Only 1,200 Bulgarians with hepatitis C are treated per year, and there should be 5,000 in order to stop the spread of hepatitis C in Bulgaria. Most infected people do not know they carry the hepatitis C virus and do not seek treatment. This became clear at a press conference on the occasion of World Hepatitis Day at UMBAL "St. Ivan Rilski" and three years after the introduction of interferon-free therapy for the treatment of hepatitis C in Bulgaria.
Non-interferon therapy for hepatitis C has been fully paid for by the NHIF since 2016. Then, 901 patients with severe liver fibrosis and other life-threatening diseases were treated as a priority. In 2017, everyone infected with hepatitis C already has access to treatment. During this period, 1,310 patients underwent therapy, of which more than 98% were completely cured. In 2018, 1,200 people were treated. Of all those treated, only 22 people did not respond to therapy and are subject to re-treatment. They are less than 1%. The good news is that from May 15, 2019, the NHIF reimburses another pangenotypic medication, especially for patients who have not responded to other therapies.
“The big problem at the moment is that the medicines are provided, but there is no one to treat. We have the opportunity to provide therapy to 5,000 patients per year, and in reality about 1,200 are undergoing treatment", stated the chairman of the Bulgarian Society of Gastroenterology Prof. Krasimir Antonov and leading hepatologist at UMBAL "St. Ivan Rilski".
Prof. Antonov, are the costs of the new interferon-free hepatitis C therapies justified?
- We can only congratulate the National He alth Fund for fully financing the diagnosis on clinical paths and the treatment of viral hepatitis. We have to realize that with the costs of the definitive (final) cure of hepatitis C, we are saving enormous human suffering, enormous costs of treating the complications of hepatitis C - severe liver fibrosis, liver cirrhosis, liver cancer, as well as and the costs of liver transplants. Society saves hundreds of millions of BGN. Moreover, the price of the new interferon-free medicines for hepatitis C is constantly falling. From BGN 100,000, it fell below BGN 50,000 thanks to pharmaceutical companies' discounts to the NHIF. And most importantly, the therapy is extremely successful - 99%. I don't know of other therapies that have such high effectiveness.
What is the balance sheet since the introduction of interferon-free therapy in 2016 so far in Bulgaria?
- At first we only treated seriously ill people. Despite the eradication of the virus, some of these patients died because their livers were severely damaged. We gradually switched to treating all patients. Extremely high results were obtained - over 99% efficiency of the therapy. It is now possible for a patient to be referred to a specialist in just 24 hours and treated immediately after diagnosis. Almost every day I have patients who come directly from Sofia airport to me to prescribe therapy. While in Great Britain, after the diagnosis of hepatitis C, the patient must wait six months for a consultation with a specialist hepatologist and for referral to therapeutic procedures.
However, is there a problem in administering the therapy?
- I will start with a world problem. At the moment, 1.4 million people die from viral hepatitis in the world annually, and only 700,000 people die from the infection considered more deadly until recently - HIV. That is why the World He alth Organization has set a target of 90% diagnosis of hepatitis C by 2030, at least 80% cure and a 65% reduction in mortality. Each WHO member country must make efforts to achieve these aims. It has been calculated that in order to eliminate hepatitis C in Bulgaria, it is necessary to treat 5,000 patients per year. Now only about 1,200 Bulgarians are being treated. We have a highly effective and free therapy for patients, but we do not have enough diagnosed patients to treat. Due to the asymptomatic course of the infection, 69,000 Bulgarians currently do not know that they are infected with the hepatitis C virus. We must reach these patients. This should be done in four directions.
First, the public must be informed about this infection and be warned about the complications it causes years later. National hepatitis C prevention measures should then be taken.
In order to eliminate hepatitis C, we need to have a good testing program and reliable diagnostics that cover as many patients as possible.
The third step is to quickly refer diagnosed patients with specialist hepatologists to prescribe therapy.
The fourth condition is fulfilled. We currently have absolutely all modern drugs for hepatitis C. Only a drug is yet to be introduced for the few patients who have not responded to therapy.
Which patient groups should be targeted for hepatitis C screening?
- First of all, these are patients from risk groups - injecting drug users, men who have sex with men, prisoners, etc. We haven't covered all the people at risk yet, but I hope we will - especially those in methadone programs.
There are national standards to test all hemodialysis patients and hemophiliacs for hepatitis C. Currently in Bulgaria we are on the way to eliminate hepatitis C in all patients who are subject to kidney transplantation.
We are concerned that the awareness of this disease among the population, even among doctors, is still very low. Therefore, through the NHIF, tests for hepatitis C and hepatitis B should be included in the preventive packages that must be completed by the personal physicians of their patients. It is not necessary to perform these tests on absolutely all citizens of Bulgaria, because mass screening is very expensive. But we can focus on a certain target group. We gastroenterologists have suggested that this target group should include people aged 34 to 69.
What makes these people more at risk for hepatitis C?
- Because these people lived in years when medicine did not know the hepatitis C virus and did not have tests for it. People have had surgeries or blood transfusions that have resulted in infection without anyone suspecting such an infection. Therefore, it is extremely important that the screening of people aged 34 to 69 is included and financed under a National Program. If I summarize the situation now: we have very good therapy, at the world level, with very reliable diagnostics, but we have few patients to treat. Therefore, we must make an effort to actively seek out our patients instead of just waiting for them to come for treatment.
We from UMBAL "St. Ivan Rilski". We are running a campaign for free hepatitis C testing from July 18 to August 31 (between 8am and 2pm every weekday). All people from 34 to 69 years of age can benefit from it. Those patients who are found to be carriers of the virus will immediately be provided with a free consultation at the hospital and an individual therapy plan will be developed for them.
What tests should be done to detect hepatitis C?
- We suggest that viral markers should be used for screening, rather than liver enzyme testing - ALT/AST. Because through the liver enzymes we will diagnose many other diseases, not specifically hepatitis C. For example, we can detect steatosis (obesity) of the liver, cirrhosis from the use of alcohol or "herbs", damage to the liver from anabolic steroids. Capturing a high volume of pathology makes sense, but we are still specifically looking for those infected with hepatitis C to enter the treatment program in time before complications occur. Our goal is prevention of viral hepatitis.
There is currently a discussion on what tests should be included in the screening for the prepared National Program for the Control and Prevention of Hepatitis A, B, C, D and E. The Bulgarian Medical Union and private doctors insist on testing ALAT. Gastroenterologists are in favor of the introduction of tests for viral hepatitis, and as far as I have contact with the experts from the He alth Insurance Fund, this proposal is viewed positively. It remains to convince our colleagues at the Ministry of He alth that this screening is worthwhile. Many people are probably not infected with the hepatitis C virus. There is no country in the world that does mass screening. Therefore, we go to the target group aged 34 to 69 years. If we don't screen this risk group, it's pointless to do a hepatitis C elimination program.
What is the world experience in screening?
- In the USA, they decided to examine the people of the baby boomer generation, who were born between 1945 and 1960, for viral hepatitis. Colleagues from France have attempted mass screening, but among part of the population. According to their data, screening makes sense. But for financial reasons, France will not switch to mass screening of the population for viral hepatitis.
30 years of infection no symptoms
Hepatitis C is an inflammation of the liver that is caused by the hepatitis C virus and is transmitted mainly through blood. In rare cases (about 3 - 6%), the virus is transmitted from mother to child, as well as sexually in men who have sex with men
Hepatitis C is the seventh leading cause of death in the world and the first cause of liver cancer. The infection can be asymptomatic for 30 years. When the first symptoms appear, patients have already developed severe complications, the most common of which is cirrhosis of the liver. In 74% of them, the disease affects not only the liver, but also the metabolic, cardiovascular, neurological and dermatological, renal and other systems
The frequency of infection is 1.1%, which means that in Bulgaria about 77,000 people are infected. Due to the lack of symptoms and prevention, more than 90% of hepatitis C patients do not know that they are infected, and therefore do not receive treatment, but continue to spread the virus
More than 50% of patients are diagnosed in the middle to severe stage of disease development due to lack of diagnosis
The mortality rate from hepatitis C is 8.05 cases per 100,000 people
In Bulgaria, hepatitis C is diagnosed twice less often than the European average. The only possibility for early screening is if a patient himself decides to be examined in a laboratory for BGN 15-20, which happens very rarely
Silvana Lesidrenska: Those without he alth insurance are not treated
Silvana Lesidrenska is the chairwoman of the Association for the fight against hepatitis "HepActiv" and is included in the working group of 54 experts at the Ministry of He alth, which is developing a National program for the prevention and control of viral hepatitis - A, B, C, D and E.
The "HepActive" association started a campaign under the patronage of the Ministry of He alth for free testing for hepatitis C in mobile offices in Targovishte (on July 24 between 10:00 a.m. and 5:00 p.m., "Svoboda" square), Razgrad (25 July between 10:00 a.m. and 5:00 p.m. in front of DKC 1) and Varna (July 26, from 10:00 a.m. to 5:00 p.m. in front of the pylons of the Cathedral and at the entrance to the Sea Garden). More dates and cities to come in September.
Ms. Lesidrenska, what problems exist in the system of prevention and treatment of viral hepatitis from the patients' point of view?
- One of the problems is in blood donation - there is an ineffective system for communicating positive results to blood donors. Recently, there was a case of a man who, four years after donating blood, learned he was infected with hepatitis C when he came to donate blood again. During that time, neither the blood donation center, nor the RZI, nor the personal physician called him. Therefore, we have repeatedly proposed that the regulation on the method of notification be updated to start operating effectively.
Another serious problem is the untimely referral of the infected by general practitioners to specialist hepatologists. We often come across people who know they are infected with hepatitis C. But their GP does not immediately refer them to a specialist, but only after a long period of time has passed. However, it is very important that the patient moves from diagnosis to therapy in the fastest way.
There is a third problem, which is related to the lack of he alth insurance for part of the population. The issue of payment for hepatitis C therapy for the uninsured has not been settled, as it is already regulated for tuberculosis and HIV-infected patients. For three years, a "Checkpoint" office has been operating in Sofia for free testing of hepatitis B and C, along with HIV and syphilis.
Our data shows that the largest percentage of people who test positive for hepatitis C antibodies are from the group of injecting drug users. They are in the age range of 30 - 49 years. After them in frequency of infection are the people from the group of baby boomers (the post-war generation). We immediately refer them to the specialized clinics for the treatment of hepatitis C. The problem is with the infected from the risk groups, because a large number of them do not have he alth insurance and there is no one to pay for their therapy. Apart from telling them they are infected, there is nothing more we can do for them. And these people are a reservoir of infection that will continue to grow if not addressed.
How can the prepared National Program for Control and Prevention of Viral Hepatitis help?
- With the help of the National Program, many of the problems would be solved because there is political will for it. I hope that with the preventive measures we will cover both the main part of the population and the risk groups. I am far from thinking that everything will be perfect. But I cannot fail to note that in Bulgaria we have wonderful specialist hepatologists and that the treatment is affordable and as effective as possible.