UPDATE: A groundbreaking initiative is underway as Bay Area liver specialist Maurizio Bonacini leads a clinical trial aimed at finding a cure for chronic hepatitis B, a disease affecting over 2 million people in the United States. With the World Health Organization reporting that one in three people globally is infected with hepatitis B, the urgency for a viable cure has never been greater.
Dr. Bonacini, based in San Francisco, is spearheading a trial that involves 300 chronic hepatitis B patients across 80 sites in 18 countries, sponsored by GlaxoSmithKline. “It’s the last frontier,” he remarked, emphasizing the critical need for a solution as existing treatments prove insufficient. Currently, patients are forced to take antiviral medications for life, which come with significant side effects, including fatigue and gastrointestinal issues.
The stakes are high: untreated hepatitis B progresses to liver cancer in 25% of cases, often resulting in death. Young children, particularly newborns, face a staggering 90% risk of developing chronic hepatitis B if infected. “When we treat patients with hepatitis B, it’s like the Olympics. What we have now is the bronze medal,” Bonacini stated. He aims for the “gold”—a sterilizing cure that completely eradicates the virus.
In this trial, Bonacini monitors 10 Bay Area participants, while keeping an eye on another 200 patients who did not qualify for the study. Participants receive monthly injections of an investigational drug designed to reduce the production of the virus’s surface antigen. After 24 weeks, they switch to a different drug for an additional 24 weeks. If successful, patients may stop all treatments but remain closely monitored.
The timeline for potential FDA approval is promising, with Bonacini indicating that the agency might consider the injections for market approval starting in late 2027. However, he stresses that the need for improved prevention and diagnosis remains urgent. This past June, he urged over 60 primary care physicians in California to enhance screening for hepatitis B in electronic health records, only to face resistance due to concerns over added burdens on their practice.
“Many doctors are hesitant to implement this screening,” he noted, pointing out that screenings are not mandated for immigrants entering the U.S., a major oversight that needs rectification. The lack of testing creates dangerous gaps, as seen in a patient who immigrated from Southeast Asia and unknowingly carried the virus despite receiving a vaccination.
One patient, who chose to remain anonymous due to the stigma surrounding hepatitis B, shared his journey. After learning of his infection in his 30s, he joined Bonacini’s trial and has seen remarkable progress—his hepatitis B DNA is now undetectable. Yet, he highlighted the ongoing financial burden of managing his health, spending hundreds on regular check-ups and imaging. “There has to be a better way,” he expressed, emphasizing his commitment to finding a cure.
Dr. Bonacini believes that with proper prevention, future generations may rarely see cases like this. Yet, he remains adamant that a cure is essential, as not every individual can be vaccinated. Collaborating with global experts, Bonacini is optimistic that a cure is within reach. “We just have to find the right drugs,” he concluded.
As this trial progresses, the world watches closely, hoping for a breakthrough that could finally change the landscape of hepatitis B treatment and prevention.