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Doctors Without Borders/Médecins Sans Frontières (MSF) has called on UK-based pharmaceutical corporation ViiV Healthcare 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, said Leena Menghaney, South Asia director of MSF's Access Campaign.
According to UNAIDS, an estimated 2.4 million people were living with HIV in India in 2021 (including 70,000 children). Out of these 1.9 million or 77 per cent knew their HIV status; 1.6 million (or 65 per cent of 2.4 million) were on lifesaving antiretroviral therapy; and 1.3 million (or 55 per cent of 2.4 million) had suppressed viral load. More alarmingly, 63,000 people were newly infected with HIV in 2021 in India - 173 new infections every day or 7 infections every hour. And sadly, there were 42,000 AIDS-related deaths in 2021 (5 deaths every hour).
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 USD 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 USD 20 per year. Today’s oral HIV PrEP pills are priced at USD 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 life saving intervention, said Menghaney.
Sustainable Development Goals of United Nations as well as National Health Policy of India promised that by 2020, 90 per cent of people living with HIV will know their status, 90 per cent of these will have access to ART and 90 per cent of those on ART will have viral suppression.
“Most countries were not able to deliver on 2020 HIV targets of 90-90-90 but made commendable progress. Conveniently shifting goal posts will not help end AIDS. We can end AIDS by 2030 but the curve will not bend by itself. We need to remember that we could have achieved these goals, had we succeeded in eliminating missed opportunities in the AIDS response. We should have ensured that the full HIV combination prevention spectrum and complete range of diagnostics, treatment, care and support services were reaching everyone, especially those among the key populations. We should have worked with a heightened sense of purpose and urgency to help prevent HIV infection transmission and avert AIDS deaths. Ending AIDS is one of the targets of UN SDGs. Unless we progress on all SDG goals and targets, we will not be able to progress towards ending AIDS as we should,” said Dr Ishwar Gilada, Secretary General of Peoples Health Organisation, President of AIDS Society of India (ASI), and Governing Council member of International AIDS Society (IAS).
“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 Gilada.
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 LMICs under its own special programme, 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.
“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 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,” said Burry.
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, stated MSF in a communication.
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