HIV

A multi-site study of women living with HIV's perceived barriers to, and interest in, long-acting injectable anti-retroviral therapy.

Date: 
3/2/20
Citation: 

Philbin MM, Parish C, Kinnard EN, Reed SE, Kerrigan D, Alcaide M, Cohen MH, Sosanya O, Sheth AN, Adimora AA, Cocohoba J, Goparaju L, Golub ET, Fischl M, Metsch LR. A multi-site study of women living with HIV's perceived barriers to, and interest in, long-acting injectable anti-retroviral therapy. J Acquir Immune Defic Syndr. 2020 Mar 2. doi: 10.1097/QAI.0000000000002337. PMID: 32141961

Adherence to antiretroviral therapy (ART) is imperative for viral suppression and reducing HIV transmission, but many people living with HIV report difficultly sustaining long-term adherence. Long-acting injectable (LAI) ART has the potential to transform HIV treatment and prevention. However, little LAI ART-related behavioral research has occurred among women, particularly outside of clinical trials.

Long-acting rilpivirine (RPV LA) pre-exposure prophylaxis does not inhibit vaginal transmission of RPV-resistant HIV-1 nor select for high frequency drug resistance in humanized mice.

Date: 
1/22/20
Citation: 

Melody K, Roy CN, Kline C, Cottrell ML, Evans D, Shutt K, Pennings PS, Keele BF, Bility M, Kashuba ADM, Ambrose Z. Long-acting rilpivirine (RPV LA) pre-exposure prophylaxis does not inhibit vaginal transmission of RPV-resistant HIV-1 or select for high frequency drug resistance in humanized mice. J Virol. 2020 Mar 31;94(8):e01912-19. doi: 10.1128/JVI.01912-19. Print 2020 Mar 31. PMID: 31969438; PMCID: PMC7108851.

As a long-acting formulation of the non-nucleoside reverse transcriptase inhibitor rilpivirine (RPV LA) has been proposed for use as pre-exposure prophylaxis (PrEP) and the prevalence of transmitted RPV-resistant viruses can be relatively high, we evaluated the efficacy of RPV LA to inhibit vaginal transmission of RPV-resistant HIV-1 in humanized mice. 

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

Date: 
12/20/19
Citation: 

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. 2020;7(6):e443-e448. doi:10.1016/S2352-3018(19)30342-X. PMID: 31870675; PMCID: PMC7376366.

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: 
12/6/19
Citation: 

Weld ED, Flexner C. Long-acting implants to treat and prevent HIV infection. Curr Opin HIV AIDS. 2020 Jan;15(1):33-41. doi: 10.1097/COH.0000000000000591. PMID: 31764198; PMCID: PMC7050620.

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: 
12/6/19
Citation: 

Rajoli RKR, Flexner C, Chiong J, Owen A, Donnelly RF, Larraneta E, Siccardi M. Modelling the intradermal delivery of microneedle array patches for long-acting antiretrovirals using PBPK. Eur J Pharm Biopharm. 2019 Nov;144:101-109.  doi: 10.1016/j.ejpb.2019.09.011. Epub 2019 Sep 13. PMID: 31525446; PMCID: PMC6917207.

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: 
10/25/19
Citation: 

Rael CT, Martinez M, Giguere R, Bockting W, MacCrate C, Mellmen W, Valente P, Greene GJ, Sherman SG, Footer, KHA, D’Aquila RT, Carballo-Dieguez A, Hope TJ. 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). AIDS Behav. 2020 May;24(5):1452-1462. doi: 10.1007/s10461-019-02703-5. PMID: 31654172; PMCID: PMC7181384.

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: 
10/22/19
Citation: 

Tolley EE, Li S, Zangeneh SZ, Atujuna M, Musara P, Justman J, Pathak S, Bekker LG, Swaminathan S, Stanton J, Farrior J, Sista N. Acceptability of a long-acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076). J Int AIDS Soc. 2019 Oct;22(10):e25408. doi: 10.1002/jia2.25408. PMID: 31651098; PMCID: PMC6813716.

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.

Sustained Release of Antivirals for Treatment or Prevention of HIV (SRATP) (R01 Clinical Trial Not Allowed)

Grant Source: 

The purpose of this Funding Opportunity Announcement (FOA) is to stimulate the high-risk research needed to develop new and innovative sustained release antiviral strategies for treatment of HIV disease or the prevention of HIV transmission and acquisition. Adherence to dosing regimens is a shared critical issue for both HIV treatment and prevention.

Advancing Sustained/Extended Release for HIV Prevention (A-SER)

Grant Source: 

The purpose of this Funding Opportunity Announcement (FOA) is to stimulate the development of new and innovative sustained/extended release (SER) drug delivery systems (DDS) that can achieve extended durations (months to years) and provide systemic protection from all routes of HIV infection/transmission in at-risk individuals.

Application Deadline: December 4, 2019, by 5:00 PM local time of applicant organization

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.

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