Hepcludex (bulevirtide) is the first drug intended to treat hepatitis D (VHD) or hepatitis delta – which until now was an orphan disease for which no effective therapy was available – that will be included among the medicines financed in Spain, in accordance with the decision adopted by the Ministry of Health.
Chronic hepatitis D only affects people infected with the hepatitis B virus (HBV) and is a serious disease that can trigger liver cirrhosis, or even the death of the patient. In Spain, according to the Seroprevalence Survey of the Ministry of Health, 0.22% of the population has active hepatitis B infection (about 90,000 people), while the percentage indicated by other epidemiological studies amounts to 0.5%. Of them, around 5% are coinfected by hepatitis D, so in Spain there would be between 5,000 and 7,000 people with chronic hepatitis due to HDV.
HDV coinfection causes more severe liver disease than that resulting from HBV infection and is associated with more rapid progression of fibrosis and an increased risk of developing liver cirrhosis, as well as higher rates of liver cancer and death. , as explained by the Alliance for the Elimination of Viral Hepatitis in Spain (AEHVE), a society made up of scientific societies and patient associations.
Javier García-Samaniego, head of the Hepatology Section of the La Paz University Hospital and coordinator of the AEHVE, considers that the incorporation of Hepcludex (bulevirtide) to the therapeutic arsenal of the health system represents a great step forward in the fight against the most serious of the viral hepatitis, which accelerates liver fibrosis and increases the risk of cirrhosis and liver cancer more than other hepatitis viruses.
A treatment for an ‘orphan’ disease: hepatitis D
Until now, combating hepatitis D has been a challenge due to the lack of effective treatments, which is why it has been considered an ‘orphan’ disease from the point of view of therapeutic options. This began to change when the drug Hepcludex was submitted to the European Medicines Agency (EMA) in October 2019 and in July 2020 it obtained a first approval, based on data from phase II clinical trials. In September 2023, and after new data from phase III studies – with more participants – confirmed and expanded its benefits, the European Commission gave its full authorization to the marketing of this medicine.
Barely three months later, Health has announced that it will finance the drug in Spain, a decision very well received by professionals and patients. “In Spain, this medication was not included in the catalog of drugs financed by the health system and could only be requested as compassionate use and with important restrictions due to cost. Hence, from the AEHVE we were requesting its inclusion, which seemed necessary to us, in order to eliminate one of the fundamental barriers in the management of the disease,” explains García-Samaniego.
“The approval of this treatment against hepatitis D is a great advance. However, other measures are necessary to solve the problem of underdiagnosis and late diagnosis.”
The lack of therapeutic options is not the only handicap that professionals face in combating hepatitis D, since a recent investigation, in which specialists from 15 Spanish hospitals have participated, concludes that the diagnosis of hepatitis generally occurs in a advanced stage (half of the patients already had cirrhosis when they were diagnosed), data that could improve if in most centers it were possible to determine HDV-RNA (preferably in the same blood sample as anti-HDV antibodies in what is known as one-step diagnosis).
Manuel Romero, president of the Spanish Association for the Study of the Liver (AEEH) stated: “The approval of this treatment against hepatitis D is a great advance. However, other measures are necessary to solve the problem of underdiagnosis and late diagnosis, given the worsening caused by co-infection with HDV and its association with an increased risk of liver cirrhosis and liver cancer.
For its part, for the National Federation of Liver Transplants (FNETH) and the ASSCAT (Catalan Association of Liver Patients), both integrated into AEHVE, the financing of this drug, which although it does not cure the disease, stops its progression, represents a step forward in the fight to achieve the goals of the World Health Organization (WHO) against viral hepatitis.
Source: Alliance for the Elimination of Viral Hepatitis in Spain (AEHVE)
