Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings : Results from the TANDEM Study
© 2024. The Author(s)..
INTRODUCTION: Dolutegravir/lamivudine (DTG/3TC) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase 3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA.
METHODS: TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18 years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6 months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC (n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3 months before switch to either DTG/3TC (n = 192) or DTG/RPV (n = 151). Clinical characteristics, treatment history, and outcomes are described.
RESULTS: Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25-33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued.
CONCLUSION: Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials.
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 891-906 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Schneider, Stefan [VerfasserIn] |
---|
Links: |
---|
Themen: |
Dolutegravir |
---|
Anmerkungen: |
Date Revised 29.04.2024 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
---|
doi: |
10.1007/s40121-024-00961-y |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM370598644 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | NLM370598644 | ||
003 | DE-627 | ||
005 | 20240429232127.0 | ||
007 | cr uuu---uuuuu | ||
008 | 240404s2024 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s40121-024-00961-y |2 doi | |
028 | 5 | 2 | |a pubmed24n1392.xml |
035 | |a (DE-627)NLM370598644 | ||
035 | |a (NLM)38570443 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Schneider, Stefan |e verfasserin |4 aut | |
245 | 1 | 0 | |a Two-Drug Regimens Dolutegravir/Lamivudine and Dolutegravir/Rilpivirine Are Effective with Few Discontinuations in US Real-World Settings |b Results from the TANDEM Study |
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) and dolutegravir/rilpivirine (DTG/RPV) are fixed-dose, complete, single-tablet, two-drug regimens (2DRs) indicated for HIV-1. DTG/3TC is approved for antiretroviral therapy (ART)-naive people with HIV-1 and virologically suppressed individuals to replace current ART; DTG/RPV is indicated for virologically suppressed individuals as a switch option. Virologic efficacy and effectiveness of these DTG-based 2DRs have been demonstrated in phase 3 clinical trials and real-world cohorts, primarily from Europe. This study characterized real-world use of DTG-based 2DRs for HIV-1 treatment in the USA | ||
520 | |a METHODS: TANDEM was a retrospective medical chart review across 24 US sites. Individuals aged ≥ 18 years who initiated DTG/3TC or DTG/RPV before September 30, 2020, with ≥ 6 months of follow-up were included. One cohort included ART-naive people who initiated DTG/3TC (n = 126), and two other cohorts included virologically suppressed (HIV-1 RNA < 50 copies/mL) people on stable ART regimens for ≥ 3 months before switch to either DTG/3TC (n = 192) or DTG/RPV (n = 151). Clinical characteristics, treatment history, and outcomes are described | ||
520 | |a RESULTS: Virologically suppressed individuals were older than those who were ART-naive, and the ART-naive cohort had higher proportions of individuals assigned male at birth and of Hispanic ethnicity. The most common healthcare provider-reported reason for choosing a DTG-based 2DR was avoidance of long-term toxicities (25-33% across cohorts), followed by simplification/streamlining of treatment. Among ART-naive people on DTG/3TC, 94% achieved virologic suppression after initiation, and 83% maintained suppression at last follow-up; discontinuation rate was < 1%. Among cohorts who switched to DTG-based 2DRs, 96% maintained virologic suppression on DTG/3TC and 93% on DTG/RPV; 2% on DTG/3TC and 3% on DTG/RPV discontinued | ||
520 | |a CONCLUSION: Motivation for selecting DTG-based 2DRs was primarily driven by a desire to avoid or manage toxicities and simplify treatment. Results demonstrate that DTG/3TC and DTG/RPV are effective in real-world settings, with few discontinuations, reflecting data from clinical trials | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Dolutegravir | |
650 | 4 | |a HIV-1 infection | |
650 | 4 | |a Lamivudine | |
650 | 4 | |a Real-world evidence | |
650 | 4 | |a Rilpivirine | |
650 | 4 | |a Two-drug regimen | |
700 | 1 | |a Blick, Gary |e verfasserin |4 aut | |
700 | 1 | |a Burke, Christina |e verfasserin |4 aut | |
700 | 1 | |a Ward, Douglas |e verfasserin |4 aut | |
700 | 1 | |a Benson, Paul |e verfasserin |4 aut | |
700 | 1 | |a Felizarta, Franco |e verfasserin |4 aut | |
700 | 1 | |a Green, Dallas |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 Patarroyo, Jimena |e verfasserin |4 aut | |
700 | 1 | |a Brogan, Andrew P |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 891-906 |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:891-906 |
856 | 4 | 0 | |u http://dx.doi.org/10.1007/s40121-024-00961-y |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 891-906 |