LA/ER Oral Therapy

Considerations and challenges in developing novel long-acting antiretrovirals modalities for treatment and prevention of HIV-1 infection: a regulatory perspective

Date: 
9/3/19
Citation: 

Sampson MR, Troy SB, Belew Y, Arya V, Struble KA. Considerations and challenges in developing novel long-acting antiretrovirals modalities for treatment and prevention of HIV-1 infection: a regulatory perspective. Curr Opin HIV AIDS. 2019 Sep 3. doi: 10.1097/COH.0000000000000587. [Epub ahead of print]. PMID: 31483323.

Outline some regulatory considerations and scientific challenges related to the development of long-acting antiretrovirals (ARVs) for the treatment and prevention of HIV-1 infection.

CROI 2021

The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational, and clinical researchers from around the world to share the latest studies, important developments, and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI 2021 will convene March 6 to March 10, 2021.

Go to CROI 2021 Website

Mar 06 2021 to Mar 10 2021
Hynes Convention Center, Boston, MA, 02115

Accelerating impact of long-acting technologies in low- and middle-income countries (LMICs)

Grant Source: 

Safe and efficacious medicines are available for the prevention and treatment of major diseases, but their effectiveness can be compromised by poor treatment completion. Lack of adherence can worsen clinical outcomes, leading to increased mortality, persistent transmission and increased drug resistance in the case of antimicrobials and antivirals. Analyses of treatment and prevention of HIV, malaria, and TB within public health programs show wide disparities in rates of completion, especially among specific populations and regions.

Application Deadline: 23 April 2019

Development of an oral once-weekly drug delivery system for HIV antiretroviral therapy

Date: 
1/9/18
Citation: 

Kirtane AR, Abouzid O, Minahan D, et al. Development of an oral once-weekly drug delivery system for HIV antiretroviral therapy. Nat Commun. 2018;9(1):2. Published 2018 Jan 9. doi:10.1038/s41467-017-02294-6. PMID: 29317618; PMCID: PMC5760734.

The efficacy of antiretroviral therapy is significantly compromised by medication non-adherence. Long-acting enteral systems that can ease the burden of daily adherence have not yet been developed.

Health Topics: 

Development of Ultra Long-Acting Oral HIV Therapies

Grant Source: 

Non-adherence to anti-retroviral therapy by HIV+ patients results in increased viral loads and risk of emergence of drug-resistant HIV strains. This poses a major public health threat. Lyndra Co. has developed an orally available, long-acting drug delivery system that it will now formulate to deliver anti-retrovirals.

Health Topics: 

Development of Sustained-Release Anti-HIV Nucleoside Phosphonate Nanoparticles

Grant Source: 

In this application, researchers propose to utilize novel synthetic chemistry to develop a series of aliphatic tenofovir prodrugs designed to greatly enhance cellular uptake and to provide prolonged intracellular exposure to molecules with potent antiviral activity. They will further extend systemic exposure to these compounds by delivering them in slow-release nanoparticle formulations. They believe that with this “dual-modulation” of drug presentation we will provide systemic exposure to therapeutic concentrations of highly active antiviral compounds for periods of at least four weeks following intramuscular injection.

Health Topics: 

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