Editorial: HIV prevention injection should be fast-tracked like COVID-19 vaccines

Editorial: HIV prevention injection should be fast-tracked like COVID-19 vaccinesTop South African HIV clinicians are setting their sights on different approaches to finding an HIV vaccine after the "disappointing" news that the Mosaico trial was stopped early because the vaccine did not show any efficacy.
Comment & Analysis

One of the most important developments in HIV in the last decade is the discovery that taking a pill combining two antiretroviral medicines every day can prevent HIV infection. This pill is finally becoming widely available in South Africa’s public healthcare system, but uptake is still relatively low.

One drawback with a pill that you have to take every day is, of course, that you have to take it every day. This requires not only remembering to take it but also staying motivated to take it. Some people may also not like those they live with to know about the pills.

Now imagine you can take an injection that protects you against HIV infection for six months. Imagine what a difference such an injection can make, especially in the lives of young women in South Africa – a group with stubbornly high HIV rates, even in 2021.

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While research is still being done on such a six-monthly injection (containing the ARV lenacapavir) and there is no guarantee that it will work, we already have a two-monthly injection (containing the long-acting ARV cabotegravir – CAB LA) that has been shown to work very well. In principle, we don’t like using terms like “game-changer”, but in this case, we might really have a game-changer on our hands if we play our cards right.

Findings from two landmark phase III studies showing that CAB LA injections every second month are highly effective at preventing HIV infection were made public in 2020. A year later, the product is not yet on the market. This is not unexpected – in pre-COVID-19 times, such long waits from trial completion to regulatory approval and products in clinics were often much longer.

But, if processes can be speeded up for COVID-19 vaccines, surely it can also be done for critically important new forms of HIV prevention?

As Catherine Tomlinson last week reported in Spotlight, experts expect CAB LA to only become available in our public healthcare system late in 2022 or early in 2023. The World Health Organization hasn’t yet recommended the use of CAB LA and, while the manufacturer ViiV Healthcare has filed for registration in the United States, they haven’t yet filed for registration with the South African Health Products Regulatory Authority (SAHPRA). Even once filed with SAHPRA, it is not guaranteed that CAB LA will receive the kind of priority attention given to COVID-19 vaccines.

Tomlinson also reported that the Department of Health is already thinking about the potential rollout of CAB LA and that they will learn lessons from the rollout of HIV prevention pills – a rollout that started very late, but that seems to have picked up speed over the last two years. That it is on the department’s radar is a good sign – but that they haven’t stressed the need to move much faster than with HIV prevention pills doesn’t bode well.

One important lesson to learn both from the COVID-19 vaccine and HIV prevention pills rollouts is that making the CAB LA injection available at clinics will only be one part of the solution. We will also need a massive awareness campaign that will empower people, especially young women, with accurate information about the injection. Thought will also have to be given to how to provide the injection to healthy young people who do not visit public sector clinics. It might even have to be offered at schools in areas with high HIV rates.

There has been much rhetoric about how HIV requires the same attention, investment, and urgency that we’ve seen for COVID-19. This is good, but it is not always clear exactly where such a revived HIV response should start and what it means to give HIV the same urgency as COVID-19. We think a good starting place would be to ensure that CAB LA reaches clinics in the first half of 2022 rather than six months, a year, or 18 months later.

Meeting such a target will require ViiV Healthcare to speed up their regulatory filings and production plans – and if production or price is a bottleneck, generic producers will have to be licenced to help out. Governments, multinational agencies, and donors can already commit to buy certain volumes of the drug at pre-set prices, should regulators approve the drug. And while regulators should not lower their standards, they should fast-track their processes as much as possible. Once CAB LA has been approved, should it be approved, the National Department of Health, provincial health departments, and entities such as the National Essential Medicines List Committee should make sure the rollout is not delayed by bureaucratic inertia and a lack of coordination.

It is, of course, easy to think of regulatory, production, and planning reasons why CAB LA will not be available in the first half of 2022. It is unfortunately also easy to imagine the rhetoric of a more urgent HIV response co-existing with a shrug of the shoulders and a meek acceptance of these reasons.

Yet, if COVID-19 taught us one thing, it is that apparently immovable obstacles can in fact often be moved without compromising safety or due process – it just depends on how much people care.