Sulggi Lee

The plenary session on long-acting technologies was presented in tandem by Claudia Cortes and Natella Rakhmanina and was an excellent juxtaposition summarizing new long-acting technologies and therapies, followed by a strong appeal for studying adolescents and children in future long-acting therapeutic trials to reach the 95-95-95 goal by 2030.

The session began with an overview of novel “long-acting” (>1 week for oral, >1 month for injectable, >6 months for implantable) drug delivery systems including injectables, vaginal rings, implants, microarray/microneedle patches, wearable infusion pumps, gastric residence devices, and broadly neutralizing antibodies. New and future long-acting therapies were discussed, including long-acting injectable cabotegravir/rilpivirine (FDA-approved for HIV treatment, given every 4 or 8 weeks intramuscularly), lenacapavir (first in class capsid inhibitor, FDA-approved for the treatment of highly resistant HIV, given every 6 months intramuscularly), Islatravir (first in class, nucleoside reverse transcriptase translocation inhibitor, currently being studied given orally weekly), and broadly neutralizing antibodies (>15 now under investigation for HIV treatment, prevention, and cure). The session highlighted the need for including adolescents, who have low rates of viral suppression, in trials evaluating novel long-acting technologies to optimize dose adjustment, tolerability, and acceptability. Adolescents have been shown to have similar pharmacokinetics to adults CAB/RPV (MOCHA trial) yet were excluded in prior adult phase trials, which might have accelerated recent FDA approval for individuals aged 12-18 years. Although trials are now beginning to include younger participants (CRAYON: age <12, LATA: age 12-19, CARES: includes age <18), still other trials continue to exclude age <18 (IMPALA).

There are now several exciting novel long-acting therapies available and currently under study, aimed at enhancing accessibility and adherence to ART. However, these new therapies must be partnered with new technologies to deliver these therapies to enhance adoption, such as self-administration of transdermal or thigh intramuscular injections. In particular, younger people living with HIV should be a major focus of ongoing and future trials as they will be critical to achieving the 95-95-95 targets for 2030.