Gilead Sciences says that patients with chronic hepatitis D (HDV) infection who initially seemed unresponsive to Hepcludex in a Phase III trial have responded after 96 weeks.

Gilead has announced the Phase III MYR301 trial results evaluating Hepcludex (bulevirtide) at the European Association for the Study of the Liver Congress 2023. The multicentre, open-label, randomised trial unfolded over 144 weeks and involved 150 patients with drug administration daily by subcutaneous injection.

Gilead said the latest data reinforces the efficacy and safety of Hepcludex for chronic HDV. Bulevirtide is reportedly the only approved treatment for HDV in the EU and is not approved in the US. GlobalData reports a sales prediction of $665m globally for Hepcludex in 2029.

GlobalData is the parent company of Clinical Trials Arena.

Positive results in previously unresponsive patients

The data showed that of the patients who appeared unresponsive or had a partial response after 24 weeks of treatment, 43% and 82%, respectively, achieved virological response by week 96. Virologic response was characterised by undetectable HDV RNA or decreased levels by ≥ two log₁₀IU/mL from baseline.

 Non-response and partial virologic response were defined as HDV RNA decline of <1-log₁₀IU/mL and ≥1 but <2-log₁₀IU/mL, respectively. In most patients with suboptimal virologic response after 24 weeks of treatment, prolonged treatment with bulevirtide produced virological and/or biochemical responses.

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The data assessing the efficacy and safety of bulevirtide at 96 weeks built on the week 48 data shared at EASL’s International Liver Congress 2022 and was published in the New England Journal of Medicine. No resistance or serious adverse events were reported at week 96. Increased bile acids without a correlation to pruritus or other symptoms were noted with bulevirtide treatment. Injection site reactions occurred in a higher proportion of patients receiving 10mg of bulevirtide.

Gilead Sciences clinical research for hepatitis, respiratory and emerging viruses vice-president Anu Osinusi said: “HDV is the most severe form of viral hepatitis and until recently there were no approved treatment options and patients faced a poor prognosis. The 96-week data not only reinforces the efficacy and safety of bulevirtide as the first and only approved treatment in the EU for people living with HDV, but also demonstrates that bulevirtide has the potential to benefit a broader range of patients, including those with suboptimal initial responses.”

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) advocated granting full marketing authorisation (MA) for bulevirtide to treat adults with chronic HDV and compensated liver disease in April 2023.