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[e-med] L'OMS a préqualifié un générique du sofosbuvir pour le traitement de l'hépatite C

(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.
http://www.who.int/medicines/news/2017/1st_generic-hepC_1stHIVself-test-prequalified/en/


“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    


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