Shs 102M for HIV Prevention? | Lenacapavir Correct Price

Everything you need to know about Lenacapavir HIV Prevention Drug

Recent reports by Daily Monitor claimed that Lenacapavir HIV Prevention will cost approximately 102 million Ugandan shillings (UGX) per person annually. This story caused a lot of noise on social media with many claiming that HIV prevention is reserved for only the rich people. But, will Lenacapavir really cost Shs 102M practically or is it in theory? This new drug, marketed as Yeztugo, offers up to 100% efficacy in preventing HIV infection when administered twice yearly. However, its high price has sparked concerns about accessibility, particularly in high-burden countries like Uganda.

United States Food and Drug Administration (FDA) approved Lenacapavir in June 2025 as a long-acting injectable drug. This will most definitely transform the global fight against HIV. This comprehensive article will help you deeply understand everything about the new breakthrough. We dig into its mechanism, benefits, side effects, target populations, cost realities, and broader implications. Read till the end if you are one of the individuals, healthcare providers, and policymakers seeking to understand this groundbreaking tool.

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What is Lenacapavir?

This is a first-in-class antiretroviral drug developed by Gilead Sciences, a U.S.-based pharmaceutical company renowned for its contributions to HIV treatment and prevention. Unlike daily oral pre-exposure prophylaxis (PrEP) medications such as Truvada or Descovy, Lenacapavir is a long-acting injectable administered subcutaneously (under the skin) once every six months. This biannual dosing schedule makes it a highly convenient option for preventing HIV infection, addressing adherence challenges associated with daily pills. As a capsid inhibitor, Lenacapavir targets the HIV capsid—the protein shell encasing the virus’s genetic material—offering a novel approach to blocking viral replication.

Clinical trials, including the PURPOSE 1 trial involving over 5,300 adolescent girls and young women in South Africa and Uganda, demonstrated 100% efficacy, with no participants in the Lenacapavir arm acquiring HIV. The PURPOSE 2 trial, covering cisgender men, transgender individuals, and non-binary people across multiple countries, showed a 96% reduction in HIV incidence. These results, hailed as the 2024 “Breakthrough of the Year” by Science magazine, position Lenacapavir as a game-changer, particularly in regions with high HIV prevalence like sub-Saharan Africa, where 1.3 million new infections occur annually.

Origins and Development

Lenacapavir emerged from Gilead Sciences’ decades-long research into antiretroviral therapies, driven by the need for innovative, user-friendly HIV prevention tools. Supported by global health partnerships, including collaborations with the World Health Organization (WHO) and clinical trial networks in high-prevalence settings, the drug underwent rigorous testing. The FDA’s approval in June 2025 for PrEP followed its earlier 2022 approval as Sunlenca for treating multi-drug-resistant HIV. Trials in Uganda and South Africa highlighted its potential to address barriers like stigma and inconsistent healthcare access.

Gilead’s pricing has drawn scrutiny, echoing debates over earlier drugs like Truvada. Advocacy from global health leaders, including Winnie Byanyima of UNAIDS, emphasizes affordable access in low- and middle-income countries. The drug’s development aligns with WHO’s push for long-acting PrEP to achieve the UNAIDS 90-90-90 targets and end AIDS by 2030.

How Does Lenacapavir Work?

The new HIV treatment uses a mechanism as a capsid inhibitor which is unique. The HIV capsid facilitates viral entry, assembly, and replication. Lenacapavir binds to the capsid, disrupting these processes at multiple stages, preventing infection. Its long-acting formulation, delivered as a 463.5 mg/1.5 mL subcutaneous injection in the abdomen, maintains therapeutic levels for six months, offering continuous protection without daily adherence. This is particularly advantageous in Uganda, where HIV prevalence is 5.1% among adults, and key populations like sex workers (37% prevalence) and men who have sex with men (13.7% in Kampala) face stigma-related barriers.

Who is Ugandan Dr Alex Kintu at Gilead and is he involved in the Lenacapavir research?

Dr. Alex Kintu is a Ugandan physician, epidemiologist, and global health researcher who has made significant contributions to the fight against HIV. He began his career as a rural clinician in western Uganda and later took on roles in HIV clinical trials and treatment expansion across East Africa. With advanced training in epidemiology from the University of Massachusetts and a PhD in Global Health from Harvard, Dr. Kintu combined his medical expertise with rigorous scientific research.

At Gilead Sciences, where he serves as Director for Clinical Development, he played a crucial role in developing lenacapavir, a long-acting injectable drug for HIV prevention. During a major clinical trial conducted in Uganda and South Africa, lenacapavir achieved a groundbreaking result—none of the women who received the injection contracted HIV. Dr. Kintu was central in designing and overseeing these trials, ensuring the drug’s safety and its remarkable effectiveness, which marks a major breakthrough in HIV prevention, especially for women in high-risk communities.

Who is Lenacapavir For?

Lenacapavir is designed for individuals at substantial risk of HIV infection seeking effective, discreet prevention. Target populations include:

• Key Populations: Sex workers, men who have sex with men, transgender individuals, and people who inject drugs face elevated risk due to social and legal barriers. Biannual dosing reduces clinic visits, minimizing stigma exposure.
• Adolescent Girls and Young Women: In sub-Saharan Africa, this group faces high HIV incidence due to gender-based violence and limited agency. PURPOSE 1 focused on this demographic, showing 100% efficacy.
• Individuals with Adherence Challenges: Those unable to maintain daily oral PrEP due to forgetfulness, travel, or privacy concerns benefit from Lenacapavir’s simplicity.
• Serodifferent Couples: Partners of HIV-positive individuals can reduce transmission risk discreetly.
• General Population in High-Prevalence Areas: If costs decrease, broader rollout in Uganda could address community-level transmission.

Lenacapavir is for HIV-negative individuals, not treatment. Separate trials are evaluating its use for HIV treatment.

Benefits of Lenacapavir

Lenacapavir offers significant advantages:

• Unmatched Efficacy: 100% in PURPOSE 1 and 96% in PURPOSE 2, surpassing oral PrEP’s 99% with perfect adherence but lower with inconsistent use.
• Convenience: Two injections per year reduce clinic visits and adherence burdens.
• Discretion: Injectable administration avoids stigma associated with pill bottles.
• Low Resistance Risk: No major resistance mutations were found in Ugandan HIV strains (subtypes A1 and D), with only 1.6% showing minor mutations.
• Scalability: If affordable, Lenacapavir could support Uganda’s 90-90-90 goals.

Side Effects and Safety

Lenacapavir is well-tolerated, with trial data from WHO and Gilead providing detailed safety profiles:

• Common Side Effects:
• Injection site reactions (pain, redness, swelling, or nodules) affected 68.8% of Lenacapavir recipients vs. 34.9% for placebo, mostly mild and resolving quickly. Only 0.2% discontinued due to reactions.
• Nausea, fatigue, or headache occurred in 5–10% of users, typically transient.
• Less Common Side Effects:
• Gastrointestinal issues (e.g., diarrhea) were reported in under 5%.
• Allergic reactions are rare but require monitoring.
• Serious Side Effects:
• No life-threatening events were reported in prevention trials. Long-term safety monitoring continues.
• Drug interactions may occur, as Lenacapavir is metabolized by the liver. Consult providers if taking rifampin or anticonvulsants.

HIV testing is required before starting and every 6–12 months during use to prevent resistance in undiagnosed cases. Limited data on pregnancy suggests no major concerns, but consultation is advised.

Administration and Access

Lenacapavir is administered by healthcare workers as a 1.5 mL subcutaneous injection in the abdomen, taking minutes with minimal follow-up beyond monitoring reactions. In Uganda, integration into PEPFAR or Ministry of Health programs could streamline delivery, but the National Drug Authority’s approval is pending. Gilead has filed for regulatory approval in Brazil, South Africa, and other countries, with WHO review expected to guide global guidelines.

The Cost of Lenacapavir: A Detailed Breakdown

The Daily Monitor reported Lenacapavir’s annual cost at 102 million UGX ($28,218 USD, based on a 2025 exchange rate of 3,600 UGX to 1 USD), covering two injections at approximately $14,109 (51 million UGX) each. This U.S. list price, lower than its $42,250 treatment cost as Sunlenca, is unaffordable in Uganda, where GDP per capita is 3.5 million UGX ($970 USD). Below is a detailed analysis:

1. Sticker Price Context:

• The $28,218 price includes research, development, manufacturing, and Gilead’s profit margin. In the U.S., insurance or assistance programs may offset costs, but these are unavailable for most Ugandans.
• Researchers estimate generic Lenacapavir could cost $25–$46 per year with a 30% profit margin, assuming 5–10 million doses annually.

1. Cost Components:

• Drug Cost: The medication dominates expenses, unlike ART programs where consumables (drugs and labs) are 60% of costs ($91–$100 per client annually). Biannual dosing reduces service costs (clinic visits: $9.66–$16.43 per year).
• Administration Costs: Injections require syringes, swabs, and staff time. Human resources (4–23% of ART costs) and indirect costs (1–2%) are minimal.
• Hidden Costs: Transportation or time-off-work costs are lower than monthly ART/PrEP refills due to biannual visits.

1. Comparative Costs:

• Oral PrEP costs $30–$60 per year in low-income settings, with quarterly visits. Lenacapavir’s $28,218 is 470–940 times higher.
• ART in Uganda averages $152 per client annually, making Lenacapavir 185 times costlier.

1. Potential Reductions:

• Generic Production: Gilead’s agreements with six generic manufacturers for 120 low-income countries could lower costs, though middle-income nations like Brazil are excluded. Uganda’s Quality Chemicals Limited could produce generics.
• Donor Support: PEPFAR and the Global Fund historically funded ART/PrEP, but an 83% PEPFAR cut under the Trump administration threatens support.
• Price Negotiations: Gilead’s “no-profit” supply for 2 million people is insufficient for 1.3 million annual infections, requiring 40–50 treatments per prevented case. Advocacy seeks a $40 target price.
• Cost-Effectiveness: The Lancet estimates maximum per-dose prices for cost-effectiveness: $106.28 in South Africa, $21.15 in Zimbabwe, $16.58 in western Kenya.

1. Public Sentiment:

• X posts reflect frustration, calling Lenacapavir “for the elite” or joking “only the rich will avoid HIV”. Byanyima urged a $40 price to ensure equity.

How much will the new HIV treatment really cost in Uganda?

The reported cost of Lenacapavir in Uganda, pegged at 102 million UGX ($28,218 USD) annually per person by the Daily Monitor, reflects Gilead Sciences’ U.S. list price for the twice-yearly injectable, as confirmed by sources like The New York Times and The Observer. However, this figure is misleading for Uganda’s context, as it does not account for potential price reductions through generic production, donor support, or Gilead’s access programs.

Research published in The Lancet HIV and The Guardian estimates that generic HIV treatment could be mass-produced for $25–$46 per year (approximately 90,000–165,600 UGX) with a 30% profit margin if demand reaches 5–10 million doses annually. Gilead has agreements with six generic manufacturers to supply low-cost versions to 120 low-income countries, including Uganda, and has committed to providing doses at no profit for 2 million people until generics are available.

While National Drug Authority approval is pending, integration into donor-funded programs like PEPFAR could further reduce costs, potentially aligning Lenacapavir’s price closer to oral PrEP’s $30–$60 per year (108,000–216,000 UGX). Thus, the 102 million UGX price is a high-income market figure, and with advocacy and scale-up, the actual cost in Uganda could be over 600 times lower, making it a viable tool to combat HIV’s 5.1% prevalence.

Implications for Uganda

With 1.5 million people living with HIV and 37,000 new infections annually, Uganda’s HIV prevalence dropped from 7.2% (2010) to 5.1% (2024). Lenacapavir could accelerate progress toward ending AIDS by 2030, especially for key populations facing stigma. However, PEPFAR funding cuts and the high cost threaten access, particularly for community clinics serving high-risk groups. Strategies include:

• Advocacy: Engage Gilead for lower prices or generic licensing.
• Supply Chains: Use ART infrastructure for cold-chain storage.
• Targeted Rollout: Prioritize key populations while costs are high.
• Local Manufacturing: Leverage Uganda’s pharmaceutical capacity.

Global Context and Advocacy

Lenacapavir aligns with WHO’s push for long-acting PrEP, alongside cabotegravir and the dapivirine ring. The Access to Medicines movement urges Gilead to license generics for all low- and middle-income countries, as exclusions like Brazil hinder equity. A proposed 5-by-3 target aims for 5 million people on long-acting PrEP by 2030.

Practical Considerations for Users

• Consult Providers: Assess risk, medical history, and drug interactions.
• Confirm HIV Status: Test before starting and every 6–12 months.
• Monitor Side Effects: Report persistent reactions or symptoms.
• Access Support: Use Uganda’s HIV counseling and peer groups to navigate stigma.

What you should know

Lenacapavir is a groundbreaking HIV prevention tool, offering unmatched efficacy and convenience. Its 100% efficacy in women and 96% in diverse populations could transform Uganda’s epidemic, particularly for key populations. However, at 102 million UGX ($28,218 USD) annually, it remains inaccessible without price reductions to $25–$46 via generics, donor support, or negotiations. As advocacy pushes for equity, Lenacapavir’s promise must reach those most in need to end HIV by 2030.

Sources:

• Daily Monitor, “New HIV prevention drug to cost Shs102m,” June 19, 2025.
• The Guardian, “HIV drug could be made for just $40 a year for every patient,” July 23, 2024.
• The New York Times, “Regulators Approve Lenacapavir for H.I.V. Prevention,” June 18, 2025.
• The Lancet HIV, “Health impact, budget impact, and price threshold for cost-effectiveness of lenacapavir,” September 20, 2024.
• New England Journal of Medicine, “Twice-Yearly Lenacapavir for HIV Prevention in Cisgender Women,” July 24, 2024.
• WHO, “Long-acting injectable lenacapavir proves effective in HIV prevention for women,” July 26, 2024.
• Gilead Sciences, “Yeztugo Lenacapavir Is Now the First and Only FDA Approved HIV Prevention Option,” June 18, 2025.
• Posts on X, various users, June 19–20, 2025.