There’s new hope for the millions of people affected by chronic hepatitis B (CHB), a liver condition that can lead to cancer, scarring, or organ failure, and which is responsible for over a million deaths worldwide each year.
Following the results of two phase 3 clinical trials, published in the New England Journal of Medicine, the US Food and Drug Administration (FDA) has approved the drug bepirovirsen for CHB treatment, under the brand name Hibsago.
GSK, the pharmaceutical company behind the drug’s development, describes bepirovirsen as the first “functional cure” for CHB, meaning it doesn’t just manage the virus causing the infection – as existing treatments do – but suppresses it to undetectable levels in the blood.
What’s more, in patients who respond, the infection stays under control even after bepirovirsen treatment is stopped, which is again in contrast to the drugs currently prescribed for CHB.
“This is the start of a new era in treating people living with CHB,” says gastroenterologist Norah Terrault, from the Keck Medical Center at the University of Southern California.
“Bepirovirsen offers patients the potential to achieve functional cure after a short period of treatment, a long-standing goal for patients and physicians alike.”
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The phase 3 trial results showed that a six-month course of bepirovirsen achieved a functional cure response in 233 of 1,220 participants (19 percent), compared to 0 out of 614 participants on a placebo drug.
In those patients, the virus stayed undetectable for at least 24 weeks after all treatment stopped (72 weeks after the trial began).
The drug is administered via weekly injections and was given alongside existing pill treatments, which could then also be stopped for patients given the all-clear.
“For the first time, with Hibsago, US patients have the potential to achieve functional cure after a six-month treatment course, with the added convenience of the option of self-administration after the first dose,” says Tony Wood, Chief Scientific Officer at GSK, the pharmaceutical company developing the drug.
It’s not all completely positive.
Some patients did experience serious side effects, including liver inflammation, which the FDA says should be monitored for via regular blood tests.
Traces of the virus do stick around, too – it’s yet to be proven if the cure holds for years after treatment has ended.
However, the improvements from current treatments are stark enough that the researchers are confident that a significant number of patients are going to benefit, and that’s rubber-stamped by the FDA approval.
“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” says Wendy Carter, the Acting Director at the FDA’s Office of Infectious Diseases.
“Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease.”
Some CHB patients responded better to bepirovirsen than others. Lower levels of a key CHB protein at the start of treatment – indicating a less active infection – meant a higher chance of the new drug working. That’s something that could be tested for before bepirovirsen is prescribed.
The work doesn’t stop here.
The researchers want to see how the new treatment might be combined with other drugs to become even more effective, and GSK wants to make it available to more patients worldwide.
“CHB is a major public health challenge, affecting millions of people in the US and accounting for approximately 56 percent of all global liver cancer cases,” says Chari Cohen, the President of the Hepatitis B Foundation.
“Today marks significant progress towards our aim of transforming the way CHB is managed with improvements in screening, diagnosis, and the availability of innovative treatment options for our community.”
The results of the phase 3 clinical trials have been published in the New England Journal of Medicine.
This article was fact-checked by Rebecca Dyer and edited by Rebecca Dyer. While we pride ourselves on our process, we are only human. If you spot a mistake, please let us know.
