EACS2023: 362 Restarting bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after virologic rebound: a pooled analysis of studies in people with HIV-1 A. Pozniak , C. Orkin , F. Maggiolo , Y. Yazdanpanah , A. Baumgarten , K. Mounzer , M.L. D'Antoni , H. Huang , H. Liu , K. Andreatta , L. VanderVeen , C. Callebaut , J.T. Hindman , H. Martin , J.R. Arribas Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom, Queen Mary University of London, London, United Kingdom, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy, AP-HP Hôpital Bichat, Paris, France, Center for Infectious Diseases, Berlin, Germany, Philadelphia FIGHT, Philadelphia, United States, Gilead Sciences, Inc., Foster City, United States, Hospital Universitario La Paz, Madrid, Spain, Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain General data Abstract category: Antiretroviral therapy – randomised clinical trials Abstract body Purpose: Management of HIV-1 virologic failure without resistance includes reinitiation of antiretroviral therapy to regain virologic suppression. Most antiretroviral agents are studied for their ability to suppress HIV-1 as first-line therapy, or in people who already have virologic suppression and are switching regimens. We examined outcomes following virologic rebound in people with HIV-1 receiving B/F/TAF. Method: Participants who received B/F/TAF in switch studies 1844, 1878, 1961, 4030, 4449 and 4580, and first-line studies 1489, 1490 and 4458, were included. Viral load was analyzed at baseline/Day 1, at Weeks 4, 8 and 12, then every 12 weeks through end of study and at unscheduled visits. Virologic rebound events (defined as ≥1 viral load ≥1,000 copies/mL after virologic suppression [<50 copies/mL]) were counted and categorized by subsequent virologic suppression or viremia (≥50 copies/mL). Time to virologic suppression (first value <50 copies/mL) after virologic rebound and duration of viremia (time between virologic rebound event and last ≥50 copies/mL value) were calculated. Results: In total, 110 virologic rebound events were identified in 96 of the 3,768 participants (2.5%; Table). Ninety-one virologic rebound events (82.7%) were followed by subsequent resuppression [median time: 23 days (interquartile range [IQR]: 19–38)]. Seven virologic rebound events (6.4%) were followed by continued viremia that persisted without resuppression for a median of 30 days (IQR: 14–87) before discontinuation of B/F/TAF, without emergence of resistance; 12 virologic rebound events (10.9%) were not evaluable (virologic rebound at last assessment). Excluding non-evaluable virologic rebound events, resuppression was noted in 91/98 (92.9%) virologic rebound events. Conclusions: Among people who experienced virologic rebound after virologic control, the majority achieved rapid virologic resuppression with B/F/TAF. No treatment-emergent resistance was observed, supporting the high barrier to resistance of B/F/TAF. Table. Virologic rebound and outcomes by participant and event Participants with any virologic rebound event, n/N (%) [95% CI]* Virologic rebound events, n/N (%) [95% CI]* Resuppressed 77/96 (80.2) [70.8, 87.6] 91/110 (82.7) [74.3, 89.3] Continued viremia 7/96 (7.3) [3.0, 14.4] 7/110 (6.4) [2.6, 12.7] Virologic rebound event not evaluable 12/96 (12.5) [6.6, 20.8] 12/110 (10.9) [5.8, 18.3] Resuppressed (not evaluable=excluded) 77/84 (91.7) [83.6, 96.6] 91/98 (92.9) [85.8, 97.1] Continued viremia (not evaluable=excluded) 7/84 (8.3) [3.4, 16.4] 7/98 (7.1) [2.9, 14.2] *95% CIs were calculated using the Clopper–Pearson exact method; Resuppressed after last virologic rebound event CI, confidence interval General conditions 1. I confirm that I previewed this abstract and that all information is correct. I accept that the content of this abstract cannot be modified or corrected after the submission deadline and I am aware that it will be published exactly as submitted.: Yes 2. I confirm that the submission of the abstract constitutes my consent to publication (e.g. conference website, programmes, other promotions, etc.). : Yes 3. I herewith confirm that the contact details saved in this system are those of the corresponding author, who will be notified about the status of the abstract. The corresponding author is responsible for informing the other authors about the status of the abstract.: Yes 4. I agree that all data provided may be used (saved, stored, processed, transmitted and deleted) in compliance with the privacy policy to provide the services described.: Yes 1 2 3 4 5 6 7 7 7 7 7 7 7 7 8,9 1 2 3 4 5 6 7 8 9 † † 199
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