Table 4.
Checklist for consideration and implementation of LAI-ART in older persons with HIV.
| Domains | Considerations | Checklist Items | Next Steps |
|---|---|---|---|
| 1. Does the patient meet criteria for LAI-ART?* | |||
| Department of Health and Human Services guidelines [13] | Does patient meet baseline treatment qualifications? | □ Sustained virologic suppression (viral load <50 HIV-RNA copies/mL) for 3–6 months □ On a stable antiretroviral regimen □ No history of treatment failure □ No known or suspected resistance to CAB or RPV (may consider genotype resistance testing; |
Proceed if all met (Step 2) |
| 2. Determine potential benefits of LAI-ART | |||
| Patient and provider preferences | Perceived benefits | □ Convenience, increased freedom; reduced risk of inadvertent disclosure; pill aversion, fatigue, or intolerance; deprescribing (polypharmacy, concerns about inappropriate dosing); poor adherence* | Consider LAI-ART appropriateness and feasibility (Step 3) |
| Perceived risks/harms | □ Patient preference for oral ART, hesitations about novel therapy, needle aversion, concerns about adverse effects; unreliable follow-up or transportation | LAI-ART likely not appropriate | |
| 3. LAI-ART appropriateness and feasibility | |||
| LAI-ART eligibility screening | Risk of CAB-RPV treatment failure and need for mitigating factors | □ Body mass index (BMI) < 30 kg/m2 | Proceed if all met (Step 4) If any are not met, reevaluate appropriateness of initiating CAB-RPV LAI-ART |
| Medical history, comorbidity, and functional status screening | Medical/surgical history | □ Willingness to adhere to monthly or every other month injections □ No history of chronic hepatitis B infection □ No increased baseline risk for hepatotoxicity □ No history of buttock implants or fillers |
|
| Pharmacologic considerations | □ Contraindicated drugs: Certain anticonvulsantsa, antimycobacterialsb, systemic steroids, St. John’s Wort | Explore feasibility and potential need to change or deprescribe medications with respective providers; otherwise reevaluate appropriateness of initiating CAB-RPV LAI-ART | |
| □ Engage pharmacists to screen for risk of drug–drug interactions with other concomitant long-term medications: macrolide antibioticsd, methadonee | |||
| Past and potential future needs for interacting medications (ex. steroids, antimycobacterials, methadone) | □ Chronic reactive or inflammatory conditions (ex. chronic obstructive pulmonary disease, multiple sclerosis, gout, other autoimmune or rheumatologic disease) or chronic pain (ex. lumbago, sciatica)? | Coordinate with PCP, other specialists to ensure other providers are aware of potential drug–drug interactions and contraindications in setting of LAI-ART | |
| □ Risk for tuberculosis (TB) or TB exposure (ex. travel and work exposure history)? | |||
| Risk for LAI-ART adverse effects | □ Baseline impaired gait and/or ambulation? | Shared decision-making and anticipatory guidance on adverse effects including injection site pain, swelling, and potential impacts on function | |
| □ Past or current typical or atypical depression? | Psychobehavioral history, behavioral health screening (ex. PHQ9) | ||
| □ Consider oral lead-in period (4 weeks) to ensure tolerability | Monitor for drug–drug interactions and adverse effects;if any suspected, reconsider appropriateness of LAI-ART | ||
| Financial feasibility | Potential for increased out-of-pocket costs for copays/coinsurance for both clinic visits and injections on a monthly or every other month schedule | □ Engage pharmacists and case managers | Determine if LAI-ART falls under a medical benefit, pharmacy benefit, or both |
| Determine anticipated out-of-pocket costs to patient | |||
| Determine if and for how long patient may qualify for manufacturer or RWHAP assistance programs | |||
| Shared decision-making with patient on anticipated costs of regular visits and medication | |||
| 4. Implementation considerations for older patients | |||
| Patient education | Cognitive decline or sensory impairment | □ Develop accessible printed and digital materials about treatment regimen, drug–drug interactions, side effects, patient expectations, and plan for missed doses □ Focused, educational clinic visits on LAI-ART process leading up to and with initial doses □ Involve caregivers in education and planning discussions, if appropriate |
|
| Patient scheduling and reminders | Lower technological literacy | □ Identify best means of communication (phone, letter, online portal) to ensure reliable contact for clinical updates and scheduling | Develop a communication and clinic scheduling plan with the patient (and/or caregiver); discuss back-up means of communication if primary method is unsuccessful |
| Patient transportation | Transportation barriers (ex. vision impairment, limited access, dependence on others for rides) | □ Screen for transportation challenges | If positive, engage social work if to explore transportation options |
| Plan for missed doses | Structural and socioeconomic barriers may increase risk for missed doses among older PWH | □ Anticipatory planning with patient (and caregivers, if appropriate) on best backup plan for oral bridge therapy (ex. prescribing a preemptive bridge dose; in-person vs. mail-order pharmacy) | |
| Plan if LAI-ART resistance develops | Certain oral regimens have toxicities of particular relevance to older populations, resulting in higher rates of treatment changes (e.g., greater loss in bone mineral density) | □ Patient-provider discussion of risks of resistance to CAB-RPV and implications of toxicities of next-line therapies | |
| Integrating with chronic disease management | Multiple comorbid conditions, preventive health | □ Consider coordinating injection visits with other health or lab monitoring (ex. blood pressure monitoring, A1c, mental health screening) through discussions with PCP and specialists | |
ART, antiretroviral therapy; CAB, cabotegravir; LAI, long-acting injectables; PWH, people with HIV; RPV, rilpivirine.
Limited studies have demonstrated benefits of CAB-RPV injectable therapy if paired with comprehensive wraparound services for virally unsuppressed or ART-nonadherent patients, such as those with psycho-behavioral or social barriers to adherence.
Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin.
Antimycobacterials: rifabutin, rifampin, rifapentine.
Systemic steroids: more than a single dose of dexamethasone.
Increases risk for QT prolongation, Torsades de Pointes
CAB-RPV can reduce levels of methadone in some patients.