HIV

Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed)

Grant Source:

In 2023, an estimated 39.9 million people globally were living with HIV, there were 1.3 million people who acquired HIV, and 630,000 people died from AIDS-related illnesses worldwide (World Health Organization [WHO]). Among people living with HIV (PLWH), morbidity and mortality is increasingly driven by co-infections. The risk of tuberculosis (TB) progressing from latent to active disease is estimated to be up to 20 times greater in PLWH than among those without HIV, with fatality rates of 16-35%. For HIV-associated hepatitis, WHO estimates that 2.6 million PLWH are also living with Hepatitis B Virus (HBV) and 2.75 million are also living with Hepatitis C Virus (HCV) worldwide.

Health Topics:

HIV

Request Funding to Explore Controlled Release of HIV Vaccines

Grant Source:

NIH/NIAID

NIAID’s new notice of funding opportunity (NOFO) Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01, Clinical Trial Not Allowed) supports research to advance controlled-release strategies for HIV vaccines that aim to elicit protective and durable broadly neutralizing responses and antiviral T-cell/innate responses.

Health Topics:

HIV

Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling

Date:

10/27/22

Citation:

Kinvig H, Cottura N, Lloyd A, Frivold C, Mistilis J, Jarrahian C, Siccardi M. Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling. Eur J Drug Metab Pharmacokinet. 2022 Sep 30. doi: 10.1007/s13318-022-00793-6. Epub ahead of print. PMID: 36178586.

Technologies for long-acting administration of antiretrovirals (ARVs) for the prevention and treatment of HIV are at the forefront of research initiatives aiming to tackle issues surrounding drug adherence with the current standard of once-daily oral administration. Islatravir (ISL) is an emerging ARV that shows promising characteristics for long-acting prevention and treatment both orally as well as through alternative routes of administration.

Health Topics:

HIV

Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis

Date:

10/27/22

Citation:

Blair HA. Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis. Drugs. 2022 Oct 18. doi: 10.1007/s40265-022-01791-3. Epub ahead of print. PMID: 36255686.

Cabotegravir extended-release (ER) injectable suspension (Apretude™) is the first long-acting injectable option to be approved for HIV-1 pre-exposure prophylaxis (PrEP). As an HIV-1 integrase strand transfer inhibitor, cabotegravir ER injectable suspension prevents DNA integration and inhibits HIV-1 replication.

Health Topics:

HIV

Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California

Date:

8/12/22

Citation:

Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, Biello KB, Roth AM, Strathdee SA, Pines HA. Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California. AIDS Patient Care STDS. 2022 Jul;36(7):254-262. doi: 10.1089/apc.2022.0068. Epub 2022 Jun 21. PMID: 35727647.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood.

Health Topics:

HIV

Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review

Date:

4/18/22

Citation:

Sued O, Nardi N, Spadaccini L. Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Curr Opin HIV AIDS. 2022 Apr 18. doi: 10.1097/COH.0000000000000734. Epub ahead of print. PMID: 35438662.

The objective of the current review is to update the perceptions of key populations and PLWH about LA, based on their opinion, acceptability, and willingness to use it.

Health Topics:

HIV

Pre-exposure Prophylaxis (PrEP)

Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01 Clinical Trial Not Allowed)

Grant Source:

NIH/NIAID

The purpose of this FOA is to provide investigators working on the development of novel therapeutic products for HIV and HIV-associated co-infections (hepatitis B virus, hepatitis C virus, and Mycobacterium tuberculosis) with a mechanism to request NIAID DAIDS preclinical services to fill gaps in their product development efforts and facilitate the advancement of promising therapeutics from bench to clinics.

Health Topics:

HIV

Viral Hepatitis

Factors associated with interest in a long-acting HIV regimen: perspectives of people living with HIV and healthcare providers in four European countries

Date:

6/16/22

Citation:

Akinwunmi B, Buchenberger D, Scherzer J, Bode M, Rizzini P, Vecchio F, Roustand L, Nachbaur G, Finkielsztejn L, Chounta V, Van de Velde N. Factors associated with interest in a long-acting HIV regimen: perspectives of people living with HIV and healthcare providers in four European countries. Sex Transm Infect. 2021 Dec;97(8):566-573. doi: 10.1136/sextrans-2020-054648. Epub 2021 Feb 25. PMID: 33632889.

A novel long-acting regimen (LAR) of cabotegravir and rilpivirine for HIV treatment requires dosing every 2 months instead of daily. We assessed what proportion of people living with HIV and physicians would be interested in trying and offering LAR respectively and why.

Health Topics:

HIV

Notice of Special Interest (NOSI): Sustained Release of Antivirals for Treatment or Prevention of HIV or Treatment of Latent TB/HBV (SRATP)

Grant Source:

NIH/NIAID

Clinical experience for HIV treatment and prevention has demonstrated that adherence to a drug regimen schedule is a significant factor in the success of the HIV treatment regime and/or prevention strategies. Effective treatment of HIV-infected individuals requires strict adherence to a multi-component regimen of antiretroviral agents taken at least daily for the remainder of a patient’s life. Non-adherence can lead to emergence of drug-resistance and loss of therapeutic effectiveness. Among people living with HIV, morbidity and mortality is increasingly driven by co-infections, such as tuberculosis (TB) and hepatitis B, where the compliance and completion of prolonged multidrug regimens are significant factors in treatment success.

Effective prevention requires that the inhibitor be present at the right time, place, and concentration to stop HIV transmission and acquisition. Although many factors (social, behavioral, and individual preference) can influence adherence, the use of drug delivery systems to provide for a longer therapeutic exposure or window of protection and/or less frequent administration may improve their consistent use, reduce dosing intervals, and potentially improve adherence to the drug regimens.

Development of safe, effective, and well-tolerated sustained release (SR)/long acting (LA) products and strategies that maintain consistent and effective drug levels in plasma and target tissues for longer periods of time is critical for successful treatment and prevention of HIV and HIV-associated co-infections.

Health Topics:

HIV

Tuberculosis

Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV

Grant Source:

HRSA

This notice announces the opportunity to apply for funding under the Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV cooperative agreement Increasing viral suppression and client retention in care are critical components of meeting the goals of the National HIV/AIDS Strategy (2022-2025) and ending the HIV epidemic. In order to reach these goals, it is imperative for HIV care communities to address health care inequities. With the advent of FDA-approved long-acting injectable (LAI) antiretroviral (ARV) medication formulations, initiatives that promote, facilitate, and evaluate the uptake and ongoing utilization of LAI ARV medication may improve clinical outcomes for people with HIV, especially for minority populations who continue to face disparate health care inequities and stigma. This project is designed to develop protocols, implement them and modify as needed, to increase uptake of LAI ARV medications among people of color with HIV, since LAI ARV medications may offer benefits in addressing health inequities and achieving viral suppression.

Health Topics:

HIV

HIV

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