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Real-World Experience

Real-World Studies Supporting Findings From Phase III Trials1-17*

*All data below are reported as available, from a literature search up to October 2020, for studies including patients with no known or suspected resistance to integrase inhibitors or lamivudine. Available data shows:

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Low Risk of Virological Failure

Between 0 and 2.3% VF in studies with available data.2,6-8,10,14,15,17
Includes studies reporting applicable effectiveness outcomes for >50 patients receiving DTG + 3TC

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High Barrier to Resistance

Dovato has demonstrated a high barrier to resistance in 874 patients across eight-real world switch studies1-8,11,15,17

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Low Rate of Treatment Discontinuations

Between 1.5 and 6.2% discontinued due to AEs in studies with available data2,5-8,10,15,17
Percentage calculated based on overall N on DTG + 3TC as the denominator. Only those studies that include >50 patients on DTG + 3TC and report data on treatment discontinuation due to AEs have been included

DTG 50 mg + 3TC 300 mg used in the GEMINI-1 and -2, and real-world studies
*From a literature search, up to October 2020, for studies including patients with no known or suspected resistance to INIs or 3TC 
RWE complements data from RCTs and builds confidence in the effectiveness and safety of new treatments in clinical practice.

Real-world Effectiveness Studies*

Support findings from Phase III RCTs*†

  • Low risk of VF
  • High barrier to resistance
  • Low rate of treatment discontinuations
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DTG 50 mg + 3TC 300 mg used in the GEMINI-1 and -2, and real-world studies
*From a literature search, up to October 2020, for studies including patients with no known or suspected resistance to INIs or 3TC.
†Please note each study may not have reported each clinical endpoint of VF, emergent resistance or Treatment discontinuations

DTG + 3TC has been evaluated across diverse patient populations in clinical trials and real-world studies*1-12

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DTG 50 mg + 3TC 300 mg used in the GEMINI-1 and -2, and real-world studies
*From a literature search, up to October 2020, for studies including patients with no known or suspected resistance to INIs or 3TC

* From a literature search, up to October 2020, for studies including patients with no known or suspected resistance to integrase inhibitors or lamivudine.2-13

References:

  1. van Wyk J, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose two-drug regimen versus continuing a tenofovir alafenamide–based three- or four-drug regimen for maintenance of virologic suppression in adults with HIV-1: Phase 3, randomized, non-inferiority TANGO study. Clinical Infectious Diseases 2020. pii: ciz1243.
  2. Borghetti A, et al. Shall we dance? Extending TANGO’s results to clinical practice. Clinical Infectious Diseases 2020; ciaa313
  3. Castelli A et al. Simplification to dual antiretroviral therapy with lamivudine and dolutegravir in HIV-infected patients with solid organ transplantation: a preliminary single-center experience. Presented at: 17ᵗʰ European AIDS Conference; November 6-9, 2018; Basel, Switzerland. Poster PE2/35
  4. Diaco N, et al. Systematic de-escalation of successful triple antiretroviral therapy to dual therapy with dolutegravir plus emtricitabine or lamivudine in Swiss HIV-positive persons. EClinicalMedicine 2018;6:21–5
  5. Digaetano M, et al. A real-life analysis of dolutegravir adverse effects in a cohort of naïve and experienced HIV-infected patients. HIV Glasgow 2018. Poster P203
  6. Gagliardini R, et al. Effect of past virological failure on dolutegravir + lamivudine as maintenance regimen. CROI 2020. Poster 486
  7. Hart J, et al. Experience of dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) two-drug antiretroviral regimens in a London tertiary centre. BHIVA 2019. Poster P9
  8. Hidalgo-Tenorio C, et al. DOLAMA study. Effectiveness, safety and pharmoeconomic analysis of dual therapy with dolutegravir and lamivudine in virologically suppressed HIV-1 patients. Medicine 2019;98:e16813
  9. Lanzafame M, 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 Microbiology 2018;41:262–7
  10. Maggiolo F, et al. Dolutegravir + lamivudine in patients with suppressed HIV-RNA: long term virologic and immunologic results of a multicenter cohort. HIV Glasgow 2018. Abstract P104
  11. Moreno Zamora A, et al. Long-term safety and efficacy of integrase strand transfer inhibitor (INSTI)-based HAART in HIV-infected patients after solid organ transplantation (SOT). EACS 2017. Abstract PE9/38
  12. Pereira Goulart S, et al. ART simplification: use of dual therapy for HIV in a public health reference center (CRT-DST/Aids) in São Paulo, Brazil. EACS 2019. Poster PE2/34
  13. Teira R, et al. Shorter time to treatment failure in PLHIV switched to dolutegravir plus either rilpivirine or lamivudine compared to integrase inhibitor-based triple therapy in a large Spanish cohort - VACH. EACS 2019. Poster PS8/5.
  14. Correia RMA & Carvalho AC. Real life study with dual therapy in a HIV-1 treatment experienced Portuguese cohort. AIDS 2020. Poster PEB0235
  15. Postel N, et al. Real-world Data from the Prospective URBAN Cohort Study on the use of Dolutegravir (DTG) + Lamivudine (3TC) in ART-naïve and Pre-treated People Living with HIV in Germany. HIV Glasgow 2020; Virtual. Poster P044
  16. Hiryak K, et al. Real-world Implementation of Dolutegravir-Lamivudine to Achieve and Maintain HIV-1 Viral Suppression at an Academic Medical Center. ID Week 2020. Poster 1040
  17. Calza L, et al. Simplification to dual therapy containing lamivudine and raltegravir or dolutegravir in HIV-infected patients on virologically suppressive antiretroviral therapy. J Antimicrob Chemother 2020;75:3327–33

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.

Date of preparation August 2022 PM-IE-DLL-WCNT-200026