South Africa’s Health Product Regulatory Authority (SAHPRA) is expected to make a decision on whether to approve the use of the twice-yearly HIV prevention drug, lenacapavir by the end of October.
SAHPRA’s approval is a prerequisite for the country to start rolling out the drug, which is expected to be available around April 2026. South Africa is among the first countries that will receive doses of lenacapavir through a donation facilitated by the Global Fund and PEPFAR.
With around two million people having started on the daily HIV prevention pill since 2016, South Africa has the biggest pre-exposure prophylaxis (PrEP) programme in the world. But the country has not reaped the full benefits of this rollout. New HIV infections remain high – an estimated 170 000 new infections were reported in 2024.
“Despite all our advances, the truth remains: prevention still eludes us. The reality is that for many individuals at risk of HIV, our current prevention options are not yielding the results required,” says health minister Dr Aaron Motsoaledi, speaking at a roundtable on lenacapavir access and sustainability in Kempton Park this week.
The two-day event brought together stakeholders, including civil society, development partners and top researchers to discuss key issues around the immediate and long-term roll-out of the drug.
Need for more prevention options
“Condoms are still not being used as widely as we would like. Oral PrEP is effective, but retention and adherence have been suboptimal. Many users find it difficult to take a pill every single day due to stigma, pill fatigue, or life circumstances,” says Motsoaledi.
This is the reason that lenacapavir has been touted as the tool to turn the tide in the fight against HIV. The drug is long-acting, requiring only two jabs a year when compared to the daily PrEP pill.
“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,” says Motsoaledi.
In addition to regulatory approval, supply is key to kick-start the roll-out of lenacapavir. The Global Fund’s donation of about $29 million (R502 million) will provide approximately 912 000 doses, which is enough to start 456,000 people on lenacapavir over two years.
According to government estimates, this translates into:
- 219 680 people aged 15 and older
- 131 480 pregnant and breastfeeding women
- 25 600 sex workers
- 40 800 men who have sex with men (MSM)
- 18 800 transgender people
According to modelling estimates by the Health Economics and Epidemiology Research Office (HE2RO), for the Global Fund donated doses of lenacapavir to have the biggest impact; half (55%) would need to go to pregnant and breastfeeding women, 26% to MSM and 18% to female sex workers.
“This scenario averted 20,500 new infections over the next 5 years,” according to Dr Lise Jamieson, a senior researcher at HE2RO.
Need local ownership
Motsoaledi says, for a sustainable implementation of lenacapavir, South Africa will have to move beyond donation and take ownership of the programme.
Gilead, the original manufacturer of lenacapavir, has given voluntary licensing to six pharmaceutical companies to manufacture generic versions of the drug at a fraction of the original cost of $28 000.
Partnering with CHAI, UNITAID and WITS-RHI, Dr Reddy’s will manufacture a lenacapavir generic at $40 per person per year. The Bill and Melinda Gates Foundation has partnered with HETERO to produce a generic at the same price.
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“We are already working to include lenacapavir in the Essential Medicines List, which will pave the way for provinces to procure lenacapavir using the normal budgets via the HIV conditional grant,” says Motsoaledi.
After two years, the Department of Health plans to transition to routine funding. “We will be earmarking resources in our Medium-Term Expenditure Framework to ensure that once generic versions become available or prices drop, we can scale up access without interruption,” says Motsoaledi.
HE2RO estimates that scaling up lenacapavir will be more cost-effective than the daily oral PrEP. – Health-e News
