Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies

Abstract

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission.

The HIV drug optimization agenda: promoting standards for earlier investigation and approvals of antiretroviral drugs for use in adolescents living with HIV

“…There are concerns that adolescents have difficulty adhering to medication regimens, which might hinder adherence to study drugs and attendance at follow-up visits after enrolment [23]. The advanced FDA Paediatric HIV guidance for Industry suggests that adolescents have lower adherence rates than adults [2].…”

HIV Prevention Interventions for Adolescents

“…Since 1996, one goal of the National Institutes of Health as well as the US FDA has been to increase the participation of children in research so that adequate data can be developed to support treatment (and prevention) modalities for disorders and conditions that affect adults as well as children. In order for adolescents to access safe and effective new biomedical HIV prevention products at the same time that these products are approved and marketed for adults, the scientific development and testing of these products for adolescents must proceed concurrently [92]. Similarly, adolescents are often excluded from behavioral and structural intervention trials due to concerns from regulatory or ethics boards as well as investigator concerns around the complexity of recruitment/retention and/or fear that adolescent difficulties will adversely impact the primary outcomes of the trial [93–94].…”

Dosing Common Medications in Hospitalized Pediatric Patients with Obesity: A Review

“…An alternate strategy is to identify young patients who are taking or expected to be prescribed a medication requiring biologic sample collection, then obtain consent from the parents to have samples for drug levels collected at the same time as clinical care samples (27,40,83). A third approach is to intensify the use of existing clinical research resources designed for adults (84). Specifically, including older adolescents with obesity in clinical studies of adults across a body weight spectrum may be considered.…”