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Bulevirtide (Hepcludex°) and chronic hepatitis D: no evidence of efficacy based on clinical endpoints

FEATURED REVIEW Bulevirtide (Hepcludex°) is the first antiviral drug authorised in the European Union for adults with chronic hepatitis D. In this situation, does bulevirtide reduce the incidence and severity of hepatic complications? Does it reduce HDV transmission? And what are its adverse effects?
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  •  JUDGEMENT RESERVED  Bulevirtide is a peptide that blocks a bile acid transporter at the surface of hepatocytes that is also used by hepatitis D virus (HDV) to enter these cells. In comparative trials providing only low-quality evidence, bulevirtide appeared to reduce HDV viral load, especially when combined with a drug with antiviral activity against hepatitis B virus. Viral load often increased again after treatment cessation. These clinical trials do not provide evidence that bulevirtide reduces HDV transmission or the incidence of hepatic complications. And its adverse effects cannot be determined from the scant data available. Bulevirtide requires further evaluation in clinical trials.

©Prescrire 1 October 2021

Source: "Bulevirtide (Hepcludex°) and chronic hepatitis D. No evidence of efficacy based on clinical endpoints" Prescrire International 2021; 30 (230): 229-231. Subscribers only.

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