Recent Publications - LA/ER Injectable Therapy

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.

Health Topics: 
HIV
LA/ER Injectable Therapy
Viral Hepatitis

    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.

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

      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)

        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)

          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

                  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

                    Modelling the long-acting administration of anti-tuberculosis agents using PBPK: a proof of concept study

                    Date: 
                    8/17/18
                    Citation: 

                    Rajoli RKR, PodanyAT, Moss DM, et al. Modelling the long-acting administration of anti-tuberculosis agents using PBPK: a proof of concept study. Int J Tuberc Lung Dis. 2018 Aug 1;22(8):937-944. PMID: 29991405; PMCID: PMC6166436.

                    SETTING:
                    Anti-tuberculosis formulations necessitate uninterrupted treatment to cure tuberculosis (TB), but are characterised by suboptimal adherence, which jeopardises therapeutic efficacy. Long-acting injectable (LAI) formulations or implants could address these associated issues.

                    OBJECTIVE:
                    niazid, rifapentine, bedaquiline and delamanid—in adults for treatment for latent tuberculous infection (LTBI).

                    Health Topics: 
                    LA/ER Implantable Therapy
                    LA/ER Injectable Therapy
                    Tuberculosis

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