Target Product Profile for Future LA/ER ARVs
A table outlining a target product profile for long-acting, extended-release ARVs
Health Topics:
HIV
Long-acting HIV Drugs Advanced to Overcome Adherence Challenge
Date:
4/7/14
Citation:
Dolgin E. Long-acting HIV Drugs Advanced to Overcome Adherence Challenge Nat Med. 2014 Apr 7;20(4):323-4. PMID: 24710366.
The results from a particular drug trial presented here last month at the annual Conference on Retroviruses and Opportunistic Infections (CROI) may not have seemed particularly noteworthy. It simply showed that two pills performed as well as another combination of medicines. But the antiretroviral agents tested in the trial were not your ordinary drugs.
Health Topics:
Long-acting injectable antiretrovirals for HIV treatment and prevention
Date:
11/15/13
Citation:
Spreen WR, Margolis DA, & Pottage JC Jr. Long-acting injectable antiretrovirals for HIV treatment and prevention. Curr Opin HIV AIDS. 2013 Nov;8(6):565-71. PMID: 24100877; PMCID: PMC3815009.
Investigational long-acting injectable nanoformulations of rilpivirine and GSK1265744 are clinical-stage development candidates.
Health Topics:
Physiologically Based Pharmacokinetic Modelling to Inform Development of Intramuscular Long-Acting Nanoformulations for HIV
Citation:
Rajoli RK, Back DJ, Rannard S, et al. Physiologically Based Pharmacokinetic Modelling to Inform Development of Intramuscular Long-Acting Nanoformulations for HIV. Clin Pharmacokinet. 2015;54(6):639-650. doi:10.1007/s40262-014-0227-1. PMID: 25523214; PMCID: PMC4450126.
These data may help inform the target product profiles for LA antiretroviral reformulation strategies.
Health Topics:
Grand Challenges Explorations.
Grant Source:
The Gates Foundation invests in areas that advance the development and delivery of new HIV prevention methods while improving the efficiency and effectiveness of existing prevention and treatment efforts.
Health Topics:
Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection
Date:
7/1/15
Citation:
Arya V, Au S, Belew Y, Miele P, Struble K. Regulatory challenges in developing long-acting antiretrovirals for treatment and prevention of HIV infection. Curr Opin HIV AIDS. 2015 Jul;10(4):278-81. doi: 10.1097/COH.0000000000000163. PMID: 26049954.
Despite advances in drug development that have reduced ARV dosing to once daily, suboptimal drug adherence remains an obstacle to successful HIV treatment. Further, large randomized trials of once daily oral ARVs for preexposure prophylaxis (PrEP) have shown that drug adherence correlates strongly with prophylactic effect and study outcomes. Thus, the prospect of developing long-acting ARVs, which may mitigate drug adherence issues, has attracted considerable attention lately.
Health Topics: