OpinionPREMIUM

STAVROS NICOLAOU | Breakthrough HIV drug could be a game-changer for Africa

But for that to happen, Lenacapavir needs to be manufactured locally, writes Dr Stavros Nicolaou

The South African Health Review says HIV prevalence among adolescents, especially girls, is a challenge.
In the early 2000s, Aids was claiming roughly 300,000 South African lives, mainly young people who are the economic future of our nation. (123RF/Gamjai)

From liberation to medical innovation, South Africa has always turned adversity into invention — we are wired for breakthrough, not surrender.

When South Africa introduced antiretrovirals at scale, a study analysing data from more than 101,000 individuals in rural KwaZulu-Natal revealed that life expectancy in the hardest-hit communities surged from 49.5 years in 2000 to 60.5 years by 2011 — a national resurrection powered not by a miracle, but by science and collective activism.

In the early 2000s, Aids was claiming roughly 300,000 South African lives, mainly young people who are the economic future of our nation. We fought back. We disrupted. We led the world.

But victories unguarded disappear quietly.

Today, HIV is no longer dominating headlines, donor funding is contracting, and the rising tsunami of non-communicable diseases threatens to push a once-prioritised epidemic to the periphery of political urgency. In 2024, 53,000 South Africans still died of AIDS-related complications, despite 6.25-million people being on life-saving treatment. Now we come face to face with a moment that could rewrite Africa’s trajectory again.

Lenacapavir, a twice-yearly injectable PrEP (pre-exposure prophylaxis) treatment, isn’t just incremental progress, it is disruption in liquid form. A long-acting capsid inhibitor, Lenacapavir shuts the door on viral replication inside cells with near-total efficacy in clinical trials. It turns what was once a daily burden of adherence into a twice-a-year act of prevention.

Lenacapavir, a twice-yearly injectable PrEP (pre-exposure prophylaxis) treatment, isn’t just incremental progress, it is disruption in liquid form. A long-acting capsid inhibitor, Lenacapavir shuts the door on viral replication inside cells with near-total efficacy in clinical trials. It turns what was once a daily burden of adherence into a twice-a-year act of prevention.

The US Food and Drug Administration (FDA) approved injectable Lenacapavir for prevention in 2025, and the World Health Organisation (WHO) has enthusiastically endorsed it as a critical new pillar of global HIV prevention — it has both HIV preventative and treatment indications.

The science is suddenly different.

The maths is suddenly different.

And the impossible is also suddenly different.

HIV eradication by 2035: is it possible? Yes. But here’s the blunt truth: you cannot eliminate a virus on a continent that does not manufacture its own medicines.

At a clearly inaccessible price per dose on international markets (pre-generic negotiation), Lenacapavir’s promise risks echoing a familiar story in Africa: groundbreaking science, limited access, endless dependency. If production remains offshore, every African needle delivered will carry the invisible tax of delay — procurement bottlenecks, currency vulnerability, supply insecurity, geopolitical mood swings and, more devastatingly, preventable infections.

Local manufacturing isn’t simply about commerce or even access. It is about controlling our own destiny.

South Africa is at the exact point of opportunity and responsibility. We have the regulatory sophistication to lead continental alignment through the South African Health Products Regulatory Authority. We have the industrial capacity to scale pharmaceutical production through proven ecosystem players like Aspen Pharmacare and others. We have amazing continental policies that the likes of the Africa CDC and the African Continental Free Trade Area (AfCFTA) are driving towards catalytic activation to save African lives and optimise economic growth. What we lack is urgency — that fleeting fuel that changed the epidemic curve before. We need it again.

If we want to deliver on the promise of “eliminating HIV forever”, then three things must move — in parallel, not sequence:

WHO pre-qualification

Without WHO pre-qualification, African manufacturers cannot supply UN procurement lists at scale. With it, new markets unlock, demand aggregates, unit costs fall and local production becomes profitable enough to sustain itself without the charity of donors — we become self-reliant. The government must fund a co-ordinated pre-qualification sprint with manufacturers, virologists, regulators and data agencies united in one room, moving at outbreak speed. But what is needed as a primary and urgent priority to get the whole process chain activated is the WHO review. At the margins of the G20 summit in Johannesburg, the WHO started to create discourse around the likelihood of this finally coming to fruition for Africa. We hope that these delays have finally come to an end.

Pooled African procurement

South Africa must push for AU-wide pooled procurement commitments that create the only thing that de-risks manufacturing investments: demand certainty. When African nations buy together, pharmaceutical manufacturers build factories here — not beyond our borders, but here in Africa. Here in South Africa.

Domestic financing

Foreign aid cuts mean Africa must manufacture and finance its own prevention agenda. Development finance institutions, African multilateral banks and domestic investors must plug the capital gap for factories, cold-chain logistics, workforce training and community deployment. Prevention fails if drugs don’t reach clinics; clinics fail if systems don’t adapt.

We are in the process of establishing Project Africa First, a continental public-private partnership initiative — led by the AU and championed by the South African government — to save African lives through a localised manufacturing agenda for improved access to medicines.

Africa doesn’t need more policies or more targets; it needs more united political will and more pharmaceutical manufacturing lines.

South Africa was the global epicentre of HIV/Aids activism and treatment scale-up; now we must become its industrial heart.

Dr Nicolaou is Aspen Pharmacare’s senior executive responsible for strategic trade development



Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.

Comment icon