Europe approves BMS hep C drug for HIV and liver transplant patients
pharmafile | February 1, 2016 | News story | Research and Development, Sales and Marketing | Bristol-Myers Squibb, daclatasvir, daklinza
The European Commission has approved the expanded use of Bristol Myers-Squibb’s hepatitis C drug Daklinza (daclatasvir), to include liver transplant patients as well as those also infected with HIV.
The approval, based on the results of several clinical studies provides an important new, generally well-tolerated, option for patients who have historically been more difficult to treat. Almost 9% of the 9,000 HIV-positive individuals in the UK are also infected with hepatitis C virus (HCV). HCV infection is also believed to progress more rapidly to liver damage in people also infected with HIV.
Professor Geoffrey Dusheiko, Emeritus Professor of Medicine at the UCL Institute of Liver and Digestive Health, the Royal Free Hospital, London, says: “People with chronic hepatitis C who are co-infected with HIV or have had a liver transplant offer a unique challenge. Concurrent therapy must be carefully taken into consideration. However, the risks of disease progression in these groups of patients necessitates that they are a high priority for treatment. This approval now opens the door to a new treatment option that provides a high chance of curing the infection in a relatively short timeframe and is generally well tolerated.”
HCV infection is the cause of over one in six of all liver transplants in England, and is the leading indication for liver transplantation worldwide. Without treatment, HCV infection of the new liver after transplant is a certainty and is associated with rapid progression to cirrhosis, with up to 30% of transplanted patients developing cirrhosis within five years.
The ALLY-1 study evaluated the combination of daclatasvir and sofosbuvir with ribavirin regimen in 113 adult hepatitis C patients (treatment-naive or experienced) with either advanced cirrhosis or recurrent HCV post-liver transplant. 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis were cured of their infection. In the advanced cirrhosis cohort, patients whose treatment was interrupted by liver transplantation could be given an additional 12 weeks of treatment immediately post-transplant. The daclatasvir/sofosbuvir combo with ribavirin was generally well tolerated in both patient cohorts.
The ALLY-2 study evaluated the combination of daclatasvir and sofosbuvir administered for 12 weeks in 153 adults with chronic hepatitis C and HIV co-infection (treatment-naive or experienced). In this trial, 96% of treatment-naive genotype 1 patients were cured of their infection.
European Commission approval means a product may be used in any of the EU member states, but it is up to the individual health authorities in each country to decide whether or not to pay for the treatment.
Joel Levy
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