Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials
Abstract Introduction Older adults with HIV, particularly those ≥ 50 years of age, face unique health challenges due to a higher prevalence of comorbidities and polypharmacy, which can impact medication adherence and increase the risk of adverse events. We assessed the efficacy and safety of bictegr...
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2025-08-01
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| Online Access: | https://doi.org/10.1186/s12879-025-11476-3 |
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| author | Cissy M. Kityo Samir K. Gupta Princy N. Kumar Amy R. Weinberg Bhumi Gandhi-Patel Hui Liu Jason T. Hindman Jürgen K. Rockstroh |
| author_facet | Cissy M. Kityo Samir K. Gupta Princy N. Kumar Amy R. Weinberg Bhumi Gandhi-Patel Hui Liu Jason T. Hindman Jürgen K. Rockstroh |
| author_sort | Cissy M. Kityo |
| collection | DOAJ |
| description | Abstract Introduction Older adults with HIV, particularly those ≥ 50 years of age, face unique health challenges due to a higher prevalence of comorbidities and polypharmacy, which can impact medication adherence and increase the risk of adverse events. We assessed the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV (PWH) ≥ 50 years of age across treatment-naïve and virologically suppressed cohorts over a long-term follow-up. Methods This post hoc analysis included participants ≥ 50 and < 50 years of age from six phase 3 trials of B/F/TAF, comprising 2 treatment-naïve studies and 4 virologically suppressed studies. Outcomes were assessed through Week 240 for the treatment-naïve cohort and Week 48 for the virologically suppressed cohort. Key measures included virologic outcomes (HIV-1 RNA < 50 or ≥ 50 copies/mL), CD4 T-cell changes, adherence, metabolic and renal parameters, treatment-emergent adverse events, and treatment-emergent diabetes and hypertension. Results The treatment-naïve cohort included 96 participants ≥ 50 years of age and 538 participants < 50 years of age, while the virologically suppressed cohort included 450 participants ≥ 50 years of age and 640 participants < 50 years of age. By Week 240, virologic suppression was achieved in 98.5% of treatment-naïve participants ≥ 50 years of age and in 98.6% of those < 50 years of age, as determined using missing = excluded analysis. By Week 48, virologic failure was 0.9% versus 1.4% in participants ≥ 50 years of age versus < 50 years of age, respectively, and virologic suppression was maintained in 93.6% of virologically suppressed participants in both the ≥ 50 and < 50 years of age groups, as assessed using the US Food and Drug Administration snapshot algorithm. Across age groups, the treatment-naïve and virologically suppressed cohorts demonstrated comparable outcomes beyond viral load through Weeks 240 and 48, respectively, including CD4 T-cell changes, adherence rates of ≥ 95%, body weight, lipid profiles, renal function, bone health, treatment-emergent adverse events, and the incidence of treatment-emergent diabetes and hypertension. Conclusions These results highlight the durability, long-term efficacy, safety, and overall benefits of B/F/TAF in PWH ≥ 50 years of age. |
| format | Article |
| id | doaj-art-74459031c2d14ba19013f997c857382a |
| institution | Kabale University |
| issn | 1471-2334 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj-art-74459031c2d14ba19013f997c857382a2025-08-24T11:10:12ZengBMCBMC Infectious Diseases1471-23342025-08-0125111210.1186/s12879-025-11476-3Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trialsCissy M. Kityo0Samir K. Gupta1Princy N. Kumar2Amy R. Weinberg3Bhumi Gandhi-Patel4Hui Liu5Jason T. Hindman6Jürgen K. Rockstroh7Joint Clinical Research CentreIndiana University School of MedicineGeorgetown University Medical CenterGilead Sciences, IncGilead Sciences, IncGilead Sciences, IncGilead Sciences, IncUniversity Hospital BonnAbstract Introduction Older adults with HIV, particularly those ≥ 50 years of age, face unique health challenges due to a higher prevalence of comorbidities and polypharmacy, which can impact medication adherence and increase the risk of adverse events. We assessed the efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with HIV (PWH) ≥ 50 years of age across treatment-naïve and virologically suppressed cohorts over a long-term follow-up. Methods This post hoc analysis included participants ≥ 50 and < 50 years of age from six phase 3 trials of B/F/TAF, comprising 2 treatment-naïve studies and 4 virologically suppressed studies. Outcomes were assessed through Week 240 for the treatment-naïve cohort and Week 48 for the virologically suppressed cohort. Key measures included virologic outcomes (HIV-1 RNA < 50 or ≥ 50 copies/mL), CD4 T-cell changes, adherence, metabolic and renal parameters, treatment-emergent adverse events, and treatment-emergent diabetes and hypertension. Results The treatment-naïve cohort included 96 participants ≥ 50 years of age and 538 participants < 50 years of age, while the virologically suppressed cohort included 450 participants ≥ 50 years of age and 640 participants < 50 years of age. By Week 240, virologic suppression was achieved in 98.5% of treatment-naïve participants ≥ 50 years of age and in 98.6% of those < 50 years of age, as determined using missing = excluded analysis. By Week 48, virologic failure was 0.9% versus 1.4% in participants ≥ 50 years of age versus < 50 years of age, respectively, and virologic suppression was maintained in 93.6% of virologically suppressed participants in both the ≥ 50 and < 50 years of age groups, as assessed using the US Food and Drug Administration snapshot algorithm. Across age groups, the treatment-naïve and virologically suppressed cohorts demonstrated comparable outcomes beyond viral load through Weeks 240 and 48, respectively, including CD4 T-cell changes, adherence rates of ≥ 95%, body weight, lipid profiles, renal function, bone health, treatment-emergent adverse events, and the incidence of treatment-emergent diabetes and hypertension. Conclusions These results highlight the durability, long-term efficacy, safety, and overall benefits of B/F/TAF in PWH ≥ 50 years of age.https://doi.org/10.1186/s12879-025-11476-3HIVOlder adultsB/F/TAFAntiretroviral therapyComorbidities |
| spellingShingle | Cissy M. Kityo Samir K. Gupta Princy N. Kumar Amy R. Weinberg Bhumi Gandhi-Patel Hui Liu Jason T. Hindman Jürgen K. Rockstroh Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials BMC Infectious Diseases HIV Older adults B/F/TAF Antiretroviral therapy Comorbidities |
| title | Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials |
| title_full | Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials |
| title_fullStr | Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials |
| title_full_unstemmed | Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials |
| title_short | Efficacy and safety of B/F/TAF in treatment-naïve and virologically suppressed people with HIV ≥ 50 years of age: integrated analysis from six phase 3 clinical trials |
| title_sort | efficacy and safety of b f taf in treatment naive and virologically suppressed people with hiv ≥ 50 years of age integrated analysis from six phase 3 clinical trials |
| topic | HIV Older adults B/F/TAF Antiretroviral therapy Comorbidities |
| url | https://doi.org/10.1186/s12879-025-11476-3 |
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