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hiv long acting injectable

Ameya R Kirtane, Robert Langer, Giovanni Traverso
The human immunodeficiency virus has infected millions of people and the epidemic continues to grow rapidly in some parts of the world. Antiretroviral (ARV) therapy has provided improved treatment and prolonged the life expectancy of patients. Moreover, there is growing interest in using ARVs to protect against new infections. Hence, ARVs have emerged as our primary strategy in combating the virus. Unfortunately, several challenges limit the optimal performance of these drugs. First, ARVs often require life-long use and complex dosing regimens...
October 19, 2016: Journal of Pharmaceutical Sciences
George J Greene, Greg Swann, Angela J Fought, Alex Carballo-Diéguez, Thomas J Hope, Patrick F Kiser, Brian Mustanski, Richard T D'Aquila
HIV prevention method preferences were evaluated among 512 U.S. men who have sex with men (MSM; median age: 22 years). Approximately 90 % consistently preferred one option across pairwise comparisons of condoms, daily oral pre-exposure prophylaxis (PrEP), and long-acting PrEP delivered via either an injectable or one of two types of PrEP implants differing in visibility. Condoms were most frequently preferred (33.8 %), followed by non-visible implants (21.5 %), and oral PrEP (17.0 %); HIV risk was reported by more choosing implants...
October 21, 2016: AIDS and Behavior
Robert L Glaubius, Urvi M Parikh, Greg Hood, Kerri J Penrose, Eran Bendavid, John W Mellors, Ume L Abbas
Background.  A long-acting injectable formulation of rilpivirine (RPV), under investigation as antiretroviral pre-exposure prophylaxis (PrEP), may facilitate PrEP adherence. In contrast, cross-resistance between RPV and nonnucleoside reverse-transcriptase inhibitors comprising first-line antiretroviral therapy (ART) could promote human immunodeficiency virus (HIV) drug resistance and reduce PrEP's effectiveness. Methods.  We use novel mathematical modeling of different RPV PrEP scale-up strategies in KwaZulu-Natal, South Africa, to investigate their effects on HIV prevention and drug resistance, compared with a reference scenario without PrEP...
September 2016: Open Forum Infectious Diseases
Ian McGowan, Charlene S Dezzutti, Aaron Siegel, Jarret Engstrom, Alexiy Nikiforov, Kathryn Duffill, Cory Shetler, Nicola Richardson-Harman, Kaleab Abebe, David Back, Laura Else, Deidre Egan, Saye Khoo, James E Egan, Ronald Stall, Peter E Williams, Khaleel K Rehman, Amy Adler, Rhonda M Brand, Beatrice Chen, Sharon Achilles, Ross D Cranston
BACKGROUND: Long-acting injectable antiretroviral agents are being developed for HIV-1 prevention. The MWRI-01 study was done to characterise the safety, acceptability, and pharmacokinetic and pharmacodynamic profile of long-acting rilpivirine. METHODS: We did a phase 1 open-label study at the University of Pittsburgh. We enrolled healthy individuals (aged 18-45 years) who were seronegative for HIV-1. Participants were assigned alternately one intramuscular dose of either 1200 mg or 600 mg long-acting rilpivirine, beginning with the 1200 mg dose...
September 16, 2016: Lancet HIV
Catherine E Oldenburg, Bao Le, Hoang Thi Huyen, Dinh Duc Thien, Nguyen Hoang Quan, Katie B Biello, Amy Nunn, Philip A Chan, Kenneth H Mayer, Matthew J Mimiaga, Donn Colby
Background: The HIV/AIDS epidemic in Vietnam is concentrated in subgroups of the population, including men who have sex with men (MSM). Pre-exposure prophylaxis (PrEP) is a viable strategy for HIV prevention, but knowledge about and preferences for PrEP delivery among Vietnamese MSM are not well understood. Methods: In 2015, an online survey was conducted with recruitment via social networking websites for MSM and peer recruitment. A description of daily oral, long-acting injectable, and rectal microbicide formulations of PrEP was provided to participants...
July 22, 2016: Sexual Health
Barbara S Taylor, Susan A Olender, Hong-Van Tieu, Timothy J Wilkin
The 2016 Conference on Retroviruses and Opportunistic Infections highlighted exciting advances in antiretroviral therapy, including important data on investigational antiretroviral drugs and clinical trials. Clinical trials demonstrated benefits from a long-acting injectable coformulation given as maintenance therapy, examined intravenous and subcutaneous administration of a monoclonal antibody directed at the CD4 binding site of HIV-1, and provided novel data on tenofovir alafenamide. Several studies focused on the role of HIV drug resistance, including the significance of minority variants, transmitted drug resistance, use of resistance testing, and drug class-related resistance...
May 2016: Topics in Antiviral Medicine
Susan P Buchbinder, Albert Y Liu
The 2016 Conference on Retroviruses and Opportunistic Infections (CROI) highlighted hot spots in HIV infection. Men who have sex with men (MSM), transgender populations, people who inject drugs, fisherfolk, migrants, adolescents, and older adults are heavily impacted in a number of regions. Stigma contributes to risk behaviors and HIV acquisition across populations. HIV testing is a crucial first step in the HIV care continuum, and several large community-based surveys are underway in Africa to increase HIV testing, linkage to care, and uptake of antiretroviral treatment...
May 2016: Topics in Antiviral Medicine
Jennifer A Smith, Sarah-Jane Anderson, Kate L Harris, Jessica B McGillen, Edward Lee, Geoff P Garnett, Timothy B Hallett
BACKGROUND: Many ways of preventing HIV infection have been proposed and more are being developed. We sought to construct a strategic approach to HIV prevention that would use limited resources to achieve the greatest possible prevention impact through the use of interventions available today and in the coming years. METHODS: We developed a deterministic compartmental model of heterosexual HIV transmission in South Africa and formed assumptions about the costs and effects of a range of interventions, encompassing the further scale-up of existing interventions (promoting condom use, male circumcision, early antiretroviral therapy [ART] initiation for all [including increased HIV testing and counselling activities], and oral pre-exposure prophylaxis [PrEP]), the introduction of new interventions in the medium term (offering intravaginal rings, long-acting injectable antiretroviral drugs) and long term (vaccine, broadly neutralising antibodies [bNAbs])...
July 2016: Lancet HIV
Matthew Quaife, Robyn Eakle, Maria Cabrera, Peter Vickerman, Motlalepule Tsepe, Fiona Cianci, Sinead Delany-Moretlwe, Fern Terris-Prestholt
INTRODUCTION: For the past few decades, condoms have been the main method of HIV prevention. Recent advances in antiretroviral (ARV)-based prevention products have substantially changed the prevention landscape, yet little is known about how popular these products will be among potential users, or whether new methods might be used in conjunction with, or instead of, condoms. This study will use a discrete choice experiment (DCE) to (1) explore potential users' preferences regarding HIV prevention products, (2) quantify the importance of product attributes and (3) predict the uptake of products to inform estimates of their potential impact on the HIV epidemic in South Africa...
2016: BMJ Open
Robert L Glaubius, Greg Hood, Kerri J Penrose, Urvi M Parikh, John W Mellors, Eran Bendavid, Ume L Abbas
BACKGROUND: Long-acting injectable antiretrovirals such as rilpivirine (RPV) could promote adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) prevention. However, the cost-effectiveness of injectable PrEP is unclear. METHODS: We constructed a dynamic model of the heterosexual HIV epidemic in KwaZulu-Natal, South Africa, and analyzed scenarios of RPV PrEP scale-up for combination HIV prevention in comparison with a reference scenario without PrEP...
August 15, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Michael A Collier, Matthew D Gallovic, Eric M Bachelder, Craig D Sykes, Angela Kashuba, Kristy M Ainslie
PURPOSE: Since the adoption of highly active antiretroviral therapy, HIV disease progression has slowed across the world; however, patients are often required to take multiple medications daily of poorly bioavailable drugs via the oral route, leading to gastrointestinal irritation. Recently, long acting antiretroviral injectables that deliver drug for months at a time have moved into late phase clinical trials. Unfortunately, these solid phase crystal formulations have inherent drawbacks in potential dose dumping and a greater likelihood for burst release of drug compared to polymeric formulations...
August 2016: Pharmaceutical Research
G Justus Hofmeyr, Mandisa Singata-Madliki, Theresa A Lawrie, Eduardo Bergel, Marleen Temmerman
BACKGROUND: The copper intrauterine device (IUD) is under-utilised in South Africa, where injectable progestin contraception (IPC) dominates contraception usage. There is a lack of robust comparative data on these contraceptive options to inform policy, programs, clinical counseling, and women's choices. METHODS: Within the context of a South African program to increase women's access to the IUD, we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial of the IUD versus IPC at two South African hospitals...
2016: Reproductive Health
Tomas Cihlar, Marshall Fordyce
Current antiviral treatments can reduce HIV-associated morbidity, prolong survival, and prevent HIV transmission. Combination antiretroviral therapy (cART) containing preferably three active drugs from two or more classes is required for durable virologic suppression. Regimen selection is based on virologic efficacy, potential for adverse effects, pill burden and dosing frequency, drug-drug interaction potential, resistance test results, comorbid conditions, social status, and cost. With prolonged virologic suppression, improved clinical outcomes, and longer survival, patients will be exposed to antiretroviral agents for decades...
June 2016: Current Opinion in Virology
Martina Kovarova, Michael D Swanson, Rosa I Sanchez, Caroline E Baker, Justin Steve, Rae Ann Spagnuolo, Bonnie J Howell, Daria J Hazuda, J Victor Garcia
OBJECTIVES: Pre-exposure prophylaxis (PrEP) using antiretroviral drugs (ARVs) has been shown to reduce HIV transmission in people at high risk of HIV infection. Adherence to PrEP strongly correlates with the level of HIV protection. Long-acting injectable ARVs provide sustained systemic drug exposures over many weeks and can improve adherence due to infrequent parenteral administration. Here, we evaluated a new long-acting formulation of raltegravir for prevention of vaginal HIV transmission...
June 2016: Journal of Antimicrobial Chemotherapy
Jeffrey T Parsons, H Jonathon Rendina, Thomas H F Whitfield, Christian Grov
We sought to determine preferences for oral versus long-acting injectable (LAI) PrEP among gay and bisexual men (GBM). We surveyed a national U.S. sample of 1071 GBM about forms of PrEP. LAI PrEP was found to be acceptable among 43.2 % of men when injected monthly compared with 53.6 % of men when injected every 3 months. When asked to choose between forms of PrEP, 46.0 % preferred LAI, 14.3 % oral, 21.7 % whichever was most effective, 10.1 % had no preference, and 7.8 % would not take PrEP. There were no differences in PrEP preferences by race/ethnicity, income, region of residence, or relationship status...
July 2016: AIDS and Behavior
Andrew Owen, Steve Rannard
Advances in solid drug nanoparticle technologies have resulted in a number of long-acting (LA) formulations with the potential for once monthly or longer administration. Such formulations offer great utility for chronic diseases, particularly when a lack of medication compliance may be detrimental to treatment response. Two such formulations are in clinical development for HIV but the concept of LA delivery has its origins in indications such as schizophrenia and contraception. Many terms have been utilised to describe the LA approach and standardisation would be beneficial...
August 1, 2016: Advanced Drug Delivery Reviews
Charlene S Dezzutti, Laura J Else, Sarah E Yandura, Cory Shetler, Julie Russo, David J Back, Ian McGowan
A long-acting injectable form of rilpivirine (RPV) is being evaluated in clinical trials for the prevention of HIV infection. Preclinical testing was undertaken to define RPV pharmacokinetic (PK) and pharmacodynamic (PD) activities in ectocervical and colonic tissue treated in vitro Tenfold dilutions of RPV were added to the basolateral medium of polarized ectocervical and colonic explant tissues. To half the explants, HIV-1BaL was applied to the apical tissue surface. After culture overnight, all the explants were washed and the RPV in the explants not exposed to HIV was quantified using a validated liquid chromatography-mass spectrometry assay...
May 2016: Antimicrobial Agents and Chemotherapy
Raphael J Landovitz, Beatriz Grinsztejn
No abstract text is available yet for this article.
May 15, 2016: Journal of Infectious Diseases
Rochelle P Walensky, Margo M Jacobsen, Linda-Gail Bekker, Robert A Parker, Robin Wood, Stephen C Resch, N Kaye Horstman, Kenneth A Freedberg, A David Paltiel
BACKGROUND: For young South African women at risk for human immunodeficiency virus (HIV) infection, preexposure prophylaxis (PrEP) is one of the few effective prevention options available. Long-acting injectable PrEP, which is in development, may be associated with greater adherence, compared with that for existing standard oral PrEP formulations, but its likely clinical benefits and additional costs are unknown. METHODS: Using a computer simulation, we compared the following 3 PrEP strategies: no PrEP, standard PrEP (effectiveness, 62%; cost per patient, $150/year), and long-acting PrEP (effectiveness, 75%; cost per patient, $220/year) in South African women at high risk for HIV infection (incidence of HIV infection, 5%/year)...
May 15, 2016: Journal of Infectious Diseases
Raphael J Landovitz, Ryan Kofron, Marybeth McCauley
PURPOSE OF REVIEW: Preexposure prophylaxis for HIV prevention is highly effective when taken as prescribed. Adherence to required dosing regimens for protection may pose challenges. Long-acting agents for HIV prevention may have the potential to improve adherence via favorable pharmacokinetics supportive of infrequent dosing. This review focuses on the potential benefits and considerations for the study and use of 2 long-acting injectable agents, cabotegravir (GSK1265744LA, CAB LA) and rilpivirine (TMC278LA, RPV LA), for use as chemoprophylaxis for HIV prevention...
January 2016: Current Opinion in HIV and AIDS
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