Josep M Llibre1, Carlos Brites2, Chien-Yu Cheng3,4, Olayemi Osiyemi5, Carlos Galera6, Laurent Hocqueloux7, Franco Maggiolo8, Olaf Degen, Stephen Taylor9,10, Elizabeth Blair11, Choy Man11, Brian Wynne11, James Oyee12, Mark Underwood11, Lloyd Curtis12, Gilda Bontempo11, Jean van Wyk13. 1. Hospital Universitari Germans Trias i Pujol, Barcelona, Spain. 2. Universidade Federal da Bahia, Salvador, Brazil. 3. Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. 4. Institute of Public Health, School of Medicine, National Yang-Ming Chiao Tung University, Taipei, Taiwan. 5. Triple O Research Institute PA, West Palm Beach, FL, USA. 6. Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain. 7. Centre Hospitalier Régional d'Orléans, Orléans, France. 8. ASST Papa Giovanni XXIII, Bergamo, Italy; 9Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany. 9. Birmingham Heartlands Hospital, Birmingham, UK. 10. University of Birmingham, Birmingham, UK. 11. ViiV Healthcare, Research Triangle Park, NC, USA. 12. GlaxoSmithKline, Brentford, UK. 13. ViiV Healthcare, Brentford, UK.
Abstract
BACKGROUND: In TANGO, switching to dolutegravir/lamivudine (DTG/3TC) demonstrated long-term non-inferior efficacy vs continuing tenofovir alafenamide-based regimens in treatment-experienced adults with HIV-1. The phase 3 SALSA study evaluated efficacy and safety of switching to DTG/3TC compared with continuing various 3-/4-drug current antiretroviral regimens (CAR). METHODS: Adults with HIV-1 RNA <50 copies/mL and no previous virologic failure were randomized (1:1, stratified by baseline third agent class) to switch to once-daily fixed-dose combination DTG/3TC or continue CAR (primary endpoint: proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48; Snapshot, intention-to-treat-exposed population, 5% non-inferiority margin). RESULTS: Overall, 493 adults (39% women; 39% aged ≥50 years; 19% African American/African heritage; 14% Asian) were randomized to switch to DTG/3TC (n=246) or continue CAR (n=247). At Week 48, 1 (0.4%) participant in the DTG/3TC group and 3 (1.2%) in the CAR group had HIV-1 RNA ≥50 copies/mL (Snapshot), demonstrating non-inferiority (adjusted difference, -0.8%; 95% CI, -2.4%, 0.8%). Zero participants met confirmed virologic withdrawal criteria; therefore, no resistance testing was performed. Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through Week 48 but comparable post-Week 24 (5% vs 2%, respectively). Proximal tubular renal function and bone turnover biomarkers improved with DTG/3TC. Both groups had generally minimal changes in lipids and inflammatory biomarkers. CONCLUSIONS: Switching to DTG/3TC was non-inferior to continuing CAR for maintaining virologic suppression at Week 48 with no observed resistance, supporting the efficacy, good safety, and high barrier to resistance of DTG/3TC.
BACKGROUND: In TANGO, switching to dolutegravir/lamivudine (DTG/3TC) demonstrated long-term non-inferior efficacy vs continuing tenofovir alafenamide-based regimens in treatment-experienced adults with HIV-1. The phase 3 SALSA study evaluated efficacy and safety of switching to DTG/3TC compared with continuing various 3-/4-drug current antiretroviral regimens (CAR). METHODS: Adults with HIV-1 RNA <50 copies/mL and no previous virologic failure were randomized (1:1, stratified by baseline third agent class) to switch to once-daily fixed-dose combination DTG/3TC or continue CAR (primary endpoint: proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48; Snapshot, intention-to-treat-exposed population, 5% non-inferiority margin). RESULTS: Overall, 493 adults (39% women; 39% aged ≥50 years; 19% African American/African heritage; 14% Asian) were randomized to switch to DTG/3TC (n=246) or continue CAR (n=247). At Week 48, 1 (0.4%) participant in the DTG/3TC group and 3 (1.2%) in the CAR group had HIV-1 RNA ≥50 copies/mL (Snapshot), demonstrating non-inferiority (adjusted difference, -0.8%; 95% CI, -2.4%, 0.8%). Zero participants met confirmed virologic withdrawal criteria; therefore, no resistance testing was performed. Drug-related adverse events were more frequent with DTG/3TC (20%) than CAR (6%) through Week 48 but comparable post-Week 24 (5% vs 2%, respectively). Proximal tubular renal function and bone turnover biomarkers improved with DTG/3TC. Both groups had generally minimal changes in lipids and inflammatory biomarkers. CONCLUSIONS: Switching to DTG/3TC was non-inferior to continuing CAR for maintaining virologic suppression at Week 48 with no observed resistance, supporting the efficacy, good safety, and high barrier to resistance of DTG/3TC.
Authors: Franco Maggiolo; Daniela Valenti; Rodolfo Teocchi; Laura Comi; Elisa Di Filippo; Marco Rizzi Journal: J Int Assoc Provid AIDS Care Date: 2022 Jan-Dec
Authors: Josep M Llibre; Luis Fernando López Cortés; Alicia Aylott; Brian Wynne; Jessica Matthews; Rodica Van Solingen-Ristea; Kati Vandermeulen; Jean van Wyk; Lesley P Kahl Journal: J Acquir Immune Defic Syndr Date: 2022-05-11 Impact factor: 3.771