Table 1.

Health systems and patient challenges to the implementation of long-acting ART

Systems-level challenges to implementing long-acting ART
FDA-equivalent approval process in countries outside the USA and endorsement by global recommendation guidelines
Determination of which patient populations to prioritize, both in resource-rich and constrained settings, for long-acting ART based on patient characteristics, adherence level, inadequate virologic suppression rates, cost constraints and accurate cost projections, cold chain requirements, etc.
Requirement for clinic or hospital infrastructure (clean needles, trained staff) for provider administration
Need for steady supply chains for the injectable forms of ART
Likely requirement for cold chain for transport of nanoparticle long-acting ART and refrigeration at site
Possible requirement for HIV drug resistance testing prior to use, laboratory monitoring (including for safety and HIV viral load) during use
Decentralization of care (including mobile health units) to minimize prolonged travel to clinic sites with capability to administer long-acting ART
Requirement for education programs to inform providers/clinics of the evidence behind long-acting ART, as well as bolstering systems as above to prescribe long-acting ART and monitor its outcomes
Current knowledge gaps in use of long-acting ART in children, pregnant and breastfeeding women, those on prevalent-use concomitant medications such as contraceptives, hepatitis C drugs
Individual-level challenges to implementing long-acting ART
Possible injection site reactions or other possible side effects
Possible increase in stigma from receiving injections at HIV-associated site
Patient preference and acceptability of injection-based therapy; loss of perceived “control” associated with not taking oral medications
Insurance status and cost
As with all chronic diseases, patient understanding of the need for the medication and commitment to adherence

ART, antiretroviral therapy; FDA, Food and Drug Administration.