A twice-a-year shot for HIV prevention could make it easier for people to protect themselves from the virus, argues an executive from Gilead Sciences, which developed the drug.
“You can go to your doctor, go behind a closed door, get the injection, walk out of the closed door, and no one knows why you were there," said Jared Baeten, the company’s senior vice president and virology therapeutic area head.
"No one knows that you have been there, and you don't have to think about it again until six months from now.”
Lenacapavir, as the drug is known, can make the virus undetectable in individuals infected and protect people not infected with the virus from becoming infected.
While existing prevention methods usually require people to take a pill daily, a twice-a-year injection option solves the adherence challenge, and provides better privacy to people who worry about the stigma of holding a bottle of the pills, Baeten told The Japan Times in an interview on Sept. 17.
“It’s like a flu shot,” he said of lenacapavir. “It takes care of the challenges of adherence, because the adherence decision is only twice a year, rather than 365 times a year.”
Foster City, California’s Gilead Sciences received the first regulatory approval for lenacapavir as a preexposure prophylaxis (PrEP) — for reducing the risk of contracting HIV — in the United States in June, and then in the European Union two months later.
The World Health Organization and the U.S. Centers for Disease Control and Prevention both issued guidelines this year recommending the drug as an additional HIV prevention method.
Lenacapavir for PrEP was a breakthrough two decades in the making, said Baeten, a life-long professional in researching infectious diseases who oversaw the development of the drug.
It was initially developed for treating individuals with multi-drug-resistant HIV, meaning they could not be successfully treated with other existing medicines. It took 12 years from preclinical discovery to the first human trial in 2018.
In lenacapavir for PrEP clinical trials, involving over 9,000 volunteers across five continents, a 100% efficacy rate was reported during the first trial, and 99% in the second.
“I remember seeing the results for the first time — when you know what your work means for the world, that’s when it is emotional,” Baeten said.
Baeten said the next step is all about how to deliver the appropriate PrEP method to the people who need it the most.
Before lenacapavir for PrEP had even acquired regulatory approval anywhere in the world, Gilead signed voluntary licenses with six generic manufacturers, providing the know-how that allows them to produce the medicine in 120 low- to middle-income countries, Baeten said.
The company is hopeful that it will receive regulatory approval in at least one low-income country by the end of 2025, Baeten said. The goal is to get 2 million people on lenacapavir worldwide in the next two years.
“All the science that we do, as amazing as it could be ... we do all of that so that medicines actually get to people, because that’s where the impact happens,” he said.
Baeten praised Japan’s robust public health system, which for years has done exceptionally well in treating HIV and AIDS and achieved relatively low new infection numbers.
Still, Japan reports roughly 1,000 new HIV infections and AIDS cases each year, and it needs to do more to get that number to zero, he said.
This is a reminder that "treatment alone will not end the epidemic,” Baeten said.
Japan approved the first medication for PrEP only a year ago, which came more than a decade after the medicine became widely available in many other countries. Medical professional and community leaders have been pushing to get it accessible and affordable for all.
Although lenacapavir has yet to receive approval as PrEP in Japan, Baeten said he hopes the development elsewhere could lead to real discussions toward ending HIV in the country.
“I think it's a very opportune moment to really have the discussion about what Japan can do to eliminate this public health threat, to be an example regionally and globally, and to be able to show the leadership that it would take to really eliminate a deadly infectious disease that has been around for 40 years,” Baeten said.
“I think this would be the opportunity to say we can end HIV in Japan,” he added. “I would like to be able to see when I retire, no one else has to work on HIV at all. I think this is the beginning of that.”
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