Cabotegravir Long-Acting Injectable for PrEP Treatment Overview
The content discusses the potential benefits of cabotegravir, a long-acting injectable for HIV Pre-exposure prophylaxis (PrEP), as compared to current options like daily oral TDF-FTC. It covers the safety, efficacy, and objective comparison studies of cabotegravir in high-risk populations.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Cabotegravir long-acting injectable for PrEP treatment Amber Lee, OSU PharmD candidate 2022 November 29th, 2021
Objectives Overview HIV and current PrEP treatment options Discuss new possible PrEP long-acting injectable: cabotegravir Discuss the safety and efficacy of cabotegravir for PrEP compared to current treatment options using primary literature
Background The number of new HIV infections worldwide exceeds 5000 per day Pre-exposure prophylaxis (PrEP) decreases the risk of getting HIV from sex by ~99% Current PrEP treatment include daily oral tenofovir/emtricitabine (TDF-FTC) Efficacy is directly correlated to adherence A long-acting injectable such as cabotegravir will be beneficial to increase adherence, therefore reducing the risk of HIV transmission
Cabotegravir (long-acting injectable) Integrase strand-transfer inhibitor (INSTI) Potent anti-HIV activity Generally safe without toxic effects in humans FDA approved drug - Cabenuva (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL) Once a month injection for HIV-infected adults Oral rilpivirine and oral cabotegravir to be used 1 month before starting
Objective To compare the safety and efficacy of CAB-LA, administered intramuscularly every 8 weeks, with daily oral TDF FTC in cisgender men who have sex with men (MSM) and in transgender women who have sex with men in the United States, Latin America, Asia, and Africa
Methods Study design Phase 2b-3 Randomized Double-blinded Double-dummy Non-inferiority 4570 HIV-negative, high-risk cisgender men and transgender women who have sex with men 6333 participants were screened at 43 sites in the United States, Latin America, Asia, and Africa 4570 went through randomization and enrolled, 4 were ineligible 4566 participants
Methods Interventions Participants were randomized in a 1:1 ratio into 2 groups: TDF-FTC group Cabotegravir group Three phases: Oral-tablet lead-in phase Injection phase Tail phase Study length: December 6, 2016-March 16, 2020 Intention to treat: 4566 participants
Patient Population Inclusion criteria Cisgender MSM and transgender women who have sex with men ( 18 years of age) in generally good health Negative HIV serologic test at enrollment Undetectable blood HIV RNA viral load within 14 days before trial entry CrCl 60 mL/min Exclusion criteria Use of illicit intravenous drugs within 90 days before enrollment Previous participation in the active treatment group of an HIV vaccine trial Coagulopathy Buttock implants or fillers Seizure disorder or a corrected QT interval of greater than 500 msec Positive results on a hepatitis B virus surface antigen test or hepatitis C virus antibody test
Outcomes Primary endpoint: Incident HIV infection Primary safety endpoint: Occurrence of an adverse event of grade 2 or higher Severity graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1
Statistical Analysis Non-inferiority margin: hazard ratio of 1.23 To achieve 90% power to detect an alternative hazard ratio of 0.75 (at a one-sided type I error rate of 0.025), 172 incident HIV infections would need to occur Assumed an incidence of 1.75 events per 100 person-years enrolled approximately 4500 participants
Discussion CAB-LA was superior to TDF FTC in preventing HIV among MSM and transgender women who have sex with men Risk of HIV infection was lower by 66% in the cabotegravir group than in the TDF FTC group
Strengths Studies done in many countries Included participants that have lower reported rates of adherence and broad age ranges Studies done in high-risk population Double-blinded, double-dummy
Limitations Studies only done in cisgender men and transgender women Partially funded by ViiV Healthcare, the manufacturer of Cabenuva (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL)
Conclusion Long-acting cabotegravir injectable is a safe and effective strategy for the prevention of HIV infection that will expand PrEP options Logistics involving implementation will have to be considered Something to think about: the role of community pharmacists in regards to administering this drug
References Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women. N Engl J Med. 2021 Aug 12;385(7):595-608. doi: 10.1056/NEJMoa2101016. PMID: 34379922; PMCID: PMC8448593. Cdc.gov. 2021. Pre-Exposure Prophylaxis (PrEP) | HIV Risk and Prevention | HIV/AIDS | CDC. [online] Available at: <https://www.cdc.gov/hiv/risk/prep/index.html> [Accessed 18 November 2021]. CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended- release injectable suspension) [package insert]. Research Triangle Park, NC; ViiV Healthcare; 2021. Fletcher C. Human immunodeficiency virus infection. In: DiPiro JT, Talbert RL, Yee G, et al, eds. Pharmacotherapy: A Pathophysiologic Approach. 9th ed. New York, NY: McGraw-Hill Education; 2014:2034.
