Speaking notes by the Minister of Health, Dr Aaron Motsoaledi, during Lenacapavir Access and Sustainability in SA Roundtable, Protea Hotel OR Tambo, Johannesburg
"Lenacapavir, Access, Affordability and Sustainability in HIV Prevention"
South African National AIDS Council CEO
Civil Society Forum Chairperson
Global Fund representatives
WHO representatives
UNAIDS, UNFPA, UNICEF representatives
Gates Foundation
Developmental Partners
Private Sector, Partners from the pharmaceutical industry, Research institutions
Esteemed donors
Department of Health teams and entire dedicated health workers
I'm honoured to speak today at this national roundtable on Lenacapavir Access and Sustainability. Today, we come together at a pivotal moment in South Africa’s HIV response. We are here to launch a new chapter in HIV prevention – one that introduces a groundbreaking long-acting preventive therapy and reinforces our broader strategy to finally end the HIV epidemic in our country.
This gathering is about partnership and coordination. The fight against HIV has always demanded collective effort, and the presence of a wide range of stakeholders like in this room. This demonstrates our shared commitment. Our focus is the introduction of Lenacapavir, a novel long-acting HIV prevention option. We will discuss how to ensure its accessibility, affordability, and sustainability for all who need it. I am confident that with the unity of purpose we have here, we can make this innovation a success and bring hope to hundreds of thousands of people at risk.
Progress and challenges in HIV prevention
South Africa has made remarkable strides in combating HIV. We continue to carry the highest burden of HIV globally, with an estimated 8 million People Living with HIV (PLHIV) in our country, yet we have not stood idle: our treatment program is the largest in the world, and our prevention efforts have expanded dramatically. Our nation has become a world leader in rolling out pre-exposure prophylaxis (PrEP).
To date, over 2 million people have been initiated on oral PrEP across 98% of public primary healthcare facilities – an extraordinary achievement that covers almost the entire country. So we have given millions of South Africans a tool to protect themselves from HIV. We have also implemented comprehensive education, HIV testing, condom distribution, male medical circumcision and other behavioural interventions as part of a combination prevention approach. All these efforts are paying off: new HIV infections have been steadily declining from their peak in the early 2000s.
However, despite our progress, HIV is still a challenge. Despite all our advances, the truth remains: prevention still eludes us. Approximately 149,000 South Africans acquired HIV in 2023 alone, a number that is far too high. Adolescent girls and young women continue to bear a disproportionate burden of new infections, and the other key populations.
The reality is for many individuals at risk of HIV, our current prevention options are not yielding the results required. For example, condoms are still not being used as widely as we would like. Whilst, oral PrEP is effective, retention and adherence have been suboptimal, especially among the people who could benefit the most. Many users find it difficult to take a pill every single day due to stigma, pill fatigue, or life circumstances. When people stop taking PrEP regularly, its protective benefit drops, and opportunities to prevent infections are lost.
To reach our goal of ending AIDS as a public health threat and achieve the UNAIDS target of 95% of people at risk having access to prevention options, we must continually improve and expand our prevention toolkit. We need prevention methods that fit into people’s lives, that address the gaps left by existing tools. This is where Lenacapavir comes in as a timely and much-needed innovation to help us overcome the persistent challenges in our HIV response. Lenacapavir expands the choices within our combination prevention strategy. It widens the scope of choices for citizens, an empowering option and ensuring that no one is left behind simply because the existing tools did not fit their lives.
Introducing Lenacapavir: a breakthrough in HIV prevention
Lenacapavir is a new long-acting antiretroviral drug, specifically, an HIV-1 capsid inhibitor, that is used for HIV prevention (as PrEP). What makes Lenacapavir groundbreaking is its dosing schedule and efficacy. Lenacapavir is delivered via injection only twice a year, offering six months of continuous protection per dose. Just two injections a year could protect an individual from HIV, a contrast to the daily pills or the bi-monthly injections we have used so far. Lenacapavir represents a true breakthrough in prevention science and service delivery.
This six-monthly dosing schedule has the potential to overcome many of the barriers we’ve seen with daily oral PrEP: it offers greater discretion, convenience, and likely much better adherence for users, especially for people who struggle with taking a pill every day or making frequent clinic visits.
Lenacapavir is highly effective. Clinical trials (the PURPOSE 1 and 2 studies) demonstrated outstanding efficacy of Lenacapavir in preventing HIV. In one trial among women, it showed 100% efficacy within the study period – and in another trial amongst men who have sex with men and transgender women, efficacy was around 96%. On the strength of this evidence, the World Health Organization (WHO) this year issued new guidelines recommending Lenacapavir as an additional HIV prevention choice.
WHO now strongly recommends offering long-acting injectable Lenacapavir to people at risk of HIV, as part of combination prevention approaches. This global guidance gives us confidence that we are on the right track by introducing Lenacapavir in South Africa.
Strategic rollout and supply management
As excited as we are about Lenacapavir, we are also mindful that the initial supply will be limited and must be managed strategically. South Africa has secured an initial allocation of Lenacapavir through a generous Global Fund grant, but this will only cover a fraction of the total need in the first couple of years. Specifically, the Global Fund’s catalytic investment of about US $29 million will provide approximately 456,000 Lenacapavir initiations over two years, translating into 912 000 doses.
Our approach is firmly data-driven. Modelling analysis by our local experts, Health Economics and Epidemiology (HE2RO) and others indicates that if we focus the initial rollout on those populations at highest risk of HIV, we can achieve the most infections averted. In particular, prioritizing pregnant and breastfeeding women (PBFW), adolescent girls and young key populations (AGYW), female sex workers (FSW), and men who have sex with men (MSM), would yield the highest impact.
We plan to roll out Lenacapavir initially in about 23 high-incidence districts across six provinces, targeting around 360 high-performing public clinics within these areas for Phase 1 implementation.
New developments
During UNGA, a very successful, innovative and life-changing program was announced by Clinton Health Access Initiative (CHAI), UNITAID, WITS RHI, and Dr Reddy’s Laboratories whereby Gilead, the original manufacturer of Lenacapavir, offered voluntary licensing to six pharmaceutical companies. Dr Reddy’s laboratories is one of those. The price of Lenacapavir will drop from US $28,000 to US $40 per person per year — a 700-fold reduction. Another powerful partnership was announced with the Bill and Melinda Gates Foundation and HETERO.
Public sector and community coordination
The National Department of Health, together with provincial departments, SAHPRA, SANAC and Civil Society Forum, will lead the rollout with WHO, Gates Foundation, Global Fund, and donors providing vital support.
This is not just a drug rollout — it’s a movement. A shared responsibility for a shared solution. Let us move with urgency and unity, and make history.
Announcement
We were in agony, the beginning of this year when PEPFAR pulled out of our shores. What we were left with was funding through the CDC. Unfortunately, that too expired at the end of September.
We have since received a letter from Washington that, in the meantime, we will receive R2,008 billion to carry us until the end of March. We ought to be happy about this because it could have been worse.
Thank you.
Enquiries:
Foster Mohale
National Health Department
Cell: 0724323792
E-mail: foster.mohale@health.gov.za
#ServiceDeliveryZA
