Viral suppression remains the main objective of ART (antiretroviral therapy) for HIV-infected individuals. However, achieving an undetectable viral load continues to be a challenge for many individuals. Among the obstacles that hinder ART success, poor drug adherence is responsible for most episodes of failure to achieve and maintain virologic suppression. Up to 25% of individuals on chronic ART may experience episodes episodes of non-adherence and only 51% of HIV-infected adults in the US are virally suppressed (1). This is a suboptimal outcome from both an individual and public health perspective. Thus, improving ART adherence remains of critical importance in HIV treatment.
Researchers are currently investigating long-acting & injectable forms of antiretroviral medications (LA-ART) as a potential alternative for people who struggle with adherence to present, oral treatments. In the LATTE-2 trial, researchers provided long-acting forms cabotegravir + rilpivirine to HIV-positive people who had not previously taken HIV treatment before in the United States and Spain. Injections occurred every four or eight weeks, depending on which study arm a person was randomized to. (2) At 160 weeks, 104 of 115 participants (90%) and 95 of 115 participants (83%) receiving the injectable regimen, every 8 and 4 weeks respectively, remained virally suppressed. Of the patients on the oral comparator arm who chose to switch to the injectable regimen at week 96, 33 of 34 participants (97%) and 10 of 10 participants (100%) remained virally suppressed on every 8 and 4-week dosing, respectively. (3) While researchers were excited by the results of the LATTE-2 study, the study did not specifically investigate the efficacy of LA-ART in people who struggle with adherence. Researchers hope to explore this question in this particular study.
This study is investigating if Long-Acting Injectable ART will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. The main
advantages of LA ART in this population include infrequent dosing and directly observed therapy. A challenge for participants is that, to be eligible to receive LA ART, they will need to attain virologic suppression through adherence to their SOC oral medications. Financial incentives will be used during the first 20 weeks of the study to motivate participants to be adherent to an oral regimen until they are eligible to be randomized to either the LA ART arm or the standard of care arm.
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