HIV prevention drug hailed as breakthrough, but who gets access?

Lenacapavir, a twice-a-year injection could transform HIV prevention, but it will not be available to all.

A health official holds lenacapavir, a long‑acting HIV prevention treatment, in Epworth outside the capital Harare, Zimbabwe, February 19, 2026 [Philimon Bulawayo/Reuters]

A medicine injected just twice a year could transform the fight against HIV.

In a 2024 clinical trial involving more than 2,000 young women in South Africa and Uganda, no participants who received lenacapavir contracted HIV.

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Developed by United States pharmaceutical company Gilead Sciences, the injectable drug can be used to prevent HIV.

“It’s the most innovative tool that has reached the HIV arena for the last decade, because it’s the closest we have [to] a vaccine,” Carlota Baptista da Silva, global HIV lead at Doctors Without Borders (known by its French initials, MSF), told Al Jazeera.

The World Health Organization has recommended the long-acting injectable as an additional form of pre-exposure prophylaxis, or PrEP – medicine to reduce the risk of getting HIV.

But the arrival of the drug comes at a challenging juncture in the global fight against HIV.

International funding for HIV fell 18 percent in 2025, to $7.3bn, its lowest level in nearly two decades, according to the United Nations programme on HIV/AIDS (UNAIDS). The squeeze has already hit prevention programmes: The number of people receiving medicine to reduce risk fell from 1.4 million in 2024 to 1.1 million in 2025.

That makes the arrival of a highly effective, twice-yearly prevention option significant. The question of who can access it is now more urgent.

For MSF, the scientific question has largely been answered: lenacapavir can prevent HIV with remarkable efficacy.

The fight now is whether the rules governing manufacture, price and supply will allow that scientific breakthrough to reach the people who need it.

Why some countries are excluded

In the United States, lenacapavir costs about $28,000 per person annually. Generic versions are expected to cost about $40 a year.

A generic version is a copy of the original drug made by another manufacturer after the patent holder licenses the technology. It contains the same active ingredient, but it can be produced and sold at a much lower price.

In June 2025, the US Food and Drug Administration (FDA) approved lenacapavir for HIV prevention, giving people the option of an injection twice a year. But in several low- and middle-income countries, access to cheaper versions is not expected at scale until 2027.

Gilead is supplying its own version of lenacapavir at no profit for programmes supported by the Global Fund and the US President’s Emergency Plan for AIDS Relief (PEPFAR), with rollouts under way in countries including South Africa, Kenya, Zambia, Nigeria and Eswatini.

These are not the cheaper generic versions expected to cost about $40 per person a year. Gilead has licensed six manufacturers to produce those, with large-scale generic rollout expected in 2027.

At least 26 middle-income countries are excluded from Gilead’s generics agreement, MSF says, including countries with rising HIV infections and some that helped test the drug. Among them are Brazil, Mexico, Argentina and Peru.

“People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access,” da Silva said.

According to MSF, countries excluded from the licence accounted for close to 23 percent of new HIV infections globally in 2023.

Gilead has since announced a separate agreement with the Pan American Health Organization, creating an access pathway for 14 Latin American and Caribbean countries outside its generic licensing territory, including Brazil, Mexico, Argentina and Peru.

MSF argues that leaves those countries dependent on Gilead rather than able to automatically buy the cheaper generics.

MSF says it still cannot buy the drug

For more than a year, MSF says it has sought permission to purchase lenacapavir directly from Gilead for its medical programmes, without demanding a discounted price.

“Despite those requests, Gilead has not allowed MSF to purchase this medicine directly,” da Silva said.

That matters particularly in humanitarian emergencies, she argues. People displaced by conflict or disaster may struggle to take a prevention pill every day, while sexual violence and other vulnerabilities can increase the risk of HIV.

Daily PrEP pills are already available as an alternative to the injection. But unlike lenacapavir, they need to be taken consistently to provide protection. An injection offering six months of protection could be particularly valuable.

“People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation,” da Silva said.

Gilead declined Al Jazeera’s request for an interview due to scheduling constraints. In its emailed statement, it said its access strategy combines no-profit supplies, royalty-free licensing and regional agreements. It didn’t reply to questions about why it won’t sell its drug to MSF, or why certain countries were excluded from its generics agreement.

The company plans to provide enough lenacapavir for up to three million people through 2028 as generic manufacturers scale up production, with large-scale generic rollout expected in 2027.

MSF says that is nowhere near the scale required, pointing to projections that close to 20 million people worldwide need access to PrEP to substantially reduce new HIV infections. That includes all forms of PrEP, not just lenacapavir.

But countries left outside Gilead’s generic licensing deal may have another option.

Can governments bypass the patent barriers?

World Trade Organization (WTO) rules allow governments, in some cases, to bypass a drug company’s patent so cheaper versions of a medicine can be made or imported without the company’s permission.

They can also authorise government use of patents and challenge patents they consider weak or unjustified. The 2001 Doha Declaration affirmed WTO members’ right to use such safeguards to protect public health.

Brazil has used them before in the fight against HIV. In 2007, after negotiations with pharmaceutical company Merck over the price of the HIV drug efavirenz failed, Brazil issued a compulsory licence allowing it to access cheaper generic versions of the medicine.

Nearly two decades later, activists are urging Brazil to consider using those powers again for lenacapavir if patent barriers prevent affordable generic access.

MSF says governments excluded from Gilead’s licence could consider those same legal safeguards for lenacapavir, including compulsory licensing, government-use authorisations and challenges to patents.

It is also calling on Gilead to ensure its agreements with generic manufacturers do not prevent them from supplying countries where patent barriers have been removed through such measures.

For MSF, the stakes go beyond lenacapavir. The way the drug is made available could determine whether one of the greatest advances in HIV prevention in decades reaches people based on need, rather than where they live or what their health systems can afford.

“For a humanitarian medical organisation, we should not have to spend more than a year trying to find a way to buy a WHO-recommended medicine,” da Silva said.

每年注射两次的Lenacapavir可能会改变艾滋病毒的预防方式，但并非所有人都能获得这种药物。

2026年2月19日，在津巴布韦首都哈拉雷郊外的埃普沃斯，一名卫生官员手持长效艾滋病预防药物来那卡帕韦。[菲利蒙·布拉瓦约/路透社]

每年只需注射两次的药物，就能彻底改变抗击艾滋病的斗争。

2024 年，南非和乌干达进行了一项涉及 2000 多名年轻女性的临床试验，结果显示，接受 lenacapavir 治疗的参与者中，没有一人感染 HIV。

列表 1/4：实现无艾滋病一代的目标指日可待，但并非必然。

报告显示，美国削减对全球艾滋病治疗的资金援助，造成四项援助中的第二项沉重打击：美国削减援助资金将对全球艾滋病治疗造成打击

列表 3/4：在塞内加尔，一位母亲的遭遇暴露了不堪重负的医疗系统。

列表 4/4：它是“最接近 HIV 疫苗的东西”，但谁能获得它？

该注射药物由美国制药公司吉利德科学公司研发，可用于预防艾滋病毒感染。

“这是过去十年来艾滋病领域最具创新性的工具，因为它最接近疫苗，”无国界医生组织（MSF）全球艾滋病负责人卡洛塔·巴普蒂斯塔·达席尔瓦告诉半岛电视台。

世界卫生组织建议将长效注射剂作为一种额外的暴露前预防（PrEP）方式，即降低感染 HIV 风险的药物。

但这种药物的到来正值全球抗击艾滋病毒斗争面临严峻挑战之际。

根据联合国艾滋病规划署（UNAIDS）的数据，2025年国际社会对艾滋病防治的资金投入下降了18%，至73亿美元，为近20年来的最低水平。资金紧缩已经对预防项目造成了冲击：接受降低感染风险药物治疗的人数从2024年的140万下降到2025年的110万。

因此，一种高效的、每年两次的预防方案的出现意义重大。现在，谁能获得这种方案的问题变得更加紧迫。

对于无国界医生组织来说，科学问题已基本得到解答：lenacapavir 可以显著有效地预防 HIV。

现在争论的焦点在于，现行的生产、价格和供应规则是否能够让这项科学突破惠及真正需要它的人。

为什么有些国家被排除在外？

在美国，每人每年服用勒那卡帕韦的费用约为28,000美元。预计仿制药的费用约为每年40美元。

仿制药是指专利持有人获得技术许可后，由其他生产商生产的原研药的复制品。它含有相同的活性成分，但生产和销售价格要低得多。

2025年6月，美国食品药品监督管理局（FDA）批准了lenacapavir用于预防艾滋病毒感染，使人们可以选择每年注射两次。但在一些中低收入国家，预计要到2027年才能大规模获得价格更低廉的同类药物。

吉利德公司正以非盈利方式向全球基金和美国总统艾滋病紧急救援计划（PEPFAR）支持的项目提供其自主研发的lenacapavir，目前已在包括南非、肯尼亚、赞比亚、尼日利亚和斯威士兰在内的多个国家推广使用。

这些并非预计每人每年花费约40美元的廉价仿制药。吉利德已授权六家制造商生产这些仿制药，预计将于2027年大规模上市。

无国界医生组织表示，至少有26个中等收入国家被排除在吉利德公司的仿制药协议之外，其中包括艾滋病毒感染率不断上升的国家以及一些曾参与该药物测试的国家。这些国家包括巴西、墨西哥、阿根廷和秘鲁。

“人们不应该真正帮助产生突破性药物的证据，然后却发现自己的国家被排除在负担得起的仿制药之外，”达席尔瓦说。

据无国界医生组织称，2023 年，被排除在许可范围之外的国家占全球新增 HIV 感染病例的近 23%。

吉利德随后宣布与泛美卫生组织达成一项单独协议，为吉利德仿制药许可区域之外的 14 个拉丁美洲和加勒比海国家（包括巴西、墨西哥、阿根廷和秘鲁）开辟了一条准入途径。

无国界医生组织认为，这使得这些国家依赖于吉利德公司，而不是能够自动购买更便宜的仿制药。

无国界医生组织表示，他们仍然无法购买这种药物。

无国界医生组织表示，一年多来，他们一直寻求直接从吉利德公司购买lenacapavir用于其医疗项目，而没有要求折扣价。

“尽管我们提出了这些请求，但吉利德公司仍未允许无国界医生组织直接购买这种药物，”达席尔瓦说。

她认为，这一点在人道主义紧急情况下尤为重要。因冲突或灾害而流离失所的人可能难以每天服用预防性药物，而性暴力和其他脆弱因素会增加感染艾滋病毒的风险。

目前已有每日服用的PrEP药片作为注射剂的替代方案。但与来那卡帕韦不同，药片需要持续服用才能提供保护。如果能注射一种药物，提供长达六个月的保护，那就显得尤为重要。

“生活在冲突和人道主义危机中的人们不应该成为医疗创新最不重要的群体，”达席尔瓦说。

吉利德公司以日程安排冲突为由拒绝了半岛电视台的采访请求。该公司在电子邮件声明中表示，其药品获取策略结合了非营利性供应、免版税许可和区域性协议。对于为何不向无国界医生组织出售其药品，以及为何某些国家被排除在其仿制药协议之外，吉利德公司均未作出回应。

该公司计划到 2028 年为多达 300 万人提供足够的 lenacapavir，同时仿制药生产商扩大生产规模，预计将于 2027 年大规模推出仿制药。

无国界医生组织表示，这远远达不到所需规模，并指出据预测，全球近2000万人需要获得暴露前预防（PrEP）药物才能大幅降低新增艾滋病毒感染病例。这包括所有形式的PrEP药物，而不仅仅是来那卡帕韦。

但那些未获得吉利德仿制药授权协议的国家可能还有其他选择。

政府能否绕过专利壁垒？

世界贸易组织 (WTO) 的规则允许各国政府在某些情况下绕过制药公司的专利，以便在未经公司许可的情况下生产或进口更便宜的药品。

它们还可以授权政府使用专利，并对它们认为薄弱或不合理的专利提出质疑。2001 年《多哈宣言》确认了世贸组织成员有权使用此类保障措施来保护公众健康。

巴西此前曾在抗击艾滋病疫情中使用过强制许可。2007年，在与制药公司默克就艾滋病药物依非韦伦的价格谈判失败后，巴西颁布了强制许可，允许其使用价格更低的仿制药。

近二十年后，活动人士敦促巴西考虑再次利用这些权力来获取lenacapavir，以防专利壁垒阻碍了人们获得价格合理的仿制药。

无国界医生组织表示，被排除在吉利德许可范围之外的各国政府可以考虑对lenacapavir采取同样的法律保障措施，包括强制许可、政府使用授权和专利挑战。

它还呼吁吉利德公司确保其与仿制药生产商的协议不会阻止他们向通过此类措施取消专利壁垒的国家供应药品。

对无国界医生组织而言，事关重大，远不止是莱那卡帕韦本身。这种药物的供应方式可能决定着，几十年来艾滋病预防领域最伟大的进展之一，能否真正惠及有需要的人，而不是取决于他们的居住地或医疗系统的经济能力。

达席尔瓦说：“对于一个人道主义医疗组织来说，我们不应该花费一年多的时间来寻找购买世界卫生组织推荐药物的方法。”