On a Tuesday in October, American regulators gave their approval to Hibsago, a hepatitis B medicine from the British drugmaker GSK, opening a new chapter in a disease that has long been managed rather than resolved. The drug, known scientifically as bepirovirsen, is the first of its kind, a new class of antisense treatment, cleared for the chronic infection that quietly affects more than 250 million people across the world. For patients who have lived for years under daily suppression, the prospect of stopping treatment and keeping the virus at bay is a meaningful shift, even if most of those
FDA Approves GSK's Hibsago, First Antisense Drug for Chronic Hepatitis B, Offering Path Off Lifelong Treatment
More than 250 million people worldwide live with chronic hepatitis B, and current standard treatments help only 1% to 4% of patients clear the virus for a sustained period.
Nearly one in five patients stayed off antivirals for at least six months
Mark
Why is this approval a bigger deal than another hepatitis B drug coming to market?
Mimi
Because of what it's built to do. Current drugs mostly hold the virus down, and people often take them for life. Hibsago is the first antisense drug approved for this disease, and the aim is control after treatment stops.
Mark
How big is the improvement, in numbers?
Mimi
Standard treatments get 1% to 4% of patients to a sustained clearance, what doctors call a functional cure. In Hibsago's trials, nearly one in five patients reached undetectable virus and stayed off antivirals for at least six months.
Luke
I'd be careful with that comparison. The six-month window is the trial's measure. The reporting doesn't say how long those results last beyond that.
Mimi
Fair. And it also means most trial patients did not get there.
Mark
Does the scale of the disease change how we read this?
Mimi
It does. More than 250 million people live with chronic hepatitis B worldwide. Even a minority benefiting would be a lot of people.
Luke
Though who qualifies, and how many in practice, isn't in this report. Nor is the price or the launch date. GSK didn't respond on that.
Mark
And the company's side of it?
Mimi
GSK expects peak annual sales above £2 billion and ties the drug to a £40 billion revenue goal by 2031, as HIV drug patents approach expiry.
Luke
Those are the company's expectations, not results. Worth treating as a projection.
O Pulso
- The US Food and Drug Administration has approved Hibsago, the first antisense oligonucleotide cleared for chronic hepatitis B, ending a long wait for a different kind of treatment.
- Current drugs suppress the virus for life but clear it for only 1% to 4% of patients, leaving millions in a state of perpetual management.
- In trials, nearly one in five patients cleared the virus and stayed off antiviral medication for at least six months, a rate that stands well above existing options.
- Pricing and US availability remain undisclosed, so the drug's real reach into patients' lives is still waiting on GSK's next announcement.
- GSK, under new chief executive Luke Miels, is racing to launch new medicines before its HIV patents expire, with Hibsago central to a £40 billion revenue goal by 2031.
On a Tuesday in October, American regulators gave their approval to Hibsago, a hepatitis B medicine from the British drugmaker GSK, opening a new chapter in a disease that has long been managed rather than resolved. The drug, known scientifically as bepirovirsen, is the first of its kind, a new class of antisense treatment, cleared for the chronic infection that quietly affects more than 250 million people across the world. For patients who have lived for years under daily suppression, the prospect of stopping treatment and keeping the virus at bay is a meaningful shift, even if most of those in the trials did not yet reach it. Whether this becomes a turning point depends on what comes next: the price, the availability, and the patience of those who have waited so long for something beyond control.
On Tuesday, the US Food and Drug Administration approved Hibsago, a hepatitis B drug from the British company GSK. For people living with the chronic liver infection, it offers something current treatment rarely does: a way to keep the virus under control after they stop taking medication.
Hibsago, whose scientific name is bepirovirsen, is the first antisense oligonucleotide approved in the United States for chronic hepatitis B. It is a new kind of drug for this disease rather than another variation on an existing class.
Today's standard options, such as nucleotide analogues, are often taken for life. They suppress the virus but seldom eliminate it, and only 1% to 4% of patients achieve a sustained clearance that doctors call a functional cure. With more than 250 million people worldwide living with the infection, that gap is significant.
In trials, bepirovirsen was more hopeful. Nearly one in five patients reached undetectable virus levels and stayed off antiviral treatment for at least six months. Most participants still did not achieve that result, but the figure is well above what existing therapies deliver.
For GSK, the approval is also a commercial milestone. Under new chief executive Luke Miels, the company is working to bring new medicines to market before patents on its HIV drugs expire, and it expects Hibsago to reach peak annual sales above £2 billion. Key questions about US pricing and launch timing remain unanswered, and those details will determine how many patients can ultimately benefit.
On Tuesday, the US Food and Drug Administration announced that it had approved Hibsago, a hepatitis B drug from the British drugmaker GSK. The approval gives people with the chronic liver infection a way to keep the virus under control after they stop treatment, something current therapy rarely offers.
Hibsago is the brand name for bepirovirsen. According to the agency, it is the first antisense oligonucleotide approved in the United States for chronic hepatitis B. That makes it a new kind of drug for this disease, not another entry in an existing class.
The existing treatments set the context. Nucleotide analogues are a widely used class of hepatitis B drugs, and patients often take them for life. They suppress the virus but rarely eliminate it. Across the standard-of-care options, only 1% to 4% of patients clear the virus for a sustained period, which doctors call a functional cure.
The numbers behind the disease are large. More than 250 million people worldwide live with chronic hepatitis B. The virus spreads through infected bodily fluids such as blood, saliva and semen. It can cause serious liver damage and cirrhosis, the scarring of the liver.
Against that backdrop, the clinical trial results for bepirovirsen are modest but notable. In the trials, nearly one in five patients reached undetectable levels of the hepatitis B virus and stayed off antiviral treatment for at least six months. That is well above the 1% to 4% sustained clearance rate associated with current options, though it still means most trial patients did not reach that result.
The approval also matters commercially for GSK. The company is under new chief executive Luke Miels, who is trying to speed the development and launch of new medicines before patents expire on its blockbuster HIV drugs. GSK expects Hibsago to reach peak annual sales of more than £2 billion, or about $2.68 billion. The drug is central to the company's plan to reach more than £40 billion in annual revenue by 2031.
Several practical questions remain open. GSK did not immediately respond to a Reuters request for comment on US pricing and when the drug will be commercially available. Those answers will shape how quickly the drug reaches patients and how many of them can use it.
Citações Notáveis
GSK did not immediately respond to a request for comment on US pricing and commercial availability.— Reuters report on GSK
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