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

Journal of Medical Ethics
Michelle HumeRobert M Nelson

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.

References

Mar 31, 2010·Pediatrics·Robert E ShaddyUNKNOWN Committee on Drugs and Committee on Pediatric Research
Jul 1, 2010·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Robert M NelsonSusan F Wood
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Jun 9, 2014·Lancet·Gary MaartensSharon R Lewin
Nov 5, 2014·The American Journal of Bioethics : AJOB·Michelle Roth-Cline, Robert Nelson
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Citations

Sep 12, 2018·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Bill G KapogiannisRohan Hazra
Feb 2, 2019·Current HIV/AIDS Reports·Sybil Hosek, Audrey Pettifor
May 23, 2020·Obesity·Barbara Ameer, Michael A Weintraub
May 16, 2019·Therapeutic Innovation & Regulatory Science·Margaret Gamalo-SiebersRonald Portman
Aug 17, 2020·The Journal of Adolescent Health : Official Publication of the Society for Adolescent Medicine·Deven T HamiltonSteven M Goodreau
Dec 5, 2020·The Lancet. HIV·Suzanne DayUNKNOWN PATC3H Consortium Adolescent Bioethics Working Group
Sep 9, 2021·The New England Journal of Medicine·Anne M NeilanAmelia S Knopf

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