CDC Urges Greater Awareness of Daily HIV Prevention Pill

The CDC’s latest estimates and guidance on HIV pre-exposure prophylaxis (PrEP) highlight both the proven effectiveness of daily PrEP pills and the expanding options for prevention, including new injectable formulations. While the original 2015 CDC telebriefing underscored the potential of daily PrEP to prevent HIV infection, recent data and recommendations reflect a more nuanced and evolving landscape—one that now includes highly effective injectable alternatives and ongoing challenges in ensuring widespread access, and adherence.

New Recommendations and Effectiveness

As of 2025, the CDC strongly recommends the use of injectable lenacapavir (LEN) as a new PrEP option for people weighing at least 77 pounds (35 kg) who would benefit from PrEP. This recommendation is based on results from two randomized controlled trials, PURPOSE 1 and PURPOSE 2, which reported LEN’s efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population over a 52-week follow-up period. The injectable formulation is administered every six months, potentially improving adherence compared to daily oral regimens.

The CDC’s PrEP Guidelines Work Group assessed the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach and found a high certainty of evidence for both efficacy and safety. The most common adverse events were mild to moderate injection site reactions, with no significant safety concerns identified in the trials.

Challenges in PrEP Adherence and Coverage

Despite the availability of PrEP, adherence and acceptance remain suboptimal. In 2023, over 39,000 people in the U.S. Were diagnosed with HIV, with the majority of diagnoses attributed to male-to-male sexual contact. The CDC’s most recent data indicate that, while PrEP is highly effective, less than one-third of those who could benefit from PrEP had been prescribed it as of 2022. This gap underscores the need for increased awareness, access, and education about PrEP options, including both daily pills and new injectable formulations.

Context and Public Health Implications

The CDC’s Ending the HIV Epidemic (EHE) initiative aims to reduce new HIV infections by 90% by 2030. PrEP coverage is a key indicator of progress toward this goal. However, recent staffing reductions at the CDC have paused the reporting of PrEP coverage data, delaying the ability to track progress in real time. This pause highlights the importance of maintaining robust data systems to inform public health strategies.

What Comes Next

The introduction of lenacapavir as a PrEP option represents a significant advancement in HIV prevention. It offers an alternative for those who may struggle with daily pill adherence, potentially increasing the number of people who can benefit from PrEP. However, ensuring equitable access and addressing barriers to care remain critical challenges.

For those at risk of HIV infection, PrEP—whether in daily pill form or as an injectable—remains a powerful tool in preventing transmission. Health providers and public health officials will continue to work toward expanding access, improving adherence, and leveraging new options to meet the EHE initiative’s ambitious goals.

The CDC’s latest estimates and guidance on HIV pre-exposure prophylaxis (PrEP) highlight both the proven effectiveness of daily PrEP pills and the expanding options for prevention, including new injectable formulations. While the original 2015 CDC telebriefing underscored the potential of daily PrEP to prevent HIV infection, recent data and recommendations reflect a more nuanced and evolving landscape—one that now includes highly effective injectable alternatives and ongoing challenges in ensuring widespread access and adherence.

New Recommendations and Effectiveness

As of 2025, the CDC strongly recommends the use of injectable lenacapavir (LEN) as a new PrEP option for people weighing at least 77 pounds (35 kg) who would benefit from PrEP. This recommendation is based on results from two randomized controlled trials, PURPOSE 1 and PURPOSE 2, which reported LEN’s efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population over a 52-week follow-up period. The injectable formulation is administered every six months, potentially improving adherence compared to daily oral regimens.

Based on a high certainty of evidence for the efficacy and safety of LEN as assessed by the GRADE analysis, subcutaneous injection of LEN every 6 months is strongly recommended as a PrEP option in persons weighing ≥77 lbs (≥35 kg) who would benefit from PrEP.

CDC PrEP Guidelines Work Group, MMWR, September 18, 2025

The CDC’s PrEP Guidelines Work Group assessed the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach and found a high certainty of evidence for both efficacy and safety. The most common adverse events were mild to moderate injection site reactions, with no significant safety concerns identified in the trials.

Challenges in PrEP Adherence and Coverage

Despite the availability of PrEP, adherence and acceptance remain suboptimal. In 2023, over 39,000 people in the U.S. Were diagnosed with HIV, with the majority of diagnoses attributed to male-to-male sexual contact. The CDC’s most recent data indicate that, while PrEP is highly effective, less than one-third of those who could benefit from PrEP had been prescribed it as of 2022. This gap underscores the need for increased awareness, access, and education about PrEP options, including both daily pills and new injectable formulations.

Context and Public Health Implications

The CDC’s Ending the HIV Epidemic (EHE) initiative aims to reduce new HIV infections by 90% by 2030. PrEP coverage is a key indicator of progress toward this goal. However, recent staffing reductions at the CDC have paused the reporting of PrEP coverage data, delaying the ability to track progress in real time. This pause highlights the importance of maintaining robust data systems to inform public health strategies.

What Comes Next

The introduction of lenacapavir as a PrEP option represents a significant advancement in HIV prevention. It offers an alternative for those who may struggle with daily pill adherence, potentially increasing the number of people who can benefit from PrEP. However, ensuring equitable access and addressing barriers to care remain critical challenges.

For those at risk of HIV infection, PrEP—whether in daily pill form or as an injectable—remains a powerful tool in preventing transmission. Health providers and public health officials will continue to work toward expanding access, improving adherence, and leveraging new options to meet the EHE initiative’s ambitious goals.