NICE recommends Daklinza (daclatasvir) for use in some patients with the most difficult-to-treat type of chronic hepatitis C

Bristol-Myers Squibb has today welcomed the decision by the National Institute for Health and Care Excellence (NICE) to recommend Daklinza® (daclatasvir) in England and Wales as a treatment option for adult patients with chronic hepatitis C virus (HCV) infection.1 A first-in-class oral, once-a-day pill used in combination with other agents and is recommended to treat certain patients with genotypes 1, 3 and 4.^1,3 Around 214,000 people in the UK are thought to have chronic HCV4 and approximately 100,000 patients in the UK are thought to have hepatitis C genotype 3, a difficult-to-treat and often aggressive form of chronic HCV.^2,4

Commenting on the NICE recommendation, Anna Maria Geretti, Professor of Virology and Infectious Diseases, University of Liverpool, said: "It is a challenge to treat patients with hepatitis C virus infection, including the significant number of patients with genotype 3, whose condition tends to progress rapidly. In the past there have been limited treatment options available and therefore this decision is an important milestone. 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."

HCV genotype 3 is associated with accelerated progression to end-stage liver disease, making treatment time critical.² Genotype 3 is associated with increased incidence of hepatocellular carcinoma in cirrhotic patients⁵, and more rapid progression to fibrosis compared with other genotypes⁶, leading to increased mortality.⁷ Deaths from HCV have nearly quadrupled between 1996 and 2012 in England.⁸

Up until recently treatment options for genotype 3 patients have been limited.^9,10,11,12 Standard of care has been up to 48 weeks of interferon-based therapy which could be associated with a number of debilitating side effects throughout the body.^13,14,15,16 Daclatasvir in combination with other treatments, has been generally well tolerated and has been shown to clear the infection in most of these patients after 12 or 24 weeks of therapy.^3,17,18 It is currently one of only two all oral treatment regimens recommended in EU guidelines by The European Association for the Study of the Liver (EASL) for patients with genotype 3.¹⁵

This is an important decision by NICE and very good news for patients," said Charles Gore, Chief Executive of The Hepatitis C Trust. "Each new treatment for hepatitis C takes us closer to making the elimination of this virus as a serious public health problem a realistic possibility. At present, it is estimated that only 3% of people with hepatitis C in England get access to treatment each year. It is therefore crucial that patients are able to access new medicines, which offer much better efficacy and tolerability than previous treatments."

HCV is usually asymptomatic in the early years, which contributes to the fact that as many as 50% of people living with the disease may be undiagnosed.⁸ Furthermore, 60-70% of all those infected will go on to develop chronic liver disease.¹⁹

Commenting on the guidance, Liz Carroll, Chief Executive of The Haemophilia Society said, "We are delighted with the decision by NICE to recommend this treatment option for people with hepatitis C, particularly those with genotype 3 which is difficult-to-treat and progresses quickly. This decision means patients will have access to an effective treatment that could clear their infection, is a shorter course, and is more tolerable compared to traditional therapies, providing hope for the future."

In 2012, healthcare costs associated with the condition were estimated at £82.7m in the UK.20 A study has found that by 2035 this figure is projected to rise to £115m, if current treatment levels remain the same.²⁰

Johanna Mercier, General Manager of Bristol-Myers Squibb UK & Ireland commented, "Before now hepatitis C patients have had limited treatment options and we are delighted that NICE has taken the decision to recommend daclatasvir-based regimens. BMS and clinicians alike have seen the positive impact this treatment has had among some patients in the UK to date and it is therefore good news that it will now be available to a wider group of people who are in much need of new treatment options."