Lamivudine-based two-drug regimens with dolutegravir or protease inhibitor : Virological suppression in spite of previous therapy failure or renal dysfunction
Copyright © 2023. Published by Elsevier España, S.L.U..
BACKGROUND: Two-Drug Regimens (2DR) have proven effective in clinical trials but real-world data, especially in resource-limited settings, is limited.
OBJECTIVES: To evaluate viral suppression of lamivudine-based 2DR, with dolutegravir or ritonavir-boosted protease inhibitor (lopinavir/r, atazanavir/r or darunavir/r), among all cases regardless of selection criteria.
PATIENTS AND METHODS: A retrospective study, conducted in an HIV clinic in the metropolitan area of São Paulo, Brazil. Per-protocol failure was defined as viremia above 200 copies/mL at outcome. Intention-To-Treat-Exposed (ITT-E) failure was considered for those who initiated 2DR but subsequently had either (i) Delay over 30 days in Antiretroviral Treatment (ART) dispensation, (ii) ART changed or (iii) Viremia > 200 copies/mL in the last observation using 2DR.
RESULTS: Out of 278 patients initiating 2DR, 99.6% had viremia below 200 copies/mL at last observation, 97.8% below 50 copies/mL. Lamivudine resistance, either documented (M184V) or presumed (viremia > 200 copies/mL over a month using 3TC) was present in 11% of cases that showed lower suppression rates (97%), but with no significant hazard ratio to fail per ITT-E (1.24, p = 0.78). Decreased kidney function, present in 18 cases, showed of 4.69 hazard ratio (p = 0.02) per ITT-E for failure (3/18). As per protocol analysis, three failures occurred, none with renal dysfunction.
CONCLUSIONS: The 2DR is feasible, with robust suppression rates, even when 3TC resistance or renal dysfunction is present, and close monitoring of these cases may guarantee long-term suppression.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:27 |
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| Enthalten in: |
The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious Diseases - 27(2023), 3 vom: 01. Mai, Seite 102757 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Matsuda, Elaine Monteiro [VerfasserIn] |
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| Links: |
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| Themen: |
2DR |
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| Anmerkungen: |
Date Completed 13.06.2023 Date Revised 13.06.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.bjid.2023.102757 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353161934 |
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| 100 | 1 | |a Matsuda, Elaine Monteiro |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Lamivudine-based two-drug regimens with dolutegravir or protease inhibitor |b Virological suppression in spite of previous therapy failure or renal dysfunction |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 13.06.2023 | ||
| 500 | |a Date Revised 13.06.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023. Published by Elsevier España, S.L.U. | ||
| 520 | |a BACKGROUND: Two-Drug Regimens (2DR) have proven effective in clinical trials but real-world data, especially in resource-limited settings, is limited | ||
| 520 | |a OBJECTIVES: To evaluate viral suppression of lamivudine-based 2DR, with dolutegravir or ritonavir-boosted protease inhibitor (lopinavir/r, atazanavir/r or darunavir/r), among all cases regardless of selection criteria | ||
| 520 | |a PATIENTS AND METHODS: A retrospective study, conducted in an HIV clinic in the metropolitan area of São Paulo, Brazil. Per-protocol failure was defined as viremia above 200 copies/mL at outcome. Intention-To-Treat-Exposed (ITT-E) failure was considered for those who initiated 2DR but subsequently had either (i) Delay over 30 days in Antiretroviral Treatment (ART) dispensation, (ii) ART changed or (iii) Viremia > 200 copies/mL in the last observation using 2DR | ||
| 520 | |a RESULTS: Out of 278 patients initiating 2DR, 99.6% had viremia below 200 copies/mL at last observation, 97.8% below 50 copies/mL. Lamivudine resistance, either documented (M184V) or presumed (viremia > 200 copies/mL over a month using 3TC) was present in 11% of cases that showed lower suppression rates (97%), but with no significant hazard ratio to fail per ITT-E (1.24, p = 0.78). Decreased kidney function, present in 18 cases, showed of 4.69 hazard ratio (p = 0.02) per ITT-E for failure (3/18). As per protocol analysis, three failures occurred, none with renal dysfunction | ||
| 520 | |a CONCLUSIONS: The 2DR is feasible, with robust suppression rates, even when 3TC resistance or renal dysfunction is present, and close monitoring of these cases may guarantee long-term suppression | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a 2DR | |
| 650 | 4 | |a 3TC resistance | |
| 650 | 4 | |a CKD-EPI | |
| 650 | 4 | |a Dual therapy | |
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| 650 | 7 | |a Lamivudine |2 NLM | |
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| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a HIV Protease Inhibitors |2 NLM | |
| 650 | 7 | |a Anti-Infective Agents |2 NLM | |
| 700 | 1 | |a Campos, Ivana Barros |e verfasserin |4 aut | |
| 700 | 1 | |a de Oliveira, Isabela Penteriche |e verfasserin |4 aut | |
| 700 | 1 | |a Colpas, Daniela Rodrigues |e verfasserin |4 aut | |
| 700 | 1 | |a López-Lopes, Giselle Ibete Silva |e verfasserin |4 aut | |
| 700 | 1 | |a Chiavegato, Victor Oliveira |e verfasserin |4 aut | |
| 700 | 1 | |a Brígido, Luís Fernando de Macedo |e verfasserin |4 aut | |
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