Menu

PROVEN EFFICACY IN >6,000 PLHIV

PATIENTS SWITCHING TO DOVATO IN THE REAL WORLD

Patients Switching to DOVATO (Studies With >100 Patients Reporting Virological Effectiveness Outcomes [n=6/20])

All data reported from studies with on-label populations

This bar graph for real-world evidence shows the high virological effectiveness of DOVATO across 6 of the real-world studies.
This bar graph for real-world evidence shows the high virological effectiveness of DOVATO across 6 of the real-world studies.

DTG 50 mg + 3TC 300 mg used in most reported real-world 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.
*18 virological rebound events (calculation assumes ≤1 virological rebound event per patient).
†Three patients experienced virological failure in the DOVATO group; 31 additional patients discontinued treatment in the study (total population=299), treatment regimen was not reported.
‡Per-protocol analysis used; in accordance with the EU SmPC, 173/177 patients were included.
§Includes n=4 with 50 copies/mL to 200 copies/mL and subsequent HIV-1 RNA assessment of <50 copies/mL.
||Effectiveness set (missing=excluded).

  • Baseline Characteristics

    PROVEN ACROSS A BROAD RANGE OF PATIENTS IN 20 REAL-WORLD SWITCH STUDIES

    All Data Reported From Studies With On-Label Populations*†[1-20]

    Baseline characteristics of >3,000 switch patients across 20 studies in 8 countries.
    Baseline characteristics of >3,000 switch patients across 20 studies in 8 countries.

    DTG 50 mg + 3TC 300 mg used in most reported real-world 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.
    †Note: For some studies, baseline characteristics are reported for the total population.
    ‡Includes renal, bone, CV and GI.

TREATMENT-NAÏVE PATIENTS IN THE REAL WORLD

(Treatment-Related Discontinuations=Failures)[21]

This bar graph for the REDOLA real-world study shows the high virological effectiveness of DOVATO in treatment-naïve patients.
This bar graph for the REDOLA real-world study shows the high virological effectiveness of DOVATO in treatment-naïve patients.

In ITT–E analysis, virological effectiveness was 85.2% overall, 83.9% for <100.000 copies/mL and 91.3% for ≥100,000 copies/mL.

Available data show real-world effectiveness is consistent with that seen in Phase III studies for treatment-naïve patients.

ITT–E=intent-to-treat–exposed.

  • Baseline Characteristics

    DOVATO IS NOW BEING ASSESSED IN TREATMENT-NAÏVE PATIENTS IN THE REAL WORLD[21]

    Baseline characteristics of the 135 patients in the REDOLA study.
    Baseline characteristics of the 135 patients in the REDOLA study.

    Patients started DTG + 3TC and switched to DOVATO when it became available.
    IQR=interquartile range. 

LOW DISCONTINUATION RATES IN THE REAL WORLD

Studies Reporting Discontinuations Due to AEs With >50 Patients (n=7/21)

This chart for real-world evidence shows that there were low rates of discontinuations due to adverse events for patients who switched to DOVATO across 7 real-world studies.
This chart for real-world evidence shows that there were low rates of discontinuations due to adverse events for patients who switched to DOVATO across 7 real-world studies.

DTG 50 mg + 3TC 300 mg used in most reported real-world studies
AE=adverse event.
Percentage calculated based on overall N on DOVATO as the denominator.

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

*Full study population=177; however, 4 patients were excluded in accordance with the EU SmPC.[4]
†Effectiveness analysis set (missing=excluded).[6]

Want to hear from the experts, including past webinar recordings?

Watch here

Real-world evidence also confirms the high barrier to resistance of DOVATO

See the data

Click here

The efficacy of DOVATO has been proven in clinical trials

See the data

Click here

References:

  1. Borghetti A, Ciccullo A, Baldin G, et al. Shall we dance? Extending TANGO’s results to clinical practice. Clin Infect Dis. 2020;71(7):e200-e201. doi:10.1093/cid/ciaa313 
  2. Gagliardini R, Lorenzini P, Cozzi-Lepri A, et al; for the Icona Foundation Study Group. Effect of past virological failure on dolutegravir + lamivudine as maintenance regimen. Presented at: Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, MA. Poster 0486. 
  3. 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. 
  4. 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 
  5. Maggiolo F, Gulminetti R, Pagnucco L, et al. Five years 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.
  6. 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. 
  7. Calza L, Colangeli V, Borderi M, 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;75:3327-3333. doi:10.1093/jac/dkaa319 
  8. Castelli A, Manzardo C, Ambrosioni J, et al; for the SOT in HIV-infected patients Working Group Investigators. Simplification to dual (2D) antiretroviral therapy with lamivudine and dolutegravir in HIV- infected patients with solid organ transplantation: a preliminary single-centre experience. Presented at: 17th European AIDS Conference; November 6-9, 2019; Basel, Switzerland. Poster PE2/35. 
  9. Correia RMA, Carvalho AC. Real life study with dual therapy in HIV-1 treatment experienced Portuguese cohort. Presented at: 23rd International AIDS Conference; July 6-10, 2020; Virtual. Slides PEB0235. 
  10. Diaco ND, Strickler C, Giezendanner S, Wirz SA, Tarr PE. Systematic de-escalation of successful triple antiretroviral therapy to dual therapy with dolutegravir plus emtricitabine or lamivudine in Swiss HIV-positive persons. EClinicalMedicine. 2018;6:21-25. doi:10.1016/j.eclinm.2018.11.005 
  11. Digaetano M, Monari C, Rogati C, et al. A real-life analysis of dolutegravir adverse effects in a cohort of naïve and experienced HIV-infected patients. Presented at: HIV Drug Therapy Glasgow; October 28-31, 2018; Glasgow, UK. Poster P203.
  12. Fernández Zamora C, Rodriguez Martinez T, Merono Saura MA, et al. Effectiveness of dolutegravir and lamivudine therapy in a two drug regimen in a third level hospital. Eur J Hosp Pharm. 2020;27(suppl 1):A79. doi:0.1136/ejhpharm-2020-eahpconf.169
  13. Hiryak K, Kludjian G, Samuel R, et al. Real-world implementation of dolutegravir-lamivudine to achieve and maintain HV-1 viral suppression at an academic medical centre. Presented at: ID Week; October 21-25, 2020; Virtual. 
  14. 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. 
  15. Moreno A, del Campo S, Pérez-Elías 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.
  16. Pereira Goulart S, de Albuquerque Moraes C, Furtado da Costa A, et al. ART simplification: use of dual therapy for HIV in a public health reference centre (CRT-DST/Aids) in São Paulo, Brazil. Presented at: 17th European AIDS Conference; November 6-9, 2019; Basel, Switzerland. Poster PE2/34. 
  17. Stephenson L, Pan D. Clinical experience of dolutegravir + lamivudine dual treatment regimens at University Hospitals of Leicester NHS Trust. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual. 
  18. Teira R, Diaz-Cuervo H, Aragão F, 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). Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual. Poster P031.
  19. Toja F, Pereira Vazquez M. Dual therapy with dolutegravir and lamivudine: efficacy and safety. Eur J Hosp Pharm. 2020;27(suppl 1):A165-A166. doi:10.1136/ejhpharm-2020-eahpconf.352 
  20. Uriel AJ, Banks T, Ashton K, et al. Dual antiretroviral (ARV) therapy: safe and efficacious even in a heavily ARV experienced real-world cohort. Presented at: 26th Annual Conference of the British HIV Association; November 22-24, 2020; Virtual 
  21. Cabello A, López Bernaldo de Quiros JC, Pulido F, et al. 48 weeks efficacy and tolerability of dolutegravir (DTG) + lamivudine (3TC) in adult HIV naive patients. A multicenter real life cohort. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual.

October 2022 PM-GB-DLL-WCNT-220004

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.