The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study
Open accessAbstract
Background: The 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppressed individuals. Methods: TANGO is an open-label, multicenter, phase 3 study that randomized adults (1:1, stratified by baseline third agent class) with HIV-1 RNA <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or remain on a tenofovir alafenamide (TAF)–based regimen. The primary end point was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention-to-treat–exposed population (4% noninferiority margin). Results: 743 adults were enrolled; 741 received ≥1 dose of study drug (DTG/3TC, N = 369; TAF-based regimen, N = 372). At week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL receiving DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% confidence interval], −0.3 [−1.2 to .7]), meeting noninferiority criteria. No participants receiving DTG/3TC and 1 receiving a TAF-based regimen met confirmed virologic withdrawal criteria, with no emergent resistance at failure. Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4.6%) and 13 (3.5%) participants with DTG/3TC and 3 (0.8%) and 2 (0.5%) with a TAF-based regimen, respectively. Conclusions: DTG/3TC 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. Clinical Trials Registration: NCT03446573.
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Cites
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Wensing, A. M. J., Cálvez, V., Ceccherini‐Silberstein, F., Charpentier, C., Günthard, H. F., Jacobsen, D. M., Paredes, R., Shafer, R. W., & Richman, D. D. (2015) · PubMed · doi:10.5167/uzh-122257 · Cited by 415
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Self-citation2017 Update of the Drug Resistance Mutations in HIV-1.
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Self-citationTaiwo, B., Marconi, V. C., Berzins, B., Moser, C., Nyaku, A. N., Fichtenbaum, C. J., Benson, C. A., Wilkin, T. J., Koletar, S. L., Colasanti, J., et al. (2017) · Clinical Infectious Diseases · doi:10.1093/cid/cix1131 · Cited by 84
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Mimtsoudis, I., Tsachouridou, O., Akinosoglou, K., & Metallidis, S. (2024) · Viruses · doi:10.3390/v16091392 · Cited by 13
Metadata
- Authors
- van Wyk, J., Ajana, F., Bisshop, F., De Wit, S., Osiyemi, O., Portilla Sogorb, J., Routy, J.-P., Wyen, C., Ait-Khaled, M., Nascimento, M. C., Pappa, K. A., Wang, R., Wright, J., Tenorio, A. R., Wynne, B., Aboud, M., Gartland, M. J., & Smith, K. Y.
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-01-06
- Volume
- 71
- Issue
- 8
- Pages
- 1920-1929
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- OpenAlex
- W3000709627
- Cited by
- 282
- References
- 13
- FWCI
- 5.07
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. https://app.cochat.ai/papers/10.1093/cid/ciz1243
- The paper
- van Wyk, J., Ajana, F., Bisshop, F., De Wit, S., Osiyemi, O., Portilla Sogorb, J., Routy, J.-P., Wyen, C., Ait-Khaled, M., Nascimento, M. C., Pappa, K. A., Wang, R., Wright, J., Tenorio, A. R., Wynne, B., Aboud, M., Gartland, M. J., & Smith, K. Y. (2020). Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide–Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciz1243
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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