(pas encore de traduction en français...CB)
In the lead-up to Paris AIDS conference, WHO prequalifies first generic
hepatitis C medicine and first HIV self-testHepatitis C
WHO today 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 Ltd., India.
“This is a break-through medicine with a 95% 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.”
WHO prequalification means the product can now be procured by the United
Nations and financing agencies such as UNITAID, which has recently introduced
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. The fact that WHO has prequalified one of those generics will give
them extra guarantee of the product’s quality, safety and efficacy.
“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 next week.”
The average price of the required three-month treatment course of Mylan’s
sofosbuvir is around US$ 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.
Medicines/Finished Pharmaceutical Products