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A PROVEN HIGH BARRIER TO RESISTANCE 

THE TANGO STUDY: 0 VIROLOGICAL FAILURES OUT TO 144 WEEKS[1]

ZERO CONFIRMED VIROLOGICAL WITHDRAWALS*

ZERO CASES OF RESISTANCE-ASSOCIATED MUTATIONS[1]

No INI or NRTI Mutations Observed at Confirmed Virological Withdrawal*

Table showing 0 confirmed virological withdrawals, INI mutations and NRTI mutations in the DOVATO arm vs 3 confirmed virological withdrawals and 0 INI mutations and NRTI mutations in TAF-containing regimens.
Table showing 0 confirmed virological withdrawals, INI mutations and NRTI mutations in the DOVATO arm vs 3 confirmed virological withdrawals and 0 INI mutations and NRTI mutations in TAF-containing regimens.
*Patients met confirmed virological withdrawal criteria if they had ≥200 copies/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 copies/mL[2].

THE SALSA STUDY: SAME HIGH BARRIER TO RESISTANCE IN DIVERSE PATIENT POPULATIONS AT 48 WEEKS[3]

ZERO CONFIRMED VIROLOGICAL WITHDRAWALS*

ACROSS BOTH ARMS

ZERO CASES OF RESISTANCE-ASSOCIATED MUTATIONS

ACROSS BOTH ARMS

*Confirmed virological withdrawal criteria defined as 1 assessment of HIV-1 RNA ≥200 copies/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 copies/mL.

1,177 PATIENTS ACROSS 10 REAL-WORLD SWITCH STUDIES

All Data Reported From Studies With On-label Populations

0 reported cases of treatment-emergent resistance to DOVATO across 10 real-world switch studies.
0 reported cases of treatment-emergent resistance to DOVATO across 10 real-world switch studies.

From a literature search up to July 2021, for studies including adult patients with no known or suspected resistance to integrase inhibitors or lamivudine.

DTG 50 mg + 3TC 300 mg used in most reported real-world studies.
*Full study population=177; however, 4 patients have been excluded here in accordance with the EU SmPC. Genotypic testing, at time of failure, revealed K103R and S147G mutations in 1 patient with prior exposure to RAL +ABC/3TC. However, no baseline resistance data were available, therefore, the analysis was unavailable to determine if treatment emergent.
†Effectiveness analysis set (missing=excluded).

Efficacy in virologically suppressed patients

See the data from the TANGO study

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Efficacy in virologically suppressed patients

 See the data from the SALSA study

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References:
  1. Osiyemi O, De Wit S, Ajana F, et al. Efficacy and safety of switching to dolutegravir/lamivudine (DTG/3TC) versus continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with HIV-1: results through week 144 from the phase 3, non-inferiority TANGO randomized trial. Clin Infect Dis. 2022;ciac036 and suppl 1-18. doi:10.1093/cid/ciac036
  2. van Wyk J, Ajana F, Bisshop F, et al. 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. Clin Infect Dis. 2020;71(8):1920-1929. doi:10.1093/cid/ciz1243
  3. Llibre JM, Alves Brites C, Cheng CY, et al. Switching to the 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) fixed-dose combination is non-inferior to continuing a 3-drug regimen through 48 weeks in a randomized clinical trial (SALSA). Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Slides OALB0303. 
  4. Borghetti A, Ciccullo A, Baldin G, et al. Shall we dance/ Extending TANGO’s results to clinical practice. Clin Infect Dis. 2020;7(7):e200-e201. doi:10.1093/cid/ciaa313
  5. Calza L, Colangeli V, Borderi M, et al. Simplification to dual therapy continuing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. J Antimicrob Chemother. 2020;75(11):3327-3333. doi:10.1093/jac/dkaa319
  6. Diaco ND, Strickler C, Glezendanner S, Wirz SA, Tarr PE. Systemic de-escalation of successful triple antiretroviral therapy to dual therapy with dolutegravir plus emtricitabine or lamivudine in Swiss HIV-positive persons. EClinicalMedicine. 2018;6:21-25. doi:10.1016/j.eclinm.2018.11.005
  7. Hart J, Katiyar A, Smith C, et al. Switching to dolutegravir based two drug anti-retroviral regimens (DTG-2DR): performance in clinical practice. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual.
  8. Hidalgo-Tenorio C, Cortés LL, Gutiérrez A, et al. DOLAMA study: effectiveness, safety and pharmacoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients. Medicine. 2019;98(32):e16813. doi:10.1097/ MD.0000000000016813 
  9. Lanzafame M, Nicole S, Rizzardo S, et al. Immunovirological outcome and HIV-1 DNA decay in a small cohort of HIV-1 infected patients deintensificated from abacavir/lamivudine/dolutegravir to lamivudine plus dolutegravir. New Microbiol. 2018;41(4):262-267.
  10. Maggiolo F, Gulminetti R, Pagnucco L, et al. Five years of durability of dolutegravir + lamivudine in patients with suppressed HIV-RNA. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual.
  11. Moreno A, del Campo S, Pérez-Elias MJ, et al. Long-term safety and efficacy of integrase strand transfer inhibitor (INSTI)-based HAART in HIV-infected patients after solid organ transplantation (SOT). Presented at: 16th European AIDS Conference; October 25-27, 2017; Milan, Italy. Poster PE9/38.
  12. Postel N, Schneeweiss S, Wyen C, et al. Real-world data from prospective URBAN cohort on the use of dolutegravir (DTG) + lamivudine (3TC) in ART-naïve and pre-treated people living with HIV in Germany. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster 044.
  13. Stephenson L, Pan D. Clinical experience of dolutegravir + lamivudine dual treatment regimens at University Hospital Leicester NHS Trust. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual.

October 2022 PM-GB-DLL-WCNT-220005 

Prescribing Information

Adverse event reporting

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