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WHO prequalifies first generic HCV medicine
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WHO has prequalified the first generic version of sofosbuvir for the treatment of hepatitis C, a development that could improve access to quality-assured generic medicines, according to a press release.
Sofosbuvir, sold under the brand name Sovaldi, was approved for use in the United States in 2013 as part of an antiviral regimen for the treatment of HCV genotypes 1, 2, 3 or 4.
“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,” Gottfried Hirnschall, MD, MPH, director of WHO’s HIV/AIDS department and global hepatitis program, said in the release.
On average, a 3-month treatment course of sofosbuvir costs approximately $260 and remains highly expensive in many countries; however, licensing agreements between the drug’s developer, Gilead Sciences, and some generic manufacturers have made it possible for lower income countries to provide the medicine at more affordable prices. Many Asian and African countries are already procuring generic versions of sofosbuvir.
According to WHO, the prequalification of sofosbuvir means this new generic medication for HCV can now be procured by the U.N. and financing agencies, and it helps guarantee the quality, safety and efficacy of the product.
“This is a breakthrough medicine with a 95% cure,” Suzanne Hill, PhD, director of WHO’s Essential Medicines and Health Products, said. “The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product.”
Disclosures: Hill and Hirnschall report no relevant financial disclosures.