CROI 2025 Abstract eBook

Abstract eBook

Invited Session

49

Leveraging Private-Sector Pharmacies to Expand Reach of Biomedical HIV Prevention Interventions Katrina Ortblad Fred Hutchinson Cancer Center, Seattle, WA, USA Background: Private-sector pharmacies are ubiquitous in many African countries yet underutilized for delivery of HIV prevention services, including pre- and post-exposure prophylaxis (PrEP and PEP). This is a missed opportunity, as pharmacies are staffed by medical professionals (e.g., pharmacists, pharmaceutical technologists); are frequently accessed for sexual and reproductive health products (e.g., contraception, treatment for sexually transmitted infections); and—unlike many healthcare facilities—are open evenings and weekends. Additionally, research evidence suggests that some individuals prefer accessing PrEP/PEP at private pharmacies over public clinics because of their convenience, privacy, and lack of HIV stigma. Key barriers to pharmacy-delivered PrEP/PEP services, however, include gaps in enabling policy and guidelines (e.g., limitations to pharmacy providers’ scope of practice) and private pharmacies’ exclusions from pooled PrEP/PEP procurement mechanisms that are critical to keeping the cost of PrEP/PEP affordable to clients. In collaboration with the Kenya Ministry of Health, our research team developed a care pathway for pharmacy-delivered PrEP/PEP that enables trained pharmacy providers (working under remote clinician oversight) to deliver drugs procured from government stock to eligible clients. Pilot studies have found this delivery approach reaches demographics underrepresented in clinic-based PrEP/PEP programs (e.g., men, unmarried individuals) and is highly acceptable and feasible to pharmacy clients and providers. Implementation challenges, however, include heavy burden on provider time (particularly for conducting the requisite HIV testing and counseling) and evidence gaps around how government might subsidize pharmacy PrEP/PEP delivery in ways that incentivize pharmacy providers and keep services affordable for clients. To fill these gaps, our research team is conducting hybrid cluster-randomized controlled trials to test different pharmacy PrEP/PEP delivery models that vary client cost and cadre of staff involved in delivery. In this presentation, we will present key implementation insights from these trials to date and potential paths forward. Empowering Communities: Peer-Based Model for Expanding Equitable Access to PrEP & PEP in Mexico Alaín Pinzón Vihve Libre, Mexico City, Mexico Background: In Mexico, stigma and inequality limit access to HIV prevention tools like PrEP and PEP. Alain Pinzón of VIHve Libre has developed a peer-based, technology-supported program to overcome these barriers. Participants connect via social media, enroll through a digital platform, and access testing and medication either in person or via courier services. Personalized counseling ensures informed use of PrEP (daily or on-demand), while PEP is made accessible even in underserved regions across the country. This model highlights the power of community-driven approaches to dismantle stigma, promote adherence, and scale equitable HIV prevention solutions while establishing a permanent community network nationwide. We’ll Come to You: A Mobile Clinic Preexposure Prophylaxis Delivery Model Elzette Rousseau Desmond Tutu HIV Foundation, Cape Town, South Africa Background: Effective HIV prevention requires well-designed and well targeted services tailored according to client characteristics and needs. PrEP biomedical product choice allows young people to select a formulation that works for them and their lifestyle, while HIV prevention impact may be even greater if PrEP service delivery models also match young people’s diverse lifestyles and unique needs. During this presentation, we will discuss how to link PrEP-interested young people to PrEP products (oral, dapivirine vaginal ring, and injectable cabotegravir) and services (including community-based models) most appropriate for their lifestyles and prevention needs. The talk will highlight effective PrEP choice frameworks for adolescents and young people; provide a detailed description of community-based mobile clinic delivery of a range of PrEP products (oral, dapivirine vaginal ring, and injectable cabotegravir) integrated into other sexual and reproductive health services; and describe how young people accessing PrEP from mobile clinics may be different than those seeking traditional healthcare.

2. Could baseline InSTI test required if transmitted DR to DTG becomes more prevalent? A. Also relevant: problem of ART “initiators” actually being re-initiators, esp. in LMIC. This would further increase the prevalence of “pretreatment” resistance. Implications for management algorithms 1. I n most settings, DTG resistance will necessitate PI (DRV)-based therapy for the foreseeable future, which is: A. Not coformulated with full regimen as a single tablet B. More expensive C. More prone to side effects D. A ssociated with a worse metabolic profile and more drug-drug interactions 2. Paradoxical reduction in treatment options compared to situation before 1st line DTG rollout. Previously started with NNRTIs 1st, then had PIs and DTG (3 backbone class options in total), but if starting with InSTI, can really only move to PIs currently (i.e. 2 backbone class options in total) – most NNRTIs don’t do well with concomitant NRTI resistance, unlike PIs/DTG. 3. Potential to derail CAB injectable options via cross-resistance: G118R, Q148H/K/R, etc. [BIC almost always cross-resistant also] 4. Also derails oral dual therapy options: 3TC+DTG, DTG+RPV. 5. Accelerated need for other options: (doravirine), lenacapavir, islatravir, CAB/ RPV, VH-184. A. Huge problems with access in many settings though (cost, availability, coformulation, logistics). Not nearly as well studied either. Conclusion: We’ve been here before! DTG-era was atypical – this is a return to business as usual for HIV community. Parallels to antimicrobial resistance problems/solutions. Long-Acting InSTI Strategies: Understanding the Risks for Failure and Resistance Saye Khoo University of Liverpool, Liverpool, UK Background: Long-acting injectables (LAI) represents one of the most significant advances in antiretroviral therapy in recent years, offering durable suppression for PLWH who find daily oral medications challenging. Confirmed virological failure (CVF) is a low-incidence (1.4% over 152 weeks) but high consequence event, with almost all developing drug-resistant mutations. This is in contrast to daily oral INSTI-based regimens. Risk factors for CVF with LAI therapy are well-characterised and include having 2 or more of the following risk factors: i) prior rilpivirine resistance associated mutations, ii) HIV subtype A1/A6 and iii) BMI ≥30kg/m2. In real-world deployment, CVF can be minimised through careful selection of patients for LAI. However this could exclude significant numbers of people for whom LAI would have the greatest benefit, since stigma, the need for treatment concealment and the psychological challenges of daily oral medications affects so many people. In combined analyses, 82% (18/22) of participants with CVF had low predicted plasma trough concentrations of cabotegravir or rilpivine (lowest quartile). LAIs are associated with considerable inter- and intra-patient variability. In the latter case, injection-to-injection variability is likely to be a dominant contributory factor. This pharmacokinetic variability has led to some calls for therapeutic drug monitoring but its availability, feasibility and the scope of actions that should follow are some of the many barriers to uptake. Is LAI therapy incremental or transformative ? In public health terms, pragmatic limits to delivery (based on current service models) and careful case-selection (to limit CVF) lean to the former, making this a valuable addition to the existing armamentarium of drugs. To be transformative, LAIs need to reach those who would not otherwise be treated, and to suppress those who would otherwise fail. These are generally populations explicitly excluded from pivotal trials. Recent clinical studies in these challenging populations provide important evidence that LAIs could be transformational, and this work will be reviewed.

Invited Session

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CROI 2025