Daclatasvir is a novel direct-acting antiviral that is proven to help cure multiple genotypes of the hepatitis C virus.

Generics companies Cipla, Emcure, Hetero and Natco have signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell daclatasvir in 112 low- and middle-income countries. It is estimated that 130–150 million people worldwide have hepatitis C. The vast majority of these are in low- and middle-income countries.

The sub-licences follow the MPP’s announcement of its first hepatitis C licensing agreement, which was signed with Bristol-Myers Squibb in November 2015. The agreement marks the first time that generics makers have worked through a non-profit, public health organization to increase access to new hepatitis C medicines for developing world patients.

The MPP licence allows generics makers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C (HCV). Daclatasvir, in combination with sofosbuvir, for example, produces high cure rates after 12 weeks of treatment, with recent phase III studies demonstrating that the regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease.

The news is very welcome for poorer countries, who would, without this agreement, have had to wait many years to gain access to this treatment at prices affordable for the general population. Bristol-Myers Squibb only received approval for Daklinza in Europe on 22 August 2014 and in the US on 24 July 2015.

The MPP is also assessing applications from other generics companies and is expected to grant further sub-licences in the near future.

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