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Phase III trial of Hepcludex shows efficacy in chronic hepatitis delta virus infection.- Gilead Sciences

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Published:25th Jun 2022

Gilead Sciences announced Week 48 results from the Pivotal Phase III clinical trial evaluating the first-in-class entry inhibitor Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection.

In addition, Week 48 data demonstrating the positive impact of bulevirtide on patient-reported outcomes (PROs) in people living with chronic HDV is also reported. Together, these data reinforce the clinical utility of bulevirtide as monotherapy for the treatment of chronic HDV. There are currently no other approved treatment options for HDV and people living with HDV typically have a poor prognosis.

At Week 48, study participants treated with bulevirtide monotherapy at 2 mg or 10 mg once daily achieved a significantly greater combined virological and biochemical response (45% and 48%, respectively) when compared to participants who had not received antiviral treatment at this stage of the study (2%). Combined response was defined as undetectable HDV RNA or a decrease by 2 log10 IU/mL from baseline and ALT normalization. Similarly, when the Week 48 data is considered alongside the integrated Week 24 analyses of the ongoing Phase II studies (MYR202 and MYR203) and the interim Week 24 Phase III MYR301 data, combined response rates of bulevirtide increased from Week 24 to Week 48, highlighting an improved response of bulevirtide with prolonged treatment.

The safety profile of bulevirtide at Week 48 is consistent with prior reports, with no participants having an adverse event (AE) leading to discontinuation of bulevirtide and no serious AEs attributed to bulevirtide treatment. Findings from the study underscore the efficacy and safety of bulevirtide for the treatment of chronic HDV and are being presented in the International Liver Congress (ILC) 2022 Official Press Program.

Condition: Hepatitis B/Hepatitis D
Type: drug

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