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February 22, 2022
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‘We should be screening now’ for HDV with emerging drug therapies in phase 3

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Without approved treatment options for hepatitis D, screening has largely fallen by the wayside; however, promising therapies in phase 3 trials may shift that paradigm, according to a presenter at the GUILD Conference.

Hepatitis D is a virus that I think we don’t talk very much about; in fact, the general sense among several of my colleagues is ‘I don’t even test for delta," Norah Terrault, MD, MPH, professor of medicine and chief of gastroenterology and liver at the Keck School of Medicine at USC, told attendees. “I’m trying to convince you otherwise. We should be screening for delta. It’s out there; you just have to look for it.”

Highlighted liver
Although there are currently no approved therapies for hepatitis D, promising therapies in phase 3 trials may shift that paradigm, and providers should “start thinking about doing more testing” among their surface antigen positive patients, noted a speaker at the GUILD Conference.

However, Terrault indicated that the current screening approach, as recommended by the AASLD, “is probably not the best means of finding delta.”

Current AASLD guidance recommends risk-based screening for HDV, including “at risk” groups such as persons who inject drugs, men who have sex with men, individuals infected with HCV or HIV, individuals with multiple sexual partners or a history of sexually transmitted diseases, and those who have emigrated from countries with high HDV endemicity.

“It’s recommended you base it on their country of origin,” Terrault said. “But that means you have to have a map at hand or a list at hand to know whether you have a patient that is from a country that warrants surveillance.”

In contrast, the EASL has a very different approach, she said. “They say, ‘screen every hepatitis B surface antigen-positive patient at least once’ and then if patients are in an ‘at risk’ group, you should screen them again, because they may get it de novo.”

Terrault noted that the need for screening is clear as HDV carries a “much worse prognosis” compared with HBV, with a higher rate of progression to cirrhosis, hepatocellular carcinoma and liver-related death.

“At every level, delta has a higher rate, in particular the rate of cirrhosis is markedly higher and typically occurring at a younger age,” she said. “All the delta patients at my practice are generally under the age of 40 and they already have cirrhosis. Many of the patients that have gone to transplant are also younger, so it’s a very aggressive disease which is why we care about it.”

Terrault suggested that what has discouraged screening for HDV in the past has been the lack of available therapies if providers did come across a patient with the disease.

“The only drug that has been studied at all is pegylated interferon and it does not work that well,” she said. “But the times are changing, and there are now two drugs in phase 3 studies as specific treatments for delta: bulevirtide [Hepcludex, Gilead Sciences], which is already approved as an orphan drug in Europe, and lonafarnib.”

Terrault urged attendees to “start thinking about doing more testing” among their surface antigen-positive patients, and “advocate for broader testing” in HDV.

“The reason we should be screening now for delta is that we will have therapeutic alternatives available to us in the very near future,” she said.