Introduction <p>Extensive real-world data in people with HIV (PWH) switching from non-nucleoside reverse transcriptase inhibitors (NNRTIs), in particular from rilpivirine (RPV)-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), are lacking.</p> Methods <p>This is a single-center retrospective study. Inclusion criteria were PWH aged ≥ 18&#xa0;years, virologically suppressed on NNRTI triple antiretroviral regimens. The primary endpoint was the proportion of PWH with HIV-RNA &lt; 50 cp/mL at 12&#xa0;months from time of switch to B/F/TAF.</p> Results <p>Overall, 214 PWH were included, of whom 105 (49.1%) were switching from RPV/FTC/TAF. After 12&#xa0;months, the proportion of PWH with HIV-RNA &lt; 50 copies/mL was 82.7% (95% confidence interval, CI, 77.1–87.2) at intention-to-treat (ITT) and 95.7% (95% CI 91.7–97.8) at missing=excluded (M=E) analysis. In the group switching from RPV/FTC/TAF, the proportion of PWH with HIV-RNA &lt; 50 copies/mL at 12&#xa0;months was 74.3% (95% CI 65.2–81.7) at ITT and 95.1% (95% CI 88.1–98.1) at M=E analysis. Two PWH (0.93%, 95% CI 0.26–3.34) experienced virological failure after switching to B/F/TAF, with no resistance mutations detected. Six treatment discontinuations were observed (2.8%, 95% CI 1.3–5.6). A decrease in low-density lipoprotein (LDL) cholesterol was documented when switching from RPV/FTC/TAF to B/F/TAF.</p> Conclusion <p>Switching to B/F/TAF from NNRTI-based regimens, particularly if RPV-based, showed high virological effectiveness and rare treatment discontinuations. No resistance mutations were detected at failure.</p>

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Effectiveness of Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide from Rilpivirine or Other Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Based Antiretroviral Therapy in Virologically Suppressed People with HIV: A Retrospective Analysis (DRIVE-SWITCH Study)

  • Roberta Gagliardini,
  • Alessandro Caioli,
  • Marisa Fusto,
  • Sandrine Ottou,
  • Federica Forbici,
  • Lavinia Fabeni,
  • Fabrizio Maggi,
  • Maria Maddalena Plazzi,
  • Federico De Zottis,
  • Rita Bellagamba,
  • Jessica Paulicelli,
  • Ilaria Mastrorosa,
  • Elisabetta Grilli,
  • Carmela Pinnetti,
  • Valentina Mazzotta,
  • Roberto Caldera,
  • Gabriele Forcina,
  • Andrea Antinori

摘要

Introduction

Extensive real-world data in people with HIV (PWH) switching from non-nucleoside reverse transcriptase inhibitors (NNRTIs), in particular from rilpivirine (RPV)-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), are lacking.

Methods

This is a single-center retrospective study. Inclusion criteria were PWH aged ≥ 18 years, virologically suppressed on NNRTI triple antiretroviral regimens. The primary endpoint was the proportion of PWH with HIV-RNA < 50 cp/mL at 12 months from time of switch to B/F/TAF.

Results

Overall, 214 PWH were included, of whom 105 (49.1%) were switching from RPV/FTC/TAF. After 12 months, the proportion of PWH with HIV-RNA < 50 copies/mL was 82.7% (95% confidence interval, CI, 77.1–87.2) at intention-to-treat (ITT) and 95.7% (95% CI 91.7–97.8) at missing=excluded (M=E) analysis. In the group switching from RPV/FTC/TAF, the proportion of PWH with HIV-RNA < 50 copies/mL at 12 months was 74.3% (95% CI 65.2–81.7) at ITT and 95.1% (95% CI 88.1–98.1) at M=E analysis. Two PWH (0.93%, 95% CI 0.26–3.34) experienced virological failure after switching to B/F/TAF, with no resistance mutations detected. Six treatment discontinuations were observed (2.8%, 95% CI 1.3–5.6). A decrease in low-density lipoprotein (LDL) cholesterol was documented when switching from RPV/FTC/TAF to B/F/TAF.

Conclusion

Switching to B/F/TAF from NNRTI-based regimens, particularly if RPV-based, showed high virological effectiveness and rare treatment discontinuations. No resistance mutations were detected at failure.