NEW YORK/GENEVA, NOVEMBER 29, 2022—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) today called on pharmaceutical corporation ViiV to urgently dismantle price, registration, and possible supply barriers that are blocking people from accessing the most effective form of HIV pre-exposure prophylaxis (PrEP) that exists, long-acting cabotegravir (CAB-LA). CAB-LA is administered as an injection every two months and has shown to be more effective in preventing HIV transmission than daily oral PrEP pills, but ViiV is not making the drug affordable or available in places where it is urgently needed. Approximately 1.5 million people were newly infected with HIV in 2021, far from the global target of reducing new annual infections to 370,000 by 2025.
“The rollout of long-acting injectable cabotegravir would be hugely beneficial for reducing new HIV infections for people at risk and break the cycle of transmission, particularly in places where HIV prevalence is high,” said Dr. Mounia Amrani, medical team leader with MSF-Southern Africa. “ViiV must lower and publish the price of this transformative drug and ensure that it is available and registered everywhere. No corporation should be prioritizing profits over preventing HIV.”
ViiV has an “access price,” but that price will likely still be too high for government treatment programs to roll out CAB-LA for use at the scale that’s needed. While ViiV has not been transparent about its “access-price” or published it themselves, publicly available information shows that ViiV’s “access price” will be between $240-276 per person per year. This is 12 times higher than what the Clinton Health Access Initiative (CHAI) estimates a generic price could be at less than $20 per year. Today’s oral HIV PrEP pills are priced at $40 per year. ViiV should publicly announce its “access price” and ensure that it is comparable to the current price of oral PrEP in low- and middle- income countries so that governments and treatment providers can accelerate the rollout of this injection.
In December 2021, CAB-LA's registration was approved for the prevention of HIV infection by the US Food and Drug Administration, and was then approved in August 2022 in Australia, followed by Zimbabwe and Uganda. While there are some pending submissions for CAB-LA registration—which governments must prioritize for approval—ViiV should do more to register CAB-LA globally as it is still not available in almost any country in the world. This is particularly concerning since ViiV will be the only supplier of CAB-LA until generic versions are developed, registered, and commercially available, which will take at least four to five years following the announcement of a voluntary license agreement between ViiV and the Medicines Patent Pool (MPP) in July 2022. This agreement was reached after civil society raised grave concerns about ViiV’s lackadaisical approach to making CAB-LA available.
As for barriers related to manufacturing the injection, CAB-LA is currently produced in only one manufacturing site in the UK. Until generics are registered and available, ViiV must ensure sufficient supply of CAB-LA and should be transparent about its manufacturing capacity. Additionally, in order to mitigate the risk of shortages and stockouts should there be any issues at the current site, ViiV should ensure that a second manufacturing site can produce CAB-LA.
“CAB-LA could significantly reduce new HIV infections globally, so it is beyond frustrating that ViiV is not doing more to get this drug to the places where it is needed most,” said Jessica Burry, HIV/HCV pharmacist with MSF’s Access Campaign. “MSF has been able to negotiate out of many of ViiV’s cumbersome constraints, but we should not be the exception here. ViiV should urgently prioritize increasing access to CAB-LA by reducing and publishing its price, ensuring sufficient supply until generics are available, and getting rid of unwieldy requirements for governments and others who want to use this ground-breaking HIV PrEP.”
In addition to the steps that ViiV should take to increase access to CAB-LA, governments should act fast to approve CAB-LA in their countries, include it in national HIV guidelines, and accelerate its rollout to prevent HIV transmission.