Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis
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Chronic hepatitis Delta (CHD) is a rare but severe form of chronic viral hepatitis that affects approximately 12-72 million patients worldwide.[1] It is sustained by the hepatitis D virus (HDV), a small defective virus that requires the helper function of HBV to replicate and propagate.[2] In the last 30 years, the only therapeutic approach has been the off-label use of a 48-week course of Interferon (IFNα).[3] However, this antiviral strategy is characterized by limited off-therapy responses and an unfavorable safety profile.[3],[4]
To our knowledge this is the first report assessing the safety, effectiveness and clinical response of BLV administered as monotherapy for up to three years in patients with HDV-related compensated cirrhosis in whom Peg-IFN therapy was contraindicated. The long-term administration of BLV monotherapy in these difficult to treat patients was associated with positive virological and clinical results coupled with a favorable safety profile. All patients reported excellent compliance to BLV therapy (2 subcutaneous injections every morning), as confirmed by the increase of bile salts levels, a biomarker of target engagement.
One of the most important findings of the study is the positive virological and biochemical response observed as all three patients achieved and maintained undetectable HDV-RNA, which was tested by a very sensitive assay. These findings are unprecedented for at least three reasons: first, no studies to date have reported the outcome of BLV treatment beyond week 48; second, no data exists to demonstrate that virological response was maintained upon dose reduction; third, the effectiveness of the administration of this drug for such a long-term in difficult to treat patients such as those with advanced compensated cirrhosis, including one case with clinical significant portal hypertension (CSPH), has never been reported so far.
Another important finding was the clinical response that we have observed in these patients. One patient who had compensated cirrhosis with CSPH, showed a clinically relevant improvement of liver function tests, AFP and platelet levels, as well as portal hypertension features, with the regression of EV.作者: StephenW 时间: 2021-10-27 19:06