First self-test kit for Hepatitis C gets greenlight from WHO
The incubation period for hepatitis C ranges from 2 weeks to 6 months.
What you need to know:
- Hepatitis C is inflammation of the liver cause by the Hepatitis C Virus (HCV).
- Depending on how mild or severe it is, it can lead to lifelong illnesses such as liver cirrhosis and cancer.
The World Health Organisation (WHO) has pre-qualified the first self-test for Hepatitis C Virus in efforts to accelerate elimination of the disease, which affects 50 million people globally and about 1.9 million people in Kenya.
Hepatitis C is inflammation of the liver caused by the Hepatitis C Virus (HCV). Depending on how mild or severe it is, it can lead to lifelong illnesses such as liver cirrhosis and cancer. Hepatitis C 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 and sexual practices that lead to exposure to blood, explains WHO. Symptoms can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine and yellowing of the skin or eyes (jaundice).
The pre-qualification comes three years after WHO recommended HCV self-testing in 2021 to aid existing testing services. Now the self-test kit will allow individuals to choose the method of testing, giving them autonomy and access to stigma-free self-care services.
The new kit, which has been manufactured by OraSure Technologies, is called OraWuick HCV self-test and is set to provide critical support in expanding access to testing and diagnosis.
The kit is also an extension of an already pre-qualified rapid antibody test, a test strip which works by detecting antibodies in blood of people with signs and symptoms of Hepatitis, and individuals at risk for infection with Hepatitis C. The antibody test is, however, for use only by professionals.
“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 had received curative treatment by the end of 2022,” says Dr Meg Doherty, WHO director for the Department of Global HIV, Hepatitis and STI Programmes.
“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,” adds Dr Meg.
According to Dr Roogerio Gaspar, the WHO director for the Department of Regulation and Prequalification, availability of the pre-qualified self-test will allow low-and middle-income countries to access safe and affordable self-testing options, and while at it ensure that 90 per cent of people with the disease are diagnosed.
The diagnosis, says WHO, is key since it paves way for treatment, leading to treating about 95 per cent of the cases . Access to both diagnosis and treatment remains low in many countries. Globally, WHO records about one million new infections annually. It also estimates that in 2022, about 242, 000 people died from Hepatiitis C, mostly from liver cirrhosis and 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 six months without any treatment. The remaining 70 per cent 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,” says WHO.
“Because new HCV infections are usually asymptomatic, few people are diagnosed when the infection is recent. In those people who develop chronic HCV infection, it is often undiagnosed because it remains asymptomatic until decades later when symptoms develop secondary to serious liver damage,” adds WHO.
According to the Gastroentology Society Of Kenya, the prevalence of HCV in blood donors is between 1.5-2.5 per cent with higher values in intravenous drug users up to 30 per cent. The Society estimates that intravenous drug use accounts for 80 per cent of acute HCV infections.
Where routine screening is unavailable, the Society highly recommends screening for patients donating blood or blood products for transfusion, kidney dialysis patients and staff, healthcare workers and those exposed to blood, intravenous drug users and individuals with risky sexual behaviour, including men who have sex with men, bisexual individuals and individuals with multiple sexual partners.
The Society also recommends screening for patients with compromised immunity such as those who are HIV positive, renal transplant patients and patients on chemotherapy. Individuals with pre-existing liver diseases are also recommended for screening as well as people who experience accidental injuries-needle stick injury, shared razor blades and tattoo clients.
