KAMPALA: The United States Food and Drug Administration (FDA) has approved a new treatment for chronic hepatitis B that could allow some patients to stop taking antiviral medicines while maintaining control of the virus.
The drug, Hibsago (bepirovirsen), developed by pharmaceutical company GSK, was approved on October 20, 2026, becoming the first antisense oligonucleotide therapy authorised by the FDA for chronic hepatitis B.
The approval represents a significant development in the fight against hepatitis B, a potentially life-threatening liver infection that can cause cirrhosis, liver failure and liver cancer.
Ugandan physician and kidney specialist Dr Robert Kalyesubula welcomed the development, describing it as a major medical breakthrough.
“The U.S. Food and Drug Administration (FDA) approved Hibsago (bepirovirsen) on October 20, 2026, as the first antisense oligonucleotide therapy for chronic Hepatitis B Treatment!” Kalyesubula said in a statement published on Friday.
“What a great breakthrough!” he added.
Unlike conventional antiviral medicines, which many patients must take for years to suppress hepatitis B, Hibsago targets the genetic instructions the virus uses to produce viral proteins and replicate.
The FDA said the new treatment could give some patients an opportunity to maintain viral control after discontinuing medication.
“For many people living with chronic hepatitis B, treatment can mean taking antiviral medication for years to keep the virus suppressed,” said Dr Wendy Carter, Acting Director of 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.”
Clinical Trials
According to the FDA, two clinical trials showed that 24% of patients receiving Hibsago met the requirements to discontinue their existing hepatitis B medication, compared with none among patients who received a placebo.
Twenty-four weeks after stopping all hepatitis B treatment, 19% of patients who received Hibsago still had the virus under control, with hepatitis B surface antigen (HBsAg), a marker of infection, undetectable in their blood.
The findings suggest that some patients could achieve sustained viral control without continuous medication, although the drug does not guarantee a cure.
Hibsago is administered through injections under the skin for up to 24 weeks alongside existing antiviral medicines.
Patients must continue their conventional treatment for at least another 24 weeks after completing the injections before doctors can determine whether medication can safely be discontinued.
The FDA restricted approval to certain adults without cirrhosis who have been taking hepatitis B antiviral medicines for at least six months, have suppressed viral levels and have HBsAg levels of 3,000 IU/mL or less.
Uganda
The development could have implications for Uganda, where hepatitis B remains a major public health concern.
According to the Ministry of Health, approximately 4.1% of Ugandan adults have hepatitis B, with prevalence reaching 4.6% in the mid-northern region compared with 0.8% in the southwest. 
Many patients with chronic hepatitis B require long-term antiviral treatment to prevent liver damage and reduce the risk of liver cancer.
However, the US approval does not automatically make Hibsago available in Uganda.
Its introduction would depend on regulatory authorisation, pricing, procurement and the availability of specialised laboratory testing.
Safety Concerns
Despite the promising results, the FDA warned that Hibsago carries risks of serious liver reactions and low platelet counts, which can result in potentially life-threatening bleeding.
Other complications include worsening kidney function and serious inflammatory reactions.
Common side effects include fever, fatigue, headaches and injection-site reactions.
The FDA granted Hibsago Fast Track and Breakthrough Therapy designations, as well as Priority Review, before approving the treatment.
The approval offers a new possibility for patients who have traditionally faced years of antiviral medication, although longer-term evidence will be needed to establish how many can safely remain off treatment.
Doctors caution that patients currently taking hepatitis B medicines should not discontinue them without medical supervision.
