By Catherine Tomlinson for Spotlight
Aspen Pharmacare has announced that it will not be manufacturing the lenacapavir HIV prevention injection, and that it will instead focus on producing alimatravir, an experimental HIV prevention pill.
At the start of 2020, the only medicine approved to prevent HIV infection in people who are not living with HIV in South Africa was tablets containing the antiretroviral drug tenofovir. Apart from the tablets, ideally taken daily, HIV transmission could also be prevented by the correct use of condoms and reduced through medical male circumcision. Treating people living with HIV also helps a lot, since most people who are stable on antiretroviral treatment become non-infectious.
Since 2020, three more HIV prevention medicines have been registered in South Africa. Most prominent of these is the lenacapavir injection, which provides almost complete protection for six months at a time. The cabotegravir injection (CAB-LA) provides two months of protection and the dapivirine vaginal ring a month of partial protection. Several more products are in advanced clinical trials – including a new formulation of lenacapavir that may provide 12 months of protection and a tablet that could protect for a month.
Yet, despite the promise of new HIV prevention medicines, the rollout and uptake of these products in South Africa and globally has been slower than expected. Currently, only around 350 000 people are using HIV prevention tablets in South Africa, while in the region of 60 000 people have started taking the twice-yearly lenacapavir injections. At these levels, the number of people taking HIV prevention medicines in South Africa remains far too low to make a significant dent in the rate of new infections.
Cost has been a barrier
HIV prevention tablets cost the health department around $40 (roughly R700) per person per year. This price is considered to be affordable and the tablets are currently available at almost all public sector clinics in the country.
But modelling shows that long-acting injections can prevent more HIV infections than daily tablets, because their efficacy is less reliant on people taking the tablets every day. There is also evidence that many people prefer long-acting injections over daily tablets.
The cost of these newer, long-acting products has been a challenge. The health department has not procured CAB-LA injections, which was registered in the country in 2022. This was largely due to the price of around $160 per person per year. It also didn’t help that the current formulation of CAB-LA provides only two months of protection, compared to lenacapavir’s six.
In June, the health department started rolling out lenacapavir injections to around 10% of public sector facilities – for now the potential demand by far outstrips supply. The limited scale of the rollout is due to both supply and affordability challenges. The health department is paying $60 per person per year for lenacapavir through a Global Fund procurement arrangement that is allowing donors to pay an additional confidential top-up amount to Gilead Sciences above what the health department pays. For now, Gilead is the only supplier of the jab.
Supply should however improve over the next 12 months and prices are likely to come down. Gilead has licensed six companies to manufacture generic lenacapavir and is considering granting additional licenses, possibly to South African companies through a process coordinated by the South African National AIDS Council. Deals are in place with Indian pharmaceutical companies Hetero and Dr Reddy’s that should ensure a generic price of $40 per person per year. Hetero has already filed its product for registration with the South African Health Products Regulatory Authority – although it is expected to only get the green light early in 2027.
Is a new highly affordable option on the way?
In light of these pricing and supply concerns, news from the 2026 International AIDS Society Conference about a monthly HIV prevention tablet under development has made waves. Health economists presented research showing that the monthly tablet, alimatravir, could be profitably produced for a price tag as low as $3 per person per year (a $15 price was indicated in a conference abstract and previously quoted by Spotlight, but the price presented in the conference session was $3).
Not only is this a fraction of the cost of long-acting injections, but it is also substantially cheaper than the cost of daily tablets.
“Alimatravir for $3 per year could be the cheapest HIV prevention drug the world has ever seen, affordable worldwide,” Dr Samuel Cross of Christchurch Hospital told delegates.
He told conference delegates that the methodology used to calculate the $3 per person per year price is the same methodology that has previously been used to predict the manufacturing cost of several medicines. He said that “[o]ver the past decade, this methodology has correctly predicted production costs for [several] drugs,” including drugs for HIV, TB, Hepatitis B and C, and other conditions.
Some caution would however be prudent, given that alimatravir’s safety and efficacy hasn’t been definitively proven. The final verdict will come from two ongoing Phase 3 clinical trials, called EXPrESSIVE-10 and EXPrESSIVE-11 – both expected to report in 2027. Regulators typically approve medicines only after positive findings from such phase 3 trials.
Alimatravir is already influencing the market
Despite the absence of phase III data, alimatravir is already making waves and affecting the market for HIV prevention products.
The most stark example of this is the recent announcement by Aspen Pharmacare that it will no longer pursue a license to locally manufacture lenacapavir and focus instead on developing its capacity to manufacture alimatravir.
Aspen, along with six other companies, are already licensed to produce generic versions of alimatravir. The unusually early licensing of these companies by MSD (known as Merck in the US and Canada) is a key factor as to why this product is expected to be affordable right out of the gate, if it is shown to be effective in preventing HIV.
No generic companies have yet indicated what price they will charge for alimatravir – but the $3 reference price will no doubt exert some downward pressure.
Why Aspen is no longer pursuing lenacapavir manufacturing
Stavros Nicolaou, senior executive for strategic trade at Aspen Pharmacare, this week told Spotlight that Aspen halted its pursuit of a license to manufacture generic lenacapavir because the South African government’s current pharmaceutical procurement policies and practices provide insufficient assurance that the company will be able to recoup its investments.
The absence of guaranteed procurement by the health department, the lack of a local preference procurement policy, and the existence of competitive products – such as alimatravir – coming down the pipeline all factored in Aspen’s decision, said Nicolaou.
He said that developing manufacturing capacity for tablets, such as alimatravir, is less costly than developing manufacturing capacity for injectables, such as lenacapavir.
“We need greater certainty before we make these investments,” Nicolaou told Spotlight.
He added that the early licensing of alimatravir to enable accelerated generic registration of the product following Phase III trials also made the product an attractive candidate for the company to pursue. He said it was premature to comment on the price they might charge for alimatravir.
Aspen’s decision comes against a broader debate regarding the obligations of the health department to support local pharmaceutical manufacturers, while also delivering on its obligations to maximise the benefits derived from the country’s constrained health budget.
What’s next?
A cheap monthly HIV prevention pill could be a game changer in the fight against HIV in the coming years. However, while data on alimatravir are awaited, its potential arrival has complicated the investment decisions facing pharmaceutical companies, governments, and donors regarding new HIV prevention medicines. It has also raised questions over how the state is, or is not, incentivising local production and procurement of locally produced pharmaceuticals.
The prospect of a monthly pill costing around $3 per year is undeniably exciting. Yet scientists have repeatedly shown that offering a range of prevention medicines—allowing people to choose the option that best suits their needs and lives—improves overall uptake. Even if alimatravir works as well as hoped, there will still be a role for six-monthly lenacapavir, let alone the potential 12-monthly version of the jab that is currently being evaluated in a phase 3 clinical trial.
Either way, while the health department must keep a close eye on the products in the pipeline as it plans for the future, it cannot afford to slow the rollout of the products already available.
*This article was first published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.
