• The World Health Organisation (WHO) has prequalified the first hepatitis C virus (HCV) self-test which can provide critical support in expanding access to testing and diagnosis, accelerating global efforts to eliminate hepatitis C.
• The product, called OraQuick HCV self-test, manufactured by OraSure Technologies, is an extension of the pre-qualified, OraQuick HCV Rapid Antibody Test which was initially prequalified by WHO in 2017 for professional use.
• The self-test version, specifically designed for use by lay users, provides individuals with a single kit containing the components that are needed to perform the self-test.
• WHO recommended HCV self-testing (HCVST) in 2021, to complement existing HCV testing services in countries. The recommendation was based on evidence demonstrating its ability to increase access to and uptake of services, particularly among people who may not otherwise test.
• Every day 3,500 lives are lost to viral hepatitis. Of the 50 million people living with hepatitis C, only 36 per cent had been diagnosed, and 20 per cent have received curative treatment by the end of 2022.
• The addition of this product to the WHO prequalification list provides a safe and effective way to expand HCV testing and treatment services, ensuring more people receive the diagnoses and treatment they need, and ultimately contributing to the global goal of HCV elimination.
Hepatitis C
• Hepatitis C is a viral infection that affects the liver. It can cause both acute (short term) and chronic (long term) illness. It can be life-threatening.
• Hepatitis C virus (HCV) is spread through contact with infected blood. This can happen through sharing needles or syringes, or from unsafe medical procedures such as blood transfusions with unscreened blood products. HCV can be passed from an infected mother to her baby
• Hepatitis C is not spread through breast milk, food, water or casual contact such as hugging, kissing and sharing food or drinks with an infected person.
• Globally, an estimated 50 million people have chronic hepatitis C virus infection, with about one million new infections occurring per year.
• WHO estimated that in 2022, approximately 242,000 people died from hepatitis C, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer).
• Acute HCV infections are usually asymptomatic and most do not lead to a life-threatening disease. Around 30 per cent of infected persons spontaneously clear the virus within 6 months of infection without any treatment.
• The remaining 70 per cent of persons will develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis ranges from 15 per cent to 30 per cent within 20 years.
• Hepatitis C virus infection occurs in all WHO regions. The highest burden of disease is in the Eastern Mediterranean Region with 12 million people chronically infected. In the South-East Asia Region (9 million), European Region (9 million) and the Western Pacific Region (7 million) people are chronically infected. Eight million people are chronically infected in the African Region and 5 million the Region of the Americas.
Symptoms
• Most people do not have symptoms in the first weeks after infection. It can take between two weeks and six months to have symptoms.
• Symptoms can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine and yellowing of the skin or eyes (jaundice).
Treatment
• There is no effective vaccine against hepatitis C. The best way to prevent the disease is to avoid contact with the virus.
• There are effective treatments for hepatitis C. The goal of treatment is to cure the disease and prevent long-term liver damage.
• Some people’s immune system can fight the infection on their own and new infections do not always need treatment. Treatment is always needed for chronic hepatitis C.
• People with hepatitis C may also benefit from lifestyle changes, such as avoiding alcohol and maintaining a healthy weight. With proper treatment, many people can be cured from hepatitis C infection and live healthy lives.
• Early detection and treatment can prevent serious liver damage and improve long-term health.
