Injectable PrEP is already available in the United States. The FDA approved Apretude (cabotegravir) on December 20, 2021, making it the first long-acting injectable option for HIV prevention. If you’re in the U.S. and looking to start it, you can get it now through a healthcare provider. Availability in other countries is expanding but varies significantly.
How Injectable PrEP Works
Apretude is given as an injection in the gluteal muscle (the buttock) every two months after a brief loading period. You start with two initiation shots given one month apart, then continue with a shot every two months from that point on. Each injection delivers 600 mg of the drug, which stays active in your body between visits.
You can either take a month of oral cabotegravir tablets first to make sure you tolerate the medication, or skip straight to injections. If you start with the oral lead-in, your first injection happens on the last day of those pills (or within three days). If you go directly to injections, the every-two-month schedule begins after your second shot.
Who Can Get It
Injectable PrEP is approved for adults and adolescents weighing at least 77 pounds (35 kg) who are at risk of acquiring HIV through sex. Before starting, you’ll need an HIV test to confirm you’re negative, since the medication should not be used by anyone who already has HIV.
One notable advantage over daily pills: injectable PrEP doesn’t require healthy kidney function. Daily oral PrEP options contain tenofovir, which can be hard on the kidneys, so people with serious kidney disease who couldn’t use oral PrEP now have an alternative.
How Well It Works
In the two large clinical trials that led to approval, injectable cabotegravir outperformed daily oral PrEP. Among cisgender men and transgender women who have sex with men, the injectable reduced new HIV infections by 66% compared to the daily pill. Among cisgender women in sub-Saharan Africa, the reduction was 89%. These numbers compare injectable PrEP to oral PrEP, not to no protection at all, so they reflect an advantage over an already effective method.
What the Injection Feels Like
Injection site reactions are common and worth knowing about in advance. In one major trial, about 81% of participants receiving the actual injection reported some kind of reaction at the site, with pain being the most frequent complaint (61% of all reported reactions), followed by tenderness (24%). In the other trial, the rate was lower at 32%. Most reactions are mild and temporary. Only 0.2% of participants in the lenacapavir trial (a different injectable, discussed below) stopped treatment because of injection site discomfort, which gives a rough sense of how rarely the pain is severe enough to be a dealbreaker.
Cost and Financial Assistance
The list price of Apretude is $4,229 per injection as of January 2026, which translates to roughly $25,000 a year at six injections annually. That sticker price rarely reflects what patients actually pay, though.
If you have commercial insurance, ViiV Healthcare (the manufacturer) offers a savings program that can bring your out-of-pocket cost to as little as $0. Medicare covers Apretude and related services, including the injection itself and HIV testing, at no out-of-pocket cost for people at increased risk of HIV. Medicaid coverage varies by state. If you’re uninsured, ViiV’s patient assistance program may cover the cost entirely depending on your eligibility. Details on all of these programs are available through ViiVConnect.com.
Availability Outside the U.S.
The European Medicines Agency authorized Apretude across the EU on September 15, 2023, though actual availability through national health systems varies by country. In the UK, NHS England announced in October 2025 that it would begin rolling out cabotegravir injections through sexual health clinics, but with a significant restriction: it’s only available to the roughly 1,000 people who cannot take oral PrEP. That includes people with medical contraindications, difficulty swallowing tablets, or circumstances like homelessness or domestic violence that make daily pill-taking impractical.
If you’re outside the U.S. or UK, access depends on your country’s regulatory and reimbursement decisions, many of which are still in progress.
A Twice-Yearly Option on the Horizon
The next generation of injectable PrEP could cut clinic visits in half. Lenacapavir, a twice-yearly injection given every 26 weeks, produced remarkable results in a phase 3 trial published in the New England Journal of Medicine. Among over 5,300 adolescent girls and young women in South Africa and Uganda, zero participants in the lenacapavir group acquired HIV, compared to a background infection rate of 2.41 per 100 person-years in the broader screened population. That’s a level of protection no other PrEP method has matched in a clinical trial.
Lenacapavir is already approved for HIV treatment under a different brand name, and its manufacturer has submitted data supporting its use as PrEP. If approved for prevention, it would mean just two clinic visits per year instead of six. Injection site reactions were reported in about 69% of participants, mostly mild, and only 0.2% stopped because of them. No regulatory timeline has been publicly confirmed, but the strength of the trial data makes approval a question of when, not if.