Gilead's Chronic Hepatitis Delta Infection Treatment Shows Sustained Efficacy, Safety Profile At Two Years

Gilead Sciences Inc GILD announced Week 96 results from the MYR301 Phase 3 clinical trial evaluating bulevirtide for chronic hepatitis delta (HDV) infection.

Bulevirtide is the only approved treatment for HDV in Europe and is not approved in the U.S.

The Week 96 findings demonstrated improved combined response compared to Week 48, with no signs of treatment resistance and sustained virologic response with continued bulevirtide monotherapy.

Prolonged bulevirtide treatment showed clinical benefit, even for individuals who initially had a partial decline in HDV viral load.

The Week 96 data, published in the New England Journal of Medicine, confirmed the efficacy and safety of bulevirtide, with similar response rates for both 2 mg and 10 mg doses.

The safety profile at Week 96 remained consistent with Week 48, with no resistance observed and no serious adverse events related to bulevirtide.

Bile acid increases were noted without significant symptoms, and injection site reactions were more frequent with the 10 mg dose.

An analysis revealed that patients with a suboptimal virologic response at Week 24 achieved virologic response by Week 96 with prolonged bulevirtide treatment, highlighting its potential benefits.

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