New Drug Just Functionally Cured Hepatitis B In 1 In 5 Patients
Researchers have published phase 3 clinical trial results showing that a new drug called bepirovirsen, developed by GSK and Ionis Pharmaceuticals, functionally cured chronic hepatitis B in approximately one in five patients who received it, a result described by leading hepatologists as remarkable and a major step forward for a disease that has been notoriously difficult to treat. The study, published in the New England Journal of Medicine and presented simultaneously at the European Association for the Study of the Liver, enrolled 1,838 adults with chronic hepatitis B across 29 countries, and participants received weekly injections of bepirovirsen in addition to their standard antiviral medication for six months. Nineteen percent of those treated with bepirovirsen achieved what researchers define as a functional cure, meaning their immune systems were able to control the virus without any further medication after the treatment period ended. None of the participants who received a placebo reached that threshold in either of the two replicate trials.
The result is significant because chronic hepatitis B has historically been one of the hardest viral infections to cure, with fewer than one percent of the more than 240 million people worldwide living with the disease able to achieve a functional cure using the oral antiviral drugs that are currently the standard of care. The condition is the leading cause of liver cancer globally and earned the name silent killer because the vast majority of those infected are unaware they have it. Bepirovirsen works as an antisense oligonucleotide, a type of molecule designed to target and block the RNA instructions that the hepatitis B virus uses to reproduce, and it appears to be most effective in patients whose infection was already relatively well controlled on existing antivirals, with that group showing functional cure rates of up to 26 percent. Hepatologist Anna Lok of the University of Michigan, who wrote an editorial accompanying the NEJM publication, called the findings a major step, while noting that the drug's effectiveness in more challenging patient populations still needs to be established before it can be considered a broad solution.
