Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start
Introduction The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK t...
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Taylor & Francis Group
2025-12-01
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| Series: | HIV Research & Clinical Practice |
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| Online Access: | http://dx.doi.org/10.1080/25787489.2024.2447015 |
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| author | Akif A. Khawaja Gary Whitlock Sarah Fidler Alfredo Soler-Carracedo Merle Henderson Graham P. Taylor Marta Boffito Michael Emerson |
| author_facet | Akif A. Khawaja Gary Whitlock Sarah Fidler Alfredo Soler-Carracedo Merle Henderson Graham P. Taylor Marta Boffito Michael Emerson |
| author_sort | Akif A. Khawaja |
| collection | DOAJ |
| description | Introduction The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function. Methods Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary’s Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák’s multiple comparisons post-test. Results An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23–78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet αIIbβ3 integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function. Conclusions Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens. Clinical Trial Number NCT04653194. |
| format | Article |
| id | doaj-art-d6e81644bb6e4bd29475b953556c8f2d |
| institution | Kabale University |
| issn | 2578-7470 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | HIV Research & Clinical Practice |
| spelling | doaj-art-d6e81644bb6e4bd29475b953556c8f2d2025-01-20T14:37:59ZengTaylor & Francis GroupHIV Research & Clinical Practice2578-74702025-12-0126110.1080/25787489.2024.24470152447015Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART startAkif A. Khawaja0Gary Whitlock1Sarah Fidler2Alfredo Soler-Carracedo3Merle Henderson4Graham P. Taylor5Marta Boffito6Michael Emerson7National Heart and Lung Institute, Imperial College LondonChelsea and Westminster HospitalDepartment of Infectious Disease, Imperial College LondonChelsea and Westminster HospitalDepartment of Infectious Disease, Imperial College LondonDepartment of Infectious Disease, Imperial College LondonChelsea and Westminster HospitalNational Heart and Lung Institute, Imperial College LondonIntroduction The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function. Methods Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary’s Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák’s multiple comparisons post-test. Results An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23–78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet αIIbβ3 integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function. Conclusions Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens. Clinical Trial Number NCT04653194.http://dx.doi.org/10.1080/25787489.2024.2447015drv/c/f/tafbic/ftc/tafhiv infectionrapid art strategytest-and-treatplatelets |
| spellingShingle | Akif A. Khawaja Gary Whitlock Sarah Fidler Alfredo Soler-Carracedo Merle Henderson Graham P. Taylor Marta Boffito Michael Emerson Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start HIV Research & Clinical Practice drv/c/f/taf bic/ftc/taf hiv infection rapid art strategy test-and-treat platelets |
| title | Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start |
| title_full | Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start |
| title_fullStr | Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start |
| title_full_unstemmed | Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start |
| title_short | Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start |
| title_sort | evaluation of the effect of 48 weeks of bic f taf and drv c f taf on platelet function in the context of rapid art start |
| topic | drv/c/f/taf bic/ftc/taf hiv infection rapid art strategy test-and-treat platelets |
| url | http://dx.doi.org/10.1080/25787489.2024.2447015 |
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