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
MSF responds to daclatasvir’s approval by the EC/EMA with the following
“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
– Dr Jennifer Cohn, Medical Director, MSF Access Campaign.