Geneva, 28 July 2018 – The Medicines Patent Pool (MPP) welcomes the new global guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection published today by the World Health Organization. These guidelines recommend treating all people aged 12 and above living with chronic hepatitis C virus (HCV) infection (with the exception of pregnant women) and recommends the use of pan-genotypic regimens.
The MPP signed a licence agreement for pan-genotypic direct-acting antiviral daclatasvir (DAC) and its combinations with Bristol-Myers Squibb in November 2015. Since then, ten generic manufacturing partners of the MPP signed a licence to produce lower-cost versions of these products for sale in 112 low- and middle-income countries.
Four MPP licensees have already filed daclatasvir (DAC) 30mg and 60mg for regulatory approval through the WHO Prequalification Program and three more plan to do so in 2019. One manufacturer has already received approval from the Expert Review Panel (ERP), a group coordinated by the WHO, who assesses the risks and benefits of pharmaceutical products, including safety and efficacy, and makes recommendations to procurement agencies. At the country-level, generic daclatasvir from MPP licensees is already approved in 16 low- and middle-countries (LMICs) and has been filed in another 30 LMICs. Filings in other countries are expected in the coming months.
In addition, four generic manufacturers are developing daclatasvir/sofosbuvir (DAC/SOF) combination products, which are already approved in 3 countries and have been filed in another 14 countries. They are expected to file for WHO Prequalification in 2018 and 2019.
“I am thrilled that the new guidelines recommend treatment for all with pan-genotypic medicines,” said Charles Gore, MPP Executive Director. “We will continue supporting and encouraging the development and roll-out of generic DAC and SOF/DAC combinations. This will enable more people living with HCV in low- and middle-income countries to benefit from quality-assured affordable versions of these products.”
Hepatitis C can be eliminated if people with HCV infection are tested, diagnosed and have access to treatment.
Access the WHO 2018 Hepatitis C treatment guidelines
Join the WHO Test.Treat.Hepatitis campaign
About the Medicines Patent Pool:
The Medicines Patent Pool is a United Nations-backed public health organisation working to increase access to HIV, hepatitis C and tuberculosis treatments in low- and middle-income countries. Through its innovative business model, the MPP partners with civil society, international organisations, industry, patient groups and other stakeholders to prioritise, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with nine patent holders for 13 HIV antiretrovirals, two hepatitis C direct-acting antivirals and a tuberculosis treatment. The MPP was founded and is funded by Unitaid.
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