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Lenacapavir is being rolled out across Africa as a breakthrough in HIV prevention. In this op-ed, Kennedy Odokonyero, a specialist, examines whether current access strategies are adequately supported by pharmacovigilance systems, warning that rapid deployment without clear safety oversight risks repeating past mistakes seen during earlier antiretroviral rollouts.
“Access alone is not success. Without clear accountability for safety monitoring, we risk undermining the long-term impact of even the most promising innovations,” says Mr Odokonyero.
He argues that ambiguity between drugmaker Gilead Sciences, global health partners and national regulators is weakening ownership of safety systems. As the marketing authorisation holder, Gilead must lead pharmacovigilance efforts, supported by locally coordinated frameworks to ensure Lenacapavir is safely deployed.
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By Kennedy Odokonyero, a pharmacovigilance specialist from Uganda.
About a fortnight ago, the Ministry of Health in Uganda launched the use of Lenacapavir, which has been described as a revolutionary drug for HIV prevention. Other African countries like Mozambique, Lesotho, Zimbabwe, and Kenya, have also recently introduced the drug. Lenacapavir has been praised for its high effectiveness and convenience, as it is administered subcutaneously only twice a year, in contrast to the daily pills previously used for pre-exposure prophylaxis (PrEP).
Public discourse on Lenacapavir (LEN) has largely focused on access, on ensuring it reaches populations most in need, particularly in countries with the highest HIV burden. On 14 April 2026, the Global Fund, together with the United States, announced plans to expand access to LEN to reach 3 million people by 2028.
According to Gilead Sciences, the patent holder and Marketing Authorisation Holder (MAH) of Lenacapavir, the access strategy for low and middle-income countries has two components: direct provision in coordination with the Global Fund and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), and voluntary licensing to generic manufacturers. The former is the mechanism through which countries like Uganda are currently accessing the drug. Generic manufacturing is expected to begin next year.
The rollout of Lenacapavir brings back memories of the introduction of Dolutegravir (DTG) about a decade ago, whose ambitious implementation and related treatment strategies was unfortunately not accompanied by commensurate efforts to strengthen safety monitoring. As a drug safety enthusiast, I have been keen to understand the strategy for monitoring the safety of Lenacapavir among those receiving it.
Are we going to make the same mistake with Lenacapavir? I hope not. We should have learned from safety issues such as hyperglycemia and erectile dysfunction that emerged with DTG. While no major safety concerns were documented in the Lenacapavir clinical trials; the most commonly reported adverse reactions being injection site reactions, headache, and nausea, the inherent limitations of clinical trials may not identify all safety issues before a drug is approved for use. This is where pharmacovigilance becomes critical, ensuring continuous monitoring of a product’s safety after approval.
Cursory review of the access strategy by Gilead, the Global Fund, and PEPFAR, points to a lack of pharmacovigilance incorporated within it. However, the WHO Kenya office noted during the launch of Lenacapavir in Kenya in February this year that it was strengthening safety monitoring systems for the drug.
A key challenge with this access model, where drugs are donated to countries by development partners, is that responsibility for pharmacovigilance often becomes blurred. National Medicines Regulatory Authorities (NMRAs) may face undue pressure from partners and political leaders to fast-track drug approvals. In such environments, pharmacovigilance requirements are frequently sidelined.
The responsibility for pharmacovigilance (PV) lies with the MAH, in this case, Gilead Sciences. Yet Gilead could argue that it does not directly supply the drug to countries, as distribution is facilitated through the Global Fund. In turn, the Global Fund may shift responsibility to the ministries of health receiving the drug. Within this web of ambiguity and lack of a clear strategy, it becomes difficult to determine who is responsible for resourcing and ensuring accountability for the safety of Lenacapavir. Moreover, with Gilead providing low-cost versions of the drug to African countries, it may argue that it lacks sufficient financial incentive to invest heavily in PV systems.
Since October last year, 12 NMRAs in Africa have approved Lenacapavir through accelerated regulatory pathways. These include South Africa, Eswatini, Zambia, Zimbabwe, Malawi, Tanzania, Rwanda, Botswana, Uganda, Kenya, Namibia, and Mozambique. These regulatory authorities should compel Gilead to take full responsibility for the pharmacovigilance of Lenacapavir and ensure compliance with national PV regulations and guidelines. Gilead should appoint Local Qualified Persons for Pharmacovigilance (LQPPVs) at the country or regional level to coordinate PV activities with NMRAs and partners.
In the short term, Gilead, together with its partners, should establish an active surveillance system to monitor the safety of Lenacapavir. Under such a system, individuals receiving LEN would complete a baseline survey at initiation and consent to follow-up contact to report any suspected adverse drug reactions (ADRs) or adverse events (AEs). A risk management programme should also be implemented, including a robust safety communication strategy targeting both the public and healthcare professionals. This programme should not adopt a one-size-fits-all approach; rather, it should be tailored to the specific context of each country where the drug is deployed.
As noted during the launch in Uganda, there are concerns that some individuals might misuse LEN by engaging in higher risk sexual behaviour, potentially increasing their risk of other sexually transmitted infections (STIs). This further underscores the importance of effective safety communication during rollout.
Routine pharmacovigilance activities such as reporting ADRs and AEs, and submitting Periodic Safety Update Reports (PSURs) to NMRAs, should be conducted alongside active surveillance. In the long term, Post Authorisation Safety Studies (PASS) should be undertaken to better understand the incidence of safety concerns and associated risk factors. Longitudinal follow up studies should also be conducted among individuals receiving LEN to identify any adverse effects associated with long term use.
Lenacapavir represents a major breakthrough in HIV prevention, but access without accountability is a missed opportunity. If pharmacovigilance is not built into its rollout from the outset, we risk repeating avoidable mistakes. Clear ownership, adequate resourcing, and coordinated safety monitoring are not optional extras; they are essential components of responsible public health delivery. The success of Lenacapavir will not only be measured by how many people receive it, but also by how safely it is used.
This was first published here