HIV

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

    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: 
    HIV
    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: 
      HIV
      LA/ER Implantable Therapy

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

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

                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: 
                HIV
                LA/ER Implantable Therapy
                Pre-exposure Prophylaxis (PrEP)

                  Recent developments of nanotherapeutics for targeted and long-acting, combination HIV chemotherapy

                  Date: 
                  8/14/18
                  Citation: 

                  Gao Y, Kraft JC, Yu D, Ho RJY.  Recent developments of nanotherapeutics for targeted and long-acting, combination HIV chemotherapy. Eur J Pharm Biopharm. 2019 May;138:75-91. doi: 10.1016/j.ejpb.2018.04.014. Epub 2018 Apr 17. PMID: 29678735; PMCID: PMC6482852.

                  Combination antiretroviral therapy (cART) given orally has transformed HIV from a terminal illness to a manageable chronic disease. Yet despite the recent development of newer and more potent drugs for cART and suppression of virus in blood to undetectable levels, residual virus remains in tissues.

                  Health Topics: 
                  HIV
                  LA/ER Injectable Therapy

                    Mechanism-based pharmacokinetic (MBPK) models describe the complex plasma kinetics of three antiretrovirals delivered by a long-acting anti-HIV drug combination nanoparticle formulation.

                    Date: 
                    2/12/18
                    Citation: 

                    Kraft JC, Treuting PM, Ho RJY. Mechanism-based pharmacokinetic (MBPK) models describe the complex plasma kinetics of three antiretrovirals delivered by a long-acting anti-HIV drug combination nanoparticle formulation. J Control Release. 2018 Apr 10;275:229-241. doi: 10.1016/j.jconrel.2018.02.003. Epub 2018 Feb 10. PMID: 29432823; PMCID: PMC5878144.

                    Existing oral antiretroviral (ARV) agents have been shown in human studies to exhibit limited lymph node penetration and lymphatic drug insufficiency. As lymph nodes are a reservoir of HIV, it is critical to deliver and sustain effective levels of ARV combinations in these tissues. To overcome lymph node drug insufficiency of oral combination ARV therapy (cART), we developed and reported a long-acting and lymphocyte-targeting injectable that contains three ARVs-hydrophobic lopinavir (LPV) and ritonavir (RTV), and hydrophilic tenofovir (TFV)-stabilized by lipid excipients in a nanosuspension.

                    Health Topics: 
                    HIV
                    LA/ER Injectable Therapy

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