LA/ER Injectable Therapy

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)

    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

              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

                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

                    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

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