Cabotegravir—Global Access to Long-Acting Pre-exposure Prophylaxis for HIV

Abstract

A novel injectable pre-exposure prophylaxis, cabotegravir, has greater efficacy and acceptability than oral TDF/FTC for prevention of HIV infection. Cabotegravir is currently priced at $22,200 per year, over 185-times higher than the $60-$119 estimated cost-effectiveness threshold for MICs. Following civil society pressure, ViiV agreed access to generic versions in 90 countries with the Medicines Patent Pool (MPP), including all African nations. However, several MICs outside Africa have rapidly growing HIV epidemics. We analysed the ViiV-MPP deal to assess population covered and Gross Domestic Product (GDP) per capita. There were 38 countries excluded from the ViiV-MPP deal despite having a GDP per Capita lower than the highest earning African country. These countries include 2.4 billion people (30% global population), with an incidence of 122 thousand (8%). For cabotegravir to have a significant impact on HIV infections, millions will need to be treated at affordable prices in a wide range of countries.

Global HIV Incidence Analysis and Implications for Affordability Using Long-Acting Cabotegravir Versus Continuous and Event-Driven Oral Preexposure Prophylaxis

“…IPERGAY, PREVINIR, and cost-effectiveness studies on event-driven PrEP demonstrate that it is equally as efficacious as continuous PrEP [ 15–18 ]. Investigations including a CAB-LA cost-effectiveness analysis by Jamieson et al criticize its inaccessibility and impracticality, calling for marked reductions in its cost to be an effective and realistic PrEP option [ 11 , 19 , 20 , 32 ].…”

“…Annual costs for continuous CAB-LA and continuous TDF/FTC are based on currently available branded, target and generic prices, respectively [ 19 , 20 ]. Annual event-driven TDF/FTC is estimated at $12 pppyassuming 3 months of event-driven PrEP use pppy, based on existing usage estimates [ 16 ].…”

“…However, CAB-LA costs $22 200 per person per year (pppy) in the United States and $9275 pppy in the United Kingdom, despite a $250 pppy target price and an estimated generic price of $16–$34 pppy [ 11 , 19 , 20 , 24 ]. The voluntary licensing agreement between the CAB-LA manufacturer, ViiV, and the Medicines Patent Pool leaves many countries without affordable CAB-LA, despite high HIV incidence [ 19 ]. It is unclear what the final generic CAB-LA prices will be or when they will become available under this voluntary license.…”

Control groups for HIV prevention efficacy trials: what does the future hold?

“…It will be difficult to demonstrate superiority over CAB-LA, as clinic administration minimizes the adherence challenges that appear to influence oral PrEP efficacy [27][28][29][30]. Its high cost has restricted CAB-LA adoption as standard of care [31,32], thus providing it as part of a clinical trial raises questions around poststudy access. Daily oral PrEP was the comparator in both PURPOSE-1 [33] and PURPOSE-2 [34] studies (ClinicalTrials.gov #NCT04994509 and NCT04925752, respectively) of semi-annual lenacapavir compared with oral PrEP, and the prematurely terminated Merck studies (MK-8591-022 [35] and MK-8591-024 [36]) of oral monthly islatravir (ClinicalTrials.gov #NCT04644029 and NCT04652700, respectively).…”

Promises and potential pitfalls of long-acting injectable pre-exposure prophylaxis

“…ViiV Healthcare has provided generic version access to 90 countries in the Medicines Patent Pool, which includes South Africa alongside all other African nations, but notably excludes other middle-income countries with similar gross domestic products. 45 Beyond the cost of CAB LA product, the need for and cost of close monitoring and follow-up with CAB LA users, at least initially, in order to monitor for breakthrough HIV infections and resistance development, should be considered.…”