An experimental drug for hepatitis B, bepirovirsen, developed by transnational pharmaceutical firms GSK and Ionis Pharmaceuticals, is currently under fast-track review by the U.S. Food and Drug Administration, with regulators in Japan, China, and Europe also considering its approval. This globalized regulatory process for a potential 'functional cure' for chronic hepatitis B demonstrates the increasing consolidation of national health decisions within an international corporate and institutional sphere.
In two international studies, approximately one in five patients given the experimental drug saw their virus reduced to levels low enough for the immune system to keep in check, a result researchers described as a functional cure. This marks a new development in the treatment of the dangerous liver virus.
The drug, nicknamed 'bepi,' was developed by GSK and Ionis Pharmaceuticals, two prominent entities in the global pharmaceutical sector. Dr. Seng Gee Lim of the National University Health System of Singapore, who played a leading role in the GSK-funded studies, presented these findings at a scientific meeting in Barcelona, Spain, with the data also published on Thursday in the New England Journal of Medicine.
Elite Interests and Global Governance
Chronic hepatitis B, a serious liver infection spread through contact with blood or other bodily fluids, including childbirth, causes liver cancer or liver failure and is responsible for approximately 1.1 million deaths around the world each year. The chronic form of the disease affects more than 250 million people worldwide, including an estimated 1.7 million people in the U.S.
Dr. Anna Lok, a hepatitis expert at the University of Michigan, who was not involved in the research, acknowledged the new findings in the New England Journal of Medicine, writing that they 'represent a major step.' However, she also cautioned that further study is needed to determine how long this remission-like state lasts, highlighting the ongoing uncertainties in this global health initiative.
For decades, improvements to existing lifelong therapy for hepatitis B have been sought. Current standard treatments, which include daily pills, aim to reduce virus levels and prevent liver damage, but a true cure has remained elusive due to the virus's unusual ability to hide in the body and rebound if therapy stops. These existing therapies can also be hard to stick with or to access in some countries, creating a global demand that transnational pharmaceutical companies are now addressing.
The Mechanism of Control
According to GSK vice president Melanie Paff, the new drug, bepirovirsen, targets hepatitis B by binding to its genetic components. This action suppresses viral replication and a key protein, known as the 'S' or surface protein, while simultaneously stimulating the immune system to combat the infection.
The clinical trials involved 1,838 patients, who were assigned to receive either a bepi shot or a dummy shot weekly for six months, in addition to their regular pills. The protocol allowed patients to stop their regular pills if the virus was undetectable for six months after discontinuing the shots. Researchers reported that approximately 20% of bepi recipients achieved a functional cure, meaning the virus remained undetectable for six more months after stopping all treatment, a result not observed in any patients given the dummy shots.
GSK has continued to track a small number of patients from earlier-stage studies, with most reportedly faring well up to three years later. Dr. Lim also noted that bepi recipients who started the study with lower levels of the S protein were slightly more likely to achieve a functional cure, and he is conducting additional research to understand why only some individuals respond. Side effects observed included mild injection-site redness or pain and a temporary rise in enzymes that can indicate liver stress. It was also noted that the trials did not include patients with cirrhosis, high S protein levels, or other complicating factors.