WHO prequalifies first generic Hepatitis C medicine & first HIV self-test

It means that the product can now be procured by the UN and financing agencies such as UNITAID, which now includes co-infection with HIV and hepatitis C in the portfolio of diseases it covers

WHO recently prequalified the first generic version of sofosbuvir, a critical medicine for the treatment of hepatitis C. The development could expand access to treatment by increasing the number of quality-assured generic medicines on the market. Sofosbuvir, 400 mg tablet, is manufactured by Mylan Laboratories, India.

WHO prequalification means the product can now be procured by the United Nations and financing agencies such as UNITAID, which now includes co-infection with HIV and hepatitis C in the portfolio of diseases it covers. Countries such as Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Kenya, Zambia, Ethiopia, Pakistan and Egypt are already procuring generic versions of sofosbuvir.

“This is a break-through medicine with a 95 per cent cure,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products at WHO. “The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.”

“Direct acting antiviral medicines such as sofosbuvir are highly effective for treating and curing chronic hepatitis C infection. But, at best, 1 out of 10 people in need had access to these medicines in 2015,” said Dr Gottfried Hirnschall, WHO’s Director of the HIV Department. “Prequalification of the hepatitis C medicine for the first-time is therefore exciting news, ahead of World Hepatitis Day.”

The average price of the required three-month treatment course of Mylan’s sofosbuvir is around $260, a small fraction of the medicine’s market entry price in late 2013, and of the price set in the majority of high-income countries. The medicine remains highly expensive in many countries, but licensing agreements between Gilead Sciences, who developed sofosbuvir, and a number of generic manufacturers have made it possible for low-income and some middle-income countries to provide the medicine at more affordable prices.