Real-World Data Show Lenacapavir PrEP Reaching New Users

Twice-yearly lenacapavir (Yeztugo; Gilead Sciences) is reaching people new to PrEP in the US, according to real-world data presented at IDWeek 2026.¹ The oral presentation examined US adoption patterns from June 2025 through March 2026, the first 9 months after FDA approval.¹ Among women, uptake was higher in PrEP-naive individuals than in those switching from cabotegravir or oral PrEP.¹

Access timelines also moved quickly. Approximately 90% of recipients had their injection and oral loading dose dispensed on the same day, and the prescription-to-injection rate reached 70% by March 2026.¹

A companion interrupted time series analysis examined PrEP cost sharing after US Preventive Services Task Force (USPSTF) and Affordable Care Act (ACA) coverage milestones.² Zero cost sharing for PrEP claims rose after each milestone, reaching 91% after the October 2024 ACA FAQ update, while new HIV diagnoses declined in parallel.² Zero cost sharing for ancillary services, including HIV and sexually transmitted infection testing, improved but never reached universal compliance.²

Because of the USPSTF grade A recommendation, most private insurance and Medicaid programs must cover PrEP services without cost sharing.³ Both IDWeek analyses were observational and not designed to establish causality.^1,2

For clinicians, the findings point to long-acting PrEP as a route to engage people outside existing prevention programs. They also highlight persistent coverage gaps for the testing and visits required alongside PrEP.

Li Tao, PhD, senior director of Real-World Evidence/Epidemiology at Gilead Sciences, contributed to both analyses. In the following interview, Tao spoke with Contagion about drivers of early uptake, remaining access barriers, and the limits of population-level data.

Contagion: Why was lenacapavir taken up more often by PrEP-naive women than by women switching from other PrEP, and what does this suggest for underserved groups?

Tao: That’s actually the key question people were asking about our study. First and foremost, this is an observational epidemiology study. We did not design the study to address the why question, but when we looked at the population, it really stood out that lenacapavir has been used by a higher percentage of women, and half of them were naive. That really excited us and pushed us forward to present at IDWeek.

We have thought about how lenacapavir has a much lower dosing frequency than the other regimens. Some of them require dosing every 2 months, and some of them are daily oral. Lenacapavir offers a different frequency, and that can really reach individuals who were not previously engaged with HIV PrEP. That is our hypothesis and the population characteristic we wanted to observe, and the data turned out to be really aligned with what we wanted to observe.

Again, this is not going to answer why people were choosing it, but we are happy to see on a population level that people are not simply switching from a previous PrEP option but were previously not engaged with HIV prevention. That’s something we are really excited to see.

Contagion: What has driven faster access to lenacapavir compared with earlier long-acting PrEP options, and what barriers remain?

Tao: That’s also something we are happy to share with the field as a scientific piece of evidence. The prescription-to-injection rate has been increasing over time. In the earliest period, there were more structural barriers, like insurance prior authorization or reimbursement. But our data also show cabotegravir has a similar trend, and it’s increasing as well. I think the system is learning. More people have the need to get to long-acting PrEP, insurance has improved, and the process has improved.

There are some remaining financial barriers, but those are really broader barriers to PrEP access that other studies and our studies are trying to address. Again, that’s something we observed. The rate has been increasing and still remains at around 70% to 75%, and there is room to improve for the broader population to get PrEP access.

Contagion: How confident are you improved affordability is driving the decline in HIV diagnoses, and what other factors might contribute?

Tao: That’s a very key question for our second study as well. For the second study, we also want to strongly emphasize it was not designed to draw causality. We are not saying anything about associations or which factors drove it. We want to push the evidence forward, and it’s purely observational.

The answer to your question is an observation at the population level. We observed that zero cost sharing has been increasing over time, and we observed that PrEP access and uptake have been increasing. In the same period of time, this coincided with a decline in the number of new HIV diagnoses. That is a visualization of how the trend has been at the population level in the US.

So we are not saying improved PrEP access led to the decline in HIV diagnoses. What we are saying is we observed it alongside the decline in the outcome. We are not strongly saying the milestones are driving this, but we are saying it has an impact on the population level, where new HIV diagnoses have declined.

Contagion: Ancillary services never reached universal zero cost-sharing compliance. What gaps remain, and what oversight would most effectively close them?

Tao: What we observe in our data is a substantial increase, but in a more steady trend compared with the HIV PrEP regimen, because everything is in a package. If individuals are coming in for claims or prescriptions, other tests are going to be used. So we see a slow but increasing trend, and to your point, gaps still persist, especially for the ancillary services.

Again, the data are not going to show the reasons, what policy implementation needs to be done, or what factors could drive a further increase. But we do observe the milestones had some impact on the uptake of the guideline, as well as remaining gaps where there may be an opportunity to reduce financial barriers. We know financial barriers affect access as well as coverage for those ancillary services.

So it’s a multistep process. It takes a village, and a lot of parties are going to play a role in policy implementation, adoption of those guidelines, and geographic variations.

Again, we are showing population-level data, and we are showing the trend. But there are things out there, including policy implementation, to push forward more engagement at the individual level. Is that impacting each individual who wants to get PrEP? Maybe. But on the population level, we do see a change.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

References

1. Tao L, et al. Early real-world adoption patterns of long-acting lenacapavir for HIV PrEP in the United States (June 2025-March 2026). Presented at: IDWeek 2026; October 24, 2026; Washington, DC.

2. Tao L, et al. Changes in pre-exposure prophylaxis (PrEP) cost sharing and HIV diagnoses following United States Preventive Services Task Force (USPSTF) and Affordable Care Act (ACA) coverage milestones: an interrupted time series analysis. Poster P-974. Presented at: IDWeek 2026; October 23, 2026; Washington, DC.

3. Centers for Disease Control and Prevention. Clinical guidance for PrEP. Accessed November 5, 2026. https://www.cdc.gov/hivnexus/hcp/prep/index.html