Bristol-Myers Squibb today announced the launch of Daklinza®▼ (daclatasvir) in the UK, a new medicine for the treatment of adult patients with chronic hepatitis C. Daclatasvir, a treatment that works across multiple hepatitis C genotypes, will allow up to 90% of UK patients the option of a potentially curative oral treatment regimen that does not include interferon, a standard of care commonly associated with sustained flu-like side effects. In 2014, the New England Journal of Medicine (NEJM) reported that daclatasvir (the first NS5A inhibitor to be licensed in Europe), used in combination with sofosbuvir, offered clinical cure rates of 98% and 89% in patients with hepatitis C genotype 1 and 3 respectively. Daclatasvir has also shown, in a separate study, to provide clinical cure rates in hepatitis C genotype 4 of up to 100% when combined with peginterferon alfa and ribavirin.
“Over the last decade we have seen an alarming rise in the number of deaths and hospital visits caused by people with hepatitis C,” said Dr. Kosh Agarwal, Consultant Hepatologist and Transplant Physician at the Institute of Liver Studies, King’s College Hospital. “The launch of this treatment is welcome news as it represents an important new option for patients with chronic hepatitis C that can offer high cure rates for some patients, and be taken as a pill. Another significant point is that this treatment removes the need to use interferon, which is a widely used medicine that often makes patients feel extremely unwell, for example causing flu-like symptoms, fatigue or depression. Diagnosis and treatment of this disease is fundamental to countering the worrying trend in its prevalence, and having effective therapy options such as this is an important part of this step.”
In January 2014, daclatasvir was brought forward for priority review by the European Medicines Agency (EMA), recognising the unmet need that exists in the hepatitis C patient population. Its submission included data from a trial published in the NEJM in 2014. In this study (040), daclatasvir was combined with the NS5B inhibitor, sofosbuvir. Results showed that 98% of previously untreated patients (n=126) and 98% of previously treated patients (n=41) with hepatitis C genotype 1, experienced 12 week sustained virologic response (SVR12), which is widely recognised as a clinical cure. In the genotype 1 population (one of the most prevalent in the UK), the 98% of patients cured included some who had already failed on currently available treatment options. In addition, this study also showed that a daclatasvir/sofosbuvir-based combination was effective in patients with genotype 3, with 89% (n=18) of patients experiencing SVR12. The most common adverse events were fatigue, headache, and nausea. Other data supporting the submission included results from the 010 study of daclatasvir in combination with interferon-alpha and ribavirin. In this, at 12 weeks from the start of treatment, 100% of patients (12/12) with genotype 4 achieved SVR12.
“We are delighted by today’s announcement,” said Charles Gore, Chief Executive of The Hepatitis C Trust. “Each new treatment for hepatitis C takes us closer to making the elimination of hepatitis C a realistic possibility, by improving both cure rates and tolerability. With only 3% of people with hepatitis C in England accessing treatment each year, it is crucial patients are able to access new treatments as early as possible so they have the opportunity to get cured of this cancer-causing virus.”
Hepatitis C is a blood-borne virus which, if left untreated, can lead to potentially fatal cirrhosis or cancer of the liver. Hepatitis C 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. Deaths from hepatitis C have nearly quadrupled since 1996 in the UK. However, it has been estimated that only 3% of those infected are treated each year. The increase in this disease also represents a pressing financial burden on the UK; in 2012, healthcare costs associated with the condition were estimated at £82.7m. According to a Public Health England modelling study, by 2035, this figure is projected to rise to £115m, if current treatment levels remain the same. In addition, productivity losses (people unable to work due to hepatitis C) could rise as high as £427 million in the same year.
“We are committed to improving the quality of life of patients living with hepatitis C and paving the way to cure this chronic and devastating condition,” said Johanna Mercier, General Manager, Bristol-Myers Squibb, UK and Ireland. “Study results have highlighted that daclatasvir has the potential to offer high cure rates, notably offering some of its most successful results in genotypes 1 and 3, which account for 90% of all hepatitis C cases in the UK. We are therefore delighted to be able to make this treatment option available to patients.”