Abstract Background Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) is a guideline-recommended treatment for HIV that has shown high levels of efficacy. EMPOWER assessed experiences with and reasons for switching to daily oral B/F/TAF from bimonthly injectable cabotegravir + rilpivirine (CAB + RPV) among people with HIV (PWH). Methods This Phase 4, single-arm, open-label multicenter study (NCT06104306) assessed switching to B/F/TAF in virologically suppressed PWH unable to continue on CAB + RPV or who expressed a preference to switch to oral therapy. Participants were aged ≥ 18 years, had received ≥ 1 (and no missed) doses of CAB + RPV, and had documented HIV-1 RNA 50 copies/mL for ≥ 6 months prior to screening. Treatment satisfaction was assessed using the HIV Treatment Satisfaction Questionnaire: status version (HIVTSQs) at baseline (BL), Week (W)12, and W24. Satisfaction with treatment change was assessed using the HIVTSQ: change version (HIVTSQc) at W4. A study-specific questionnaire on reasons for decision to switch therapies was completed at BL and W4. W12 interim analyses were completed using descriptive statistics. Results 29 participants from North America were included (Table 1). Of those with available data, 21 (84.0%) had ≥ 95% adherence up to W12. All participants achieved HIV-1 RNA 50 copies/mL at W4 and W12 (missing = excluded). After switching to B/F/TAF, improvements from BL in treatment satisfaction (HIVTSQs) were reported at W12 (Figure 1). At W4, participants (n = 28) reported a mean (SD) increase in treatment satisfaction (HIVTSQc) of 28 (6.8) points . Improvements were seen in all aspects of treatment satisfaction (Figure 2).The most common reason for switching from CAB + RPV was due to side effects (Table 2): 16/28 (57.1%) reported that side effects of CAB + RPV affected their ability to do daily activities. All participants reported feeling hopeful or very hopeful about successfully treating their HIV with B/F/TAF. No grade 3/4 treatment-related adverse events were reported with B/F/TAF. Conclusion Participants choosing to discontinue CAB + RPV and start B/F/TAF reported a meaningful increase in treatment satisfaction and fewer side effects. B/F/TAF is an option for PWH wanting to switch from CAB + RPV to a daily oral regimen. Disclosures Samir K. Gupta, MD, Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Honoraria|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support|ViiV Healthcare: Honoraria Thomas CS Martin, MD, Gilead Sciences, Inc.: Grant/Research Support Cyril Gaultier, MD, Gilead Sciences, Inc.: Advisor/Consultant|GSK: Advisor/Consultant|Merck: Advisor/Consultant|ViiV: Advisor/Consultant Alexandra Kissling, PhD, Gilead Sciences, Inc.: Advisor/Consultant Kathleen Beusterien, MPH, Oracle America, Inc.: Employee Megan Chen, MSPH, Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Megan Dunbar, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Hui Liu, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Private Company) Brenda Ng, PhD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Moti Ramgopal, MD, AbbVie: Honoraria|Gilead Sciences, Inc.: Advisor/Consultant|Gilead Sciences, Inc.: Honoraria|Shionogi: Advisor/Consultant|ViiV: Advisor/Consultant|ViiV: Honoraria
Gupta et al. (Thu,) studied this question.
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