MSF calls on ViiV to urgently dismantle barriers to access for long-acting cabotegravir
Geneva, 29 November 2022 – Doctors Without Borders/Médecins Sans Frontières (MSF) today called on pharmaceutical corporation ViiV to urgently dismantle the barriers hindering broad access to the most effective form of HIV pre-exposure prophylaxis (PrEP) that exists, long-acting cabotegravir (CAB-LA), which could turn the tide against new HIV infections globally. CAB-LA is administered as an injection every two months and has shown to be more effective than once-daily oral PrEP pills, but ViiV is not making the drug affordable or available in places where it is urgently needed. Around 1.5 million people were newly infected with HIV in 2021, which is far from the global target of reducing new annual infections to 370,000 by 2025, and affordable access to CAB-LA could play a major role in reducing infections and saving more lives.
“The implementation of daily PrEP programs in Africa that have been so far hindered by inconsistent visit attendance and low adherence can be greatly overcome by the use of CAB-LA which is more discreet and easier for people to stick to than the daily preventative pill. ViiV must lower and publish the price of this transformative drug and ensure that it is available and registered everywhere: no corporation should be prioritising profits over preventing HIV,” Dr Mounia adds.
ViiV’s still prohibitive so-called “access price” will likely hinder government treatment programmes from being able to roll out CAB-LA for use at the scale needed. ViiV have not been transparent about the “access-price” and have not published it themselves. However, according to publicly available information, ViiV’s “access price” will be between US$240-276 per person per year which is 12 times higher than what the Clinton Health Access Initiative (CHAI) estimates a generic price could be, namely less than $20 per year. Today’s oral HIV PrEP pills are priced at $40 for one 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 (LMICs) so that governments and treatment providers can accelerate rollout of this lifesaving intervention.
In December 2021, CAB-LA’s registration was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA), 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 prioritise for approval, ViiV should do more to register CAB-LA globally as it is still not available in almost every country in the world, preventing millions of people from being able to benefit from it. This is particularly concerning, as 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 happened after civil society raised grave concerns about ViiV’s lackadaisical approach to making CAB-LA available.
Moreover, CAB-LA is currently produced in only one manufacturing site in the UK. Until generics are registered and available, ViiV should ensure sufficient supply of CAB-LA and should be transparent about its manufacturing capacity. And, 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.
In addition to barriers of price, registration, and possibly supply, ViiV currently donates CAB-LA in some low-and middle-income countries (LMICs) under its own special program, based on approval by the corporation of research protocols submitted by the organisations wishing to use the drug for HIV PrEP. MSF also wants to start using CAB-LA for HIV PrEP in several pilot projects and negotiated around this requirement, and urges ViiV to cease this requirement in general to allow normal procurement, importation and use as per World Health Organization (WHO) recommendations, and for independent research.
“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 prioritise 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-country, include it in national HIV guidelines and accelerate its rollout to prevent HIV transmission.