TABLE Information

Indications

Potential contraindications

Common adverse events

Special considerations

Lai Len

• HTE adults with multidrug-resistant HIV failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations

• Concomitant administration with strong CYP3A inducers increases risk of virologic failure

• Concomitant administration with strong CYP3A inhibitors increases risk of adverse events

• Mild to moderate injection-site reactions (pain, redness, swelling)

• Nausea

• Insufficient data on use during pregnancy or in pediatric patients

• Not a complete regimen on its own (must be combined with other ARV agents) administration of the medication in the clinic setting; (2) personal patient preference for oral agents or needle phobia; (3) limited insurance coverage; and (4) lack of HCP comfort, including unease related to the long PK tail and potential for side effects.61,62 Fortunately, pharmacists have the ability and knowledge base to alleviate many of the system-related barriers to LAI ART. For example, pharmacists can aid in identifying and selecting the appropriate patients (eg, no risk factors for nonadherence, evaluation of ARV resistance, assessing HBV status), counsel and educate patients regarding adherence, potential side effects, and DDIs, investigate insurance coverage and assist with out-of-pocket costs, manage medication inventory, send timely injection reminders to patients, and administer the IM and SQ injections to patients. Moreover, pharmacists can aid in confirming and obtaining information regarding patient insurance coverage.

One of the unique intricacies related to LAI therapies is their extended half-life, with their corresponding long PK tail after discontinuation. Although this can be beneficial by allowing for less-frequent injections, it also increases to the risk of side effects, especially serious ones, and DDIs that can occur numerous months or even a year after the last LAI ARV dose has been administered. Pharmacists have both experience and education on the nuances of pharmacokinetics, making them ideally positioned to manage these issues.

Because LAI ART is administered in the health care setting, it may be covered as a medical or a pharmacy benefit under a patient’s insurance.63 There are 2 types of insurance coverage for LAI ART: buy-and-bill and whitebagging. With the buy-and-bill approach, the provider purchases the drug from a specialty distributor and stores it for the patient until the time of administration, when the claim is submitted for reimbursement to the patient’s insurance. With the white-bagging approach, insurance companies make coverage of drugs contingent on the medication being distributed directly from a third-party specialty pharmacy to the provider’s office. Buy-and-bill is typical of medications covered as a medical benefit; white-bagging is typical of medications covered as a pharmacy benefit.63 Not only does this complicate matters for patients, but clinics must separate buy-and-bill and white-bag inventories before they can be administered to patients and address patient out-ofpocket responsibilities for each method of acquisition. Although there are many complex details that need to be addressed regarding LAI ART administration, the phase 3b CUSTOMIZE study demonstrated that LAI CAB + RPV was not only successfully implemented across a range of US healthcare settings, but also that barriers were mitigated with minor process adjustments.64 At 4 months and 12 months, the proportion of staff-study participants (SSPs) who experienced barriers to LAI implementation at baseline decreased in all categories evaluated except patient injection/soreness, which stayed consistent (Figure 13).64 Additionally, 78% of SSPs reported optimal implementation of LAI CAB + RPV in their clinics within 3 months. Based on SSP interviews, successful implementation was achieved through teamwork, using a web-based treatment planner, and having a designated person to track appointment scheduling.64

How do PWH feel about LAI ART?

In addition to systemic barriers to LAI ART administration, patients must be willing and able to adhere to LAI regimens to achieve positive outcomes from this therapy. The results of a recent self-administered patient questionnaire revealed that 74% of PWH would be willing to accept injections every month.65 Patients’ perceived advantages of LAI ART were being able to stop taking oral pill(s) every day, being more certain about efficacy, and being certain that they would not forget to take their ART (Figure 14).65 On the other hand, PWH’s most common perceived drawbacks of LAI ART were a fear of adverse effects and concern that the clinic appointments would be too much of a constraint (Figure 15).65 Understanding PWH’s perceptions regarding LAI ART can help to guide shared decisionmaking discussions and reduce the risk of missed doses (nonadherence) and the development of treatmentemergent resistance patterns. Adherence is especially critical in HTE PWH because the armamentarium of active agents available to them is small.

In the SOLAR study mentioned previously, patient treatment preference was assessed, and it was found that 90% of patients preferred every-2-month injections compared with oral daily ART. Furthermore, more than 80% of the total respondents preferred LAI CAB + RPV because of convenience and not having to worry about remembering to take their HIV medication every day (Figure 16).46

Overall, LAI ART is a welcome addition to the HIV treatment armamentarium and will likely benefit many PWH through its less-frequent administration schedule, especially for patients who are concerned about the stigma associated with daily oral ART intake or are inconvenienced by high pill burden (possibly leading to nonadherence). Because each PWH has unique preferences, social situations, and feelings toward their HIV diagnosis and management, it is imperative that all members of the HIV care team implement shared decision-making strategies and continue to educate and counsel patients about the importance of adherence to ART regimens to achieve and maintain virologic suppression.

I don’t have to worry as much about remembering to take HIV medication every day

It is more convenient for me to receive injections Q2M

I do not have to carry my HIV medication with me

I do not have to think about my HIV status every day

I don’t have to worry about others seeing or finding my HIV pills

Proportion of Participants

BIC/FTC/TAF No preference