The US Food and Drug Administration (FDA) has recently granted accelerated approval to Gilead Sciences’ antiviral, Hepcludex (bulevirtide-gmod), for the treatment of adults with chronic hepatitis delta virus (HDV) infection without cirrhosis or with compensated cirrhosis. Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for HDV patients and addressing a serious unmet need in the HDV market, says GlobalData, a leading intelligence and productivity platform.
Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “HDV can only occur in patients who are infected with the hepatitis B virus (HBV). While chronic HBV can be managed with antiviral medication, there is currently no cure for the virus. Likewise, until the approval of Hepcludex, there were no treatments for chronic HDV in the US, leaving patients vulnerable to the severe effects of HBV-HDV co-infection.”
HBV-HDV co-infection is regarded as the most severe presentation of chronic viral hepatitis. This is due to the rapid deterioration of the liver, including liver fibrosis, cirrhosis, liver failure and hepatocellular carcinoma (HCC). Mortality rates in chronic HDV patients suffering from complications can reach as high as 50% within five years.
Kurdach continues: “The FDA approval of Hepcludex marks the first entrance of an HDV therapeutic into the HDV market in the US. The synthetic peptide antiviral has previously been approved in other markets, including Europe, Canada and Australia. Worldwide, the only other approved therapy for HDV is Huayunuo (libevitug), a monoclonal antibody marketed by Huahui Health in China.”
Hepcludex’s FDA approval was supported by data from the pivotal Phase III MYR301 trial. MYR301 evaluated the safety and efficacy of Hepcludex in 150 adult patients aged 18-65 years with chronic HDV. At Week 48, Hepcludex met its primary endpoint, demonstrating a statistically significant improvement versus the control group, as observed by reductions in HDV RNA and normalization of alanine aminotransferase (ALT). Additional analyses, including a confirmatory trial, may still be necessary for continued approval of the drug.
Kurdach concludes: “The lack of available therapies for HDV patients remains a serious unmet need. However, according to GlobalData, there are nine HDV therapeutics in the late-stage (Phase II-III) development pipeline. Drugs to look out for include Vir Biotechnology’s antisense RNAi oligonucleotide, elebsiran, and monocloncal antibody, tobevibart, Eiger InnoTherapeutics’ small molecule antiviral, lonafarnib, and Mirum Pharmaceuticals’ monocloncal antibody, brelovitug, all of which are in Phase III development.”
