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

By David Rowlands, Jul 24 2017 10:10AM

Hepatitis C


WHO 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.”


HIV self-test


WHO prequalified the first HIV self-test in a move to increase HIV diagnosis and treatment. The product, OraQuick ® HIV Self-Test (manufactured by OraSure Technologies Inc.) uses oral fluid as a specimen and provides results in as little as twenty minutes.


“The prequalification of this product means that countries with poor laboratory infrastructure will be able to safely increase testing capacity, thereby facilitating treatment of people living with HIV,” said Dr Suzanne Hill, Director, Essential Medicines and Health Products, WHO.


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