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PROVEN EFFICACY IN >6,000 PLHIV

PROVEN VIROLOGICAL CONTROL ACROSS DIVERSE PATIENT GROUPS

UP TO 144 WEEKS OF CLINICAL TRIAL DATA[1,2] + UP TO 5 YEARS IN A REAL-WORLD SETTING[3]

GEMINI-1 & GEMINI-2
DURABLE SUPPRESSION

1,433 treatment-naïve patients
DOVATO (n=716; pooled)
144 weeks[1]

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STAT
EFFECTIVE IN A TEST-AND-TREAT SETTING

131 newly diagnosed patients
48 Weeks[4]

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TANGO
NON-INFERIORITY ITT–E AND SUPERIOR PP EFFICACY vs TAF-CONTAINING REGIMENS

741 virologically suppressed patients
DOVATO (n=369)
3 Years[2]

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SALSA
PROVEN EFFICACY IN A DIVERSE POPULATION

493 virologically suppressed patients
DOVATO (n=246)
48 Weeks[5]

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Real-world data
EFFICACY CONFIRMED IN THE REAL WORLD

>5,000 real-life treatment-naïve and switch patients*[3,6-26]

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DTG 50 mg + 3TC 300 mg used in the GEMINI and most real-world studies.
ITT–E=intent-to-treat–exposed; PP=per protocol.
*From a literature search, up to July 2021.

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DURABLE AND ROBUST[2,3]

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KEEPING LONG-TERM HEALTH IN MIND

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WITHOUT TDF, TAF AND ABC

DOVATO IS RECOMMENDED IN TREATMENT GUIDELINES

BHIVA Guidelines 2022

Recommended as an initial treatment for most people living with HIV in naïve and switch settings.[27]

Eligibility guidance:

  • No baseline lamivudine resistance
  • Baseline viral load less than 500,000 copies/mL
  • Baseline CD4 count greater than 200 cells/mm3
  • No active Hepatitis B infection and if at risk of Hepatitis B, Hepatitis B virus immune

Exceptions (not suitable for those):

  • In the context of transmitted drug resistance
  • With documented/archived/suspected M184IV mutation
  • HIV-related cognitive impairment
  • Diagnosed during pregnancy
  • Consider with caution with patients with PHI, opportunistic diseases, or renal impairment

EACS Guidelines 2021

Recommended as an initial regimen for treatment-naïve patients and as a switch strategy for virologically suppressed patients[28]

Requirements for treatment-naïve patients:

  • HBsAg negative
  • HIV viral load <500,000 copies/mL
  • Not recommended after PrEP failure

Requirements for switch patients:

  • No historical resistance
  • HBV immunity, or if non-immune, concomitant HBV vaccination

DHHS Guidelines 2022

Recommended as an initial regimen for most PLHIV (AI)* and as a good option for virologically suppressed patients who have no evidence of resistance to either drug[29]

Exclusions for treatment-naïve patients:

  • HIV viral load >500,000 copies/mL
  • HBV co-infection
  • Where ART is to be started before the results of HIV genotype resistance testing for reverse transcriptase or HBV testing are available

*Rating of recommendations: A=strong; B=moderate; C=optional. Rating of evidence: I=data from randomised controlled trials; II=data from well-designed non-randomised trials, observational cohort studies with long-term clinical outcomes, relative bioavailability/bioequivalence studies or regimen comparisons from randomised switch studies; III=expert opinion.[29]

IAS Guidelines 2020

Recommended as an initial regimen for most people with HIV and as an appropriate switch strategy for virologically suppressed patients (AIa)*[30]

Not recommended in:

  • Rapid start, because baseline laboratory evaluation results must be reviewed before initiation
  • Chronic hepatitis B
  • HIV-1 RNA >500,000 copies/mL, and perhaps a CD4+ T-cell count <200 cells/mm3, although the latter is unclear
  • Patients being treated for an active opportunistic infection

Guidelines state close monitoring for adherence and virological response is needed.

*AIa-Strong panel support with evidence from ≥1 RCTs published in the peer-reviewed literature.[30]

References:

  1. Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
  2. 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. doi:10.1093/cid/ciac036
  3. 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.
  4. Rolle C-P, Berhe M, Singh T, et al. High rates of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load ≥500,000 c/mL: 48-week subgroup analysis of the STAT study. Presented at: IDWeek 2021; September 29-October 3, 2021; Virtual.
  5. 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 OALB030.
  6. 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:101093/cid/ciaa313
  7. Cabello A, López Bernaldo de Quiros JC, Pulido F, et al. 48 weeks efficacy and tolerability of dolutegravir (DTG) + lamivudine (3TC) in adult HIV naïve patients. A multicenter real life cohort. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021. Virtual.
  8. 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
  9. 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.
  10. 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.
  11. 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
  12. 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.
  13. 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:10.1136/ejhpharm-2020-eahpconf.169
  14. 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.
  15. 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.
  16. 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
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. Toja F, Pereira Vazquez M. Dual therapy with dolutegravir and lamivudine: efficacy and safety. Eur J Hosp Pharm. 2020;27(suppl 1):A165-166. doi:10.1136/ejhpharm-2020-eahpconf.352
  25. 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.
  26. Evitt LA, Kumar R, Kamath RD, et al. Effectiveness and tolerability of DTG+3TC in clinical practice: evidence in PLHIV from real-world data. Presented at: IDWeek™️; September 29-October 3, 2021; Virtual. Slides 898.
  27. British HIV Association. Guidelines. Updated October 20, 2022. Accessed October 24, 2022. https://www.bhiva.org/file/63513a1745ea9/BHIVA-guidelines-on-antiretroviral-treatment-for-adults-living-with-HIV-1-2022.pdf
  28. European AIDS Clinical Society. Guidelines. Version 11.0. Accessed December 17, 2021. https://www.eacsociety.org/media/final2021eacsguidelinesv11.0_oct2021.pdf
  29. National Institutes of Health. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Updated January 20, 2022. Accessed February 1, 2022. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/whats-new-guidelines
  30. Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 Recommendations of the International Antiviral Society–USA Panel. JAMA. 2020. doi:10.1001/jama.2020.17025

October 2022 PM-GB-DLL-WCNT-220004

Prescribing Information

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