HIV

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.

Health Topics: 
HIV
LA/ER Injectable Therapy
Pre-exposure Prophylaxis (PrEP)

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

    Grant Source: 
    NIH/NIAID

    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.

    Health Topics: 
    HIV
    LA/ER Injectable Therapy

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

      Grant Source: 
      NIH/NIAID

      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

      Health Topics: 
      HIV
      LA/ER Implantable Therapy
      LA/ER Injectable Therapy
      LA/ER Transdermal Drug Delivery

        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.

        Health Topics: 
        HIV
        LA/ER Implantable Therapy
        LA/ER Injectable Therapy
        LA/ER Oral Therapy
        LA/ER Transdermal Drug Delivery
        Pre-exposure Prophylaxis (PrEP)

          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: 
          8/9/19
          Citation: 

          Nachman S, Townsend CL, Abrams EJ, et al. 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. Lancet HIV. 2019 Aug;6(8):e552-e558. doi: 10.1016/S2352-3018(19)30147-X. Epub 2019 Jul 12. PMID: 31307946; PMCID: PMC7152795.

          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.

          Health Topics: 
          HIV

            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
            900 Boylston St.
            Boston, MA 02115
            United States
            Health Topics: 
            HIV
            LA/ER Implantable Therapy
            LA/ER Injectable Therapy
            LA/ER Oral Therapy
            LA/ER Transdermal Drug Delivery
            Pediatric Formulations
            Pre-exposure Prophylaxis (PrEP)

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

              Date: 
              4/30/19
              Citation: 

              Kudalkar SN, Ullah I, Bertoletti N, et al. Structural and pharmacological evaluation of a novel non-nucleoside reverse transcriptase inhibitor as a promising long acting nanoformulation for treating HIV. Antiviral Res. 2019;167:110-116. doi:10.1016/j.antiviral.2019.04.010. PMID: 31034849; PMCID: PMC6554724.

              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.

              Health Topics: 
              HIV
              LA/ER Injectable Therapy

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

                Date: 
                4/1/19
                Citation: 

                Hobson JJ, Al-khouja A, Curley P, et al. Semi-solid prodrug nanoparticles for long-acting delivery of water-soluble antiretroviral drugs within combination HIV therapies. Nature Communications. 2019 Mar;10:1413. PMID: 30926773; PMCID: PMC6441007.

                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.

                Health Topics: 
                HIV
                LA/ER Injectable Therapy

                  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: 
                  HIV
                  LA/ER Injectable Therapy

                    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: 
                    HIV
                    LA/ER Implantable Therapy
                    LA/ER Injectable Therapy

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