British Medical Journal

 First hepatitis D medicine is given restricted approval in Scotland after US rejection
 
Scotland has become the first country in the UK to approve a specific treatment for the hepatitis delta virus (HDV), after it granted bulevirtide (Hepcludex) ?restricted use? approval for patients with chronic infection and compensated liver disease.1The drug (2 mg powder for injection) will be made available for patients with evidence of significant fibrosis who have not responded to or cannot take interferon based treatment.Hepatitis D is found only in people with chronic hepatitis B and infects about 5% of such patients. It is considered the most severe form of chronic viral hepatitis and is known to progress rapidly towards liver cancer and liver related death.2The approval by the Scottish Medicines Consortium comes after the drug was rejected by the US Food and Drug Administration last year. Its manufacturer, Gilead, said that the US agency had raised ?concerns regarding the manufacture and delivery? but did not request any new studies...