Recent Publications

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. 

Health Topics: 
HIV
Pre-exposure Prophylaxis (PrEP)

    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

      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.

      Health Topics: 
      HIV
      LA/ER Implantable Therapy
      Viral Hepatitis

        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.

        Health Topics: 
        HIV
        LA/ER Transdermal Drug Delivery

          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)

                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

                  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

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