Hepatitis D: Spain does not fund a “promising” drug approved by Europe

  • It is estimated that there are between 5,000 and 7,000 patients with a disease associated with an increased risk of cirrhosis, end-stage liver disease, liver cancer and death.

  • The Spanish Association for the Study of the Liver has the first patient registry and asks health to prioritize the inclusion of a new drug, approved by the EMA, and effective for a subgroup of patients .

It’s called bulevirtide and it’s a medication for the treatment of infection with Chronic delta virus hepatitis (HDV), the most severe form of viral hepatitiswho, as doctors have warned, is gaining momentum in our country. Since 2020, the use of the drug, promising for a subgroup of patients, has been authorized by Europebut Spain does not finance it, deplore the specialists. In our country, it is estimated that there are between 5,000 and 7,000 people who have a disease associated with an increased risk of cirrhosis, end-stage liver disease, liver cancer and death.

On the occasion of world viral hepatitis daywhich is commemorated this Thursday, July 28, the Spanish Association for the liver study (AEEH) put on the table, like she did before Spanish Society of Digestive Pathology (SEPD), the need for new drugs for so-called hepatitis D, a life-threatening disease which, they specify, affects only people infected with the virus of the Hepatitis B (HBV).

After believing “virtually extinct” in the 1990s – when this hepatitis viral came to have it big clinical importanceaffecting 20% ​​of patients who have had a chronic infection by the hepatitis B virus-, cases of hepatitis D experience a rebound: the prevalence of the disease, with SEPD data, is currently around 5%. But it remains an understudied disease, experts admit.

More severe liver disease

With data from the Spanish Association for the Study of the Liver, from the seroprevalence survey of Ministry of Healthin Spain, 0.22% of the population is infected with active hepatitis B (about 90,000 people) while in other epidemiological studies this percentage rises to 0.5%. Of them, an estimated 5% are co-infected with hepatitis D. Co-infection, they detail, leads to more severe liver disease than hepatitis B alone and is associated with faster fibrosisincreased risk of develop cirrhosis of the liver and higher rates of liver cancer and death.

The first registry of patients with hepatitis D includes 213 people with active follow-up in 15 Spanish hospitals.

However, he explains THE SPAIN NEWSPAPER the scientific society, continues being a little known disease. The company has the first Hepatitis D Patient Registrywhich includes 213 people with active follow-up in 15 hospitals Spaniards, with their respective epidemiological, clinical and virological variables and their evolution since the start of the follow-up. With an average age of 52, 54% are male, 57% were born in Spain and 21% in Eastern Europe. The mean duration of follow-up was 6 years.

At the time of diagnosis45% of patients whose data are included in the Registry already had cirrhosis and 19% had portal hypertension (an increase in pressure inside the portal vein that passes by the liver). During follow-up, an additional 11% and 15% of patients also developed cirrhosis and portal hypertension. For doctors “a high percentage” given The median follow-up was six years.

“Absence of treatment history”

It is in this scenario that specialists warn: the “limited knowledge” of the disease and the “historical lack of effective treatments” have harmed screening and “have led to high rates of underdiagnosis of hepatitis delta”, as well as diagnosis of the disease “at an advanced stage”. Indeed, they consider that the creation of this register is a “fundamental breakthrough”.

The only treatment available in Spain is interferon, which only manages to suppress viral and hepatic activity in a minority of patients.

Currently the only treatment available in Spain for hepatitis D is interferonan agent who manages to remove viral and hepatic activity only in a minority of patients treated, say the doctors. However, there are new pharmacological advances with more efficiency and tolerance. One of them is bulevirtide which, as AEHH explains, does not cure the disease but is “promising” for subgroup of these patients.

In 2020, the European Medicines Agency (EMA, for its acronym in English), approved the use of this drug for hepatitis D, based on data from phase 2 clinical trials and considering that it is an “orphan” disease in terms of treatment options.

In Spain, the new drug can only be ordered “for compassionate use with significant restrictions due to its cost”.

With information from the EMA itself consulted by this journal, it is an antiviral used to treat chronic hepatitis D in adults with compensated liver disease – when the liver is damaged but continues to function – when blood tests have confirmed the presence of viral RNA (genetic material). HDV infection, says the European body, is considered rare and, therefore, the treatment has been designated as an “orphan drug” June 19, 2015.

However, in Spain this medicine is still is not included in the arsenal of medicines financed by the National Health System – it is not yet authorized by the Spanish Medicines and Health Products Agency (Time)-, and can only be ordered “for compassionate use with significant restrictions due to its cost“. That’s why doctors do “a call to the health authorities” favor the inclusion of new drugs” as therapeutic alternatives to these the patients.

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