HIV

Notice of Special Interest (NOSI): Sustained Release of Antivirals for Treatment or Prevention of HIV or Treatment of Latent TB/HBV (SRATP)

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Clinical experience for HIV treatment and prevention has demonstrated that adherence to a drug regimen schedule is a significant factor in the success of the HIV treatment regime and/or prevention strategies. Effective treatment of HIV-infected individuals requires strict adherence to a multi-component regimen of antiretroviral agents taken at least daily for the remainder of a patient’s life. Non-adherence can lead to emergence of drug-resistance and loss of therapeutic effectiveness. Among people living with HIV, morbidity and mortality is increasingly driven by co-infections, such as tuberculosis (TB) and hepatitis B, where the compliance and completion of prolonged multidrug regimens are significant factors in treatment success.

Effective prevention requires that the inhibitor be present at the right time, place, and concentration to stop HIV transmission and acquisition. Although many factors (social, behavioral, and individual preference) can influence adherence, the use of drug delivery systems to provide for a longer therapeutic exposure or window of protection and/or less frequent administration may improve their consistent use, reduce dosing intervals, and potentially improve adherence to the drug regimens.

Development of safe, effective, and well-tolerated sustained release (SR)/long acting (LA) products and strategies that maintain consistent and effective drug levels in plasma and target tissues for longer periods of time is critical for successful treatment and prevention of HIV and HIV-associated co-infections.

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Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV

Grant Source: 

This notice announces the opportunity to apply for funding under the Increasing Uptake of Long-Acting Injectable Antiretrovirals Among People with HIV cooperative agreement Increasing viral suppression and client retention in care are critical components of meeting the goals of the National HIV/AIDS Strategy (2022-2025) and ending the HIV epidemic. In order to reach these goals, it is imperative for HIV care communities to address health care inequities. With the advent of FDA-approved long-acting injectable (LAI) antiretroviral (ARV) medication formulations, initiatives that promote, facilitate, and evaluate the uptake and ongoing utilization of LAI ARV medication may improve clinical outcomes for people with HIV, especially for minority populations who continue to face disparate health care inequities and stigma. This project is designed to develop protocols, implement them and modify as needed, to increase uptake of LAI ARV medications among people of color with HIV, since LAI ARV medications may offer benefits in addressing health inequities and achieving viral suppression.

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Unitaid to introduce new long-lasting injection to prevent HIV in Brazil and South Africa, as high-income countries begin deployment

Date: 
3/18/22

People at risk of HIV in Brazil and South Africa will be among the first to benefit from a highly effective, long-acting injectable HIV preventive treatment through two large-scale operational projects funded by global health agency Unitaid.  

Long-acting cabotegravir is a new HIV prevention method that provides eight weeks of continuous protection against HIV infection through a single intramuscular injection.  

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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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"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.

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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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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