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June 25, 2021

Gilead reports interim late-stage data from viral hepatitis drug trial

The company plans to include the Phase III data of bulevirtide in the FDA filing to be submitted later this year. 

Gilead Sciences has reported interim data from its Phase IIb and Phase III clinical trials, which showed Hepcludex (bulevirtide) provided a substantial response in patients with chronic hepatitis delta virus (HDV).

Hepcludex is an investigational entry inhibitor agent in the developmental stage.

According to data from the Phase III MYR301 trial, 36.7% of the HDV patients receiving bulevirtide 2mg had combined virological and biochemical response after 24 weeks, along with 28% of those who were given bulevirtide 10mg.

Bulevirtide 2mg was observed to offer an increased response rate as against the 10mg dose in 24-week treatment.

Gilead noted that the Phase III trial results support the safety and efficacy profile of the once-daily dose of bulevirtide 2mg.

The company intends to submit the Phase III data of bulevirtide to the US Food and Drug Administration (FDA) later this year.

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Phase IIb MYR204 trial evaluated the safety and efficacy of bulevirtide monotherapy or along with peginterferon alfa-2a at varying doses, in 175 HDV patients.

Interim trial data showed that a higher proportion of subjects receiving bulevirtide had combined response at 24 weeks and the maximum response rate was noted in the bulevirtide monotherapy arm.

Bulevirtide monotherapy or bulevirtide plus peginterferon alfa-2a was found to be well-tolerated in this trial.

Gilead Sciences chief medical officer Merdad Parsey said: “HDV is the most serious form of chronic viral hepatitis and is associated with rapid progression of serious complications including fibrosis, cirrhosis and liver cancer.

“These data add to the growing body of evidence demonstrating the potential role for bulevirtide in the treatment of HDV.”

Bulevirtide received breakthrough therapy and orphan drug status from the FDA and obtained conditional marketing authorization from the European Commission.

The drug has been selected under the Priority Medicines scheme by the European Medicines Agency as the first approved therapy in the region for the treatment of chronic HDV and compensated liver disease in adults.

The latest development comes after Gilead reported that real-world data from three retrospective studies showed its antiviral treatment, Veklury, lowered the risk of mortality in hospitalised Covid-19 patients.

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