In This Article:
Gilead Sciences has reported final outcomes from the Phase III MYR301 trial, indicating adults with chronic hepatitis delta virus (HDV), when treated with the entry inhibitor bulevirtide, could maintain virologic suppression nearly two years following treatment cessation post-achieving undetectable HDV RNA at end of treatment (EOT).
The study found that 36% of subjects treated with bulevirtide at 2 mg or 10 mg doses achieved virologic suppression.
Gilead noted that 90% of the subjects who had undetectable HDV RNA for 96 weeks or more at the EOT remained HDV undetectable off-treatment.
The MYR301 trial is aimed at assessing long-term efficacy as well as safety of the therapy in 150 chronic HDV patients, who were randomly assigned to receive either 2 mg or 10 mg of therapy once a day, or no antiviral treatment for a delayed approach.
The primary efficacy and safety outcomes were evaluated at the week-48 mark, with the primary endpoint being a combined response, which is said to be an undetectable HDV RNA or a significant decline of ≥2log10 IU/ml from baseline and normalisation of alanine aminotransferase (ALT) levels at week 48.
Secondary endpoints of the study at week-48 included ALT normalisation, undetectable HDV RNA, and transient elastography-measured changes in liver stiffness.
The total treatment period of the trial groups is 144 weeks, and at the week-48 mark, the delayed treatment group subjects transitioned to the 10mg daily dose for an extra 96 weeks.
Gilead Sciences Clinical Research for Hepatitis, Respiratory and Emerging Viruses vice president Anu Osinusi said: “Previous results from MYR301 demonstrated the potential benefits of long-term treatment with bulevirtide. With this new data, we now have valuable insight into the durability of the response even after treatment has ended.”
Hepcludex (bulevirtide) 2 mg has secured full marketing authorisation from the European Commission in July 2023 for treating adult subjects with chronic HDV and compensated liver condition.
Currently, bulevirtide 2 mg is approved in the UK, Australia, Switzerland, and the European Economic Area, but not in the US. The 10 mg dosage remains an investigational product.
In April this year, the company announced positive topline data from the Phase III ASCENT-04/KEYNOTE-D19 trial of Trodelvy and MSD’s Keytruda combo in patients with inoperable locally advanced or metastatic triple-negative breast cancer.
"Gilead reports final outcomes from trial of bulevirtide for chronic HDV" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.