Monthly HIV injections cuts treatment failure in half, offering hope for 126,000 Kenyans
The injection removes the daily decision entirely. There is one appointment per month. The health worker administers the dose. The patient leaves protected for 30 days.
What you need to know:
- While 91 per cent of Kenyans on HIV treatment achieve viral suppression, 126,000 people are left behind due to adherence hurdles.
People living with HIV who struggle to take daily medication and maintain an undetectable viral load may soon have a far more manageable option: a monthly injection. A major clinical trial has now proven this long-acting regimen to be significantly more effective than the daily pill.
The LATITUDE trial specifically enrolled the patients that most programmes quietly give up on; those who had stopped taking their antiretroviral drugs, been lost to follow-up for months, or maintained dangerously high viral loads despite having an active prescription. These were not patients who didn't want to get better, but those for whom the daily discipline of HIV treatment had become an impossible ask.
According to the findings, monthly injections of cabotegravir combined with rilpivirine, two antiretroviral drugs delivered as a long-acting injectable formulation, were superior to continued daily oral antiretroviral therapy in reducing treatment failure among people with HIV who had documented adherence challenges. Researchers say the implications should reshape how every country managing an HIV epidemic approaches the patients not being reached by the current standard of care.
The trial, presented during the just-concluded International AIDS Society conference and published in the New England Journal of Medicine, enrolled 453 participants across 33 sites in the United States, with 63 per cent of the participants being Black.
The trial unfolded in two steps. In the first, participants received up to 24 weeks of adherence support, counseling, and conditional financial incentives tied to viral-load reduction and clinic attendance. Of the 453 enrolled, 306 achieved viral suppression sufficient to proceed to the second step.
In step two, participants were randomly assigned either to continue their daily oral antiretroviral regimen or to switch to monthly injections of cabotegravir-rilpivirine.
The injections were administered at the clinic, no remembering required, no daily decision, no pill bottle to hide or forget.
Among those who received the monthly injections, regimen failure, defined as either confirmed viral rebound or permanent treatment discontinuation, occurred in 22.8 per cent of participants by week 48. Among those who continued daily oral therapy, regimen failure occurred in 41.2 per cent, nearly double.
The trial, funded by the National Institute of Allergy and Infectious Diseases, was designed to show non-inferiority, that the injection was at least as good as the pill.
Instead, it showed that in patients with adherence challenges, the injection was substantially better.
Across the step-two visits, only 34 per cent to 46 per cent of participants in the daily oral therapy group reported no missed doses in the 30 days before their clinic visit.
This means that between 54 per cent and 66 per cent of patients on daily pills missed at least one dose in the preceding month, every month. For the injection group, 94 per cent of injections were administered on time.
The injection removes the daily decision entirely. There is one appointment per month. The health worker administers the dose. The patient leaves protected for 30 days.
A daily antiretroviral regimen demands that one take the pill at the same time every day, without missing a dose. In HIV treatment, where the consequences of inconsistent dosing include viral rebound, treatment failure, and the development of drug resistance that narrows future options, that daily decision is a sustained act of will requiring routine and stability.
A discrete choice experiment conducted among 700 people with HIV at Kenyatta National Hospital and two sex worker outreach clinics in Nairobi found that patients living with HIV in Kenya expressed clear preferences for long-acting antiretroviral therapies over daily oral regimens, citing potential to improve adherence and achieve viral suppression.
More than 1.4 million people in the country live with the virus. Kenya's HIV programme is one of the most successful in sub-Saharan Africa, and its adherence data reflects both how far the country has come and how far it has yet to go.
Of the approximately 1.4 million Kenyans living with HIV, 96 per cent know their status, 94 per cent are on antiretroviral therapy, and 91 per cent have achieved viral suppression, figures that place Kenya ahead of many peer countries on the UNAIDS 95-95-95 targets.
However, the nine per cent of the 1.4 million Kenyans who are on treatment but not suppressed, about 126,000 people, requires urgent attention. It means they are taking antiretroviral drugs that are not controlling their virus. Some were newly initiated; others have developed resistance or are struggling to take their medication consistently.
Kenya approved injectable cabotegravir for HIV prevention in 2024. The regulatory pathway for injectable cabotegravir-rilpivirine for HIV treatment is the logical next step, and the LATITUDE trial has now provided the phase 3 randomised evidence that would support a regulatory submission.
The question is whether NASCOP, the Pharmacy and Poisons Board, and Kenya's health financing system will move fast enough for patients failing on daily pills right now to benefit from an intervention that has been proven to work.
Four years remain before the 2030 target of ending AIDS as a public health threat. Kenya is at 91% viral suppression. Getting from 91 per cent to 95 per cent, the final gap, will not be achieved by doing more of what has already been done. It will be achieved by reaching the patients for whom what has already been done is not working.
