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Special Populations Including End Organ Failure: Focus on Long-Acting Cabotegravir and Rilpivirine
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International Workshop on Clinical Pharmacology of HIV, Hepatitis and Other Antiviral Drugs, September 20-22, 2021
Parul Patel, PharmD
Global Medical Affairs Director, Cabotegravir
ViiV Healthcare, Research Triangle Park, NC, United States
*HIV-1 RNA <50 copies/mL at Week 48 for selected subpopulations per the FDA Snapshot algorithm. 391/1636 participants rolled over from ATLAS into ATLAS-2M with prior CAB exposure and were included in both counts.3-5
BMI, body mass index; FDA, U.S. Food and Drug Administration; INSTI, integrase strand transfer inhibitor; LA, long-acting; NNRTI, non-nucleoside reverse transcriptase inhibitor; PK, pharmacokinetic; PLWH, people living with HIV.
1. U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. 2021. Available from:
https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/15/virologic-failure. Accessed August 2021. .
2. Saag MS, et al. JAMA. 2020;324(16):1651-1669. 3. Swindells S, et al. N Engl J Med. 2020;382(12):1112-1123. 4. Orkin C, et al. N Engl J Med. 2020;382(12):1124-1135. 5. Overton ET, et al. Lancet. 2020;396(10267):1994-2005
*CYP3A4, CYP3A5, CYP2C19, UGT1A1, and UGT1A4.
CAB, cabotegravir; LA, long-acting; PK, pharmacokinetic; PLWH, people living with HIV; Q4W, every 4 weeks; Q8W, every 8 weeks; RPV, rilpivirine.
1. Parasrampuria R, et al. Clin Pharmacol Drug Dev. 2019;8(5):674-681. 2. Janssen Therapeutics. Edurant® (rilpivirine) prescribing information. Available from:
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/EDURANT-pi.pdf. .
Accessed August 2021. 3. Shaik JSB, et al. Clin Pharmacol Drug Dev. 2019;8(5):664-673. 4. Patel P, et al. J Antimicrob Chemother. 2020;75(8):2240-2248. 5. Aouri M, et al. Antimicrob Agents Chemother. 2016;61(1):e00899-16.
6. Xue Z, et al. ID Week 2018; October 3-7, 2018; San Francisco, CA. Poster 552.
CAB, cabotegravir; CI, confidence interval; Cmax, peak concentration; Cmin, minimum concentration; IM, intramuscular; LA, long-acting; PA-IC90, protein binding-adjusted 90% inhibitory concentration; PK, pharmacokinetic; PO, by mouth; Q4W, every 4 weeks; QD, once-daily;
RPV, rilpivirine; WK, week.
BMI, body mass index; CAB, cabotegravir; IM, intramuscular; LA, long-acting; PI, prediction interval; PK, pharmacokinetic; PrEP, pre-exposure prophylaxis; RPV, rilpivirine; WT, weight.
1. Patel P, et al. Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Poster 3718.
2. Crauwels H, et al. 11th International Workshop on HIV & Women; April 26-28, 2021; Virtual. Poster 14.
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