WHO prequalifies generic hepatitis C drug

THE World Health Organization - neric 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-percent cure,” said Suzanne Hill, director, Essential Medicines and WHO- prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.”

product can now be procured by the 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 of those generics will give them extra guarantee of the product’s quality,

“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 Gottfried Hirnschall, WHO director of the HIV 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 $260, which is 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.

First HIV self-test

self-test in a move to increase HIV diagnosis and treatment. The product, OraQuick ® HIV Self-Test manufactured by OraSure Technologies Inc. uses results in as little as 20 minutes.

- uct 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.

step in allowing countries to implement WHO guidelines, released in 2016, recommending HIV self-testing as a complementary approach to reach those who remain undiagnosed due to fear of stigma and discrimination.

“Over the past year, the number of countries incorporating HIV selftesting into their policies has increased from 16 to 40. This is impressive progress,” said Hirnschall. “Having qualityassured self-tests is essential to enable countries to implement more rapidly. It is a positive step toward making innovative HIV self-testing accessible to

In 2016, an estimated 30 percent of all people living with HIV remained unaware of their HIV status, many from higher risk populations who are either less likely to approach a health facility or are unable to do so.

is a major step that will help give gov adopt and scale up use of self-testing,” said Philippe Duneton, deputy executive director of Unitaid.

There is currently great interest from the international community in deploying tests intended for HIV self-testing, with numerous countries having developed national guidelines and plans for implementation. Support for procurement and deployment of these tests has been pledged by and procurement agencies, including a specific agreement on affordable pricing for 50 lower-middle income countries in Africa and Asia between the manufacturer and the Bill and Melinda Gates Foundation, a funder