Recent Publications

Be informed about the latest research and clinical studies being done in long-acting, extended release drugs for HIV and TB.

Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV

Date Posted: 
Fri, 12/20/2019
Author(s): 
Bollinger RC, Thio CL, Sulkowski MS, et al.
Citation(s): 
Bollinger RC, Thio CL, Sulkowski MS, McKenzie-White J, Thomas DL, Flexner C. Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV. Lancet HIV. 2019 Dec 20. pii: S2352-3018(19)30


The first long-acting formulations of HIV drugs are undergoing regulatory review for use in maintenance of viral suppression in people with HIV.

Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV

Date Posted: 
Fri, 12/20/2019
Author(s): 
Bollinger RC, Thio CL, Sulkowski MS, et al.
Citation(s): 
Bollinger RC, Thio CL, Sulkowski MS, McKenzie-White J, Thomas DL, Flexner C. Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV. Lancet HIV. 2019 Dec 20. pii: S2352-3018(19)30

The first long-acting formulations of HIV drugs are undergoing regulatory review for use in maintenance of viral suppression in people with HIV.

Long-acting implants to treat and prevent HIV infection

Date Posted: 
Fri, 12/06/2019
Author(s): 
Weld ED, Flexner C.
Citation(s): 
Curr Opin HIV AIDS. 2020 Jan;15(1):33-41. doi: 10.1097/COH.0000000000000591.


Subcutaneous implants are a promising technology to enable long-acting parenteral delivery of antiretroviral drugs (ARV) because they may be able to provide protective drugs concentrations for a year or longer following a single implant. The present review covers the current status of preclinical and clinical development of antiretroviral implants.

Modelling the intradermal delivery of microneedle array patches for long-acting antiretrovirals using PBPK

Date Posted: 
Fri, 12/06/2019
Author(s): 
Rajoli RKR, Flexner C, Chiong J, Owen A, et al.
Citation(s): 
Eur J Pharm Biopharm. 2019 Nov;144:101-109. doi: 10.1016/j.ejpb.2019.09.011. Epub 2019 Sep 13.

Existing HIV therapy using oral antiretrovirals (ARVs) can result in pill fatigue and sub-optimal adherence. Microneedle array patches (MAPs) offer non-invasive, blood-free and painless drug delivery, and may improve patient adherence.

Transgender Women's Concerns and Preferences on Potential Future Long-Acting Biomedical HIV Prevention Strategies: The Case of Injections and Implanted Medication Delivery Devices (IMDDs)

Date Posted: 
Fri, 10/25/2019
Author(s): 
Rael CT, Martinez M, Giguere R, et al.
Citation(s): 
Transgender Women's Concerns and Preferences on Potential Future Long-Acting Biomedical HIV Prevention Strategies: The Case of Injections and Implanted Medication Delivery Devices (IMDDs). Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellman W


There are several long-acting biomedical HIV prevention products in the development pipeline, including injections and implanted medication delivery devices (IMDDs). It is critical to understand concerns and preferences on the use of these products in populations that shoulder a disproportionate burden of the HIV epidemic, such as transgender women. This will allow researchers and public health professionals to construct interventions tailored to the needs of these women to promote optimal use of these tools. In studies of other biomedical HIV prevention products (e.g., oral PrEP) it is clear that transgender women have unique concerns related to the use of these strategies.

Acceptability of a long-acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

Date Posted: 
Tue, 10/22/2019
Author(s): 
Tolley EE, Li S, Zangeneh SZ, Atujuna M, et al.
Citation(s): 
Tolley EE, Li S, Zangeneh SZ, Atujuna M, Musara P, Justman J, Pathak S, Bekker LG, Swaminathan S, Stanton J, Farrior J, Sista N. J Int AIDS Soc. 2019 Oct;22(10):e25408. doi: 10.1002/jia2.25408. PMID: 31651098 [PubMed - in process]


High HIV incidence and low adherence to daily oral PrEP among women underscore the need for more acceptable and easier to use HIV prevention products. Global demand for injectable contraception suggests that new, long-acting, injectable formulations could meet this need. We examine acceptability of a long-acting injectable PrEP among HIV-uninfected women in Zimbabwe, South Africa and two United States phase 2 trial sites.

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

Date Posted: 
Tue, 09/03/2019
Author(s): 
Sampson MR, Troy SB, Belew Y, Arya V, Struble KA
Citation(s): 
Curr Opin HIV AIDS. 2019 Sep 3. doi: 10.1097/COH.0000000000000587. [Epub ahead of print]


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.

Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities.

Date Posted: 
Fri, 08/09/2019
Author(s): 
Nachman S, Townsend CL, Abrams EJ, et al.
Citation(s): 
Lancet HIV. 2019 Aug;6(8):e552-e558. doi: 10.1016/S2352-3018(19)30147-X. Epub 2019 Jul 12.


Antiretroviral agents with long-acting properties have potential to improve treatment outcomes substantially for people living with HIV. In November 2017, the Long acting/Extended Release Antiretroviral Resource Program (LEAP) convened a workshop with the aim of shaping the research agenda and promoting early development of long-acting or extended release products for key populations: pregnant and lactating women, children aged up to 10 years, and adolescents aged 10-19 years.

Structural and pharmacological evaluation of a novel non-nucleoside reverse transcriptase inhibitor as a promising long acting nanoformulation for treating HIV

Date Posted: 
Tue, 04/30/2019
Author(s): 
Kudalkar SN, Ullah I, Bertoletti N, et al.
Citation(s): 
Antiviral Res. 2019 Jul;167:110-116.


Combination antiretroviral therapy (cART) has been proven effective in inhibiting human immunodeficiency virus type 1 (HIV-1) infection and has significantly improved the health outcomes in acquired immune deficiency syndrome (AIDS) patients. The therapeutic benefits of cART have been challenged because of the toxicity and emergence of drug-resistant HIV-1 strains along with lifelong patient compliance resulting in non-adherence.

Semi-solid prodrug nanoparticles for long-acting delivery of water-soluble antiretroviral drugs within combination HIV therapies

Date Posted: 
Mon, 04/01/2019
Author(s): 
Hobson JJ, Al-khouja A, Curley P, et al.
Citation(s): 
Nature Communications. 2019 Mar;10:1413.


The increasing global prevalence of human immunodeficiency virus (HIV) is estimated at 36.7 million people currently infected. Lifelong antiretroviral (ARV) drug combination dosing allows management as a chronic condition by suppressing circulating viral load to allow for a near-normal life; however, the daily burden of oral administration may lead to non-adherence and drug resistance development.

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