Our LEN is here; Now for quality checks in Ireland

South Africa’s first consignment of the twice-a-year anti-HIV injection, lenacapavir — 37 920 doses — arrived last week at OR Tambo Airport via two shipments from Dublin, Ireland on March 30 and April 2

The batches reached the country six weeks later than expected and are 19 215 doses fewer than what the department says it ordered.

Lenacapavir, in short known as LEN, is injected into the fatty layer of an HIV-negative person’s tummy once every six months and is near perfect in stopping someone from getting the virus through sex. 

But, unlike vaccines, which often give lifelong protection, because they train the body’s immune system to fight infections, LEN only works for as long as someone takes it, because it instead blocks HIV from entering someone’s cells. 

That’s why the medication is called pre-exposure prophylaxis medicine, or PrEP — a drug that is taken before someone is exposed to a germ like HIV, so that if the bug enters their body later it cannot easily infect them. 

LEN used as PrEP is new and was registered with the country’s medicines regulator, the South African Health Products Regulatory Authority (Sahpra), in October. 

Modelling scientists predict that if between one and two million 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 LEN doses that arrived at OR Tambo 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 a million 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 which LEN’s maker, Gilead Sciences, told Bhekisisa normally takes between six to 12 weeks but will be cut to four weeks for LEN, from the time samples are received by the testing lab to the release of the results.

Post-importation testing is when scientists test samples of a medicine after it arrives in a country to make sure it matches the product that was registered and that it, for instance, didn’t get damaged during transit by being shipped at incorrect temperatures. 

The delay of the shipment meant the health department couldn’t start its roll-out on April 1, as it had originally planned and had to postpone it to middle to late May. 

Why did our LEN arrive late? 

The late arrival of our first consignment from the Global Fund is due to a combination of complicated logistics between the Fund and Gilead Sciences, as well as two types of regulatory approvals they had to obtain before being able to ship the medicine. 

The Fund buys South Africa’s LEN — and eight other “early adopter” African countries they support — directly from Gilead. Normally, the health department would use money from the Fund’s grant to procure medicine — and negotiate the price thereof — directly with 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 needs to ship South Africa’s LEN itself (via appointed agents) and also has to apply for South African Revenue Service (Sars) exemption of VAT, something the health department would normally do.

Because the Global Fund LEN doses are effectively 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 they’re 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 they need 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,” explains Auton. “That would introduce massive inefficiencies.”

According to Sahpra, Gilead applied for label exemption on January 23 and it was granted a month later on February 23. Sars exemption took four days and was granted on March 9. 

Both of these 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 a period of two years from the Global Fund. 

In 2026, the Fund says, the country will receive 342 100 doses, which will consist of 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. 

Auton explains: “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.

“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 — the date of manufacture until the expiry date printed on the package — for LEN injections is 36 months; for LEN tablets it is 24 months, according to Gilead. 

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 product was transported at correct temperatures by checking the data from the temperature loggers inside containers.

Sahpra chief executive Boitumelo Semete-Makokotlela says post-importation testing is 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 a South African 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. 

“This is the standard way to confirm that another lab can reliably run the same tests we do,” he explains. 

McKeel says this process 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 to make lenacapavir available in South Africa at this time, is to continue using our established lab in Ireland for the post-importation testing required by the South African government.” 

Semete-Makokotlela says 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],” she explains, “which could later be expanded to include post-importation testing.” 

What’s the way forward?

South Africa’s Global Fund LEN doses for 2026 and 2027 is the branded product manufactured by Gilead. Gilead 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,” says Auton. 

“What we wouldn’t want them to do is to stop supplying and then there’s a gap, because generic companies may not be producing at scale right from the start or there could be a delay with the generics becoming available.” 

But 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 the treasury, have launched a renewed effort to help local companies make LEN. 

Three South African drugmakers — Aspen Pharmacare, Pharmacare and Cipla Medpro — 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 South African 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, the international health organisation, Unitaid, and scientific body, United States Pharmacopeia (USP), will help South African companies to master manufacturing processes.

Either way, the government would need to invest heavily in generics. The country’s 2026 and 2027 supplies from the Global Fund come to only 3% of the total number of doses needed. Modelling scientists say 29-million HIV-negative people must take it at least once between now and 2043 to end Aids. 

The country’s Global Fund grants will also end within the next five years. In a March letter to Sanac, the Fund informed the country that its final three-year grant will be from April 1 2028 to March 31 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. 

“Africa carries the heaviest burden of HIV, yet has historically had the least control over the medicines needed to fight it,” explains Jean Kaseya, director general of the Africa Centres for Disease Control and Prevention. “South Africa’s bold step to pursue local production of lenacapavir changes that narrative.”

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.