Expert Q&A: Long-Acting Injectables, PrEP Expansion, and Closing HIV Care Gaps Through Pharmacy-Led Innovation

In an interview with Pharmacy Times, Maria Pulido, PharmD, CPh, AAHIVP, CSP, clinical coordinator of specialty pharmacy at Baptist Health South Florida, discussed recent advancements in HIV treatment and prevention, highlighting the growing availability of long-acting injectable (LAI) antiretroviral therapies (ARTs) such as cabotegravir-rilpivirine (Cabenuva; ViiV Healthcare and Janssen Pharmaceuticals) and lenacapavir (Sunlenca; Gilead Sciences), which offer patients flexible, less frequent dosing alternatives to daily oral regimens. She emphasized that persistent disparities in preexposure prophylaxis (PrEP) access across racial, ethnic, and gender groups are largely driven by structural barriers, stigma, medical mistrust, and financial hurdles, including insurance coverage gaps and prior authorization requirements that continue to limit uptake across diverse patient populations. Pulido also underscored the critical role specialty pharmacists play in optimizing HIV care, from evaluating appropriate PrEP product selection and counseling patients on adherence to navigating financial assistance programs and collaborating with prescribers on clinical concerns.

“Enabling pharmacists to initiate and manage PrEP can increase access to HIV prevention services, particularly in communities where gaps in care and limited provider availability remain barriers.” — Maria Pulido, PharmD, CPh, AAHIVP, CSP

Pharmacy Times: What are some of the most important recent advancements in HIV treatment and PrEP that clinicians should be aware of today?

Maria Pulido, PharmD, CPh, AAHIVP, CSP: Recent advancements in HIV treatment and prevention include the development of long-acting and novel antiretroviral agents, expanding options for both patients and providers. Most significant is the availability of long-acting injectable antiretroviral therapies. The combination of cabotegravir plus rilpivirine was FDA approved for individuals who have achieved viral suppression and prefer not to take daily medications. Individuals living with HIV on cabotegravir-rilpivirine receive treatment every 2 months instead of daily oral therapy.

Most recently, real-world studies in the [phase 3] LATITUDE trial [NCT03635788] also showed the benefit of cabotegravir-rilpivirine in patients who have had difficulty achieving viral suppression due to issues adhering to oral ART, regardless of viral load.¹ Another important advancement is lenacapavir, a first-in-class capsid inhibitor. It received FDA approval in 2022 for heavily treatment-experienced adults with multidrug-resistant HIV-1. PrEP strategies have also expanded with the availability of long-acting injectable cabotegravir since 2021. A US Preventive Services Task Force Evidence Report showed that long-acting injectable cabotegravir had superior efficacy compared to daily oral tenofovir disoproxil fumarate/emtricitabine, with risk reductions of 67% in cisgender men who have sex with men and transgender women, and 89% in cisgender women.²

In June 2025, lenacapavir was also approved for use as a twice-yearly LAI option for PrEP. Together, these strategies allow the care team to better tailor HIV treatment and prevention toward a patient’s specific and individual needs.

Pharmacy Times: What barriers continue to limit access to and uptake of PrEP across different patient populations?

Pulido: Significant disparities in PrEP access and uptake exist across racial, ethnic, and gender groups at all ages. These disparities are largely driven by structural barriers, stigma, medical mistrust, and broader inequities in the health care system. Women face additional challenges that include lower awareness of PrEP and the perception that PrEP is mainly intended for men who have sex with men. Transgender women may also experience added barriers, such as concern about interactions with gender-affirming hormones. Although PrEP is recommended as a preventive service, financial and administrative hurdles such as insurance coverage issues, prior authorization requirements, and medication costs can delay or prevent initiation. These are system-level factors that further limit access. In addition, PrEP services are often concentrated in specialty clinics, while primary care providers may feel it falls outside their scope of practice. This can create gaps in access, particularly for patients who rely on primary care settings for preventive services.

Pharmacy Times: How can specialty pharmacists support patients who are starting or currently taking PrEP?

Pulido: Specialty pharmacists are strategically positioned to play an important role in supporting patients who are initiating or currently using PrEP. Their involvement helps ensure appropriate PrEP product selection, promote adherence, and address barriers to medication access. At the start of therapy, specialty pharmacists evaluate whether PrEP is appropriate based on individual patient factors, including medical history, current medications, and potential drug interactions. They also assist patients [in navigating] financial barriers by identifying co-pay assistance and patient support programs where needed. Patient education is another key component of pharmacist-led care. Pharmacists counsel patients on proper medication use, dosing schedules, management of missed doses, and potential adverse effects. They also reinforce the importance of routine laboratory monitoring and follow-up visits required for safe and effective PrEP use.

In addition, specialty pharmacists regularly assess adherence and address challenges that may interfere with consistent medication use. By providing ongoing support and collaborating with prescribers when clinical concerns arise, specialty pharmacists help optimize PrEP uptake and effectiveness and reduce the risk of HIV acquisition.

Pharmacy Times: How are long-acting injectable therapies for HIV treatment and prevention changing the care landscape?

Pulido: Long-acting injectable therapies are transforming HIV treatment and prevention by providing alternatives to daily oral regimens. These options can be particularly beneficial for individuals who experience challenges with daily adherence, pill fatigue, or stigma associated with taking antiretroviral medications. By reducing dosing frequency, long-acting injectable formulations shift the mode of medication administration from daily self-administration to periodic clinic-based administration. This change can simplify treatment routines and improve convenience for many patients. In addition, less frequent dosing may help support consistent medication exposure, which is essential for maintaining viral suppression in treatment and preventing HIV acquisition in individuals using PrEP. Overall, long-acting injectable therapies represent an important advancement in HIV care, offering more flexible and patient-centered options that can improve engagement in both treatment and prevention.

Pharmacy Times: What strategies are most effective in supporting medication adherence for patients receiving HIV treatment or PrEP?

Pulido: Supporting medication adherence for individuals receiving HIV treatment or PrEP requires a patient-centered and multidisciplinary approach. Early identification of barriers such as depression, substance use, housing instability, stigma, transportation issues, medication costs, and pharmacy access allows clinicians to tailor counseling to the individual in a supportive and nonjudgmental manner. Techniques such as motivational interviewing and sharing improvements in viral load and CD4 counts can enhance the patient experience, reinforce adherence, and strengthen patient engagement. Regimen optimization is also fundamental. Once-daily single-tablet regimens with minimal food requirements and fewer [adverse] effects are associated with higher adherence, while long-acting injectable therapies offer an alternative for patients who struggle with daily oral medications. Multidisciplinary care teams that include case managers, pharmacists, social workers, and mental health providers are essential for addressing social and structural barriers and ensuring uninterrupted access to therapy through insurance navigation and copayment assistance. For PrEP specifically, fostering trust, addressing stigma and [adverse] effects, ensuring convenient pharmacy access, and offering a choice of formulations can further support consistent use.

Pharmacy Times: What opportunities exist for pharmacists to further expand their impact in HIV care and prevention in specialty and community pharmacy settings?

Pulido: Pharmacists have significant opportunities to expand their impact in HIV care and prevention across both specialty and community pharmacy settings. Integrated care models that connect pharmacists with HIV medical providers have demonstrated improvements in viral suppression and CD4 outcomes, highlighting the value of pharmacist-led medication management and patient support. Another important opportunity exists for expanding the pharmacist’s scope of practice to prescribe and administer PrEP. Enabling pharmacists to initiate and manage PrEP can increase access to HIV prevention services, particularly in communities where gaps in care and limited provider availability remain barriers.

REFERENCES

1. The LATITUDE study: long-acting therapy to improve treatment success in daily life. ClinicalTrials.gov. Updated September 2, 2025. Accessed March 19, 2026. https://clinicaltrials.gov/study/NCT03635788

2. Chou R, Spencer H, Bougatsos C, Blazina I, Ahmed A, Selph S. Preexposure prophylaxis for the prevention of HIV: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2023;330(8):746-763. doi:10.1001/jama.2023.9865