TL;DR
Get health and wellness essentials delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
The FDA approved bepirovirsen (Hibsago) for certain adults with chronic hepatitis B, to be used alongside existing antiviral therapy. In two phase III trials, about 19% to 20% of eligible participants achieved a functional cure by week 72, compared with none in the placebo group; treatment carries serious risks requiring monitoring.
The FDA approved bepirovirsen (Hibsago) on Tuesday for some adults with chronic hepatitis B, allowing eligible patients to take a six-month course alongside existing antiviral therapy in an effort to achieve a functional cure. The approval is based on two phase III trials in which roughly one in five participants meeting specified criteria reached that outcome by week 72; it does not mean the drug is a cure for every person with hepatitis B.
The approval applies to adults without cirrhosis who have taken nucleos(t)ide analog reverse transcriptase inhibitor therapy for at least six months, have suppressed hepatitis B virus levels in blood, and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less. Bepirovirsen is used with that background antiviral therapy, rather than as a replacement at the outset. After the first dose, patients can self-administer the drug, according to the report.
Results from the B-Well 1 and B-Well 2 trials showed functional cure rates of 19% to 20% by week 72 among participants with HBsAg levels at or below 3,000 IU/mL. The placebo groups had no functional cures. Among participants with HBsAg levels at or below 1,000 IU/mL, the reported rate was 26%. The source describes this lower-antigen group as representing about 45% of diagnosed cases worldwide; that estimate is not a measure of how many patients will respond to treatment.
The most common reported side effects were injection-site reactions, fatigue, fever and headache. The FDA-approved prescribing information carries a boxed warning for serious hepatic flares during treatment and low platelet counts, which may lead to life-threatening thrombocytopenia. Other warnings include worsening kidney function, serious inflammatory reactions such as vasculitis, and risks related to improper injection. Patients need regular blood tests, and the drug is not recommended for people with hepatitis D virus coinfection.
A New Route to Treatment-Free Control
Current chronic hepatitis B treatment can suppress virus levels, but the FDA’s approval gives some eligible patients a chance to maintain control after all chronic HBV treatment has ended. That potential matters because chronic infection can lead to serious liver disease, including cirrhosis, and the source report says more than half of liver cancer cases globally are attributable to hepatitis B.
The trial results also set limits on the promise: most participants did not achieve the reported functional cure, and the drug’s approved use is restricted by liver status, prior treatment and antigen levels. The six-month treatment course and need for safety monitoring are part of the decision patients and clinicians will have to weigh against the possibility of ending long-term antiviral treatment. The available report does not provide enough detail to compare individual outcomes or establish how durable the response will be for every patient.
As an affiliate, we earn on qualifying purchases.
How the Approval Was Supported
The FDA based its decision on the B-Well 1 and B-Well 2 phase III trials, according to the report. Participants received bepirovirsen alongside background antivirals, and the reported functional-cure outcome was assessed at week 72. The comparison with placebo—no functional cures in the placebo group—supports the regulatory decision, while the response rates show that the outcome was achieved by a subset, not all, of the treated participants.
FDA Center for Drug Evaluation and Research official Wendy Carter said the treatment could allow some patients to maintain virus control after chronic HBV treatment ends. Trial investigator Norah Terrault, of the Keck School of Medicine at the University of Southern California, described the development as a new era in treatment. Those statements reflect the potential clinicians see in the results; they do not alter the drug’s eligibility limits or safety warnings.
“This is the start of a new era in treating people living with [chronic hepatitis B].”
— Norah Terrault, MD, trial investigator at the Keck School of Medicine of USC
As an affiliate, we earn on qualifying purchases.
Limits of the Cure Evidence
The supplied report does not specify the full trial participant counts, the precise definition of functional cure used in the studies, or how long patients remained free of treatment after achieving the outcome. Although results are given at week 72, the report does not establish the durability of responses beyond that point or how frequently the virus may return.
It is also unclear from the report how the FDA’s safety monitoring will be implemented in routine care, or how benefits and risks vary across patient groups beyond the stated antigen-level results. The approval does not apply to people with cirrhosis, and the drug is not recommended for those with hepatitis D coinfection. Patients should discuss whether they meet the approved criteria and the risks in the prescribing information with a qualified clinician.
As an affiliate, we earn on qualifying purchases.
Monitoring During Six-Month Treatment
Eligible patients and their clinicians can now consider bepirovirsen alongside existing antiviral therapy, subject to the FDA’s conditions and warnings. The treatment is given over six months, with regular blood tests required because of risks including liver flares and low platelet counts. The source report does not give a timetable for broader clinical guidance or additional follow-up results.
Further follow-up will be needed to clarify how long functional cure persists, how many patients can stop all chronic HBV therapy, and how safety outcomes appear outside clinical trials. For now, the confirmed development is a new FDA-approved option for a defined group of adults—not a universal cure for chronic hepatitis B.
As an affiliate, we earn on qualifying purchases.
Key Questions
Who is eligible for bepirovirsen under the FDA approval?
The approval covers adults with chronic hepatitis B who do not have cirrhosis, have used nucleos(t)ide analog antiviral therapy for at least six months, have suppressed HBV blood levels, and have HBsAg levels of 3,000 IU/mL or less. It is used with existing antiviral therapy.
How often did patients achieve functional cure in the trials?
In B-Well 1 and B-Well 2, reported rates were 19% to 20% by week 72 among participants with HBsAg levels at or below 3,000 IU/mL, compared with none in placebo groups. The rate was 26% among those at or below 1,000 IU/mL.
Does the approval mean bepirovirsen cures hepatitis B for everyone?
No. The results indicate that some eligible participants achieved a functional cure, while most did not. The report also does not establish how long the response lasts beyond the measured follow-up.
What safety monitoring and risks are involved?
The FDA prescribing information includes a boxed warning for serious hepatic flares and low platelet counts. Other listed risks include worsening kidney function and serious inflammatory reactions. Patients using the drug require regular blood tests, and the treatment is not recommended for people with hepatitis D coinfection.
Source: rss
Cold & flu season Picks
humidifiers
As an affiliate, we earn on qualifying purchases.
