The Spanish Association for the Study of the Liver (AEEH) launched the first Hepatitis D Patient Registry, 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 follow-up.
With an average age of 52 years, 54% of these patients are men, the 57% were born in Spain and 21% in Eastern Europe. Similarly, the average duration of follow-up was approximately 6 years.
Chronic hepatitis delta is a life-threatening disease that only affects people infected with the hepatitis B virus (HBV). In fact, in Spain, according to the seroprevalence survey of the Ministry of Health, 0.22% of the population is infected active by hepatitis B (approximately 90,000 people) whereas in other epidemiological studies this percentage rises to 0.5%.
Of these, it is estimated that 5% are co-infected with HDV. Hepatitis D virus co-infection results in more severe liver disease than HBV alone and is associated with more rapid progression of fibrosis, increased risk of developing liver cirrhosis, and higher rates liver cancer and death. .
Limited knowledge of the disease and historical lack of effective treatments have hampered screening and have historically led to high rates of underdiagnosis of hepatitis delta, as well as diagnosis of the disease at advanced stages.
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 monitor a large number of patients and expand the determination of RNA-HDV to improve the management of the infection,” said specialist in gastroenterology and hepatology and member of the AEEH board of directors, Sabela Lens.
In the year 2020, European Medicines Agency (EMA, for its acronym in English) has 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. This is why the AEEH has called on the health authorities to favor the registration of new drugs as therapeutic alternatives for these patients.
Repunta in Spain
The Digestive System Specialist at the Central University Hospital of Asturias (Oviedo), Manuel Rodriguez Garcia, warned that hepatitis D is on the rise in Spain and that its prevalence is around 5%, after being considered practically extinct in the 1990s, when this viral hepatitis became of great clinical importance, affecting 20 % of patients with chronic hepatitis B virus infection.
The expert thus spoke during the presentation “Hepatitis D, the great unknown”, organized as part of the round table “On the way to the diagnosis and elimination of viral hepatitis”, during the LXXXI Congress of the Spanish Society of Digestive Pathology, which It took place from June 16 to 18 in León.
The profile of the patient with hepatitis D varied over time. At the end of the last century, the most affected by the disease were intravenous drug addicts and hemophiliacs who had received blood transfusions contaminated with the two viruses. However, thanks to vaccination programs against the hepatitis B virus and improved screening, the prevalence has dropped considerably in Spain.
A trend which, as explained Rodriguez Garciais reversing in our country, registering a rebound in recent years.
The main reason for this increase is due, among other circumstances, to the migratory phenomena that arrive in Spain from sub-Saharan Africa and Eastern Europe, affecting men more than women and, in particular, the young population.
“These migratory flows come from areas where hepatitis D still has a high prevalence, so we experts must be vigilant and seek Compulsory Delta Virus in patients with chronic hepatitis B,” said the expert.