Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

Landovitz, Raphael J.; Donnell, Deborah; Clement, Meredith E.; Hanscom, Brett; Cottle, Leslie; Coelho, Lara E.; Cabello, Robinson; Chariyalertsak, Suwat; Dunne, Eileen F.; Frank, Ian; Gallardo-Cartagena, Jorge A; Gaur, Aditya H.; Gonzáles, Pedro; Tran, Ha V; Hinojosa, Juan; Kallás, Esper G.; Kelley, Colleen F.; Losso, Marcelo; Madruga, José Valdez; Middelkoop, Keren; Phanuphak, Nittaya; Santos, Breno; Sued, Omar; Huamaní, Javier Valencia; Overton, Edgar Turner; Swaminathan, Shobha; Rı́o, Carlos del; Gulick, Roy M.; Richardson, Paul; Sullivan, Philip A.; Piwowar‐Manning, Estelle; Marzinke, Mark A.; Hendrix, Craig W.; Li, Maoji; Wang, Zhe; Marrazzo, Jeanne; Daar, Eric S.; Asmelash, Aida; Brown, Todd T.; Anderson, Peter L.; Eshleman, Susan H.; Bryan, Marcus; Blanchette, Cheryl; Lucas, Jonathan; Psaros, Christina; Safren, Steven A.; Sugarman, Jeremy; Scott, Hyman; Eron, Joseph J.; Fields, Sheldon D.; Sista, Nirupama; Gomez-Feliciano, Kailazarid; Jennings, Andrea; Kofron, Ryan; Holtz, Timothy H.; Shin, Katherine; Rooney, James F.; Smith, Kimberly Y.; Spreen, William; Margolis, David; Rinehart, Alex; Adeyeye, Adeola; Cohen, Myron S.; McCauley, Marybeth; Grinsztejn, Beatriz; Team, Hptn Study

doi:10.1056/nejmoa2101016

Cited by 374 publications

(316 citation statements)

References 28 publications

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“…After efficacy was demonstrated in a nonhuman primate model [ 33 , 34 ], long-acting CAB safety, tolerability and pharmacokinetics were assessed in two phase 2 studies [ 35 ▪ , 36 ]. Recently, results of two phase 3, double-blind studies evaluating long-acting CAB for PrEP were reported (Table 3 ) [ 37 ▪▪ , 38 ▪▪ ].…”

Section: Cabotegravir For Hiv Preventionmentioning

confidence: 99%

“…HPTN-083 compared long-acting CAB administered Q8W compared with daily oral TDF–FTC for the prevention of HIV in at-risk, cisgender MSM and transgender women who have sex with men [ 37 ▪▪ ]. The study was halted due to efficacy at the first preplanned interim end-point analysis.…”

Section: Cabotegravir For Hiv Preventionmentioning

confidence: 99%

“…The frequency of adverse events in HPTN-083 was similar between groups. Serious adverse events were rare (5.3%) and balanced between groups [ 37 ▪▪ ]. ISRs were reported in 81.4% of participants in the long-acting CAB arm and 31.3% of participants in the TDF–FTC arm.…”

Section: Cabotegravir For Hiv Preventionmentioning

confidence: 99%

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A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV

Bares¹,

Scarsi

2021

Current Opinion in HIV and AIDS

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Purpose of review Cabotegravir (CAB) and rilpivirine (RPV) is the first long-acting injectable antiretroviral therapy (ART) option approved for virologically suppressed adults with HIV-1. In addition, long-acting CAB is a promising agent for HIV preexposure prophylaxis (PrEP). This review focuses on phase 3 clinical trial results and implementation considerations for these long-acting ART and PrEP strategies. Recent findings Long-acting CAB and RPV administered every 4 weeks demonstrated noninferiority to oral ART through week 96 in both the ATLAS and FLAIR studies, whereas ATLAS-2M found similar efficacy through 96 weeks when the long-acting injectable ART was administered every 8 weeks instead of every 4 weeks. For prevention, two phase 3 trials were stopped early due to fewer incident HIV infections in participants receiving long-acting CAB every 8 weeks compared with daily oral tenofovir disoproxil fumarate–emtricitabine for PrEP. The long-acting therapies were well tolerated across all clinical trials. Summary Clinical trial results support the use of long-acting CAB for HIV PrEP and long-acting CAB and RPV as a switch strategy for adults with HIV-1 who are first virologically suppressed with oral ART. Implementation challenges persist, and data are urgently needed in populations who may benefit most from long-acting therapy, including adolescents, pregnant individuals, and those with barriers to medication adherence.

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Section: Cabotegravir For Hiv Preventionmentioning

confidence: 99%

Section: Cabotegravir For Hiv Preventionmentioning

confidence: 99%

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A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV

Bares¹,

Scarsi

2021

Current Opinion in HIV and AIDS

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“…Since initial approval by the US Food and Drug Administration (FDA) in 2012 under the brand name Truvada ® , PrEP has also become available as a second formulation under the brand name Descovy ® and in a generic form under the brand name Truvada ® [ 6 , 9 ]. In addition, data from a clinical trial of a long-acting injectable (LAI-PrEP) have been published, though it has not received FDA approval as of September 2021 [ 10 , 11 ]. According to CDC guidelines, MSM who have a sexual partner living with HIV, have a recent bacterial sexually transmitted infection (STI), have multiple sex partners, or have a history of inconsistent or no condom use are potential candidates for PrEP [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

A Scoping Review Investigating Relationships between Depression, Anxiety, and the PrEP Care Continuum in the United States

Miller

Harrison

Sanasi-Bhola

2021

IJERPH

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Men who have sex with men and transgender women in the United States are at increased risk for HIV and may benefit from pre-exposure prophylaxis (PrEP), a once-a-day pill to prevent HIV. Due to stigma and discrimination, sexual and gender minority (SGM) populations are also at risk for depression and anxiety. This scoping review sought to identify literature addressing relationships between the PrEP care continuum, depression, and anxiety among SGM individuals and others at high risk for HIV. We conducted a systematic review of four databases (i.e., PubMed, PsycInfo, Web of Science, Google Scholar) and identified 692 unique articles that were screened for inclusion criteria, with 51 articles meeting the final inclusion criteria. Data were extracted for key study criteria (e.g., geographic location, participant demographics, study design, main findings). Results suggest that while depression and anxiety are not associated with PrEP awareness or willingness to use, they can be barriers to seeking care and to PrEP adherence. However, empirical studies show that taking PrEP is associated with reductions in anxiety. Findings suggest the need to implement mental health screenings in PrEP clinical care. In addition, addressing systemic and structural issues that contribute to mental health disorders, as well as PrEP-related barriers, is critical.

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“…LA CAB, at a dose of 600 mg given IM once every 8 weeks, reduces the need for daily administration and may provide a useful alternative for HIV pre-exposure prophylaxis (PrEP) [ 23 ]. LA CAB was superior to daily oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) in preventing HIV infection among men who have sex with men (MSM) and transgender women who have sex with men.…”

Section: Cabotegravir: Integrase Strand Transfer Inhibitormentioning

confidence: 99%

Long-Acting Injectable Antiretroviral Agents for HIV Treatment and Prevention

Kim

2021

Infect Chemother

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Current oral antiretroviral agents provide highly effective treatment for patients infected with human immunodeficiency virus (HIV), and can be used as pre-exposure prophylaxis (PrEP) to prevent new HIV infections. Several single-tablet regimens with excellent antiviral efficacy have dramatically improved the quality of life of patients who can adhere to daily oral therapy. However, there is increasing demand on long-acting injectable antiretroviral agents for patients who cannot take oral agents or feel fatigue related to daily pill burden. Monthly long-acting (LA) cabotegravir (CAB) combined with rilpivirine (RPV) has recently been listed as optimizing agent for maintenance of HIV suppression in treatment-experienced patients whose viral load is undetectable for 3 to 6 months. Novel agents with different mechanism of action and long half-life extending dosing interval are being tested in phase 2 and 3 clinical trials. This review summarizes the data of efficacies and safety profiles of LA CAB with RPV regimen, and also new long-acting injectable antiretroviral agents in pipeline.

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Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women

Cited by 374 publications

References 28 publications

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV

A Scoping Review Investigating Relationships between Depression, Anxiety, and the PrEP Care Continuum in the United States

Long-Acting Injectable Antiretroviral Agents for HIV Treatment and Prevention

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