WHO Prequalifies Generic Hepatitis C Drug, HIV Self-Test

Prequalification will allow countries to access generic sofosbuvir and an HIV self-test.

The World Health Organization (WHO) recently prequalified the first generic version of sofosbuvir (Sovaldi) for the treatment of patients with hepatitis C virus (HCV).

The WHO prequalification of sofosbuvir could increase access to HCV treatment by expanding the number of generics being sold, according to a press release.

“This is a break-through medicine with a 95% cure,” said Suzanne Hill, PhD, 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.”

Prequalification means that the product may be acquired by the United Nations and associated financial agencies, including UNITAID.

Countries such as Indonesia, Vietnam, Cambodia, Myanmar, Mongolia, Nepal, Rwanda, Uganda, Kenya, Zambia, Ethiopia, Pakistan, and Egypt have been procuring the generic version of sofosbuvir prior to the prequalification, according to the release. The WHO prequalification will give these countries the guarantee of the generic HCV drug’s quality, safety, and efficacy, according to the release.

“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, MD, director of the HIV Department at WHO. “Prequalification of the hepatitis C medicine for the first-time is therefore exciting news, ahead of World Hepatitis Day next week.”

The cost of the generic version of sofosbuvir is approximately $260, which is a substantial reduction compared with the original cost of the drug, according to the release. The WHO said that the generic version of the drug has made it possible for lower-income countries to treat patients.

Additionally, the WHO prequalified the first HIV self-test, the OraQuick HIV Self-Test, to increase the rate of diagnosis and treatment. The test uses saliva and produces results in 20 minutes, according to the WHO.

“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,” Dr Hill said.

The prequalification also marks a step towards allowing countries to implement WHO guidelines, which recommend self-testing as a way to reach undiagnosed patients who do not get treated due to fear of stigma and discrimination, according to the release.

“Over the past year, the number of countries incorporating HIV self-testing into their policies has increased from 16 to 40. This is impressive progress,” Dr Gottfried Hirnschall said. “Having quality-assured self-tests is essential to enable countries to implement more rapidly. It is a positive step towards making innovative HIV self-testing accessible to all those who would benefit from it.”

In 2016, approximately 30% of patients with HIV were unaware of their condition. Many of these patients were from high-risk populations who were less likely or unable to receive care from a healthcare facility, according to the release.

“As the first HIV self-testing product to obtain WHO prequalification, this is a major step that will help give governments the confidence they need to adopt and scale up use of self-testing,” said Philippe Duneton, deputy executive director of UNITAID.