Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads : TANDEM Study Subgroup Analyses
© 2024. The Author(s)..
INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study.
METHODS: TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive.
RESULTS: Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup.
CONCLUSIONS: Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
|---|---|
| Enthalten in: |
Infectious diseases and therapy - 13(2024), 4 vom: 03. Apr., Seite 875-889 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Benson, Paul [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Dolutegravir |
|---|
| Anmerkungen: |
Date Revised 29.04.2024 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.1007/s40121-024-00950-1 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370598652 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370598652 | ||
| 003 | DE-627 | ||
| 005 | 20240429232127.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240404s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s40121-024-00950-1 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1392.xml |
| 035 | |a (DE-627)NLM370598652 | ||
| 035 | |a (NLM)38570444 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Benson, Paul |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads |b TANDEM Study Subgroup Analyses |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 29.04.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study | ||
| 520 | |a METHODS: TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18 years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6 months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive | ||
| 520 | |a RESULTS: Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup | ||
| 520 | |a CONCLUSIONS: Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Dolutegravir | |
| 650 | 4 | |a HIV-1 | |
| 650 | 4 | |a Lamivudine | |
| 650 | 4 | |a Real-world evidence | |
| 650 | 4 | |a Test-and-treat | |
| 650 | 4 | |a Viral load | |
| 700 | 1 | |a Kuretski, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Donovan, Cynthia |e verfasserin |4 aut | |
| 700 | 1 | |a Harper, Gavin |e verfasserin |4 aut | |
| 700 | 1 | |a Merrill, Deanna |e verfasserin |4 aut | |
| 700 | 1 | |a Metzner, Aimee A |e verfasserin |4 aut | |
| 700 | 1 | |a Mycock, Katie |e verfasserin |4 aut | |
| 700 | 1 | |a Wallis, Hannah |e verfasserin |4 aut | |
| 700 | 1 | |a Brogan, Andrew P |e verfasserin |4 aut | |
| 700 | 1 | |a Patarroyo, Jimena |e verfasserin |4 aut | |
| 700 | 1 | |a Oglesby, Alan |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Infectious diseases and therapy |d 2012 |g 13(2024), 4 vom: 03. Apr., Seite 875-889 |w (DE-627)NLM240483693 |x 2193-8229 |7 nnns |
| 773 | 1 | 8 | |g volume:13 |g year:2024 |g number:4 |g day:03 |g month:04 |g pages:875-889 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40121-024-00950-1 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 13 |j 2024 |e 4 |b 03 |c 04 |h 875-889 | ||