Cabotegravir/rilpivirine injection for HIV-infected patient treatment

Main Article Content

Pornpen Leuvittawat

Abstract

Long-acting (LA) intramuscular (IM) Cabotegravir (CAB) and Rilpivirine (RPV) extended-release sterile injections were approved in The United States of America in 2021 for the treatment of HIV patients who were virological suppressed adults (HIV-1 RNA < 50 copies/ml), of 18 years or older, with no history of treatment failure, and with no known or resistance to cabotegravir or rilpivirine. Intramuscular administration of cabotegravir and rilpivirine leads to differences in pharmacokinetic property compared to conventional oral antiretroviral therapy. The difference is the long elimination half-life with intramuscular administration, which is more than 5 weeks of time, allowing it to be given monthly or every-two-months for the treatment of HIV. LA IM CAB/RPV are considered as an alternative choice for treating HIV especially patients with medication nonadherence. According to the clinical studies, the efficacy of LA IM CAB/RPV was noninferior to standard oral therapy for maintaining HIV-1 suppression. Injection site reactions were the most adverse event in using IM CAB/RPV e.g., pain, red and swelling, and pruritus. Cost-effectiveness analysis of IM CAB/RPV versus standard oral ART in the treatment HIV-1 summarized that IM CAB/RPV was more cost-effective, however the cost-effectiveness is still unclear because of the few studies.

Article Details

Section
Review Article

References

Beyea SC and Nicoll LH. Injection technique 1: administration of medication via the intramuscular route [Online]. 2022 Aug 18 [cited 2018 July 23] Available from; https://www.nursingtimes.net/clinical-archive/assessment-skills/injection-technique-1-administering-drugs-via-the-intramuscular-route-23-07-2018.

Department of Disease Control. Thailand National Guidelines on HIV/AIDS Diagnosis, Treatment and Prevention 2020/2021 [Online]. 2021 Dec 1 [cited 2022 Jan 25] Available from; http://www.thaiaidssociety.org/index.php?option=com_content&view=article&id=79&Itemid=86.

Department of Health and Human Services. DHHS Adults and Adolescents Antiretroviral Guidelines Panel Recommendation for the Long-Acting Injectable Antiretroviral Regimen of Cabotegravir and Rilpivirine. US Department of Health and Human Services [Online]. 2021 June 3 [cited 2022 May 4]. Available from; https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultARV_GL_ID_2021_CabRpv.pdf.

Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV [Online]. 2022 Jan 20 [cited 2022 April 25]. Available from; https://clinicalinfo.hiv.gov/sites/default/files/guidelineds/documents/AdultandAdolescentGL.pdf.

Ford SL, Lou Y, Lewis N, et al. Effect of rifabutin on the pharmacokinetics of oral cabotegravir in healthy subjects. Antivir Ther 2019; 24(4): 301-308.

Ford SL, Sutton K, Lou Y, et al. Effect of rifampin on the single-dose pharmacokinetics of oral cabotegravir in healthy subjects. Antimicrob Agents Chemother 2017; 61(10): e487-e517.

HIV info HUB. AIDS Epidemic Model [Online]. 2021 April 19 [cited 2021 Dec 20]. Available from; https://hivhub.ddc.moph.go.th/index.php.

Hodge D, Back DJ, Gibbons S, et al. Pharmacokinetics and drug-drug interactions of long-acting intramuscular cabotegravir and rilpivirine. Clin Pharmacokinet 2021; 60(7): 835-853.

Howe ZW, Norman S, Lueken AF, et al. Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. Pharmacotherapy 2021; 41: 686-699.

Janssen Therapeutics, Division of Janssen Products. U.S.FDA approves streamlined process for initiating HIV therapy with CABENUVA (cabotegravir and rilpivirine), the first and only complete long-acting injectable HIV treatment [Online] 2022 March 4 [cited 2022 April 27]. Available from; https://www.jnj.com/u-s-fda-approves-streamlined-process-for-initiating-hiv-therapy-with-cabenuva-cabotegravir-and-rilpivirine-the-first-and-only-complete-long-acting-injectable-hiv-treatment.

Margolis DA, Gonzalez-Garcia J, Stellbrink HK, et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomized, open-label, phase 2b, non-inferiority trial. Lancet 2017; 390(10101): 1499-1510.

Nachega JB, Marconi VC. Gert UVZ, et al. HIV Treatment Adherence, Drug Resistance, Virologic Failure: Evolving Concepts. Infect Disord Drug Targets 2011; 11(2): 167-174.

Orkin C, Arsteh K, Hernandez-Mora MG, et al. Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 infection. N Engl J Med 2020; 382: 1124-1135.

Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HiV-1 infection (ATLAS-2M), 48-week results: a randomize, multicenter, open-label, phase 3b, non-inferiority study. Lancet 2020; 396: 1994-2005.

Parker B, Ward T, Hayward O, et al. Cost-effectiveness of the long-acting regimen cabotegravir plus rilpivirine for the treatment of HIV-1 and its potential impact on adherence and viral transmission: A modelling study. PLoS One 2021; 16(2): e0245955.

Sonthisombat P. Pharmacotherapy in HIV patients. In: Montakantikul P, Sonthisombat P, Wimonsarawong N, editors. Guidelines for the use of antiretroviral agents in adults and adolescents. 2nd ed. Bangkok: The Prachachon; 2007. 51-156.

Swindells S, Andrade-Villnueva J-F, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med 2020; 382: 1112-1123.

U.S.FDA. FDA Approves Cabenuva and Vocabria for the Treatment of HIV-1 infection [Online]. 2021 Jan 27 [cited 2022 April 24]. Available from; https://www.fda.gov/drugs/human-immunodeficiency-virus-hiv/fda-approves-cabenuva-and-vocabria-treatment-hiv-1-infection.

ViiV Healthcare Inc. Cabenuva [package insert]. Brentford, United Kingdom: ViiV Healthcare Inc; 2022.

ViiV Healthcare. ViiV Healthcare announces US FDA approval of CABENUVA (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35 kg. [Onlin]. 2022 Feb 1 [cited 2022 April 24]. https://viivhealthcare.com/en-us/media-center/news/press-eleases/2022/march/viiv-healthcare-announces-us-fda-approval-of-cabenuva/.