Switch to Dolutegravir-Lamivudine vs Continued TAF-Based Regimen in HIV Treatment
In this study comparing Dolutegravir-Lamivudine vs Continued TAF-Based Regimen in HIV treatment, findings at 48 weeks showed a high virologic response rate with minimal resistance mutations. There was also a notable difference in renal function markers between the two groups.
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Switch to Dolutegravir-Lamivudine versus Continued TAF-Based 3-Drug ART TANGO
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Design Design: Open-label, non-inferiority trial in adults with suppressed HIV RNA while taking a 3- or 4-drug tenofovir alafenamide (TAF)-based regimen, randomized to switch to fixed-dose dolutegravir-lamivudine (DTG- 3TC) or continue the baseline regimen Switch Group Dolutegravir-Lamivudine (n = 369) Inclusion Criteria - Adults with suppressed HIV RNA >6 months - Taking 3- or 4-drug TAF-based ART - No history of virologic failure - No major NRTI resistance; no INSTI resistance - No hepatitis B or C Continue Baseline Regimen Group TAF-Based 3- or 4-Drug Regimen (n = 372) Regimens - Dolutegravir-lamivudine (50/300mg) daily - TAF-based 3- or 4-drug baseline regimen Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Baseline Characteristics Dolutegravir-Lamivudine (n = 369) TAF-Based ART (n = 372) Characteristic 40 (20-74) 25 (7) 297 (81) 50 (14) 98 (27) 271 (73) 33.8 (7.1-201.2) 39 (18-73) 33 (9) 289 (78) 58 (16) 74 (20) 298 (80) 35.1 (7.0-160.8) Age, years, median (range) Female, n (%) White, n (%) African American/African, n (%) CD4 cell count <500, n (%) CD4 cell count 500, n (%) Months on ART, median (range) Baseline third agent class INSTI NNRTI PI 289 (78) 51 (14) 29 (8) 296 (80) 48 (13) 28 (8) Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Results at Week 48 Week 48 Virologic Response (Intention-to-Treat Snapshot Analysis) Dolutegravir-Lamivudine TAF-Based ART 100 HIV RNA <50 copies/mL (%) 93.2 93.0 80 60 40 20 344/369 346/372 0 Confirmed withdrawal for virologic failure: 0 in DTG/3TC arm, 1 in TAF-based ART arm No new resistance mutations occurred 4 with baseline M184V/I in DTG/3TC arm (by proviral genotype) suppressed at week 48 Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Results at Week 48 Week 48 Changes in Renal Function (Plasma/Serum Markers) Dolutegravir-Lamivudine TAF-Based ART 15 Adjusted mean change from 10 6.7 5 baseline 2.2 0.1 0 -1.6 -5 -3.0 -7.7 -10 -15 Creatinine* GFR by creatinine* GFR by cystatin C *Statistically significant difference Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG/3TC vs Continued TAF-Based 3-Drug ART TANGO: Results at Week 48 Week 48 Changes in Markers of Proximal Tubulopathy (Urine Tests) Dolutegravir-Lamivudine TAF-Based ART 15.0 Change from baseline, % 10.0 6.7 6.3 5.0 1.6 0.0 -2.7 -5.0 -2.9 -7.8 -10.0 -15.0 Protein to Creatinine (g/mol) Retinol-binding protein to Creatinine (ug/mmol) Beta-2 microglobulin to creatinine (mg/mmol) Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Conclusions Conclusion: Dolutegravir-lamivudine was was noninferior in maintaining virologic suppression vs a TAF-based regimen at week 48, with no virologic failure or emergent resistance reported with DTG/3TC, supporting it as a simplification strategy for virologically suppressed people with HIV-1. Source: van Wyk J, et al. Clin Infect Dis. 2020;71:1920-9.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: 144 Week Results Week 144 Virologic Response (ITT-Exposed) 100 Dolutegravir-Lamivudine 86 82 80 TAF-Based Regimen Participants (%) 60 40 17 20 14 1 1 0 HIV-1 RNA <50 copies/mL No Virologic Data HIV-1 RNA 50 copies/mL Source: Osiyemi O, et al. Clin Infect Dis. 2022;75:975-86.
Switch to DTG-3TC versus Continued TAF-Based Baseline Regimen TANGO: Conclusions Conclusion: The 2-drug regimen dolutegravir-lamivudine was non-inferior in maintaining virologic suppression vs a tenofovir alafenamide-based regimen at Week 48, with no virologic failure or emergent resistance reported in the dolutegravir-lamivudine group, supporting its use as a simplification strategy for virologically suppressed people living with HIV-1. Source: Osiyemi O, et al. Clin Infect Dis. 2022;75:975-86.
Acknowledgments The National HIV Curriculum is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $1,021,448 with 0% financed with non-governmental sources. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government. For more information, please visit HRSA.gov. This project is led by the University of Washington s Infectious Diseases Education and Assessment (IDEA) Program.
