The Efficacy of New HIV Treatment in Older Adults

Age-associated health issues and the adverse effects of certain antiretroviral treatments (ART) restrict the treatment options for older individuals living with HIV.

In a presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) Loice Achieng Ombajo's, MBChB, MMED, study discussed assessing the effectiveness and safety of transitioning older adults to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from a primary treatment regimen.

Transitioning to B/F/TAF has been proven effective and safe for individuals aged 60 years and older who are virally suppressed on a regimen containing Tenofovir Disoproxil Fumarate (TDF). This switch is linked to enhanced bone mineral density (BMD) and reduced need for treatment adjustments owing to declining kidney function, establishing it as a suitable therapeutic option for this demographic.

“We have an increasingly aging population of persons living with HIV,” stated Ombajo. “Half of the people living with HIV or AIDS are above 50, and with aging comes other complications and concerns. So largely, it's the accumulation of comorbidities, with terrible things like hypertension, diabetes, increasingly bone disease and kidney disease, the conditions that influence treatment, and influence patient outcome.”

None of the participants experiencing protocol-defined virologic failure reached the ≥500 copies/ml level necessary for drug resistance testing. The average percentage change in lumbar spine BMD showed a significant increase of 2.17% for the B/F/TAF group compared to an increase of 0.61% for the control group, favoring B/F/TAF. Grade 3 or 4 adverse events (AEs) were rare, with no serious treatment-related AEs reported, and a smaller number of individuals in the B/F/TAF group stopped the medication due to AEs than those in the control group (CAR).

“We found that up to 60% of patients have osteoporosis, which is a significant bone disease that increases bone fragility and the risk of bones breaking,” Ombajo explains. “So that's a high proportion that's generally not reported. And that was quite concerning. The other concern laboratory noted earlier on in the studies that many of our patients up to about 40% had impaired kidney function.”

From February to May 2022, 520 people were split into 2 treatment groups, each with 260 people: one receiving B/F/TAF and the other CAR. Out of these, 296 were also monitored for bone density (143 in the B/F/TAF group and 153 in the CAR group). All participants were Black, with an average age of 64, and about half (267 or 51%) were women, ensuring comparable diversity in both groups from the start. By the 48th week, HIV levels were above the target in 5 (1.9%) individuals in the B/F/TAF group and 7 (2.7%) in the CAR group, indicating that the treatments were similarly effective.

“We're looking at the bones, we're looking at the kidneys, the liver, the sugar, the cholesterol,” explains Ombajo. “We haven't had too many safety concerns in the study. Because this is an older population, we saw a bit of a bit of mortality from things like malignancies, and cardiovascular diseases.”

Participants were evenly split to either transition to B/F/TAF or stick with their existing ARV regimen (CAR). The main outcomes measured were the percentage of subjects with an HIV-1 RNA level of 50 copies/mL or higher at the 48-week mark in the intention-to-treat-exposed group, as per the FDA Snapshot algorithm with a 4% non-inferiority margin, and the average change in lumbar spine BMD from the start of the study to week 48.

Ombajo's investigation addresses the needs of the aging HIV population by offering a safer, more effective option with low drug resistance and adverse events. The research underscores the importance of personalized treatments for older adults with HIV, indicating a change toward accommodating the changing health challenges of this demographic in future HIV treatment protocols.

Reference

Ombajo L, Penner J, Nkuranga J, et. al. A Randomized Trial Switching Adults ≥ 60 Years Old From First-Line ART to B/F/TAF: Week 48 Results. Poster #643 presented at CROI 2024. March 3-6, 2023. Denver, CO.