A dedicated race to find a cure for chronic hepatitis B is underway, led by liver specialist Maurizio Bonacini. This disease, one of the most prevalent worldwide, is a significant contributor to liver cancer. Based in San Francisco, Dr. Bonacini has focused his career on the chronic form of the virus, which affects over 2 million individuals in the United States alone.
The World Health Organization has reported that approximately one in three people globally has been infected with acute hepatitis B. The risk of developing chronic hepatitis is alarmingly high for infants, with a 90 percent chance of progression if they contract the virus. When left untreated, hepatitis B can lead to liver cancer in 25 percent of cases, resulting in a mortality rate of one in four.
Despite the availability of vaccines and oral medications to treat hepatitis B, the virus continues to spread, even after its discovery over 60 years ago. Currently, no definitive cure exists. To change this, Dr. Bonacini has joined the clinical trial known as B-United, which involves 300 chronic hepatitis B patients across 80 sites in 18 countries. The trial is sponsored by GlaxoSmithKline, a biopharma company based in the U.K.
At one of the California investigation sites, Dr. Bonacini was the first to administer a potential cure for chronic hepatitis B to a patient. His research aims not only to find a cure but also to provide alternative treatments for patients who currently rely on lifelong antiviral medications. These medications suppress the replication of hepatitis B DNA, effectively halving the risk of liver cancer and other complications. However, they can lead to side effects such as upper respiratory infections, fatigue, and gastrointestinal issues. In some cases, patients may develop resistance to the antivirals, resulting in serious complications.
Dr. Bonacini likens the current treatment landscape to competing in the Olympics, stating, “What we have now is the bronze medal.” His aspiration is to achieve a “gold” standard—a sterilizing cure that completely eradicates the virus. In the interim, he is aiming for a “silver” solution, which would allow patients to stop taking antiviral medications while significantly reducing their cancer risk by 80 percent.
Currently, Dr. Bonacini is closely monitoring 10 participants in the Bay Area while overseeing an additional 200 patients who did not qualify for the trial. These study participants receive monthly injections of an investigational drug designed to slow the production of the surface antigen associated with the infection. Following this, they receive weekly injections of a different research drug for 24 weeks. If the surface antigens remain absent after an additional 24 weeks, patients will stop all treatments but continue to be monitored.
Dr. Bonacini anticipates that the U.S. Food and Drug Administration may consider the injections for market approval by late 2027. He has also called for improved prevention and diagnosis measures in the meantime. Earlier this year, he approached more than 60 primary care physicians in California, urging them to include state-mandated hepatitis B screenings in electronic health records. The response was mixed, with many doctors expressing concerns about the additional burden on their practices.
The current U.S. immigration laws require proof of vaccination against hepatitis B but do not mandate screenings for the virus, a gap that Dr. Bonacini believes is a significant oversight. “Even if a person shows proof of vaccination, those who are already infected do not benefit from the vaccine,” he stated.
One of Dr. Bonacini’s study participants, a man in his 40s from San Francisco, fell victim to this oversight. Immigrating to the U.S. from Southeast Asia at the age of nine, he received a hepatitis B vaccination later as a student. However, during a physical examination in his 30s, he discovered that he had contracted the virus prior to his vaccination and was now facing health issues such as fatty liver and mild cirrhosis.
Having met Dr. Bonacini while volunteering for COVID vaccine studies, he promptly enrolled in the chronic hepatitis B research. After starting oral medication, his hepatitis B DNA levels became undetectable within months. Now, he participates in the trial and reports being essentially noncontagious after 26 weeks of trial injections.
Despite the progress, the participant expressed frustration about the financial burden associated with his health care, which includes costs ranging from $100 to $200 for bloodwork and $500 to $700 for imaging every six months. He noted, “I can’t imagine the financial burden for those with inferior coverage.”
Dr. Bonacini believes that with improved prevention strategies, future generations will see a drastic reduction in cases like this patient’s. Nonetheless, he emphasizes that a cure is essential, as it is impossible to vaccinate every individual globally. He collaborates with esteemed virologists and clinicians from countries such as Tanzania and Hong Kong, where up to 7 percent of the population is affected by hepatitis B. Dr. Bonacini remains optimistic, stating that research increasingly suggests a cure is within reach, asserting, “We just have to find the right drugs.”