This article originally appeared on our sister site HCPLive.
Real-world data presented recently by the American Association for the Study of Liver Diseases (AASLD) at the 2023 Liver Conference in Boston further supports a hepatitis C virus (HCV) elimination model that has been progressively implemented in India to significantly reduce hepatitis C Virus (HCV) infection rate. long-term benefits.
Madhumita Premkumar, MD, associate professor, Department of Hepatology, National Academy of Medical Sciences, India, analyzes the Punjab HCV elimination model and explores the nationwide impact of cost-effective direct-acting antiviral (DAA) rollout HCV-related decompensation in new AASLD data The incidence of liver cirrhosis.
In an interview during the Liver conference, Premkumar previewed the presentation and discussed the design, intent and success history of the Punjab model in detail.
Question: Can you explain this program and some of the specific demographics and clinical manifestations we’re seeing in this cohort?
Prem Kumar: This project started back in 2016. We realize that India has a large untapped population with hepatitis C and hepatitis B. When direct-acting antiviral drugs became available, we realized there was a great opportunity to actually eliminate this curable disease from the population. So in 2016, the Punjab government actually made a one-time Indian fund of Rs 2 billion available, which would enable the health service to purchase medicines – and generic medicines are very affordable in India, and they are bioequivalent and very It works. We gave it to our patients and the entire course ended up being just $60. We realize that based on sampling, the population prevalence in Punjab is about 3.6%. This was done through random sampling of urban and rural areas.
So if we talk about demographics, I would say about 80% of the patients who are actually treated under the program are from rural or agricultural backgrounds. Therefore, in rural and semi-urban areas, most people only have school education and are literate. In urban areas, we don’t have that many people really taking advantage of this, probably because they already have access to treatment and medical facilities that are not part of the government sector. So the idea is to spread it to patient populations in rural areas because that’s where the spread is happening. Another interesting fact about hepatitis C in India is that it is mainly spread through unsafe injections. There is a trend towards using injectable drugs for even minor illnesses, which is a necessity based on the population. They just assume that even minor illnesses require injectable medications. If compared to the Egyptian program, most patients were actually infected in Egypt through the schistosomiasis immunization campaign. Therefore, they use the same scratching needle across a large portion of the population.
After we tested and treated this large group of people, we found that our cure rate in the general population was 91%, which is really good considering that our adhesions are an issue. And then the COVID crisis hit us, so our persistence rate is about 88%. Even after 4 and 8 weeks of treatment, our cure rate is 88 – 91%. We are very happy with the results. So once this state and India actually show us the results, we’re going to replicate that across the country through the National Viral Hepatitis Elimination Program. Currently, this model has been promoted nationwide. The beauty of it is that it’s done in a decentralized way.
So what we do is we train doctors in existing areas and then we provide help to pharmacists and local doctors. We first trained them in a workshop to educate them about hepatitis C, how to distribute the medication, and which patients could receive the medication. We’re asking patients who don’t have cirrhosis to actually be treated in the periphery. Then, for patients with compensated cirrhosis, they will receive a specific treatment regimen, and for patients with decompensated cirrhosis, if treatment fails or there are any complications, such as hepatocellular carcinoma, HIV co-infection, or hepatitis B , they will be referred to us.
This hub-and-spoke model is similar to the ECHO model used in some areas in the United States. It is now used across the country, and our cure rate is 91%. This started back in 2016, and this year we provided data to the AASLD on decompensated cirrhosis. We actually showed a reduction in the severity of liver disease—patients no longer had variceal bleeding, and they were actually off the transplant list. All of this costs $60 per patient. So, it’s a huge plan that actually demonstrates the way drugs should be made available where they are needed.
question: How much of the hepatitis C eradication problems we are seeing in countries like the United States, where drug treatment is capable but promotion and access remains inadequate, can be attributed to policy or public health restrictions?
Prem Kumar: I mean, patent laws play a role to some extent; obviously, companies need to recoup the investments they make in drug development. But at some point, the government or the public sector needs to take over and understand the needs of its people. If people need it, and people are suffering, and it can be avoided with very low-cost purchases, then it should be done. There is a lot of resistance to free HIV drugs. Fortunately, we are a welfare society and our government owns public hospitals, which are basically free. So, all of these services are testing, dispensing, they’re now free to patients using the existing infrastructure.
It’s a great way to motivate people, and through this program, not only are we providing medications, we’re also vaccinating against hepatitis B, we’re also screening family members and linking them to care. We are helping people with drug addiction reintegrate into society and rehabilitate them. They are associated with opioid substitution programs and needle exchange programs. So there are huge benefits even in these small groups. We also use this program to distribute DAA to the pediatric population. This is the first dataset from the pediatric population of Punjab.
question: As you said, this level of care interaction also facilitates other opportunities to ensure better overall health and preventive health for the population. Do we expect more long-term data and findings to be extrapolated from this project over many years?
Prem Kumar: It’s a long queue. This is not just for hepatitis C, but hepatitis B as well. We also proposed that this would actually reduce the number of subsequent liver cancers in our population because patients coming for hepatitis C treatment would also be informed of the adverse effects of alcohol. Diabetic patients are also at increased risk of cancer, so the program provides them with free HCC monitoring services. So all these new impacts of the program stem from a simple idea: to eliminate hepatitis C, as the World Health Organization calls for by 2030.
Egypt is already on track. I think we’ve been disrupted by COVID-19 to a large extent because patients are in lockdown and there are compliance issues when it comes to coming in to refill prescriptions. But we showed in the program that for the average individual with no risk factors, even 4 weeks of treatment has a 77% cure rate, and even 8 weeks of treatment has an 88% cure rate. Of course, for everyone who completed 12 weeks of treatment, the cure rate was as high as 91.6%. Therefore, even if patients miss medication, they have the opportunity to return to treatment. But I really want to commend our doctors for the aggressive exercise they are doing. They really work to keep patients coming back, informing them, educating them and making sure all medications are taken on time.
question: As you point out, this is a global eradication goal, so that’s something worth emphasizing for any society fighting hepatitis C cases and progression. Is there anything else you would like to add?
Prem Kumar: I am surprised that the United States has not embraced the program in this way. I mean, countries like Australia, even small countries like Ireland, are on their way to elimination. Egypt’s gross domestic product (GDP) is equivalent to one-eighth that of the United States. So I find it very surprising that these drugs are not made available to people because this is something that would prevent death, something that would prevent people from suffering a lot of the disease-related burdens and the life disruptions associated with disability. And it does bring about a massive restoration of health services, rather than dealing with decompensated cirrhosis, increasing transplants, increasing cancer in the community, nipping it in the bud.