Recent Publications - HIV

Tenofovir Alafenamide for HIV Prevention: Review of the Proceedings from the Gates Foundation Long-Acting TAF Product Development Meeting

Date: 
11/1/21
Citation: 

Romano JW, Baum MM, Demkovich ZR, Diana F, Dobard C, Feldman PL, Garcia-Lerma JG, Grattoni A, Gunawardana M, Ho DK, Hope TJ, Massud I, Milad M, Moss JA, Pons-Faudoa FP, Roller S, van der Straten A, Srinivasan S, Veazey RS, Zane D. Tenofovir Alafenamide for HIV Prevention: Review of the Proceedings from the Gates Foundation Long-Acting TAF Product Development Meeting. AIDS Res Hum Retroviruses. 2021 Jun;37(6):409-420. doi: 10.1089/AID.2021.0028. PMID: 33913760; PMCID: PMC8213003.

The ability to successfully develop a safe and effective vaccine for the prevention of HIV infection has proven challenging. Consequently, alternative approaches to HIV infection prevention have been pursued, and there have been a number of successes with differing levels of efficacy. At present, only two oral preexposure prophylaxis (PrEP) products are available,

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The LAIs Are Coming! Implementation Science Considerations for Long-Acting Injectable Antiretroviral Therapy in the United States: A Scoping Review

Date: 
10/14/21
Citation: 

Kanazawa JT, Saberi P, Sauceda JA, Dubé K. The LAIs Are Coming! Implementation Science Considerations for Long-Acting Injectable Antiretroviral Therapy in the United States: A Scoping Review. AIDS Res Hum Retroviruses. 2021 Feb;37(2):75-88. doi: 10.1089/AID.2020.0126. Epub 2020 Dec 7. PMID: 33176429; PMCID: PMC8020525.

Long-acting injectable antiretroviral therapy (LAI-ART) is one of the latest advancements in HIV control with the potential to overcome oral ART barriers to adherence. The objective of this article is to anticipate and examine implementation considerations for LAI-ART using components of the PRISM model, a Practical, Robust Implementation and Sustainability Model for integrating research findings into practice.

Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study

Date: 
10/4/21
Citation: 

Smith GHR, Henry WK, Podzamczer D, Masiá MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramírez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. PMID: 34557563; PMCID: PMC8454521.

In the Long-Acting Antiretroviral Treatment Enabling Trial 2 (LATTE-2) phase 2b study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or every 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with human immunodeficiency virus type 1 (HIV-1). Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over approximately 5 years.

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Population pharmacokinetics of the rilpivirine long-acting formulation after intramuscular dosing in healthy subjects and people living with HIV

Date: 
9/12/21
Citation: 

Neyens M, Crauwels HM, Perez-Ruixo JJ, Rossenu S. Population pharmacokinetics of the rilpivirine long-acting formulation after intramuscular dosing in healthy subjects and people living with HIV. J Antimicrob Chemother. 2021 Sep 12:dkab338. doi: 10.1093/jac/dkab338. Epub ahead of print. PMID: 34510179.

Rich and sparse rilpivirine plasma concentration data were obtained from seven clinical studies. In total, 18 261 rilpivirine samples were collected from 986 subjects (131 healthy subjects from Phase I studies and 855 people living with HIV from Phase IIb/III studies). Doses ranged from 300 to 1200 mg, as single-dose or multiple-dose regimens (every 4 or 8 weeks).

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The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data?

Date: 
6/29/21
Citation: 

Scarsi KK, Swindells S. The Promise of Improved Adherence With Long-Acting Antiretroviral Therapy: What Are the Data? J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211009011. doi: 10.1177/23259582211009011. PMID: 33902356; PMCID: PMC8082990.

As with other chronic conditions, adherence to daily medications remains a challenge for many individuals living with HIV due to structural, behavioral, and social barriers. Unfortunately, high levels of adherence to antiretroviral therapy are required to maintain virologic suppression. Alternative approaches are being explored to decrease the burden of daily pill administration, including long-acting injectable, oral, and implantable products.

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"Lighten This Burden of Ours": Acceptability and Preferences Regarding Injectable Antiretroviral Treatment Among Adults and Youth Living With HIV in Coastal Kenya

Date: 
6/29/21
Citation: 

Simoni JM, Beima-Sofie K, Wanje G, Mohamed ZH, Tapia K, McClelland RS, Ho RJY, Collier AC, Graham SM. "Lighten This Burden of Ours": Acceptability and Preferences Regarding Injectable Antiretroviral Treatment Among Adults and Youth Living With HIV in Coastal Kenya. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:23259582211000517. doi: 10.1177/23259582211000517. PMID: 33685272; PMCID: PMC7952847.

Since 2010, the global scale-up of antiretroviral therapy (ART) has contributed to a 50% decline in global annual deaths from AIDS-related illness, from a peak of 1.9 million in 2005 to 940,000 in 2017, highlighting the importance of ART in reducing morbidity and mortality.1 However, UNAIDS has estimated that only 77% of diagnosed persons living with HIV are accessing ART, and only 82% of patients on ART have suppressed viral loads,2 suggesting there is room for improvement in adherence.

Predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis across three phase 3 studies

Date: 
3/18/21
Citation: 

Cutrell AG, Schapiro JM, Perno CF, Kuritzkes DR, Quercia R, Patel P, Polli JW, Dorey D, Wang Y, Wu S, van Eygen V, Crauwels H, Ford SL, Baker M, Talarico CL, Clair MST, Jeffrey J, White CT, Vanveggel S, Vandermeulen K, Margolis DA, Aboud M, Spreen WR, van Lunzen J. Predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis across three phase 3 studies. AIDS. 2021 Mar 16. doi: 10.1097/QAD.0000000000002883. Epub ahead of print. PMID: 33730748.

Efficacy and safety of long-acting (LA) cabotegravir (CAB) and rilpivirine (RPV) dosed intramuscularly every 4 or 8 weeks has been demonstrated in three Phase 3 trials. Here, factors associated with virologic failure at Week 48 were evaluated post hoc.

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Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study

Date: 
12/9/20
Citation: 

Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, Deltoro MG, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses M, Solingen-Ristea RV, Eygen VV, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study, The Lancet, 2020, ISSN 0140-6736.

Phase 3 clinical studies showed non-inferiority of long-acting intramuscular cabotegravir and rilpivirine dosed every 4 weeks to oral antiretroviral therapy. Important phase 2 results of every 8 weeks dosing, and supportive modelling, underpin further evaluation of every 8 weeks dosing in this trial, which has the potential to offer greater convenience. Our objective was to compare the week 48 antiviral efficacy of cabotegravir plus rilpivirine long-acting dosed every 8 weeks with that of every 4 weeks dosing. 

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Long-Acting Drugs and Formulations for the Treatment and Prevention of HIV

Date: 
11/6/20
Citation: 

Flexner C, Owen A, Siccardi M, Swindells S. Long-Acting Drugs and Formulations for the Treatment and Prevention of HIV, International Journal of Antimicrobial Agents, 2020, 106220,ISSN 0924-8579.

Long acting and extended-release formulations represent one of the most important approaches to improving the treatment and prevention of chronic HIV infection. Long acting small molecules and monoclonal antibodies have demonstrated potent anti-HIV activity in early and late stage clinical trials. Strategies to manage toxicities and falling drug concentrations after missed doses, as well as primary and secondary resistance to current drugs and monoclonal antibodies are important considerations.

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Exploration into the opinions of patients with HIV, healthcare professionals and the lay public of the use of microneedles in clinical practice: highlighting the translational potential for their role in HIV infection

Date: 
9/18/20
Citation: 

Moffatt K, Quinn C, McCague PJ, Donnelly RF. Exploration into the opinions of patients with HIV, healthcare professionals and the lay public of the use of microneedles in clinical practice: highlighting the translational potential for their role in HIV infection. Drug Deliv Transl Res. 2020 Sep 18. doi: 10.1007/s13346-020-00848-8. Epub ahead of print. PMID: 32946042.

Poor adherence to oral antiretroviral therapy (ART) remains an important challenge in the treatment of HIV. Microneedles (MN) potentially could offer a non-invasive long-acting (LA) delivery approach, avoiding the need for daily dosing of ART. However, this claim has yet to be explored amongst its potential end-users. The aim of this mixed methods study was to investigate the perspectives from various end-users surrounding the translation of MN technology to general clinical practice, with a particular focus on delivery of ART. Quantitative postal questionnaires were distributed amongst healthcare professionals (HCPs) and the lay public (LP). A total of 208 responses were obtained (HCP, 69; LP, 139), with a completion rate of 34.7%. The consensus on MN technology was positive from both demographics (HCP, 97.1%; LP, 98.6%), with further strong support of postulated MN use within HIV (HCP, 97.1%; LP, 98.6%). 

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