Three key studies addressing the future of HIV care for people living with HIV (PLWH) presented at the 26th International AIDS conference demonstrate how locally generated evidence is helping answer the most pressing questions facing HIV programmes across Africa.
The studies presented by the Centre for Epidemiological Modelling and Analysis (CEMA), University of Nairobi, address key evidence gaps including how to safely simplify treatment for ageing populations, what next when resistance to HIV medicines develops and how mothers and children can be protected.
“HIV treatment has transformed millions of lives”, says Dr Loice Ombajo, principal investigator and CEMA co-director. “The results we presented showcase African-led research generating evidence to improve HIV treatment policies for populations often underrepresented in global research including, older adults, people experiencing treatment failure including pregnant and breastfeeding women.”
The first three abstracts are from the Ndovu study, a multi-country prospective cohort study in Kenya, Tanzania, Mozambique and Lesotho examining the optimal approach in the management of people experiencing treatment failure while on dolutegravir (DTG)-based treatment including patterns of DTG drug resistance.
“While resistance to dolutegravir (DTG) has historically been considered rare, increasing use of DTG based antiretroviral therapy (ART) across sub-Saharan Africa has led to increasing recognition of emerging drug resistance,” says Dr Ombajo.
In the first abstract presented, Dr Ombajo shared the resistance testing results following the enrollment of the first 2 994 participants across 131 sites in Kenya who were on DTG-based treatment for at least six months. Participants identified with major DTG-associated drug resistance mutations (DRMs) were enrolled into a nested clinical trial to generate evidence that will guide the optimal management of people experiencing DTG treatment failure.
Between 1 September 2025 and 2 April 2026, 72 participants were randomised to either continue on the standard-dose DTG (38 participants) or switch to a ritonavir-boosted darunavir (DRV/r)-based regimen (34 participants).
Early results demonstrated better viral suppression among participants receiving DRV/r. At one month, 80% (24 of 30) of participants in the DRV/r arm had a drop in viral load, compared with 19% (seven of 37) in the DTG arm. By month three, 83% (20 of 24) of participants receiving DRV/r had achieved viral suppression, compared with 13% (three of 23) in the DTG arm.
“There is currently limited evidence to guide the management of dolutegravir (DTG) resistance among people living with HIV,” Dr Ombajo says. “Through the Ndovu Study, we are generating much-needed evidence to inform treatment decisions for patients who develop DTG resistance. These results reinforce the urgent need for accessible tools to detect DTG resistance and support timely, evidence-based treatment decisions, particularly in resource-limited settings.”
These preliminary findings suggest that, in the presence of major DTG-associated drug resistance mutations, continuing standard-dose DTG is associated with a higher risk of virological failure and that switching to DRV/r is highly recommended.
The results also highlight the urgent need for better tools to identify DTG resistance and determine when patients should be switched to alternative treatment, particularly in settings where drug resistance testing is not widely or routinely available.
Following an early review of the interim analysis on 8 April 2026, the Independent Data Safety and Monitoring Board recommended stopping randomisation to the DTG treatment arm, reflecting the clear difference in outcomes observed between the two treatment groups.
The Ndovu study also disseminated findings on the characteristics and clinical outcomes of pregnant and breastfeeding women with persistent HIV viraemia (viruses present in the bloodstream) while receiving DTG-based treatment. Infant infections account for about 10% of new HIV infections globally with sub-optimal adherence to HIV treatment and resultant viraemia during pregnancy and breastfeeding being the most likely cause of the infection.
The findings, shared by Dr Ombajo, revealed that in a cohort of 109 pregnant and breastfeeding women, the majority of the women are 25 years old or older, have been on treatment for more than 1 year, and had high viraemia of more than 10 000 copies/mL. Enhanced adherence intervention resulted in more than half of the mothers achieving virological suppression within 3 months while on the same treatment, demonstrating the need for timely viral load testing and targeted adherence interventions to eliminate vertical transmission.
The fourth abstract is the Sungura Study,which looked at whether a simpler HIV treatment is safer for older people living with HIV. The study followed 197 adults aged 60 years and above in Kenya who switched from a three-drug HIV treatment regimen (Bictegravir/Emtricitabine/Tenofovir Alafenamide) to a simpler two-drug combination of Dolutegravir and Lamivudine.
The new treatment does not include Tenofovir, a medicine that also helps protect against the Hepatitis B virus. Researchers wanted to find out whether removing Tenofovir would increase the risk of Hepatitis B returning in people who had been exposed to the virus before.
After 72 weeks, the results were reassuring. Among the 92 participants, who had previously been exposed to Hepatitis B, 98% showed no signs of active infection, and none experienced a return of the virus or developed a new Hepatitis B infection.
These findings suggest that the simpler two-drug HIV treatment is a safe option for older adults who have previously been exposed to Hepatitis B. The study also reinforces the importance of increasing Hepatitis B vaccination to help protect more people from the disease.
The significance of these findings extended beyond the conference presentations. Dr. Ombajo was also invited to present the findings of the Ndovu study at the World Health Organization (WHO) pre-conference Think Tank on HIV treatment, where the emerging evidence contributed to ongoing discussions on updating global guidance for the management of people living with HIV who experience treatment failure despite DTG-based therapy.