On 27 August 2014, the European Commission (EC) and the European Medicines Agency (EMA) became the second stringent regulatory authority (after Japan in July) to approve new direct-acting antiviral (DAA) daclatasvir, used to treat hepatitis C. Daclatasvir is the third DAA - a new class of oral drugs used to treat hepatitis C – to be approved.
The approval of daclatasvir is medically significant, as it, in combination with other hepatitis C drugs including other DAAs, results in high cure rates; clinical trials have also shown it to be well tolerated by people. In addition, combining two DAAs is critical to simplifying treatment in developing countries, and combinations which include daclatasvir, such as sofosbuvir+daclatasvir, have pan-genotypic potential; daclatasvir has shown to be effective for genotype 3, which has proven difficult to treat with other DAAs and is highly prevalent among people living with hepatitis C in India and Pakistan.
However, Médecins Sans Frontières (MSF) is concerned about the potential lack of affordable access to daclatasvir, and patent barriers that could prevent the development of effective and affordable combinations. Development and testing of sofosbuvir/daclastavir combination treatment was delayed when Gilead (owner of sofosbuvir) stopped collaboration with Bristol-Myers Squibb (owner of daclatasvir) in favour of Gilead's proprietary sofosbuvir/GS-5816 combination. Only now is BMS able to undertake phase III trials of this combination with commercially available sofosbuvir. Further, BMS has not yet announced any access plans for low- and middle-income countries, where the majority of the hepatitis C burden lies.
MSF response to daclatasvir’s approval by the EC/EMA:
“We welcome the approval of daclatasvir by the EMA, but we must ensure that people living with hepatitis C in low- and middle-income countries can actually access this important drug, so that it can have the greatest impact on hepatitis C globally in helping to cure people.
Bristol-Myers Squibb must rapidly register daclatasvir in those countries with a high burden of hepatitis C, especially in those countries with a high prevalence of genotype 3. We urge BMS to ensure daclatasvir is affordable in those countries with a high burden of hepatitis C.
Intellectual property barriers for daclatasvir, unless they are overcome, could keep affordable versions out of reach of people and may also prevent the development of an optimal fixed-dose combination that can provide simple, highly effective treatment for all people with hepatitis C, regardless of genotype.
Patent barriers that prevent affordable access to daclatasvir and the new DAAs must be addressed by governments to promote robust generic competition, which will enable price reductions, facilitate the development of a pan-genotypic combination, and accelerate availability in all developing countries that are bearing the brunt of the hepatitis C epidemic.”
- Dr Jennifer Cohn, Medical Director, MSF Access Campaign.