Kennet Brysting, president of Gilead Sciences Japan, mentioned an intriguing possibility during an interview in Tokyo late last year.
“I do believe that Japan could be one of the first countries in the world to actually end the HIV epidemic,” he said.
The hope is not totally unrealistic given the availability of medicines that disrupt the transmission of the virus. They are not cures. But they can hold the line on HIV enough to effectively end the disease as we know it.
Brysting discussed two such drugs in Gilead’s portfolio: Truvada, which is normally taken daily as a pill, and lenacapavir. Both protect individuals not yet infected and make the virus undetectable in individuals already infected. They could, in theory, stop the spread of HIV.
“You get two injections per year and you can actually be fully protected from acquiring HIV,” Brysting said in discussing lenacapavir. “The first trial we had showed 100% efficacy. There were zero new infections of HIV. Honestly speaking, it was almost a vaccine.”
Japan approved Truvada for HIV prevention in 2024, and the drug has been available overseas in generic form. Individuals in the country have been importing the generic version on their own or buying the drug from clinics that import the generic version.
Lenacapavir, which Gilead markets as Sunlenca, has not yet been approved for prevention.
Foster City, California’s Gilead is an antiviral powerhouse. It invented Tamiflu in the 1990s, and about a decade ago, the company released what is essentially a cure for hepatitis C. Until then, there was little hope for sufferers of the chronic disease. Gilead is laser-focused on HIV and is seeking an actual cure.
The medicines it already has have the potential to make a difference in Japan right now.
The country has recorded about 25,000 cumulative infections in total. In 2023, it reported 669 new infections, the seventh consecutive year under 1,000. The numbers are relatively low, and the trend has generally been downward.
“We need to get to zero new infections in Japan, and the sooner we can get there, the better it is,” Brysting said.
“We want to end the HIV epidemic in Japan,” he added.
Brysting is a realist, and he warns that the use of these medicines to end the spread of the virus in a population is not easy. Too much has to go right and be done correctly. It is not just about having the drugs available. It’s also about how those drugs are delivered to those who need them. Approval is just the first step.
“But my belief is that every single person that is being infected with HIV, we could have avoided that,” he said. “We could have avoided that with effective implementation. And this is where we need to get to. ”
Testing needs to be increased in order to identify those who would benefit from the medicines, he argued.
According to Brysting, about 86% of people infected with HIV have been tested. The target is 95%, and he said 100% should be the goal.
Reimbursement is another issue.
In Japan, health insurance will pay for the treatment of diseases, but preventative medications are not covered. Individuals buying Truvada on their own to protect themselves from the virus have to spend about ¥70,000 ($470) a month on it.
Brysting believes that the workaround with generics — priced at about ¥12,000 a month by clinics in Tokyo — is less than ideal and that a properly regulated and properly funded access channel would help ensure that quality medicine is dispensed in the right way to all those who would benefit from it.
Truvada requires regular monitoring. Individuals using the medication need to be tested for HIV initially and then every three months. They must also be regularly tested for other infections and have their renal function checked.
“My concern is that there are some people importing medicine, and they’re not consulting a doctor when they take the medicine,” he said. “That's the reason why I do believe that they should create some kind of access to an authorized product.”
“Consultations should be paid for. Medicine should be affordable,” he added. “Now, we can only help with the medicine, and try to make it affordable. But the government needs to step up in terms of providing the health care support that those people may need. And that's my prime concern.”
Brysting said that Gilead is already in discussions with the authorities about pathways for access to Truvada and insurance coverage for it, and he notes that progress is being made.
History suggests that the working relationship is a productive one and that the Japanese bureaucracy moves quickly if and when it makes sense. During the pandemic, Japan approved Gilead’s remdesivir, an Ebola medicine that was being used to treat COVID-19, in just three days. It is still the standard treatment in Japanese hospitals for moderate to severe COVID-19.
Gilead is also focused on treatments beyond those for HIV and hepatitis C, where success will eventually end the need for treatment.
Brysting mentioned the work the company is doing in oncology. He is particularly excited about CAR-T cell therapy.
“So, you take the patient's blood and you basically reengineer their cells. And then you reinject it,” he said. “And then your own immune system is strengthened so it will fight the cancer. We have seen some tremendous results. I mean, it's a breakthrough.”
Getting approvals for medicines in Japan can be a challenge.
Phase 3 trials — the last stage of clinical trials required for regulatory approval — must be done in the country in most cases. Data from elsewhere is not accepted for most applications.
Brysting said that this can discourage drug companies from entering Japan and can slow innovation. He noted that of all the clinical trials being conducted in Europe and the United States, only one-third are also being conducted in Japan.
He discussed the so-called drug lag, the delay between when medicines are approved elsewhere and when they are approved in Japan. The country greenlit Truvada for prevention 12 years after the United States; this also came almost two decades after Japan approved the medicine for treatment of those already infected.
Money is also an issue when drugmakers consider the Japanese market. The government reprices medicines annually and invariably downward, and in a way that can be opaque and complex. It makes planning difficult and tends to disincentivize big investments.
Brysting said Gilead is all-in despite the challenges. The company's policy is to conduct Phase 3 trials in Japan at the same time they are conducted elsewhere so it can file for approvals simultaneously across geographical regions.
“Every single oncology molecule that we have internally, we're going to develop for Japan,” he said. “We're happy to do that — whatever it takes.”
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