Long-Acting Cabotegravir for HIV Prevention

Abstract

On December 20, 2021, the US Food and Drug Administration (FDA) approved long-acting cabotegravir, the first injectable medication to prevent HIV. Two randomized clinical trials that together included 7790 study participants demonstrated that long-acting cabotegravir was more likely to prevent HIV acquisition than daily oral medication for people at risk of sexually acquiring HIV, including men who have sex with men, heterosexual women, and transwomen. 1 The advantage of the medication was attributed partly to the high efficacy of this and other integrase inhibitors and, in part, to better adherence for an injection compared with a once-daily pill regimen; whether this advantage remains outside of clinical trials remains unknown. It is hoped that this new tool for HIV prevention will accelerate progress toward the US goal of reducing new infections by 90% by 2030. However, the potential for public health benefit is jeopardized by the cost and complexity of the US health care system.The manufacturer of cabotegravir (ViiV Healthcare) set the initial list price for the long-acting drug at $3700 per dose. 2 Therefore, the required 2 doses in the first month and subsequent dosing every other month will cost $22 200 per year. At this price, public and private Policy innovation is necessary for the US to realize the promise of long-acting cabotegravir and future medical advances for HIV prevention.

Relative cost-effectiveness of long-acting injectable cabotegravir versus oral pre-exposure prophylaxis in South Africa based on the HPTN 083 and HPTN 084 trials: a modelled economic evaluation and threshold analysis

“…By contrast, long-acting injectable cabotegravir, as a recently developed drug, is protected under patent laws until 2031, and is currently sold at $22 200 per year in the USA, more than 200 times the threshold price identified in this analysis. 23 Even given the uncertainty in our analysis, it is clear that unless dramatic price reductions occur, long-acting injectable cabotegravir will not be an option for HIV prevention for those at highest risk of HIV in low-income and middle-income countries. Options for these price reductions include the recently agreed voluntary licences through the Medicines Patent Pool, a buy-down similar to that establishing a market for HIV self-testing, or a combination of these factors.…”

“…Long-acting injectable cabotegravir: informed by acceptability and preference studies 19 , 22 , 23 Medium coverage ·· 15% (FSW, MSM); 5% (AGYW, ABYM) 25% (FSW, MSM); 20% (AGYW); 10% (ABYM) 40% (FSW, MSM); 35% (AGYW); 20% (ABYM) Tenofovir disoproxil fumarate and emtricitabine: PrEP implementation data from South African National Department of Health. Long-acting injectable cabotegravir: informed by acceptability and preference studies 19 , 22 , 23 Duration in PrEP programme, months 5 (FSW, AGYW, ABYM); 11 (MSM) 5 (FSW, AGYW, ABYM); 11 (MSM) 5 (FSW, AGYW, ABYM); 11 (MSM) 12 (FSW, AGYW, ABYM); 24 (MSM) Tenofovir disoproxil fumarate and emtricitabine: Chiu and colleagues. 24 Long-acting injectable cabotegravir: assumed values Additional protection since last visit in PrEP programme 1 month (all populations) 1 month (all populations) 3 months (all populations) 3 months (all populations) Tenofovir disoproxil fumarate and emtricitabine: assumed values.…”

“She is the one who knows”: A qualitative exploration of oral and injectable PrEP as part of a community empowerment approach to HIV prevention among female sex workers in the Dominican Republic and Tanzania

“…Furthermore, a critical question that must be answered is how to make LAI PrEP an accessible option for FSW, particularly in lower and middle-income countries. Many of the same access challenges to oral PrEP will remain as barriers to LAI PrEP unless concerted efforts are made to overcome them, specifically how to ensure these options are not limited to higher income individuals and settings [67]. Creative and clear solutions must be developed to address the cost of LAI PrEP for FSW and other key populations globally.…”

An update on expanding HIV preexposure prophylaxis

“…The current average wholesale monthly price for F/TAF is $2,317 23. A single dose (2 months) of CAB-LA costs $3,700 24. What USPSTF rating CAB-LA will be assigned is not known, nor is whether this delivery method of PrEP will be included in the Public Health Service Act.…”