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WHO Releases First Guidelines on C Virus Self-Testing

New guidelines from WHO strongly recommend offering self-testing for hepatitis C virus (HCV) as an additional approach to HCV testing services. WHO releases the new guidelines – its first on HCV self-testing – during the International AIDS Society Conference 2021. 

WHO set a goal to eliminate HCV as a public health problem by 2030 in its Global health sector strategy on viral hepatitis (2016–2021), with targets to diagnose 90% of those with HCV and to treat 80% of those diagnosed. However, as of 2019 only an estimated 21% of the 58 million people with chronic HCV infection globally were diagnosed. And, despite recent advances in highly effective and affordable direct-acting antiviral (DAA) treatment, only 9.4 million (62% of those diagnosed) were treated with DAAs between 2015 and 2019. In many settings people from key populations, particularly men who have sex with men and people who inject drugs, have high rates of HCV infection but do not benefit from testing and treatment. WHO’s guidance on HCV self-testing is meant to support the efforts of national programmes to reach people who may not otherwise test. 

The new guidelines highlight key considerations for policy-makers, national programmes, providers and implementers of HCV testing services. These considerations for HCV self-testing include designing appropriate and context-specific messages, service delivery models and support tools through engagement with communities; setting up efficient pathways for people who self-test to obtain confirmatory testing and treatment or prevention services; training providers; creating a supportive and enabling policy environment; and using quality-assured products. To help assure quality, WHO has published technical specifications for prequalification of HCV self-testing products. HCV self-testing kits are likely to be available soon. 

Evidence of impact and experience with HIV self-testing was an impetus to consider self-testing for HCV. Development of the HCV self-testing guidelines also drew on compelling evidence of the acceptability and usability of HCV self-testing for both users and providers in almost a dozen countries from different regions and confirmation that the great majority of lay users are able to perform HCV self-testing. 

“HIV self-testing has been an effective tool in accelerating progress towards achieving global goals, and many country programmes have benefited from the availability of HIV self-testing to support continuity of essential services in the COVID-19 context,” said Dr Meg Doherty, Director of the WHO Global HIV, Hepatitis and STI Programmes. “We encourage countries and national programmes to start planning for introduction of HCV self-testing as well, especially for priority populations and regions with the greatest gaps in testing coverage.”

Unitaid funding supported the development and evidence generation for the new HCV self-testing guidelines.

“Unitaid played a critical role in expanding access to HIV self-testing in countries and is pleased to advance efforts supporting HCV self-testing,” said Philippe Duneton, Executive Director of Unitaid. “Creating simplified and more accessible pathways to diagnosis for the 58 million people with HCV worldwide is essential to making real progress against this virus. The COVID-19 pandemic has further underscored the importance of simple, at-home tests in ensuring that people can access care. We welcome these new guidelines from WHO as an important step towards meeting HCV elimination targets.”

WHO expresses thanks to the experts who developed and reviewed these guidelines. As WHO celebrates the global Self-Care Month, culminating in Self-Care Day, 24 July, the recommendation for HCV self-testing is timely and an important addition to growing self-care options.

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