Experimental hepatitis B drug might offer ‘functional cure’ for a subset of patients
The six-month shot regimen beat dummy treatment, and analysts said a 15% to 20% response could support broad adoption.
- On Thursday, researchers reported that an experimental hepatitis B drug, bepirovirsen, achieved a "functional cure" in about 20% of patients, allowing them to stop treatment without viral rebound.
- Chronic hepatitis B affects more than 250 million people worldwide and kills about 1.1 million annually because the virus hides in the body, ready to rebound when standard lifelong therapy stops.
- The trials included 1,838 participants who received weekly bepi injections for six months; GSK vice president Melanie Paff said the drug suppresses viral replication by binding to genetic components and stimulating the immune system.
- Dr. Seng Gee Lim of the National University Health System of Singapore called the results unprecedented, while Dr. Anna Lok of the University of Michigan wrote the findings "represent a major step" in treatment.
- The U.S. Food and Drug Administration is conducting fast-track review with a decision expected in October, while regulators in Japan, China, and Europe are also considering the drug.
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44 Articles
New drug is a potential cure for the chronic hepatitis B, scientists say
Bepirovirsen, a hepatitis B drug awaiting FDA approval, shows the promise of being a functional cure, scientists say. The drug made the hepatitis B virus undetectable within 48 weeks in 20% of patients during a pair of clinical trials.
Hepatitis B drug may offer 'functional cure' for some patients
Researchers reported Thursday that in two international studies, about 1 in 5 patients given the experimental drug for six months saw their virus reduced to levels low enough that the immune system could keep it in check.
Experimental Drug Offers 'Functional Cure' For Chronic Hepatitis B
Phase III clinical trial results released Thursday show that an experimental drug can deliver a "functional cure" for patients with chronic hepatitis B. According to data published in the New England Journal of Medicine and reported by the Associated Press and CNN, the drug, bepirovirsen, eliminated detectable traces of the liver virus in nearly 20 percent of trial participants. For patients who entered the study with lower baseline viral loads,…
The Columbian
Experimental hepatitis B drug may offer ‘functional cure’ for some patients
WASHINGTON — A first-of-its-kind drug for hepatitis B is letting some patients stop treatment without showing signs of the dangerous liver virus, what’s called a “functional cure,” researchers reported Thursday. Read more...
Novel Hep B Drug Delivers Functional Cures in Late-Stage Trials
(MedPage Today) -- Treatment with the investigational antisense oligonucleotide bepirovirsen led to functional cure in one in five patients with chronic hepatitis B virus (HBV) infection, the phase III B-Well 1 and B-Well 2 trials showed. Among...
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