Weekly HIV pill matches daily treatment in landmark global trial
Pan-African · HEALTH
Key Facts
—Trial results: Two phase 3 trials, ISLEND-1 and ISLEND-2, showed the once-weekly islatravir plus lenacapavir pill was non-inferior to daily antiretroviral regimens at 48 weeks.
—Viral suppression: Both the weekly pill and daily treatment arms maintained more than 93 percent viral suppression, with no new safety signals identified.
—Detectable virus: In one trial, no patients on the weekly pill had detectable viral levels at 48 weeks, compared with 0.3 percent on daily Biktarvy. In the second, 0.3 percent on the weekly pill versus 1.3 percent on standard daily regimens.
—African relevance: Sub-Saharan Africa is home to roughly two-thirds of all people living with HIV, where daily pill adherence remains a persistent challenge undermining treatment outcomes.
—Funding crisis: Official development assistance for HIV has declined by about 70 percent, and five donors supply more than 90 percent of international HIV funding, with the United States alone providing 73 percent.
—Corporate alliance: The weekly pill is the flagship product of a global strategic collaboration between Gilead and Merck, formed in 2021 to develop long-acting HIV treatments.
A new once-weekly HIV pill combining islatravir and lenacapavir has matched the effectiveness of leading daily antiretroviral regimens in two landmark phase 3 trials, a result with profound implications for Africa, where two-thirds of the world’s people living with HIV reside and daily pill adherence remains a stubborn barrier to viral suppression.
What the weekly HIV pill trials showed
The investigational regimen is a single tablet taken once weekly, combining Merck’s islatravir, a long-acting nucleoside reverse transcriptase translocation inhibitor, with Gilead’s lenacapavir, a capsid inhibitor already in late-stage development as a twice-yearly injectable for prevention and treatment.
Two 48-week phase 3 studies, ISLEND-1 and ISLEND-2, tested the combination against standard daily antiretroviral therapy (ART) in adults with virologically suppressed HIV-1.
ISLEND-1 was a double-blind trial in which participants switched from daily Biktarvy to the weekly pill or stayed on Biktarvy. ISLEND-2 was an open-label trial comparing the weekly pill against a range of guideline-recommended daily regimens.
Both trials found the weekly pill statistically non-inferior to daily treatment, with more than 93 percent viral suppression maintained in all arms at week 48. Reuters reported that in one trial, none of the patients who switched to the weekly pill had detectable viral levels at 48 weeks, compared with 0.3 percent of those on daily Biktarvy. In the second, 0.3 percent of weekly-pill patients had detectable HIV levels versus 1.3 percent on standard daily regimens.
Why a weekly HIV pill matters for Africa
Sub-Saharan Africa carries the world’s heaviest HIV burden, yet daily oral regimens encounter persistent adherence challenges that undermine their real-world effectiveness.
In the PURPOSE 1 prevention trial among adolescent girls and young women in South Africa and Uganda, daily oral pills allowed 55 new HIV infections among more than 3,000 women, largely because most participants took three or fewer pills per week rather than the prescribed daily dose.
By contrast, the same trial recorded zero infections among 2,134 women receiving twice-yearly lenacapavir injections. For treatment, up to a million people in eastern and southern Africa have unsuppressed viral loads despite nominally being on daily ART, partly due to adherence barriers, stigma and unstable health financing.
A weekly pill directly targets pill fatigue, daily reminder stigma and the chaotic life patterns that undermine daily dosing, while preserving oral autonomy for patients wary of injections or lacking stable access to injection services.
The money question: who pays for the weekly HIV pill
If commercialised at a premium, the weekly pill could create a lucrative new long-acting segment of the global antiretroviral market dominated by Gilead and Merck, intensifying debates around tiered pricing, intellectual property waivers and generic licensing for low- and middle-income countries.
The financing backdrop is grim. Official development assistance for HIV has declined by about 70 percent, and reduced PEPFAR funding now threatens access for more than 222,000 people needing daily treatment across seven high-burden African countries.
Only three African countries meet the Abuja target of allocating 15 percent of public expenditure to health. A recent modelling study estimates that announced international HIV funding cuts of 10 to 70 percent between 2025 and 2026 will markedly increase infections and mortality in low- and middle-income countries.
In this environment, any new technology more expensive per patient than generic daily ART will force hard choices about who gets the weekly pill and who remains on basic regimens.
Donor power and the geopolitics of HIV treatment
The global HIV architecture is profoundly donor-driven. As of 2023, five donors provided more than 90 percent of international HIV funding: the United States at 73 percent, the United Kingdom at 9 percent, France at 4 percent, Germany at 3 percent and the Netherlands at 2 percent.
This concentration gives major donors significant agenda-setting power over which technologies are prioritised, where trials are run and how global guidelines evolve. Sudden cuts to PEPFAR and USAID in early 2025 froze support for HIV research and implementation programmes, terminating more than 6,000 US-funded grants worldwide and destabilising South Africa’s HIV and tuberculosis research ecosystem.
South Africa, with an estimated 7.7 million people living with HIV, saw disruptions to antiretroviral supply chains and service delivery, exposing systemic risks of over-dependence on foreign financing. These dynamics mean access to novel regimens like the weekly pill in African countries will depend heavily on whether PEPFAR, the Global Fund and other donors choose to finance rollout.
The weekly pill also fits into a broader contest over normative and institutional influence, as explored in Africa: The New Scramble. Control over cutting-edge antiretrovirals reinforces Western pharmaceutical and regulatory dominance at a time when China is expanding health investments and Russia is courting African elites.
Africa’s bargaining position and what comes next
African sites contribute significantly to global HIV trial recruitment and data, yet African institutions rarely control the intellectual property or lead large-scale product development. The ISLEND trials fit a pattern where African participants are crucial to demonstrating effectiveness, but ownership of data and commercial returns remains with Northern multinationals.
Emerging domestic financing tools, such as Nigeria’s HIV Trust Fund led by private sector coalitions, offer potential pathways to reduce donor dependency. Weekly regimens could become a catalyst for these mechanisms if framed as an opportunity for national those involved to co-finance access to more convenient, adherence-friendly technologies.
However, given current fiscal constraints and debt pressures, most African health ministries will likely prioritise universal access to basic daily ART before funding premium long-acting options at scale. The question is whether regional bodies such as the African Union and Africa CDC can use collective bargaining to secure better terms on pricing and licensing for weekly pills and injectables.
Earlier-phase data already underpins confidence in the weekly strategy. A phase 2 trial found 94.2 percent viral suppression on weekly islatravir plus lenacapavir versus 92.3 percent on daily Biktarvy at 48 weeks, with no treatment-related serious adverse events. An extension through 96 weeks showed 100 percent maintained viral suppression, mean adherence of 99.3 percent and no emergent resistance.
Frequently Asked Questions
What is the new weekly HIV pill made of?
It is a single tablet combining islatravir, Merck’s long-acting nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, Gilead’s long-acting capsid inhibitor, taken once weekly.
How effective is the weekly pill compared to daily HIV treatment?
Two phase 3 trials showed it was non-inferior to daily regimens, with more than 93 percent viral suppression at 48 weeks and very low rates of detectable virus in both arms.
Will the weekly HIV pill be available in Africa soon?
Access will depend on pricing negotiations, donor financing decisions and whether PEPFAR and the Global Fund choose to support rollout, given severe funding constraints across the continent.
Connected Coverage
For deeper analysis of how pharmaceutical innovation intersects with great-power competition and resource politics across the continent, read Africa: The New Scramble.
Sources
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