Effective oral drug for Hepatitis C approved by European agencies

Various patent barriers hinder its availability and affordability, especially in countries with high burden of disease

By Kundan Pandey
Published: Thursday 28 August 2014


European Commission (EC) and European Medicines Agency (EMA) on Wednesday, became second regulatory authorities to approve the new direct-acting antiviral (DAA) daclatasvir, used to treat hepatitis C. The drug was approved by Japan in July this year.

Daclatasvir is the third DAA—a new class of oral drugs used to treat hepatitis C. The approval of daclatasvir is medically significant as it, in combination with other hepatitis C drugs, results in high cure rates.

The drug, as clinical trials have shown, is well tolerated by people. It has proved to be effective for genotype 3 of Hepatitis C, which cannot be treated with other available DAAs and is highly prevalent among people living with hepatitis C in India and Pakistan. 
Two big challenges: availability and affordability

Its availability to the needy remains a concern as Bristol-Myers Squibb (BMS), a global biopharma company manufacturing and marketing the medicine, has not yet announced any access plans for low- and -middle income countries where the majority of hepatitis C burden lies.

Non-profit Médecins Sans Frontières (MSF), a global group engaged in providing health facilities to many, expressed its concern about the potential lack of affordable access to daclatasvir, and patent barriers that could prevent the development of effective and affordable combinations.

Jennifer Cohn, a doctor associated with MSF Access Campaign, said, “BMS must rapidly register daclatasvir in countries with high burden of hepatitis C, especially the ones with high prevalence of genotype 3.  We urge BMS to ensure daclatasvir is made affordable in such countries.”

In a statement, Cohn said that patent barriers that prevent affordable access to daclatasvir and the new DAAs must be addressed by the 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.

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