Bristol-Myers Squibb has welcomed a decision by the National Institute for Health and Care Excellence to recommend Daklinza in England and Wales as a treatment option for adult patients with chronic hepatitis C virus infection.
Draft guidelines from the National Institute for Health and Care Excellence support use of the first-in-class once-daily pill in combination with other agents to treat certain patients with genotypes 1, 3 and 4 of the disease.
Around 214,000 people in the UK are thought to have chronic HCV genotype 4 and around 100,000 genotype 3, a difficult-to-treat and often aggressive form of the condition linked with accelerated progression to end-stage liver disease.
Daklinza (daclatasvir) was the first NS5A complex inhibitor to win clearance in the EU, offering patients the chance of a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
According to BMS, the drug, when used in combination with Gilead’s Sovaldi (sofosbuvir), provides an all-oral, interferon-free regimen with cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3, and those who have previously failed treatment with protease inhibitors.
“Daclatasvir in combination with other agents represents a much needed oral treatment regimen that has been shown to cure the infection in the majority of patients, and we have already seen positive results in the real-life setting in patients with advanced disease,” said Anna Maria Geretti, Professor of Virology and Infectious Diseases at the University of Liverpool.
In further good news for hepatitis C patients with genotypes 1 and 4, the cost watchdog has also recommended Gilead’s Harvoni, which combines the mega-blockbuster Sovaldi (sofosbuvir), a nucleotide analogue polymerase inhibitor, with the NS5A inhibitor ledipasvir, and AbbVie’s Viekirax, with or without Exviera (ombitasvir-paritaprevir-ritonavir with or without dasabuvir), across various settings.