AEEH launches the first national hepatitis D registry

DAILYPHARMA | 27.07.2022 – 14:36

The Spanish Association for the Study of the Liver (AEEH) recently created the first Register of the patients with hepatitis D, which includes 213 patients actively followed in 15 Spanish hospitals, with their respective epidemiological, clinical and virological variables and their evolution since the start of the follow-up.

With an average age of 52 years, 54% of these patients are men, 57% were born in Spain and 21% in Eastern Europe. The mean duration of follow-up was 6 years.

Chronic hepatitis delta is a life-threatening disease that only affects people infected with the virus. Hepatitis B (HBV). In Spain, according to the seroprevalence survey of Ministry of Health 0.22% of the population has infection active by hepatitis B (approximately 90,000 people) whereas in other epidemiological studies this percentage rises to 0.5%. Of these, an estimated 5% are co-infected with HDV. HDV co-infection results in more severe liver disease than HBV alone and is associated with more rapid progression of fibrosis, increased risk of developing cirrhosis liver disease and higher rates of liver cancer and death.

Limited knowledge of the disease and historical lack of effective treatments have hampered the screening and has historically led to high rates of underdiagnosis of hepatitis delta, as well as late-stage disease diagnosis.

At the time of diagnosis, 45% of patients whose data are included in the Registry already had cirrhosis and 19% had portal hypertension. During follow-up, however, an additional 11% and 15% developed cirrhosis and portal hypertension, which is a high percentage considering that the median follow-up was 6 years.

“In most centers, it is not possible to quantify HDV-RNA, so this registry will be used to follow a large number of patients and to extend the HDV-RNA assay to improve the management of infection,” he said. Sabela Lens, specialist in gastroenterology and hepatology and member of the board of directors of the AEEH.

In the year 2020 the European Medicines Agency approved the use of Bulevirtide, a new drug for the treatment of chronic HDV infection, based on data from phase 2 clinical trials and considering hepatitis delta as an “orphan” disease from the point of view of therapeutic options. However, in Spain, this drug is not yet part of the arsenal of drugs funded by the health system and can only be ordered for compassionate use with significant restrictions due to cost. The AEEH also calls on the health authorities to favor the registration of new drugs, such as bulevirtide, as therapeutic alternatives for these patients.

The Spanish Association for the Study of the Liver (AEEH) considers that the creation of this registry is a fundamental advance for a better knowledge of the infection and better management of the disease, although it considers other necessary measures to address the problem of underdiagnosis and delayed diagnosis, given the aggravation caused by HDV co-infection and its association with an increased risk of liver cirrhosis and liver cancer, as well as the need for liver transplant or death from these causes.