(Photo courtesy Gilead Sciences)
The U.S. approved Yeztugo in June 2025, the first and only twice-yearly injectable shot seen by health professionals as the first step in a global rollout that could prevent HIV for millions of people.
The HIV prevention drug is a form of PrEP, or pre-exposure prophylaxis. Routinely taking the prescription medication before a person comes into contact with HIV helps prevent getting HIV through sex, though it does not prevent other sexually transmitted infections.
The drug lenacapavir is made by Gilead Sciences and sold as Yeztugo for preventative measures. It is administered every six months after starter doses.
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, chairman and CEO of Gilead Sciences after the approval. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”
Data from Gilead showed that ≥99.9% of participants who received Yeztugo in Phase 3 of its two trials remained HIV negative.
Gilead evaluated it in two “double-blind, randomized controlled trials conducted in HIV-negative individuals, including those who are often underrepresented in HIV prevention trials despite being disproportionately affected by HIV,” they explain.
Its Purpose 1 study included pregnant and lactating women 16-25 years old in South Africa and Uganda. Researchers reported in 2024 that shots administered to around 5,000 young women were 100% effective in preventing new infections.
Its Purpose 2 study included cisgender men, transgender women and men, nonbinary individuals and people who were sexually active with male partners in Argentina, Brazil, Mexico, Peru, South African, Thailand and the U.S.
Organizations in Central Florida and Tampa Bay were among participants, including CAN Community Health.
“CAN researchers helped lead this breakthrough as part of the Purpose 2 study,” they shared in June 2025. “After nearly two decades of findings, Yeztugo offers six months of high-efficacy protection, helping reduce stigma, improve adherence and give people more control over their prevention journey … This is progress. This is action. This is empowering wellness through prevention — on your terms.”
Since Yeztugo is used for adults and adolescents weighing at least 77 pounds, and patients must be HIV negative before and while receiving the drug, obtaining a prescription begins with talking to a healthcare provider.
Gilead says they will ask you about your medical history, any prescriptions, your sexual health, any past HIV and STI test results and more. Once your provider determines Yeztugo may be the right fit, the next step is to complete an HIV test.
Upon a negative result, providers will prescribe Yeztugo and take the next steps for patients to receive it. For those with insurance, that means receiving coverage approval.
Since the shots must be administered in a medical setting by a professional, providers will then schedule a patient’s injections. The first appointment includes an oral starter dose of two pills. Two injections will follow before two additional pills are taken at home the following day.
“After Yeztugo is injected it stays under the skin and slowly releases over time,” Gilead explains. “Some people may notice … a lump or bump at the injection site while others may not. Yeztugo works regardless.”
Staying on schedule “is key to HIV prevention,” Gilead also notes. “Each dose of two injections is scheduled with your healthcare provider up to two weeks before or two weeks after your six-month mark.”
HIV prevention also requires regular HIV testing. Providers will require negative test results to continue the process — something that is already happening throughout Central Florida and Tampa Bay.
“It’s a very exciting time in HIV prevention to have so many choices for our patients in offering prevention,” says Dr. Antonio Luis, founder of Tampa Bay’s Inclusive Care Group.
“I think the biggest barrier has been access and evaluating people correctly,” he notes. “It’s so important to see a patient and talk to them about all aspects of their life to see where we can impact and offer preventative care options and lifestyle modification.”
The region’s Metro Healthy Communities also offers it. Chief Marketing & Experience Officer Brian Bailey says they “created a waitlist early on for patients that were interested so we could get them on as soon as their insurance providers would cover it.”
“We think it’s a great alternative for folks that have difficulty with daily pills,” he adds.
Central Florida’s Embrace Health says the journey has been an exciting one. Founder and President Vickie Cobb-Lucien shares that their first injections of Yeztugo were given to a Black woman and a queer, Black man.
“Being able to offer Yeztugo to a Black woman — who we later found out was actually the first Black woman in the region to get it — was really special,” Cobb-Lucien says. “The process itself couldn’t have been easier. It’s just two small injections that take less than five minutes total. It’s actually simpler than giving Apretude or Cabenuva!”
Apretude is an injectable medication that you receive every two months to help prevent HIV. Cabenuva is a combination medication that’s used for HIV treatment, and it consists of two back-to-back injections on the same day every one to two months.
The challenge Dr. Carl Millner, Chief of Medicine at AIDS Healthcare Foundation, notices with Yeztugo is medical billing versus pharmacy billing.
This means that if it is medical billing the patient has to get prior authorization. He says the pharmaceutical company is aiming to make it less difficult for patients to receive Yeztugo due to the “incredible results this drug has given.”
When it comes to the price of Yeztugo, copays can vary and the medicine is $28,000 a year out of pocket. In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo.
Their Advancing Access patient support program can help find financial support options and understand coverage information once prescribed. Providers may have other assistance options and you can learn more at PrEP.AdvancingAccess.com.
“We have found with, particularly if it’s a pharmacy benefit, there’s usually not a lot of copay,” Millner shares. “When you have to do a prior authorization, someone might have $50, someone might have a $100 copay. I don’t think I’ve ever seen anything more than that, and that’s not every insurance plan. It is always contingent upon what their insurance plan is.”
Cobb-Lucien says most plans including Medicaid are covering Yeztugo without big issues. She notes that Embrace Health never wants cost to be the reason someone can’t access care.
“We actually covered a high copay for one of our patients so she could switch from Truvada to Yeztugo — that’s how strongly we believe in it,” Cobb-Lucien says.
Cobb-Lucien wants patients to know that Embrace Health is not just offering another medication, it is helping them make sure that Black, queer and other underrepresented communities have access to the latest, most effective HIV prevention options.
AHF is the largest provider of HIV PrEP in the country with around 27,000 patients on PrEP. Millner says conversations still need to happen, so people know what to do when taking PrEP and knowing their options as not everyone wants to receive the preventative by a needle.
“The biggest issue with this medication … is retention on the drug, because people take it episodically; when they’re having sex, they’re going to take it, when they’re not they’re probably going to stop,” Millner explains. “But our goal is to make sure that we continue to identify people who need to be on this drug and make sure we have conversations and to make sure people retain and stay on this drug.”
With a drug like Yeztugo, barriers can be broken as Cobb-Lucien thinks it will be much easier for patients to get appointments with only needing to come in two times a year. She has noticed it can be tough for patients to come in every two to three months for labs or refills.
There is also peace of mind that is given to providers, Cobb-Lucien notes. They know patients are covered for the full six months and don’t have to worry about missed doses or people falling outside that seven-day window like with other PrEP options.
“I really believe Yeztugo could be the key to ending the HIV epidemic,” Cobb-Lucien shares. “If every provider offered it as confidently as we promote COVID or flu vaccines, we’d make huge progress in preventing new infections. This medication makes HIV prevention easier, more accessible and more consistent — and that’s exactly what we need to finally turn the tide.”
Learn more about Yeztugo at Yeztugo.com. For more information about services and the locations of AIDS Healthcare Foundation and CAN Community Health, visit AIDSHealth.org and CANCommunityHealth.org. For Embrace Health, Inclusive Care Group and Metro Healthy Communities, visit EmbraceMyHealth.org, InclusiveCareGroup.com and MetroTampaBay.org.
This story was originally published in Watermark Out News’ 2025 Q-Health Guide. Read the digital edition here.
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