Hepatitis B (hepatitis B) is not treated in Poland in accordance with world standards, which makes patients more exposed to cirrhosis, liver failure and hepatocellular carcinoma – infectious disease specialists are alerting.
Currently, instead of a modern drug, Polish patients with hepatitis B receive an older, cheaper drug, which significantly reduces the chance of successful therapy, even if modern drugs are used later – assessed Prof. Krzysztof Simon from the Department and Clinic of Infectious Diseases, Liver Diseases and Acquired Immunodeficiencies in Wrocław.
According to the specialist, such an approach is not profitable for the state, as the treatment of serious complications of hepatitis B costs much more than the optimal therapy at an earlier stage of the disease. In advanced stages of liver failure or cancer, only a transplant is the salvation for the patient.
According to the spokesman of the Ministry of Health, Piotr Olechno, the ministry is working on changing the therapeutic program for the treatment of hepatitis B. However, due to the early stage of works, it is not known what its final shape, scope and implementation conditions will be, the spokesman said.
On Monday, June 21, the Consultative Board of the Agency for Health Technology Assessment (AOTM) is to discuss the preparation of a position on changes in therapeutic programs for the treatment of patients with hepatitis B.
Hepatitis B virus (HBV for short) is 100 times more contagious than HIV. Infection with it can occur even with slight contact with the blood of infected people, as well as through contact with body fluids, such as semen or saliva, and with contaminated objects that violate the continuity of the skin. It is not only about medical equipment, such as unsterilized needles and syringes, but also everyday objects belonging to the infected person (toothbrush, razor blade), tools used in tattooing, etc. The virus also spreads from pregnant mother to child.
HBV primarily infects liver cells (hepatocytes), leading to acute hepatitis B. In a certain percentage of people infected with it, the infection turns into a chronic form, which develops asymptomatically for a long time, but ultimately – in approx. chronically infected – leads to dangerous consequences such as cirrhosis and liver failure or hepatocellular carcinoma. They most often appear after 20-20 years, but much earlier in some patients.
According to Simon, the frequency of HBV infections in Poland is assessed as low, which is mainly the result of the obligation to vaccinate all newborns against hepatitis B in the first half of the 90s, as well as health care workers, the army, the police and the fire service.
However, due to numerous HBV infections in the past, the number of Poles chronically infected with it is now estimated at 1-1,5 percent, i.e. 300-600 thousand. Many people in this group are unaware of the infection and are not under specialist medical care.
In addition, about 5 million have had HBV in the past and have the potential to reactivate the infection, said Simon. The specialist also noted that not every person chronically infected with HBV requires treatment. The decision on therapy is made by a specialist doctor, taking into account many factors. The goal of treatment is to slow the progression of the disease by stopping the virus from replicating. According to the recommendations of Polish and international experts, in order to achieve this, one of three drugs should be used in the first place: either pegylated interferon alfa2a administered by injection, or one of the two modern antiviral drugs administered orally, i.e. entecavir or tenofovir – said the chairman of the Polish Group HBV experts prof. Jacek Juszczyk.
Oral medications are very well tolerated and can therefore be used in patients in whom interferon therapy is contraindicated. In most cases, however, they need to be taken on a long-term basis.
As Juszczyk noted, all three drugs are currently registered in Poland, but in the first line of therapy, the National Health Fund only reimburses interferon. Tenofovir has not yet been assessed by Polish control institutions (ie AOTM), although it has been done a long time ago in other European countries and in the USA.
On the other hand, entecavir – despite the positive AHT recommendation – is not available as a preparation in the first-line treatment of hepatitis B. In Poland, patients first receive the older drug lamivudine, which after a year in 30% of patients. of these causes the emergence of therapy-resistant virus mutants – emphasized the specialist. And since secondary resistance often affects new drugs as well, the chances of treatment success are significantly reduced. Brand new lamivudine-resistant HBV infections may also occur.
According to Simon, this approach can be disastrous for patients as it exposes them more to cirrhosis, liver failure and hepatocellular carcinoma. This is inconsistent with the recommendations of Polish and international experts, as well as with the position of the European Parliament, which in a relevant resolution obliges the Member States of the European Union to standardize the methods of hepatitis B therapy in accordance with the latest standards – Juszczyk noted.
On May 20, the European Medicines Agency (EMEA) published on its website recommendations on the significant limitation of the use of lamivudine in patients with chronic hepatitis B, due to the risk of generating mutants of the virus.