The Medicines Patent Pool passes one million treatments milestone for crucial hepatitis C medication, daclatasvir

Bristol Myers Squibb applauds achievement for patients

Geneva – The Medicines Patent Pool (MPP), together with Bristol Myers Squibb (BMS), has enabled over one million patients to be treated with daclatasvir (DAC) – a curative regimen for hepatitis C virus (HCV) infection when used in combination with other medications – since issuing licences to manufacture and sell generic versions of the drug in 2016.

MPP’s licensing agreements with BMS originally covered 112 countries and now cover an additional 28 countries, including Brazil and Argentina as of 2021. Thirty-four countries have been supplied with DAC (30 or 60mg) standalone or in combination with sofosbuvir (SOF) by MPP licensees; the newest of these countries include Armenia, Cuba, Ethiopia, Moldova, Philippines, Tajikistan, Tanzania, Timor-Leste, and Turkmenistan.

“Reaching over one million people in need of HCV treatment is a significant milestone and a testament to the effectiveness of voluntary licensing in increasing access to safe, quality-assured HCV treatments that allow countries and their governments to afford much-needed medicine for more people,” said Charles Gore, Executive Director, MPP. “We are delighted to see new countries placing orders each year for daclatasvir. However, if we are to eliminate viral hepatitis C by 2030, we need to see many more low- and middle- income countries (LMICs) scaling up access to HCV treatments for people living with this life-threatening virus.”

“Bristol Myers Squibb has been proud to work with the Medicines Patent Pool in supporting distribution of daclatasvir, and we applaud the achievements of the daclatasvir licence and the difference it is making for patients,” said Amadou Diarra, SVP and Head of Global Policy & Government Affairs, BMS. “Partnerships with organisations like MPP are part of BMS’ global commitment to access and we are pleased to see how this partnership has enabled a million people to be treated for HCV.”

MPP signed a royalty-free licence with BMS in November 2015 to enable generic manufacture of DAC and announced its first sublicences in January 2016. There are currently four manufacturers with World Health Organization (WHO) Prequalification (Cipla, Hetero, Laurus, and Viatris – through its subsidiary Mylan) that can supply DAC (30 and 60 mg), and Mylan also has a WHO approved DAC/SOF fixed-dose combination.

According to WHO in their recent Global Progress Report on HIV, viral hepatitis and sexually transmitted infections, around 58 million people live globally with HCV, many of them in LMICs, with the vast majority remaining undiagnosed and untreated. Around 290,000 people die each year from hepatitis C, mostly from cirrhosis and liver cancer. Direct-acting antiviral medicines can cure more than 95% of patients. Daclatasvir combined with sofosbuvir is one of three WHO-recommended pan-genotypic HCV-treatment regimens. DAC is also included in WHO’s Model List of Essential Medicines, the internationally recognised standard that helps countries select treatments for their priority health needs based on efficacy and safety.