 5 or 6 infection and chronic kidney disease stage 4 or 5; or GT 3 infection previously treated with peg-interferon, ribavirin and/or sofosbuvir.
“We are delighted to receive the EAMS positive scientific opinion, which will help ensure that eligible patients with limited current treatment options gain access to this therapy as soon as possible,” commented Dr Alice Butler, medical director of AbbVie UK.
According to the firm, the G/P regimen could provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis, as well as an additional treatment option to patients with compensated cirrhosis (Child-Pugh A).
Around 214,000 people in the UK are currently thought to be infected with the hepatitis C virus.