Gilead Sciences has shared positive results from a late-stage study of its chronic hepatitis D virus (HDV) treatment, Hepcludex (bulevirtide).
Gilead said the new 96-week data from the phase 3 MYR301 trial, which was presented at this year’s European Association for the Study of the Liver Congress, “reinforces the role of Hepcludex as an efficacious and well-tolerated treatment for the management of chronic HDV”.
Data shows that the combined virological and biochemical response rates continued to increase through week 96, with response rates of 55% and 56% at the 2mg and 10mg dose levels, respectively.
An additional analysis from the trial, presented in a late-breaker, also showed that study participants who appeared to not respond or only partially respond to the antiviral at week 24 went on to achieve a virological response at 96 weeks.
The safety profile at week 96 was consistent with what was observed at week 48, the company said, with no resistance observed and no serious adverse events attributed to the treatment.
Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients.
HDV, which is estimated to affect more than 230,000 people in the US and Europe, can occur only as a co-infection in individuals who have hepatitis B virus.
Hepcludex works by attaching to and blocking a receptor through which the hepatitis D and hepatitis B viruses enter liver cells, which limits the ability of HDV to replicate.
The treatment was initially granted conditional marketing authorisation in the EU in 2020 and has recently been recommended by the European Medicines Agency’s human medicines committee for full marketing authorisation for adults with chronic HDV and compensated liver disease.
In the US and outside of the European Economic Area, Hepcludex remains an investigational agent.
Anu Osinusi, vice president, clinical research for hepatitis, respiratory and emerging viruses at Gilead, 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 [Hepcludex] as the first and only approved treatment in the EU for people living with HDV, but also demonstrates that [it] has the potential to benefit a broader range of patients including those with suboptimal initial responses.”