Experts and NGOs working in the health sector, including Médecins Sans Frontières (MSF), have for long been calling on UK-based pharmaceutical corporation ViiV Healthcare to make information public on HIV-prevention drug long-acting cabotegravir (CAB-LA). The concern of NGOs is genuine as the drug is the most effective known form of pre-exposure prophylaxis, which can prevent new HIV infections. They have also been calling on the company to urgently dismantle the barriers hindering broad access to the drug, which could turn the tide in the fight against new HIV infections. CAB-LA is administered as an injection every two months and has proved more effective than the existing once-daily oral PrEP pills. In December 2021, CAB-LA’s registration was approved for prevention of HIV infections by the US Food and Drug Administration (US 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 most countries thereby leaving millions of people at the mercy of the available tmhods. This is particularly of concern as ViiV will be the only supplier of CAB-LA until generic versions are developed, registered and commercially available. This could take up to four to five years following the announcement of a voluntary license agreement between ViiV and the Medicines Patent Pool (MPP) last July. This agreement happened after the civil society raised grave concerns about ViiV’s lackadaisical approach to making CAB-LA available.
A bigger problem is that ViiV is not making the drug affordable or available in places where it is urgently needed. 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. A better way is for the authorities to mandate this and make it accountable.
In order to mitigate the risk of shortages and stock-outs, ViiV should ensure that a second manufacturing site is set up for manufacturing CAB-LA, which currently the most effective form of PrEP for people at high risk of contracting HIV. CAB-LA could be the key to turning the tide against new HIV infections, particularly as the daily oral PrEP pill undermines adherence. However, ViiV’s continued lack of transparency around CAB-LA’s current availability and how it will be distributed, as well as clinical research conditions set by ViiV for procurement, are acting as barriers for accessing it, particularly in countries with low- and middle-income populations. And they are the most vulnerable to the ailment.
India too has promised to eradicate AIDS by 2030 as per the 2017 National Health Policy and UN Sustainable Development Goals (SDGs). By adopting the UN SDGs, governments of over 190 nations, including India, have pledged to end the dreaded disease AIDS by 2030. To make it a reality, ViiV must reprioritise its global distribution to people at the highest risk of contracting HIV. It must immediately provide transparency on the current available volume and planned geographic distribution of CAB-LA. There is an urgent need to expedite the drug’s access for people in high-HIV-burden and low- and middle-income countries, where it could have the biggest impact. 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 3.70 lakh by 2025, and affordable access to CAB-LA could play a major role in reducing infections and saving more lives. 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 – 173 new infections every day or seven every hour. The 42,000 AIDS-related deaths in 2021 imply that five persons died every hour (2022 data is yet to be released).
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. Until we progress on all SDG goals and targets, we will not be able to progress towards ending AIDS by 2030. ViiV has a lifesaving HIV prevention drug at its fingertips but is failing to ensure there is enough for people desperately in need of it. The rollout of long-acting injectable cabotegravir would be hugely beneficial in reducing new HIV infections for people at risk and break the cycle of transmission, particularly in places where HIV prevalence is high.
(The author is freelance journalist with varied experience in different fields)
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