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:
Between 0 and 2.3% VF in studies with available data.2,6-8,10,14,15,17
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
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
Real-world Effectiveness Studies*
Support findings from Phase III RCTs*†
- Low risk of VF
- High barrier to resistance
- Low rate of treatment discontinuations
DTG + 3TC has been evaluated across diverse patient populations in clinical trials and real-world studies*1-12
References:
- 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.
- Borghetti A, et al. Shall we dance? Extending TANGO’s results to clinical practice. Clinical Infectious Diseases 2020; ciaa313
- 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
- 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
- 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
- Gagliardini R, et al. Effect of past virological failure on dolutegravir + lamivudine as maintenance regimen. CROI 2020. Poster 486
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- Correia RMA & Carvalho AC. Real life study with dual therapy in a HIV-1 treatment experienced Portuguese cohort. AIDS 2020. Poster PEB0235
- 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
- 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
- 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