A groundbreaking, twice-yearly injection for HIV prevention is hailed as a potential 'game-changer'. However, it is at the centre of a fierce debate regarding affordability. Health activists worldwide implore its manufacturer, Gilead Sciences, to prevent a "missed opportunity for achieving equity." This twice-yearly HIV jab could revolutionise prevention efforts. But that will only occur if it becomes accessible to all.
The US-based pharmaceutical company announced on Wednesday that its long-acting injectable, lenacapavir (branded as Yetzugo), has received approval from the US Food and Drug Administration (FDA). The jab has demonstrated nearly complete protection against HIV infection, providing a powerful new tool. Public health experts believe it could be as impactful as a vaccine in halting the virus. This twice-yearly HIV jab is being eagerly anticipated by many.
However, the excitement surrounding this scientific milestone is overshadowed by profound concerns about its price. In the United States, lenacapavir is expected to cost approximately $28,218 per year for treatment. Global health bodies and activists have slammed this figure. They argue the price will place the drug far beyond the reach of the governments and individuals who need it most.
'Game-Changer' with a Prohibitive Price Tag?
The core of the issue lies in the vast disparity between the announced US price and the potential cost of generic production. A recent paper in *The Lancet* estimates that a generic version could be produced for as little as $25 to $46 per person per year. This creates a stark contrast with Gilead’s commercial price. Despite its twice-yearly injection model, the HIV jab faces affordability hurdles.
UNAIDS Executive Director Winnie Byanyima said lenacapavir could be the tool we need to bring new infections under control. However, that would be possible only if it is priced affordably and made available to everyone who could benefit from it. She described the US price as "beyond comprehension" and urged Gilead to "do the right thing. Drop the price, expand production and ensure the world has a shot at ending AIDS".
Activists Demand Equitable Access
An international coalition of health activists, including South Africa’s Health Justice Initiative (HJI), has heavily criticised Gilead's access strategy. The company has offered voluntary licences to six generic manufacturers to supply 120 low- and middle-income countries.
However, the coalition points out that this list critically excludes many countries with high HIV burdens, such as South Africa and Brazil. They argue this move will allow Gilead to "maximise profit in those excluded countries through opaque, inflated 'tiered pricing' deals." These deals will be unaffordable for individuals and the health systems that serve them. Access to the twice-yearly HIV jab in these regions is uncertain.
HJI director Fatima Hassan said accelerating global access to affordable injectable lenacapavir should be the top priority for Gilead Sciences CEO Daniel O'Day. However, it will only be rolled out effectively if all low- and middle-income countries are included. Additionally, there should be a single affordable access price.
The South African Context: A Glimmer of Hope?
The debate holds particular significance for South Africa. The country carries the world's most severe HIV burden, with an estimated 7.8 million people living with the disease and 173,000 new infections last year alone.
For more than three decades, the world has searched for an HIV vaccine. Existing prevention methods like daily pills (oral PrEP) and condoms are effective, but they are not suitable for everyone. A twice-yearly injection offers a discreet and more manageable alternative. This could be a breakthrough in the form of an HIV jab.
A South African modelling study presented earlier this year found that widespread use of lenacapavir could accelerate the country's efforts. It could help eliminate HIV as a public health threat by a decade. Researchers argued that even at $100 a shot, it would be significantly more cost-effective than other prevention methods.
Gilead submitted its application for lenacapavir to the South African Health Products Regulatory Authority (SAHPRA) in March 2025. The regulator has confirmed the review is underway, but a decision is still pending.
Pricing Not Determined Outside the USA
Gilead has stated that pricing for lenacapavir has not yet been determined for any region outside the US. A spokesperson said the company is "committed to achieving broad, sustainable access" in high-incidence, resource-limited countries. The company is executing an access strategy that "prioritises speed and enables the most efficient paths for regulatory review, approval of and access". The twice-yearly HIV jab could help meet these commitments. But that will only occur if priced reasonably.
The company has also committed to providing lenacapavir at no profit to high-burden countries until generic supplies are available. However, the specific 'no-profit' price has not been disclosed.