A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT
Background Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. This study, BIC-T&T, evaluates the efficacy a...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | HIV Research & Clinical Practice |
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| Online Access: | http://dx.doi.org/10.1080/25787489.2024.2400453 |
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| _version_ | 1846094948123803648 |
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| author | Gary Whitlock Sarah Fidler Amanda Clarke Sujin Kang Arnold Xhikola Ana Milinkovic Alfredo Soler-Carracedo Merle Henderson Tanya Adams Ishrat Jahan Akif Khawaja Graham Taylor Marta Boffito |
| author_facet | Gary Whitlock Sarah Fidler Amanda Clarke Sujin Kang Arnold Xhikola Ana Milinkovic Alfredo Soler-Carracedo Merle Henderson Tanya Adams Ishrat Jahan Akif Khawaja Graham Taylor Marta Boffito |
| author_sort | Gary Whitlock |
| collection | DOAJ |
| description | Background Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. This study, BIC-T&T, evaluates the efficacy and tolerability of B vs D in a UK test‐and‐treat setting. Setting BIC-T&T was a randomised, open-label, multi-centre, study in which participants initiated ART within 14 days after confirmed HIV‐1 diagnosis before baseline laboratory. Methods The primary endpoint is the virological response (HIV RNA < 50copies/mL) at week 12 by time-weighted average change in log10 HIV RNA recorded in viral load assays from treatment initiation to week 12, using two-sample Wilcoxon rank-sum test. Results 36 participants were randomised: 94% were male, 53% white; mean (SD) age was 35 years (11.8). Baseline mean (±SD) log10 HIV-RNA was 4.79 (± 0.87) log10 copies/mL and CD4 505 (±253) cells/mm3. The mean (±SD) time from confirmed HIV diagnosis to ART initiation was 7.9 (± 3.7) days. The time-weighted mean decrease in log10 HIV RNA from treatment initiation to week 12 was significantly greater in B in comparison to D (3.1 vs. 2.6 log10 copies/mL, p < 0.001). Both regimens demonstrated good tolerability with infrequent laboratory abnormalities and no grade 3 or 4 adverse events. Conclusion In this first head-to-head study in the context of ART initiation, HIV RNA decline from baseline to week 12 was significantly more rapid for BIC/F/TAF compared with DRV/c/F/TAF. |
| format | Article |
| id | doaj-art-9e23f4a375f7405fbca2fac53b5ac0e0 |
| institution | Kabale University |
| issn | 2578-7470 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | HIV Research & Clinical Practice |
| spelling | doaj-art-9e23f4a375f7405fbca2fac53b5ac0e02025-01-02T11:44:28ZengTaylor & Francis GroupHIV Research & Clinical Practice2578-74702024-12-0125110.1080/25787489.2024.24004532400453A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnTGary Whitlock0Sarah Fidler1Amanda Clarke2Sujin Kang3Arnold Xhikola4Ana Milinkovic5Alfredo Soler-Carracedo6Merle Henderson7Tanya Adams8Ishrat Jahan9Akif Khawaja10Graham Taylor11Marta Boffito12Chelsea and Westminster HospitalImperial College LondonUniversity Hospitals Sussex NHS Foundation TrustChelsea and Westminster HospitalChelsea and Westminster HospitalChelsea and Westminster HospitalChelsea and Westminster HospitalImperial College LondonUniversity Hospitals Sussex NHS Foundation TrustImperial College LondonImperial College LondonImperial College LondonChelsea and Westminster HospitalBackground Head-to-head data for bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF; B) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF; D) are lacking in the context of rapid antiretroviral therapy (ART) initiation. This study, BIC-T&T, evaluates the efficacy and tolerability of B vs D in a UK test‐and‐treat setting. Setting BIC-T&T was a randomised, open-label, multi-centre, study in which participants initiated ART within 14 days after confirmed HIV‐1 diagnosis before baseline laboratory. Methods The primary endpoint is the virological response (HIV RNA < 50copies/mL) at week 12 by time-weighted average change in log10 HIV RNA recorded in viral load assays from treatment initiation to week 12, using two-sample Wilcoxon rank-sum test. Results 36 participants were randomised: 94% were male, 53% white; mean (SD) age was 35 years (11.8). Baseline mean (±SD) log10 HIV-RNA was 4.79 (± 0.87) log10 copies/mL and CD4 505 (±253) cells/mm3. The mean (±SD) time from confirmed HIV diagnosis to ART initiation was 7.9 (± 3.7) days. The time-weighted mean decrease in log10 HIV RNA from treatment initiation to week 12 was significantly greater in B in comparison to D (3.1 vs. 2.6 log10 copies/mL, p < 0.001). Both regimens demonstrated good tolerability with infrequent laboratory abnormalities and no grade 3 or 4 adverse events. Conclusion In this first head-to-head study in the context of ART initiation, HIV RNA decline from baseline to week 12 was significantly more rapid for BIC/F/TAF compared with DRV/c/F/TAF.http://dx.doi.org/10.1080/25787489.2024.2400453drv/c/f/tafbic/ftc/tafhiv infectionrapid art strategytest-and-treat |
| spellingShingle | Gary Whitlock Sarah Fidler Amanda Clarke Sujin Kang Arnold Xhikola Ana Milinkovic Alfredo Soler-Carracedo Merle Henderson Tanya Adams Ishrat Jahan Akif Khawaja Graham Taylor Marta Boffito A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT HIV Research & Clinical Practice drv/c/f/taf bic/ftc/taf hiv infection rapid art strategy test-and-treat |
| title | A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT |
| title_full | A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT |
| title_fullStr | A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT |
| title_full_unstemmed | A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT |
| title_short | A randomised control trial of BIC/F/TAF vs DRV/c/F/TAF in context of HIV test-and-treat, BicTnT |
| title_sort | randomised control trial of bic f taf vs drv c f taf in context of hiv test and treat bictnt |
| topic | drv/c/f/taf bic/ftc/taf hiv infection rapid art strategy test-and-treat |
| url | http://dx.doi.org/10.1080/25787489.2024.2400453 |
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