Biktarvy could be long-term option for older adults with HIV

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Bictegravir-emtricitabine-tenofovir alafenamide (BIC/FTC/TAF; Biktarvy, Gilead) could be a long-term option for older adults with HIV (HIV Med 2022 May 8 https://doi.org/10.1111/ hiv.13319).

“Clinical trial data in older people with HIV are unavailable for many treatment regimens,” said the study’s corresponding author, Joel Gallant, MD, MPH, the executive director of Global Medical Affairs for Gilead Sciences, in Santa Fe, N.M. “This study highlights the safety of switching to the BIC/FTC/TAF regimen in older PLWH [people living with HIV]. The week 96 outcomes showed that switching is an effective and well-tolerated long-term treatment option with a high barrier to resistance in the growing population of older people living with HIV.”

More Tolerable Data

The 96-week phase 3b, open-label, single-arm study compared 86 men previously taking elvitegravir-cobicistat-FTC-TAF (Stribild, Gilead) or a tenofovir disoproxil fumarate–based regimen with BIC/FTC/TAF. Ultimately, 77 men completed the study. Patients who switched to BIC/FTC/TAF achieved virologic suppression rates of 94.2% and 74.4% at weeks 72 and 96, respectively.

The lower efficacy at week 96 “was due to COVID shutdowns, with 11 participants being unable to come to their week 96 study visit,” Dr. Gallant said. By excluding these data, 96-week efficacy was 100%.

The most common adverse events (AEs) of BIC/FTC/TAF have been nausea, diarrhea and headache. In this study, two people reported a grade 3 AE and none reported a grade 4 event.

In addition, patients maintained viral suppression without it affecting weight or kidney function; some saw their lipid levels drop from baseline to week 96 with a 19% reduction in fasting triglycerides and a 0.2% reduction in total cholesterol to high-density lipoprotein ratio.

“In my experience with older patients with HIV, it is rare that I have had someone who cannot tolerate it when switched,” said Judith Aberg, MD, the chief of the Division of Infectious Disease for the Icahn School of Medicine at Mount Sinai and Mount Sinai Health System, in New York City, because it was already found to be effective and well tolerated in this age group through 48 weeks (Infect Dis Ther 2021;10[2]:775-788). “I was surprised that almost 13% experienced treatment-emergent adverse events in this small study, as we usually see this more often when you start a regimen, rather than when you switch.”

Yet, the AEs “are not surprising for an older adult population,” said Kristine Erlandson, MD, an associate professor of medicine and epidemiology at the University of Colorado Anschutz Medical Campus, in Aurora. “Distinguishing adverse effects due to medication versus new events that are more common with aging becomes a bit more challenging in this older population,” she said. She cited sleep disturbances as a common issue among older adults, “particularly over the long duration of follow-up in this study,” she said.

Dr. Erlandson also noted that questions about weight gain with this regimen were not clearly answered in this study population with limited racial/ethnic and gender diversity. However, she appreciated the study’s focus on older adults.

“I commend the authors for focusing on this older adult population who is often excluded from clinical trials.”

This study “adds a little bit, but not much” to existing research about HIV medications, but more studies that compare one regimen to another are needed, Dr. Aberg said.

In 2018, more than 50% of Americans diagnosed with HIV were at least 50 years old. “By 2030, more than 80% of people living with HIV will have at least one age-related medical condition, such as cancer or heart disease,” Dr. Gallant said. “The burdens of HIV, aging and related health comorbidities necessitate a focus on improving long-term health and quality of life.”

By Cheryl Alkon

 

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