South Africa's HIV Prevention Drug Faces Funding Gap as $29.2M Allocation Falls Short

SOUTH AFRICA’S LENACAPAVIR ROLLOUT STALLS ON COST AND SUPPLY CONSTRAINTS

A $29.2 million Global Fund allocation and a $60 per-person annual price tag sit at the center of South Africa’s lenacapavir rollout, and neither figure is large enough to close the gap between what the country has and what it needs. Fewer than 47,000 people have been initiated since the June rollout began across 360 health facilities, a number that health economists say falls dramatically short of the scale required to move the needle on transmission rates.

The Global Fund secured its procurement agreement with Gilead, the drug’s manufacturer, and directed that $29.2 million from its three-year grant to South Africa specifically toward lenacapavir. At the negotiated $60 annual per-person cost, the budget covers approximately 420,000 doses. The problem is the math on the other side of the ledger. Health economists at the Health Economics and Epidemiology Research Office at Wits University, working with the Thembisa mathematical model of South Africa’s HIV epidemic, calculate that the country needs to initiate between 1.7 million and 2.3 million people annually for at least five years to achieve meaningful reductions in transmission. The five-year investment required reaches $106 million. Experts note, however, that this remains four times more cost-effective than scaling oral pre-exposure prophylaxis, and lenacapavir could end AIDS seven to ten years earlier than existing pill-based prevention.

The pricing structure exposes the tension between current affordability and long-term viability. Hasina Subedar, senior technical advisor to the South African Department of Health, explains that while the Global Fund negotiated the $60 annual price with Gilead under confidential terms, mass rollout is not sustainable without generic competition. South Africa has added lenacapavir to its essential medicines list, but conditional on generics becoming available at $40 per annual dose.

In October 2024, Gilead signed non-exclusive, royalty-free voluntary licensing agreements with six manufacturers: Dr Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero, and Mylan. The company prioritized 18 high-incidence, resource-limited countries, South Africa among them. Of those six manufacturers, only Hetero has submitted its regulatory dossier to the South African Health Products Regulatory Authority. Generic availability is expected by mid-2027, though the timeline for actual South African market entry remains uncertain.

Meanwhile, the funding landscape has shifted in ways that complicate the picture further. The United States government declined to support South Africa’s lenacapavir procurement over political disagreements, a withdrawal that coincides with broader funding cuts affecting HIV prevention organizations since January 2025, when the Trump administration took office. The Children’s Investment Fund Foundation has stepped in to provide assistance, partially filling the gap left by the US exit. Organizations serving key populations have faced severe funding reductions regardless: sex worker advocates and peer educators have lost positions, specialized clinics have closed, and mobile outreach has halted. A newly formed organization, Tholwana e Molemo, has begun partnering with government clinics to provide lenacapavir access to sex workers, though with substantially limited resources.

Targeting strategy matters as much as total capital deployed. Experts recommend allocating 45 percent of doses to adolescent girls and young women, 30 percent to men who have sex with men, 15 percent to female sex workers, and 10 percent to pregnant and breastfeeding women. Current data tells a different story: over 70 percent of the 47,000 people initiated describe themselves as general population, making it difficult to assess whether the program is reaching priority groups at all. The health department’s own allocation targets weight teenage girls, young women, and pregnant and breastfeeding women more heavily than epidemiological modeling suggests is optimal.

On the clinical side, the initiation protocol spans two days, beginning with two 1.5-milliliter subcutaneous injections, followed by two 300-milligram pills, with two additional pills taken on day two. Patients report that the six-monthly injection schedule is substantially more convenient than daily oral pills, though injection site reactions persist for weeks (visible bumps at the abdomen that can interfere with clothing fit are among the most commonly reported effects). Despite this, over 80 percent of people surveyed by the Desmond Tutu Health Foundation, which conducted lenacapavir clinical trials, prefer the injectable over oral options. Further details on South Africa’s lenacapavir strategy are available at https://healthpolicy-watch.news/south-africa-grapples-with-the-promise-and-price-of-injectable-prevention-drug-lenacapavir/

The pharmaceutical pipeline adds another variable for investors and procurement planners to watch. Merck/MSD is conducting clinical trials on alimatravir, a monthly PrEP pill that may attract users seeking more frequent dosing intervals. The company has already granted voluntary licenses to seven generic manufacturers, including three in sub-Saharan Africa, before efficacy has even been established. Multiple prevention modalities are likely to coexist, with distribution potentially expanding beyond government clinics to private pharmacies and self-administration of follow-up doses.

Whether South Africa can mobilize sufficient capital and supply chain capacity to reach 1.7 to 2.3 million annual initiations is the question that will define the program’s legacy. Generic production timelines, sustained funding commitments, and patient retention after initial doses will determine whether lenacapavir becomes a transformative market-scale intervention or remains a limited-access tool for those who can navigate the current system’s constraints.