Cabotegravir for Prevention of HIV-1 in Women: Results From HPTN 084, a Phase III, Randomised Controlled Trial

Delany‐Moretlwe, Sinead; Böck, Peter; Ouma, Samuel Gurrion; Hunidzarira, Portia; Kalonji, Dishiki; Kayange, Noel; Makhema, Joseph; Mandima, Patricia; Mathew, Carrie; Spooner, Elizabeth; Mpendo, Juliet; Mukwekwerere, Pamela G; Mgodi, Nyaradzo; Ntege, Patricia Nahirya; Nair, Gonasagrie; Nakabiito, Clemensia; Nuwagaba‐Biribonwoha, Harriet; Panchia, Ravindre; Singh, Nishanta; Siziba, Bekezela; Farrior, Jennifer; Rose, Scott; Berhanu, Rebecca; Anderson, Peter L.; Agyei, Yaw; Eshleman, Susan H.; Marzinke, Mark A.; Piwowar‐Manning, Estelle; Hendrix, Craig W.; Asmelash, Aida; Conradie, Francesca; Moorhouse, Michelle; Richardson, Paul; Beigel-Orme, Stephanie; Emel, Lynda; Bokoch, Kevin; White, Rhonda; Hosek, Sybil; Tolley, Elizabeth E.; Sista, Nirupama; Shin, Katherine; Adeyeye, Adeola; Rooney, James F.; Rinehart, Alex; Spreen, William; Smith, Kimberly G.; Hanscom, Brett; Cohen, Myron S.; Hosseinipour, Mina C.

doi:10.2139/ssrn.4066619

Cited by 42 publications

(78 citation statements)

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“…The results indicate 0.20 HIV cases/100 personyears in the cabotegravir group and 1.85 HIV cases/100 person-years in the TDF/FTC group. The absolute risk of cabotegravir reveals to be 1.6% (1.0% to 2.3 %) lower than tenofovir disoproxil fumarate and emtricitabine [6].…”

Section: Injected Prepmentioning

confidence: 85%

Comparison of the effectiveness of different HIV-1 prevention methods, and their mechanisms.

Sawanobori¹

2023

HSET

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HIV is an incurable disease that destroys the body's immune system, resulting in acquired immune deficiencies, or AIDs. The United States, responding to UNAIDS' 90-90-90 project, is greatly focused on reducing the number of HIV-infected patients, and the deaths caused by AIDS. Over the past decade, the number of new HIV cases per year decreased by approximately 11.4% from 2010 to 2018, due to the implementation of new prevention methods. According to the study, US was committed to providing interventions to increase public awareness of HIV, reduce death caused by HIV/AIDS, and retain those diagnosed with HIV in medical care. To achieve such a goal, the prevention of HIV plays a key role. The relevant treatment plan is mainly to control the viral load by intervening in the transcription and replication of the virus through drugs. to maintain the relative number of CD4+ cells. This research, therefore, analyses the mechanism and discusses the effectiveness of the prevailing prevention strategies through availability, effectiveness, efficacy, side effects, and percent of correct usage.

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Section: Injected Prepmentioning

confidence: 85%

Comparison of the effectiveness of different HIV-1 prevention methods, and their mechanisms.

Sawanobori¹

2023

HSET

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“…The Phase III trials that brought CAB‐LA to the market are known as the HIV Prevention Trials Network (HPTN) 083 and 084 trials, which compared CAB‐LA to FTC/TDF 43,44 HPTN 083 compared CAB‐LA and FTC/TDF in cis‐gender men and TGW considered to be at high risk for HIV acquisition 43 . Adherence to CAB‐LA, defined as injections within 2 weeks of a target date, was high with 91.5% person‐years receiving on‐time injections compared with 74.2% in the FTC/TDF arm with an optimal tenofovir plasma concentration.…”

Section: Pre‐exposure Prophylaxismentioning

confidence: 99%

“…There is increasing evidence that INSTIs may be associated with weight gain 45 . At Week 96 in HPTN 083 and HPTN 084, those who received CAB‐LA had gained a median of 2.1 and 4 kg, respectively, compared with 1 and 3 kg, respectively, for those who received FTC/TDF 43,44 . The clinical significance of this weight gain is unclear, and there is less data with CAB‐LA compared with other INSTIs, but clinicians and patients should be aware of the potential for weight gain.…”

Section: Pre‐exposure Prophylaxismentioning

confidence: 99%

“…43 of the superiority of CAB-LA over FTC/TDF. 43,44 The most common adverse effects are injection site reactions (ISRs). In HPTN 083, ISRs, which lasted a median of 4 days, were seen in 81.4% of participants, versus in HPTN 084, ISRs, which lasted a median of 8 days, occurred in 38% of participants.…”

Section: Cab-lamentioning

confidence: 99%

“…During a median follow‐up of 1.4 years, a total of 13 HIV infections occurred in the CAB‐LA group (0.41/100 person‐years) compared with 39 HIV infections in the FTC/TDF group (1.22/100 person‐years), resulting in a 66% lower risk of acquiring HIV infection with CAB‐LA compared with FTC/TDF ( p < 0.001). HPTN 084, conducted in Sub‐Saharan Africa, compared CAB‐LA and FTC/TDF in cis‐gender women considered to be at high risk for HIV acquisition 44 . During a median follow‐up of 1.2 years, a total of four HIV infections occurred in the CAB‐LA group (0.2/100 person‐years) compared with 36 HIV infections in the FTC/TDF group (1.85/100 person‐years), resulting in an 88% lower risk of acquiring HIV infection with CAB‐LA compared with FTC/TDF ( p < 0.0001).…”

Section: Pre‐exposure Prophylaxismentioning

confidence: 99%

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Personalizing prevention: Advances in pharmacotherapy for HIV prevention

et al. 2023

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Population Pharmacokinetics of Cabotegravir Following Oral Administration and Long‐Acting Intramuscular Injection in Real‐World People with HIV

Thoueille,

Saldanha,

Schaller

et al. 2024

Clin Pharma and Therapeutics

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Long‐acting cabotegravir has been studied mainly in the stringent framework of clinical trials, which does not necessarily reflect the situation of people with HIV (PWH) in routine clinical settings. The present population pharmacokinetic analysis aims to build real‐world reference percentile curves of cabotegravir concentrations, accounting for patient‐related factors that may affect cabotegravir exposure. The second objective is to simulate whether dosing interval adjustments of cabotegravir could be considered in specific subpopulations. Overall, 238 PWH contributed to 1,038 cabotegravir levels (186 during the initial oral administration phase and 852 after intramuscular injection). Cabotegravir pharmacokinetics was best described using a one‐compartment model with distinct first order‐absorption for oral and intramuscular administrations, and identical volume and clearance. Our model showed almost 40% faster absorption and 30% higher clearance than previously reported, resulting in a time to steady‐state of 8 months and an elimination half‐life of 4.6 weeks for long‐acting cabotegravir. Sex and body mass index significantly influenced absorption, and bodyweight affected clearance. Model‐based simulations showed that cabotegravir trough concentrations in females were 25% lower 4 weeks after the intramuscular loading dose, but 42% higher during the late maintenance phase. Finally, simulations indicated that in females, despite significantly higher cabotegravir concentrations, longer intervals between injections may not consistently ensure levels above the 4‐fold protein‐adjusted 90% inhibitory target concentration.

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Cabotegravir for Prevention of HIV-1 in Women: Results From HPTN 084, a Phase III, Randomised Controlled Trial

Cited by 42 publications

References 0 publications

Comparison of the effectiveness of different HIV-1 prevention methods, and their mechanisms.

Comparison of the effectiveness of different HIV-1 prevention methods, and their mechanisms.

Personalizing prevention: Advances in pharmacotherapy for HIV prevention

Population Pharmacokinetics of Cabotegravir Following Oral Administration and Long‐Acting Intramuscular Injection in Real‐World People with HIV

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