2023-05-08 02:50:26
Patients with chronic hepatitis B are currently receiving lifelong therapy for permanent immune control. Leipzig researchers are now showing that stopping the medication you are taking can help.
people with chronic Hepatitis B usually have to take medication for life to reduce the viral load and normalize the inflammatory values in the liver. About half of those affected suffer from a so-called HBe-Antigen-negative form of the disease.
The antiviral therapy consists of the administration of nucleoside or Nucleotidanalog, which leads to a permanent immune control in almost no patient with HBeAg-negative form, which allows the treatment to be stopped. This therapy is associated with high costs for the healthcare system and can cause side effects.
Functional healing possible
The currently in Journal of Hepatology published Study Results show in a multicentre, controlled, randomized study with 166 HBeAg-negative patients from 20 clinics throughout Germany after an observation period of 96 weeks that the discontinuation of an antiviral treatment that had lasted at least four years and was effective led to immunological control of the disease in many cases.
Immunological control was demonstrated in ten percent of patients as a loss of previously detectable hepatitis B surface antigen (HBsAg) in the blood, an event considered to be a functional cure for hepatitis B. At the end of the study, 77 percent of the patients no longer had elevated levels of liver inflammation. In about 41 percent, the hepatitis B virus in the blood dropped below the 2,000 units per milliliter mark, which means that, according to international guidelines, there is no longer any indication for renewed antiviral therapy. In contrast, no HBsAg loss was observed in any patient who continued therapy.
End of therapy more effective than its continuation
Study leader Prof. Florian van Bömmel, senior physician in the field of hepatology at the University Hospital Leipzig, says: “We were able to show that interrupting long-term therapy with nucleoside or nucleotide analogues after at least four years is more effective for some patients than continuing it, and that many no longer require antiviral therapy after discontinuation. Especially in patients who have a low HBsAg level when they stop it, the chance of functional recovery after stopping long-term therapy is high.”
After stopping treatment, all patients experienced an initial rebound of hepatitis B virus, and many experienced a transient rebound liver inflammation. Antiviral therapy was then started again in some patients with severe liver inflammation in order to avoid liver damage. patients with liver cirrhosis were not included in the study for safety reasons.
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No serious adverse events related to discontinuation of therapy occurred during the study. “In other studies, however, severe cases of liver inflammation have been observed in individual cases after discontinuation of the antiviral therapy, which is why the discontinuation should only take place under the supervision of an experienced doctor,” explains the study leader.
Rethink guidelines worldwide
Van Bömmel and Prof. Thomas Berg, head of the hepatology department at the University Hospital Leipzig, are certain that the results of the STOP-NUC study will have a major impact on the entire therapy development for hepatitis B: “We assume that international Future guidelines for the treatment of hepatitis B will be based on this study. The results of the extension of the study will be evaluated in the middle of this year, which will show whether the rate of patients with immunological control increases in the long term after stopping the antiviral treatment.”
This text is based on a press release from the University of Leipzig. Here you can find the original publication.
Image source: Tim Foster, unsplash
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