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Hepatitis: India to keep fighting, new test may come handy

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Hepatitis: India to keep fighting, new test may come handy

In 2016, of the 400 million people infected by viral hepatitis globally, about 13% were Indians. “There is need for immediate and urgent action to arrest the spread of hepatitis. In the South-East Asia Region, viral hepatitis is driving rates of liver cancer and cirrhosis, and is causing premature death and disease with over 100 million people chronically infected with Hepatitis B and Hepatitis C,” WHO‘s Regional Director for South East Asia Poonam Khetrapal Singh told TOI.

According to experts, with challenges such as awareness, accessibility, compliance and affordability, India can only eradicate hepatitis by 2080 (as against global goal of 2030) if they start acting now.

Interestingly, a very effective vaccine is available against one of the most prevalent forms, hepatitis B, and more than 90% cases of hepatitis C are curable. Yet the mortality from the disease in the country is high, primarily due to low awareness and late diagnosis. HCV is significantly under recognized and underdiagnosed as patients may not show symptoms until more serious liver injury develops, such as cirrhosis (scarring of the liver) or liver cancer, particularly among those who are immunocompromised or are thalassemic.

Diagnosing and evaluating hepatitis can be a time-consuming, financially draining for patients in a country where per capita healthcare spend is only about US$ 80 or ~Rs.5,200 (way below global average).

Test

Cost*

Liver function Test

Rs.275

Hepatitis and viral marker profile

Rs.720

Hepatitis C virus total antibody

Rs.250

Hepatitis C virus – genotyping

Rs.1,850

Hepatitis C rapid screening

Rs.480

Hepatitis C viral load, quantitative

Rs.1,875

*as per lowest cost of individual test listed on www.1mglabs.com

On an average, it takes more than 12-48 hours to confirm diagnosis of a hepatitis viral infection. Time taken and cost of diagnosis further restricts access to impromptu care against hepatitis in a country with low affordability and healthcare spend, and limited access.

Upcoming diagnostic tools

Abbott recently announced the company’s HCV core antigen test, which can detect active infection, helping doctors connect patients to treatment sooner. With the new HCV core antigen test, doctors can confirm active infection in around 40 minutes and can be delivered in routine path labs.

Dr. Sushil G Devare, director, diagnostics research and emerging markets initiatives, Abbott Laboratories talks about how access to testing is critical to helping more people get cured, thereby reducing the transmission of this virus.

Interviewer: We have been informed about the new developments by Abbott in the Hepatitis C space. So could you tell us a bit about that?

Dr. Devare: We have come up with a new test for Hepatitis C which identifies people who have active viral infection and could then be enrolled for the anti-viral therapy. Hepatitis C is a causative agent for Hepatitis. Multiple forms of virus – A, B, C, D and E – and hence, the disease nomenclature. All these viruses can be transmitted through different sources, for example, Hepatitis A and E could be through food or water contamination; whereas B, C and D can be transmitted through blood. Patients with history of blood transfusions, on hemodialysis or exposed to blood, even through a shared toothbrush can be infected.

For Hepatitis C, the virus was discovered in 1989. In the US, blood screening started in 1990 and since then there had been multiple test that identify the virus more efficiently, thereby, eliminating the rate of transmission. The rate of transmission has gone down to 1 among a million.

However, in India, the test was introduced only in 2002. Therefore, the prevalence of the infection was very high in the country.

There are two situations of a Hepatitis C case:

1. 25-30% of the infected patient can eliminate virus on their own

2. However, about 70% of patients are unable to eliminate the virus and thereby, develop antibodies to fight the virus. These patients are the ones who we identify as having active viral infection.

The antibody test is the test done to first identify an infection. Following that, there is a need to differentiate if the patient has an active infection or if the body has ability to take care of the virus. Patients with active infections are identified using Nucleic Acid Test (NAT) looking at the viral genome in the blood. Developed countries have the test readily available than countries where it is not economically feasible to have the test. Since the test requires specialized equipment and training, the cost becomes high. In India the test is available, but it is still quite expensive, thus it is not readily utilized as it should be.

ET Fact: According to a study published in Indian Journal of Pathology & Microbiology, there are only 54 centers in the country capable of conducting a NAT. Central and Eastern India have just three centers capable of doing the test.

Given the issues, we have developed an antigen test which is parallel to NAT in terms of detecting active viral infection. This test has been used in many parts of the world and WHO has recommended the test in the countries where NAT is either not readily available or is prohibited. The European Association for Study of Liver Disease has also recommended this test as a substitute for NAT. There is data collected globally proves the new test to perform equally well.

The difference between NAT and the antigen test is that the antigen test has a fully automated platform and you can get the results in 30-40 minutes. For NAT, the patient has to go through extraction and specialized equipment and a hepatologist is involved in the entire process. It also takes a good 7 days for the results to be procured often costing the patient’s life in those 7 days.

The antigen test will allow a hepatologist to give results of an active infection in a more efficient manner. Given early diagnosis, hepatologist can now hope to eliminate the virus within 8-12 weeks. That eventually prevents any liver disease that would take place over time because of the virus.

Interviewer: You discussed the core antigen test scores over legacy NAT test. India as a geography is quite different, what are India-specific advantage of this test – example, is there a cost advantage, can it be taken out of the office or outside a clinic or if can be delivered at home for the patient’s convenience?

Dr. Devare: In terms of cost, the antigen test is much cheaper than NAT because you require specialized equipment for NAT while antigen test is fully automated and patients will get results within 40 minutes. WHO has also recognized that this test is much cheaper in comparison.

In terms of point of contact, it is a device, so patients has to go to lab to get the test done. There are many big centers in India that have the equipment to run the test.

But if the patient is in a remote location without access to a proper diagnostic lab then there is a possibility to carry the samples on ‘dry blood spots’. Blood spots can be extracted in a lab. But due to logistics and distance of the lab, it takes longer than usual to get the results.

Interviewer: India is a fragmented market dominated by local, private players. Since Abbott has come out with this innovative test, do you plan to enter into partnership with the organized players at least to ensure access to the best possible mile?

Dr. Devare: There are many labs that already have Abbott instruments so availability to the test will be much easier.

Interviewer: How costly is it for a regional, small player to acquire Abbott apparatus and then provide the test at a cost-effective price to the patient?

Dr. Devare: Interestingly, the instrument used for running this test is the same instrument that can be used for other infectious diseases such as HIV. The reagent is different but the platform for testing is same. This is an advantage for all the labs since their existing equipment can be used for more than one test. It is only about creating awareness about availability of such a test for hepatitis C. The test was just approved in December last year and simultaneously, the Indian Government announced a plan to eradicate Hepatitis from India. The GoI has allocated Rs. 600 crores for their fight against Hepatitis. We believe the antigen test will help them optimize their spend and budget.

Interviewer: What is the average skill or training required at the sample collection end? Is a specialized person required or can they be trained in-clinic?

Dr. Devare: Whenever you draw blood for a test, the same practices can be used. It doesn’t require any kind of a specialized training.

Interviewer: So any lab that is able to collect a sample can have access to this test?

Dr. Devare: Yes and the instrument can be used for diagnosing many other infectious diseases.

Interviewer: In future, will Abbott partner with the Government in their effort to eliminate Hepatitis from the country?

Dr. Devare: We always try to partner with whoever is willing to partner with us – be it government or private institutions. Major challenge is how you let people know about it. We are organizing a lot of CMEs to educate hepatologists and the government officials.

Interviewer: Due to affordability issue, would you consider developing a patient assistance program or any CSR initiative or would it be more through the Government-sponsored channels?

Dr. Devare: We are looking at multiple options to create awareness about it. We know it is important for the public to know that there is a test and in what way it can help. The plan is not finalized yet. We think we should start with people who would really believe that patients can benefit from the test – such as the hepatologists. Then we can start reaching out to people who would support our belief that the test is really useful. In India, hepatologists will like to see the result themselves before supporting it.

Interviewer: Do you think this innovation would be a path breaker to the way Hepatitis C is managed?

Dr. Devare: We are trying to come up with even better ways of manage the disease better. We also trying to develop on-the-spot testing, which can provide results even faster. So that is also being looked at and it is a continuous process.

Interviewer: What were your biggest challenges faced when you were developing this test?

Dr. Devare: Over time, we have come up with better technology which has limited the number of diseases transmitted through blood. The adaptation of the technology is slower in India but we know that we have to think about something that is easier to apply in countries like India.

Interviewer: How challenging was the science behind this?

Dr. Devare: The science is always challenging. When you come up with a test, you have to consider how sensitive the test is to detect infection. It has to be specific because you don’t want the test to come up with a false positive result, thus subjecting patients to the treatment that they don’t require. So, as a scientist, I would like to create a test that not only 100% detects all the infection but is also specific and correct. Therefore, we have to look at this extremely closely and it is challenging.



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