Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy and Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.
Get full access to this article
View all access options for this article.
References
1.
Cabenuva (cabotegravir and rilpivirine) [prescribing information]. ViiV Healthcare;2021.
KerriganDMantsiosAGorgolasM, et al. Experiences with long acting injectable ART: a qualitative study among PLHIV participating in a phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018;13(1):e0190487. doi:10.1371/journal.pone.0190487
4.
MeyersKRodriguezKBrillAL, et al. Lessons for patient education around long-acting injectable PrEP: findings from a mixed-method study of phase II trial participants. AIDS Behav. 2018;22(4):1209-1216. doi:10.1007/s10461-017-1871-x
5.
MurrayMIMarkowitzMFrankI, et al. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: patient perspectives from the ELCAIR trial. HIV Clin Trials. 2018;19(4):129-138. doi:10.1080/15284336.2018.1511346
6.
MurrayMPulidoFMillsA, et al. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019;20(4-5):111-122. doi:10.1080/25787489.2019.1661696
BowersGDCulpAReeseMJ, et al. Disposition and metabolism of cabotegravir: a comparison of biotransformation and excretion between different species and routes of administration in humans. Xenobiotica. 2016;46(2):147-162. doi:10.3109/00498254.2015.1060372
10.
SpreenWWilliamsPMargolisD, et al. Pharmacokinetics, safety, and tolerability with repeat doses of GSK1265744 and rilpivirine (TMC278) long-acting nanosuspensions in healthy adults. J Acquir Immune Defic Syndr. 2014;67(5):487-492. doi:10.1097/QAI.0000000000000365
LouYBuchananAMChenS, et al. Effect of cabotegravir on cardiac repolarization in healthy subjects. Clin Pharmacol Drug Dev. 2016;5(6):509-516. doi:10.1002/cpdd.272
13.
LandovitzRJLiSGrinsztejnB, et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018;15(11):e1002690. doi:10.1371/journal.pmed.1002690
14.
National Institute of Allergy and Infectious Diseases. Evaluating the safety and efficacy of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women. ClinicalTrials.gov identifier: NCT03164564. Updated August 4, 2020. Accessed February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT03164564
15.
National Institute of Allergy and Infectious Diseases. Safety, tolerability and acceptability of long-acting injectable cabotegravir (CAB LA) for the prevention of HIV among adolescent males – a sub-study of HPTN 083. ClinicalTrials.gov identifier: NCT04692077. Updated December 31, 2020. Accessed February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04692077
16.
MarkowitzMFrankIGrantRM, et al. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ÉCLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial. Lancet HIV. 2017;4(8):e331-e340. doi:10.1016/S2352-3018(17)30068-1
17.
PatelPFordSLLouY, et al. Effect of a high-fat meal on the pharmacokinetics of the HIV integrase inhibitor cabotegravir. Clin Pharmacol Drug Dev. 2019;8(4):443-448. doi:10.1002/cpdd.620
18.
SpreenWFordSLChenS, et al. GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects. J Acquir Immune Defic Syndr. 2014;67(5):481-486. doi:10.1097/QAI.0000000000000301
19.
PatelPXueZKingKS, et al. Evaluation of the effect of UGT1A1 polymorphisms on the pharmacokinetics of oral and long-acting injectable cabotegravir. J Antimicrob Chemother. 2020;75(8):2240-2248. doi:10.1093/jac/dkaa147
20.
LandovitzRJLiSEronJJJr, et al. Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial. Lancet HIV. 2020;7(7):e472-e481. doi:10.1016/S2352-3018(20)30106-5
21.
ShaikJSBFordSLLouY, et al. A phase 1 study to evaluate the pharmacokinetics and safety of cabotegravir in patients with hepatic impairment and healthy matched controls. Clin Pharmacol Drug Dev. 2019;8(5):664-673. doi:10.1002/cpdd.655
22.
ParasrampuriaRFordSLLouY, et al. A phase I study to evaluate the pharmacokinetics and safety of cabotegravir in adults with severe renal impairment and healthy matched control participants. Clin Pharmacol Drug Dev. 2019;8(5):674-681. doi:10.1002/cpdd.664
OrkinCArastehKGórgolas Hernández-MoraM, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. 2020;382(12):1124-1135. doi:10.1056/NEJMoa1909512 PMID: 32130806
25.
MargolisDAGonzalez-GarciaJStellbrinkHJ, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017;390(10101):1499-1510. doi:10.1016/S0140-6736(17)31917-7
26.
MargolisDABrinsonCCSmithGHR, et al. Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Lancet Infect Dis. 2015;15(10):1145-1155. doi:10.1016/S1473-3099(15)00152-8
27.
SwindellsSAndrade-VillanuevaJFRichmondGJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020;382(12):1112-1123. doi:10.1056/NEJMoa1904398
28.
MurrayMAntelaAMillsA, et al. Patient-reported outcomes in ATLAS and FLAIR participants on long-acting regimens of cabotegravir and rilpivirine over 48 weeks. AIDS Behav. 2020;24(12):3533-3544. doi:10.1007/s10461-020-02929-8
29.
National Institute of Allergy and Infectious Diseases. The LATITUDE study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE. ClinicalTrials.gov identifier: NCT03635788. Updated July 28, 2020. Accessed February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT03635788
30.
ViiV Healthcare. A study to evaluate efficacy and safety of cabotegravir (CAB) long acting (LA) plus (+) rilpivirine (RPV) LA versus Biktarvy (BIK) in participants with human immunodeficiency virus (HIV)-1 who are virologically suppressed (SOLAR). ClinicalTrials.gov identifier: NCT04542070. Updated January 27, 2021. Accessed February 11, 2021. https://clinicaltrials.gov/ct2/show/NCT04542070
31.
OvertonETRichmondGRizzardiniG, et al. 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. Lancet. 2020;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
TrezzaCFordSLGouldE, et al. Lack of effect of oral cabotegravir on the pharmacokinetics of a levonorgestrel/ethinyl oestradiol-containing oral contraceptive in healthy adult women. Br J Clin Pharmacol. 2017;83(7):1499-1505. doi:10.1111/bcp.13236
