South Africa’s first consignment of LEN, the twice-a-year anti-HIV injection lenacapavir – 37 920 doses – landed last week at OR Tambo Airport via two shipments from Dublin, Ireland, arriving six weeks later than scheduled, and being nearly 20 000 doses short, writes Mia Malan from the Bhekisisa Centre for Health Journalism, for TimesLIVE.
LEN was registered with the South African Health Products Regulatory Authority (SAHPRA), in October, and modelling scientists predict that if between 1m and 2m HIV-negative people take LEN at least once between now and 2043, South Africa could stop enough new infections to end Aids as a public health problem in 18 years’ time.
The doses that arrived in Johannesburg are being paid for with a proportion of South Africa’s grant from the Global Fund to Fight Aids, TB and Malaria, and is the first consignment of a total of just under 1m doses that the fund will finance for 2026 and 2027.
Samples of the consignment must now be sent to Cork in Ireland for post-importation testing, a process that LEN’s maker, Gilead Sciences, told Bhekisisa normally takes between six and 12 weeks but will be cut to four weeks, from the time samples are received by the testing lab to the release of the results.
The post-importation testing is crucial to ensure the delivery matches the product that was registered and that it didn’t, for instance, get damaged during transport by being shipped at incorrect temperatures.
However, the shipment’s delay means the health department was unable to start its roll-out on 1 April, as it had originally planned, and had to postpone it to middle to late May.
Why was it late?
The late arrival is due to a combination of complicated logistics between the fund and Gilead Sciences, as well as two types of regulatory approvals needed before departure.
The fund buys South Africa’s LEN – and eight other “early adopter” African countries it supports – directly from Gilead. Normally, the health department would use money from the fund’s grant to procure medicine, and negotiate the price thereof, directly from manufacturers.
But in LEN’s case, the sales contract between the Global Fund and Gilead is being kept confidential as Gilead opted not to publicise the price at which it sells its product to the fund. That means the fund must ship South Africa’s LEN itself (via appointed agents) and also apply for South African Revenue Service (SARS) exemption of VAT, which is what the health department would normally do.
Because the Global Fund LEN doses are donations, such consignments are exempted from VAT. “We require every dollar to serve patients, so products have to be imported tax-free,” Martin Auton, the head of planning and procurement at the fund, told Bhekisisa.
As the manufacturer of LEN, Gilead had to apply for SAHPRA exemption for labelling because it’s providing the text of package inserts in English only. South African regulations require manufacturers to provide such patient information in English plus at least one other official language (usually Afrikaans).
“Gilead isn’t offering labelling customisation, because it needs to get volume out: customisation would slow down deliveries to other countries as it would mean South Africa’s labels would need to be printed separately,” said Auton. “That would introduce massive inefficiencies.”
SAPHRA said Gilead applied for label exemption on 23 January and was granted a month later on 23 February. SARS exemption took four days and was granted on 9 March.
Both exemptions had to be in place before South Africa’s LEN could be shipped. But by the time consignment logistics were in place, and agents had been appointed, there was significant loss of freight capacity from specifically Middle East-based airlines used by the fund because of ongoing conflict in that region, a Global Fund spokesperson said.
Why did SA get fewer LEN doses than expected?
According to a health department presentation, South Africa will get a total of 947 450 doses over two years from the Global Fund.
In 2026, the fund says, the country will receive 342 100 doses, comprising 227 980 initiation packs and 114 120 continuation packs. In addition to two syringes and vials with injectable LEN (one LEN dose equals two injections), an initiation pack also includes four LEN pills that have to be taken with the jab when someone starts on the medication (two pills on the day they get the shot and two the day after).
South Africa’s first consignment consists of initiation packs only, because all patients would be using LEN for the first time.
The health department ordered 57 135 initiation packs for the first quarter of 2026, but only received 37 920.
“The fund has had to stagger shipments to accommodate all countries, to optimise shelf life and minimise the risk of wastage, should uptake be lower than initially projected,” said Auton.
“While shipping timelines have been adjusted accordingly, there is no change in the total volumes planned for delivery to South Africa in 2026.”
The shelf life for LEN injections is 36 months; for LEN tablets it is 24 months.
Why is the post-importation testing not done in SA?
Post-importation testing requires labs to use assays – lab tests that measure or detect something – to test if samples of medicine contain the right drug, the right amount, and if the products were transported at correct temperatures by checking the data from the temperature loggers inside containers.
SAPHRA CEO Boitumelo Semete-Makokotlela said post-importation testing was always the manufacturer’s responsibility.
Currently, these tests are performed at Gilead’s quality control lab in Cork, Ireland, because Gilead has not yet accredited an SA lab to do so.
“In principle, a South African lab could eventually conduct this testing,” Gilead spokesperson Ryan McKeel told Bhekisisa. “But before that can happen, Gilead would need to complete a detailed process known as analytical method transfer – the standard way to confirm that another lab can reliably run the same tests we do.”
McKeel says this takes time: “It involves auditing and qualifying the local lab, training its scientists on our testing methods, and providing the necessary samples, standards and materials.
“Given these factors, the fastest way, currently, to make lenacapavir available in South Africa is to continue using our lab in Ireland.”
Semete-Makokotlela said South Africa simply doesn’t have enough labs that can do post-importation testing.
“SAHPRA is planning to set up its own lab for market surveillance (collecting samples sold to make sure they aren’t substandard or falsified), which could later be expanded to include post-importation testing.”
What’s the way ahead?
South Africa’s Global Fund LEN doses for 2026 and 2027 are the branded product manufactured by Gilead, which will only supply such doses to the Global Fund until generics become available. If all goes well, that will happen by 2027.
In 2024, Gilead gave six drugmakers – in Egypt, Pakistan and India – licences to make generics.
“To ensure a smooth transition, the fund is working towards a hybrid period during which Gilead will continue to provide its branded product while generics are being phased in,” said Auton.
South Africa’s National Aids Council (SANAC), along with the Health department, the Department of Trade, Industry and Competition, the Science, Technology and Innovation Department, and National Treasury, have launched a renewed effort to help local companies make LEN.
Three local drugmakers, Aspen Pharmacare, Pharmacare and Cipla Medpro, had failed the test to secure generic licences in 2024, mostly because they couldn’t make the key ingredient.
In March, SANAC issued an expression of interest to invite local drug companies to submit applications for generic production by April 7.
It will now evaluate the applications, compile a shortlist of companies with capabilities and then ask Gilead to evaluate the list to consider issuing one or more local companies with licences to either make the full product, or import the key ingredient and then put the medicine together locally.
If Gilead does decide to issue local licences, Unitaid and scientific body United States Pharmacopeia (USP), will help South African companies master the manufacturing processes.
Either way, the government would need to invest heavily in generics. The 2026 and 2027 supplies from the Global Fund comprise just 3% of the total number of doses needed: modelling scientists say 29m HIV-negative people must take LEN at least once between now and 2043 to end Aids.
South Afria’s Global Fund grants will also end within the next five years. In a March letter to SANAC, the fund said its final three-year grant will be from 1 April 2028 to 31 March 2031.
South Africa has about 170 000 new HIV infections per year. To end Aids as a public health threat, the country needs to bring down new infections to 65 000 per year so that the rate of new infections is reduced to 0.1% or below.
TimesLIVE article – Finally, our LEN is here. Now for quality checks in Ireland (Restricted access)
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SA firms lose out on lenacapavir production
Concerns grow over lenacapavir price transparency
Donors enable deal for $40 generic anti-HIV ‘miracle’ drug
SA leading the charge for made-in-Africa anti-HIV jab