HIV

Long-Acting Injectable Antiretroviral Treatment Acceptability and Preferences: A Qualitative Study Among US Providers, Adults Living with HIV, and Parents of Youth Living with HIV

Date:

3/15/19

Citation:

Simoni JM, Beima-Sofie K, Mohamed ZH, Christodoulou J, Tapia K, Graham SM, Ho R, Collier AC. Long-Acting Injectable Antiretroviral Treatment Acceptability and Preferences: A Qualitative Study Among US Providers, Adults Living with HIV, and Parents of Youth Living with HIV. AIDS Patient Care STDS. 2019 Mar;33(3):104-111. doi: 10.1089/apc.2018.0198. PMID: 30844308; PMCID: PMC6442271.

To better understand acceptability of long-acting injectable antiretroviral treatment (LAI-ART) regimens for HIV management, we conducted seven semi-structured focus group discussions with experienced HIV care providers and persons living with HIV (PLWH) and five individual interviews with parents of children living with HIV in the western United States. Although providers were wary about a potential negative impact on consistent engagement in care, they predicted that patients, especially those with adherence challenges, would be enthusiastic about LAI options. Many PLWH, especially young adults, welcomed the option of an LAI-ART regimen; however, others feared injections and expressed concerns about possible side effects, dosing more frequent than every 2 weeks, additional costs, and lower efficacy.

Health Topics:

The Invisible Product: Preferences for Sustained-Release, Long-Acting Pre-exposure Prophylaxis to HIV Among South African Youth

Date:

3/14/19

Citation:

Montgomery ET, Atujuna M, Krogstad E, et al. The Invisible Product: Preferences for Sustained-Release, Long-Acting Pre-exposure Prophylaxis to HIV Among South African Youth. J Acquir Immune Defic Syndr. 2019 Apr 15;80(5):542-550. doi: 10.1097/QAI.0000000000001960. PMID: 30865050; PMCID: PMC6426447.

Long-acting injectable and implantable approaches aim to overcome some of the documented challenges with uptake and adherence to current HIV prevention methods. Youth are a key end-user population for these methods. We used qualitative methods to examine product attributes and preferences for current and future long-acting HIV prevention approaches.

Health Topics:

Long-acting Drug Delivery Systems for ART Optimization in HIV-1 Infected Children (R61/R33 Clinical Trial Not Allowed)

Grant Source:

NIH/NIAID

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate development of safe and effective long-acting drug delivery systems (LA-DDS) for improved, simplified treatment of HIV-1 in children. This FOA invites applicants engaged in the development of existing LA-DDS platforms at early product development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-1 infected children. Collaborative research partnerships with industry are required.

Application Deadline: March 13, 2019 - 5:00 PM local time of applicant

Health Topics:

Pediatric Formulations

Ultra-long-acting removable drug delivery system for HIV treatment and prevention

Date:

2/13/19

Citation:

Kovarova M, Benhabbour SR, Massud I, et al. Ultra-long-acting removable drug delivery system for HIV treatment and prevention. Nat Commun. 2018;9(1):4156. Published 2018 Oct 8. doi:10.1038/s41467-018-06490-w. PMID: 30297889; PMCID: PMC6175887.

Non-adherence to medication is an important health care problem, especially in the treatment of chronic conditions. Injectable long-acting (LA) formulations of antiretrovirals (ARVs) represent a viable alternative to improve adherence to HIV/AIDS treatment and prevention. However, the LA-ARV formulations currently in clinical trials cannot be removed after administration even if adverse events occur. Here we show an ultra-LA removable system that delivers drug for up to 9 months and can be safely removed to stop drug delivery.

Health Topics:

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

Grant Source:

UNITAID

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

Health Topics:

LA/ER Oral Therapy

Tuberculosis

Nanoencapsulation introduces long-acting phenomenon to tenofovir alafenamide and emtricitabine drug combination: A comparative pre-exposure prophylaxis efficacy study against HIV-1 vaginal transmission

Date:

1/28/19

Citation:

Mandal S, Kang G, Prathipati PK. et al. Nanoencapsulation introduces long-acting phenomenon to tenofovir alafenamide and emtricitabine drug combination: A comparative pre-exposure prophylaxis efficacy study against HIV-1 vaginal transmission. J Control Release. 2019 Jan 28;294:216-225. doi: 10.1016/j.jconrel.2018.12.027. Epub 2018 Dec 18. PMID: 30576746; PMCID: PMC6339842.

Abstract
Daily oral antiretroviral (ARV) drugs for pre-exposure prophylaxis (PrEP) has proven efficacy for diverse groups of high-risk individuals. However, daily dosing regimen has augmented non-adherence. These experiments comparatively investigated the long-acting (LA) PrEP potency of subcutaneous (SubQ) administrated tenofovir alafenamide (TAF) and emtricitabine (FTC) loaded nanoparticles (NPs) to solution in humanized (hu) mice.

Health Topics:

Predicting drug-drug interactions between rifampicin and long-acting cabotegravir and rilpivirine using PBPK modelling

Date:

12/19/18

Citation:

Rajoli RKR, Curley P, Chiong J, et al. Predicting drug-drug interactions between rifampicin and long-acting cabotegravir and rilpivirine using PBPK modelling. J Infect Dis. 2019 May 5;219(11):1735-1742. doi: 10.1093/infdis/jiy726. PMID: 30566691; PMCID: PMC6500558.

Cabotegravir and rilpivirine are two long-acting (LA) ARVs that can be administered intramuscularly (IM); their interaction with rifampicin, a first-line anti-TB agent, has not been investigated. The aim of this study was to simulate and predict DDIs between these LA ARV agents and rifampicin using PBPK modelling.

Health Topics:

Tuberculosis

Ultra-long-acting removable drug delivery system for HIV treatment and prevention

Date:

11/12/18

Citation:

Kovarova M, Benhabbour SR, Massud I, Spagnuolo RA, Skinner B, Baker CE, Sykes C, Mollan KR, Kashuba ADM, Garcia-Lerma JG, Mumper RJ, Garcia JV. Ultra-long-acting removable drug delivery system for HIV treatment and prevention. Nat Commun. 2018 Oct 8;9(1):4156. doi: 10.1038/s41467-018-06490-w. PMID: 30297889; PMCID: PMC6175887.

Abstract
Non-adherence to medication is an important health care problem, especially in the treatment of chronic conditions. Injectable long-acting (LA) formulations of antiretrovirals (ARVs) represent a viable alternative to improve adherence to HIV/AIDS treatment and prevention. However, the LA-ARV formulations currently in clinical trials cannot be removed after administration even if adverse events occur. Here we show an ultra-LA removable system that delivers drug for up to 9 months and can be safely removed to stop drug delivery.

Health Topics:

Extended-Duration MK-8591-Eluting Implant as a Candidate for HIV Treatment and Prevention

Date:

10/1/18

Citation:

Barrett SE, Teller RS, Forster SP, et al. Extended-Duration MK-8591-Eluting Implant as a Candidate for HIV Treatment and Prevention. Antimicrob Agents Chemother. 2018 Sep 24;62(10). PMID: 30012772; PMCID: PMC6153840.

Regimen adherence remains a major hurdle to the success of daily oral drug regimens for the treatment and prevention of human immunodeficiency virus (HIV) infection. Long-acting drug formulations requiring less-frequent dosing offer an opportunity to improve adherence and allow for more forgiving options with regard to missed doses. The administration of long-acting formulations in a clinical setting enables health care providers to directly track adherence.

Health Topics: