Data has just been released from Gilead Sciences’ Phase IIb and Phase III clinical trials, which tested Hepcludex (bulevirtide) as a potential treatment for chronic HDV Patients.
HDV is the most serious form of hepatitis and is marked by rapid progression and associated with serious complications such as liver cirrhosis and cancer, as well as fibrosis. Bulevetride received breakthrough therapy and orphan drug status under the FDA, and is acknowledged by the European Medicines Agency as the first approved therapy for chronic HDV.
The drug is an investigational entry inhibitor still in development. The results of these trials have shown a substantial response in patients, with virological and biochemical responses seen in 36.7 percent of the patients in the treatment arm receiving 2mg and 28 percent of those receiving 10mg.
Gilead said that these trials confirm the safety and efficacy profile of the 2mg treatment, given once daily. It should be noted that the Phase IIb trial evaluated the safety and efficacy of using bulevirtide in combination with another hepatitis treatment, namely peginterferon alfa-2a.
The results indicated that the highest response rate was seen in those patients who only received the new bulevirtide monotherapy. Though, both therapies were considered well-tolerated.
Later this year, the company will submit their data from these trials to the US Food and Drug Administration for Approval.