South Africa is the first African country – and SAHPRA the third regulator worldwide – to register the twice-yearly anti-HIV jab, lenacapavir (LEN), inking the approval on 21 October, writes Mia Malan for Bhekisisa.
The US Food and Drug Administration registered LEN in June under the name Yeztugo and the European Medicines Agency (EMA) approved it in July as Yeytuo.
It has been registered here under the name “Lenacapavir 464mg solution injection Gilead”, SAHPRA’s CEO, Boitumelo Semete-Makokotlela, told Bhekisisa.
SAHPRA registered LEN within 65 days, 10 days faster than the 75 days it took the regulator to approve the Johnson & Johnson Covid vaccine (drug maker Janssen) in 2021, which was the Covid jab that was registered the fastest in this country.
Although LEN’s manufacturer, Gilead Sciences, applied with SAHPRA for registration in March, the local leg of the registration only started on 22 July, after a programme – EU-Medicines for all (EU-M4all), which is a service that the EMA offers to countries like South Africa to help expedite registrations – approved it. A similar process was followed with the Janssen vaccine.
Gilead only applied for registration for LEN to be used for HIV prevention in South Africa, not as treatment, SAHPRA says.
LEN works over time, releasing itself slowly into someone’s body over six months, and along with the first dose (two injections of 464mg), people also need to take four 300mg LEN pills, two on the same day as the injections and two on the day thereafter. That way, there’s enough LEN in their body for full protection by the third day.
The second dose of LEN is given six months (24 weeks), or up to 26 weeks, after the first dose and no tablets are needed. But if someone were to turn up for their second dose later than 26 weeks, they would need to start all over again, and take the tablets too.
The most common side effects Gilead has registered are local injection site reactions.
The government placed its first order on September 30 and Gilead told Bhekisisa it plans for the first shipment to arrive before the end of this year.
Before roll-out, however, the Health Department’s essential drug committee needs to approve it, a process which is almost completed, its chief director for HIV, Gugu Shabangu, said. The department has also already developed draft national guidelines and is awaiting approval from the National Health Council.
LEN will be stocked 360 facilities in 22 of the country’s 52 health districts from early next year. All of the 22 districts have high rates of new HIV infections and have performed well with managing prescriptions for a daily HIV prevention pill, which the department said it would continue to provide, to give people choices as to which type of HIV prevention medicine works best for them.
The government will roll out LEN in three phases, the second one starting in April 2027. At around the same time, the department will start to buy generic LEN, expected to become available then as well.
At least two generic companies will make LEN available at the same price – $40 a year – but the four pills that people who start on LEN need to take are not included in that price; those tablets will cost around an extra $17.
Health Minister Aaron Motsoaledi has said that the government 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”.
Motsoaledi said the US government has also told the department it would provide a grant of R2bn “to carry us (SA) until the end of March (for programmes funded through the Centres for Disease Control)”.
It is, however, not yet clear if some of that money could be used for LEN roll-out.
Can SA make LEN?
How many doses the government would be able to afford once generics are available would depend on how much they cost.
Gilead evaluated three South African-based companies for LEN production in 2024 — Pharmacare and Cipla Medpro were two of the companies, according to Glaudina Loots of the Department of Science & Innovation, and Aspen Pharmacare’s group senior executive, Stavros Nicolaou, confirmed to Bhekisisa it was the third company.
All three failed the test, mostly because they couldn’t make the active pharmaceutical ingredient (API, also known as the drug substance; the ingredient that makes LEN work).
“It’s a complex 28-step process,” Loots said “and Gilead is looking for a one-stop shop. But we have other options for them.”
Gilead has not still announced a price for either the public or private sector in South Africa.
“We are in ongoing discussions with the Health Department to understand its needs,” Caroline Almeida, Gilead’s director of public affairs, told Bhekisisa.
See more from MedicalBrief archives:
SA’s fight against Aids gets major boost – but there’s a catch
‘Game-changing’ lenacapavir roll-out hangs in the balance
Gilead in talks with SAHPRA to register twice-yearly anti-HIV jab
Efficacy of six-monthly anti-HIV jab confirmed in second study