Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of HIV in Low- and Middle-Income Countries (LMICs)

Abstract

Long-acting injectable antiretroviral therapy (LA ART) has been found to be non-inferior to daily oral ART in phase 3 clinical trials and is poised to soon enter routine clinical care. This treatment modality has the potential to address many barriers to daily oral ART adherence among people living with human immunodeficiency virus (HIV) and for HIV Pre-Exposure prevention. Data from the Patient Reported Outcomes (PROs) showed high rates of satisfaction, acceptability, tolerability and preference for the LA regimen, compared with the daily oral treatment. Once LA ART is available, access and uptake will be limited because of current knowledge gaps in the use of these agents and multiple challenges many specific to low-income and middle-income countries, where the epidemic is most concentrated and HIV prevention and treatment options are limited. These gaps will lead to multiple systems-level and individual-level barriers to implementation. Anticipating and addressing these gaps and barriers will help fulfill the promise of these agents against the pandemic.

Preferences and feasibility of long‐acting technologies for treatment of hepatitis C virus in low‐ and middle‐income countries: A survey of providers and policymakers

“…The generalizability of findings from clinical trials conducted in high-income settings for use in LMIC populations and settings is a concern for the development of HCV LATs. 16,17 Factors that may be unique to LMIC health systems and provide a unique context for implementation of LATs include unavailability or cost of diagnostics and laboratory services, weak supply chains (including cold chain) and storage capacity, lack of trained personnel, highly centralized and overwhelmed specialty services and improper management of contaminated waste materials. 16 There currently exist limited data regarding provider preferences or potential feasibility of HCV LATs in LMICs.…”

“…16,17 Factors that may be unique to LMIC health systems and provide a unique context for implementation of LATs include unavailability or cost of diagnostics and laboratory services, weak supply chains (including cold chain) and storage capacity, lack of trained personnel, highly centralized and overwhelmed specialty services and improper management of contaminated waste materials. 16 There currently exist limited data regarding provider preferences or potential feasibility of HCV LATs in LMICs. To fill this critical evidence gap, we conducted a global survey to assess the preferences and perceived feasibility of three potential HCV LAT formulations among HCV treatment prescribers and policymakers in LMICs.…”

A novel formulation enabled transformation of 3 HIV drugs tenofovir-lamivudine-dolutegravir (TLD) from short-acting to long-acting all-in-one injectable

“…)-assisted injection [2]. Its implementation has proven challenging [3,4]. Cabenuva lacks hepatitis B virus (HBV) coverage and is not recommended for people living with HIV and HBV [5].…”

Overcoming structural barriers to diffusion of HIV pre-exposure prophylaxis

“…sexually transmitted infection (STI) testing, viral load testing, kidney function), pharmacy access, provider bias, and lack of participant knowledge or adherence support. 10 –21 These are cross-cutting barriers to PrEP uptake, impacting the scale-up of both oral and injectable PrEP agents as well as newer delivery systems expected soon. 22 –25 Knowledge of these barriers allows for planning earlier in the drug-development pathway rather than waiting for a demonstration of efficacy.…”

“…For example, in the case of the recently approved injectable cabotegravir, operational issues in medication delivery were not addressed at the time of commercial rollout. 12,14,15,26 At the time of this writing, over 2 years after FDA approval, myriad barriers persist to prescribing and delivering this medication to persons at risk for HIV. Given the similarities in barriers to PrEP uptake, there is an urgent public health need to understand and overcome PrEP delivery challenges so they can be addressed earlier in the drug-development process.…”