Three-year efficacy of switching to dolutegravir plus lamivudine: A real-world study.


Journal

HIV medicine
ISSN: 1468-1293
Titre abrégé: HIV Med
Pays: England
ID NLM: 100897392

Informations de publication

Date de publication:
09 2023
Historique:
received: 06 03 2023
accepted: 18 04 2023
medline: 14 9 2023
pubmed: 17 5 2023
entrez: 17 5 2023
Statut: ppublish

Résumé

Dolutegravir (DTG) plus lamivudine (3TC) has proven highly efficacious as a switching strategy in virologically suppressed people with HIV (PWH). As this strategy was introduced relatively recently, real-world, long-term durability studies are lacking. We performed a retrospective review of treatment-experienced patients who started DTG + 3TC in a cohort of PWH. HIV-RNA <50 copies/mL was analysed at 144 weeks in an intention-to-treat (ITT) analysis (missing = failure) and a per-protocol (PP) analysis (patients with missing data or changes for reasons other than virological failure were excluded). The study population comprised 358 PWH (19% women). Median age and time with HIV infection were 51.7 and 13.4 years, respectively. The median number of previous antiretroviral combinations was three. Previous virological failure was reported in 27.1% of patients, and the M184V resistance mutation was detected in 17 patients. At 144 weeks, the percentage of individuals with HIV-RNA <50 copies/mL was 77.4% (277/358) in the ITT analysis and 95.5% (277/290) in the PP analysis. A total of 68 participants were excluded from the PP analysis (data missing, 25, discontinuation due to toxicity, 19; other, 16; death, 8). Two people with virological failure selected resistance-associated mutations (M184V and M184V + R263K). HIV-RNA remained undetectable in 17 patients with a previous history of the M184V mutation. Our results confirm the real-world, long-term efficacy, tolerability and high genetic barrier of DTG + 3TC in treatment-experienced PWH. Although scarce, mutations causing resistance to nucleosides and integrase can emerge.

Sections du résumé

BACKGROUND
Dolutegravir (DTG) plus lamivudine (3TC) has proven highly efficacious as a switching strategy in virologically suppressed people with HIV (PWH). As this strategy was introduced relatively recently, real-world, long-term durability studies are lacking.
METHODS
We performed a retrospective review of treatment-experienced patients who started DTG + 3TC in a cohort of PWH. HIV-RNA <50 copies/mL was analysed at 144 weeks in an intention-to-treat (ITT) analysis (missing = failure) and a per-protocol (PP) analysis (patients with missing data or changes for reasons other than virological failure were excluded).
RESULTS
The study population comprised 358 PWH (19% women). Median age and time with HIV infection were 51.7 and 13.4 years, respectively. The median number of previous antiretroviral combinations was three. Previous virological failure was reported in 27.1% of patients, and the M184V resistance mutation was detected in 17 patients. At 144 weeks, the percentage of individuals with HIV-RNA <50 copies/mL was 77.4% (277/358) in the ITT analysis and 95.5% (277/290) in the PP analysis. A total of 68 participants were excluded from the PP analysis (data missing, 25, discontinuation due to toxicity, 19; other, 16; death, 8). Two people with virological failure selected resistance-associated mutations (M184V and M184V + R263K). HIV-RNA remained undetectable in 17 patients with a previous history of the M184V mutation.
CONCLUSION
Our results confirm the real-world, long-term efficacy, tolerability and high genetic barrier of DTG + 3TC in treatment-experienced PWH. Although scarce, mutations causing resistance to nucleosides and integrase can emerge.

Identifiants

pubmed: 37194419
doi: 10.1111/hiv.13500
doi:

Substances chimiques

Lamivudine 2T8Q726O95
dolutegravir DKO1W9H7M1
Anti-HIV Agents 0
Oxazines 0
Heterocyclic Compounds, 3-Ring 0
RNA 63231-63-0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1013-1019

Informations de copyright

© 2023 British HIV Association.

Références

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Auteurs

E Palmier (E)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

R De Miguel (R)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

R Montejano (R)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

C Busca (C)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

R Micán (R)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

L Ramos (L)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

J Cadiñanos (J)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

L Serrano (L)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

J I Bernardino (JI)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

I Pérez-Valero (I)

Hospital Universitario Reina Sofía, Córdoba, Spain.

E Valencia (E)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

J R Arribas (JR)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

M L Montes (ML)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

J González-García (J)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.
CIBER Infectious Diseases (CIBERINFEC), Madrid, Spain.

L Martín-Carbonero (L)

Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

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