Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies
Background As the population of people with HIV ages, concerns over managing age-related comorbidities, polypharmacy, immune recovery, and drug-drug interactions while maintaining viral suppression have arisen. We present pooled TANGO and SALSA efficacy and safety results dichotomized by age (< 5...
| Autores: | , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Universidad Autónoma de Madrid |
| Repositorio: | Biblos-e Archivo. Repositorio Institucional de la UAM |
| Idioma: | inglés |
| OAI Identifier: | oai:repositorio.uam.es:10486/724160 |
| Acceso en línea: | https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 |
| Access Level: | acceso abierto |
| Palabra clave: | Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
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Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studiesWalmsley, SharonSmith, Don E.Górgolas Hernández-Mora, MiguelCahn, Pedro E.Lutz, ThomasLacombe, KarineKumar, Princy N.Wynne, BrianGrove, RichardBontempo, GildaMoodley, RiyaOkoli, ChinyereKisare, MichelleJones, BrynClark, AndrewAit-Khaled, MounirAgingComorbidityDTG/3TCHIV-1PolypharmacySingle-tablet regimenSuppressed switch≥ 50 yearsMedicinaBackground As the population of people with HIV ages, concerns over managing age-related comorbidities, polypharmacy, immune recovery, and drug-drug interactions while maintaining viral suppression have arisen. We present pooled TANGO and SALSA efficacy and safety results dichotomized by age (< 50 and ≥ 50 years). Methods Week 48 data from the open-label phase 3 TANGO and SALSA trials evaluating switch to once-daily dolutegravir/lamivudine (DTG/3TC) fixed-dose combination vs continuing current antiretroviral regimen (CAR) were pooled. Proportions of participants with HIV-1 RNA ≥ 50 and < 50 copies/mL (Snapshot, intention-to-treat exposed) and safety were analyzed by age category. Adjusted mean change from baseline in CD4 + cell count was assessed using mixed-models repeated-measures analysis. Results Of 1234 participants, 80% of whom were male, 29% were aged ≥ 50 years. Among those aged ≥ 50 years, 1/177 (< 1%) DTG/3TC participant and 3/187 (2%) CAR participants had HIV-1 RNA ≥ 50 copies/mL at 48 weeks; proportions with HIV-1 RNA < 50 copies/mL were high in both treatment groups (≥ 92%), consistent with overall efficacy and similar to observations in participants aged < 50 years (≥ 93%). Regardless of age category, CD4 + cell count increased or was maintained from baseline with DTG/3TC. Change from baseline in CD4 + /CD8 + ratio was similar across age groups and between treatment groups. One CAR participant aged < 50 years had confirmed virologic withdrawal, but no resistance was detected. In the DTG/3TC group, incidence of adverse events (AEs) was similar across age groups. Proportions of AEs leading to withdrawal were low and comparable between age groups. Although drug-related AEs were generally low, across age groups, drug-related AEs were more frequent in participants who switched to DTG/3TC compared with those who continued CAR. While few serious AEs were observed in both treatment groups, more were reported in participants aged ≥ 50 years vs < 50 years. Conclusions Among individuals with HIV-1, switching to DTG/3TC maintained high rates of virologic suppression and demonstrated a favorable safety profile, including in those aged ≥ 50 years despite higher prevalence of concomitant medication use and comorbiditiesThese studies were funded by ViiV HealthcareSpringer NatureDepartamento de MedicinaFacultad de Medicina20242024-03-21research articlehttp://purl.org/coar/resource_type/c_2df8fbb1VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10486/724160https://dx.doi.org/10.1186/s12981-024-00604-938515183reponame:Biblos-e Archivo. Repositorio Institucional de la UAMinstname:Universidad Autónoma de MadridInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositorio.uam.es:10486/7241602026-06-23T12:46:27Z |
| dc.title.none.fl_str_mv |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| title |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| spellingShingle |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies Walmsley, Sharon Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| title_short |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| title_full |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| title_fullStr |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| title_full_unstemmed |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| title_sort |
Efficacy and safety of switching to dolutegravir/lamivudine in virologically suppressed people with HIV-1 aged ≥ 50 years: week 48 pooled results from the TANGO and SALSA studies |
| dc.creator.none.fl_str_mv |
Walmsley, Sharon Smith, Don E. Górgolas Hernández-Mora, Miguel Cahn, Pedro E. Lutz, Thomas Lacombe, Karine Kumar, Princy N. Wynne, Brian Grove, Richard Bontempo, Gilda Moodley, Riya Okoli, Chinyere Kisare, Michelle Jones, Bryn Clark, Andrew Ait-Khaled, Mounir |
| author |
Walmsley, Sharon |
| author_facet |
Walmsley, Sharon Smith, Don E. Górgolas Hernández-Mora, Miguel Cahn, Pedro E. Lutz, Thomas Lacombe, Karine Kumar, Princy N. Wynne, Brian Grove, Richard Bontempo, Gilda Moodley, Riya Okoli, Chinyere Kisare, Michelle Jones, Bryn Clark, Andrew Ait-Khaled, Mounir |
| author_role |
author |
| author2 |
Smith, Don E. Górgolas Hernández-Mora, Miguel Cahn, Pedro E. Lutz, Thomas Lacombe, Karine Kumar, Princy N. Wynne, Brian Grove, Richard Bontempo, Gilda Moodley, Riya Okoli, Chinyere Kisare, Michelle Jones, Bryn Clark, Andrew Ait-Khaled, Mounir |
| author2_role |
author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Departamento de Medicina Facultad de Medicina |
| dc.subject.none.fl_str_mv |
Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| topic |
Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| description |
Background As the population of people with HIV ages, concerns over managing age-related comorbidities, polypharmacy, immune recovery, and drug-drug interactions while maintaining viral suppression have arisen. We present pooled TANGO and SALSA efficacy and safety results dichotomized by age (< 50 and ≥ 50 years). Methods Week 48 data from the open-label phase 3 TANGO and SALSA trials evaluating switch to once-daily dolutegravir/lamivudine (DTG/3TC) fixed-dose combination vs continuing current antiretroviral regimen (CAR) were pooled. Proportions of participants with HIV-1 RNA ≥ 50 and < 50 copies/mL (Snapshot, intention-to-treat exposed) and safety were analyzed by age category. Adjusted mean change from baseline in CD4 + cell count was assessed using mixed-models repeated-measures analysis. Results Of 1234 participants, 80% of whom were male, 29% were aged ≥ 50 years. Among those aged ≥ 50 years, 1/177 (< 1%) DTG/3TC participant and 3/187 (2%) CAR participants had HIV-1 RNA ≥ 50 copies/mL at 48 weeks; proportions with HIV-1 RNA < 50 copies/mL were high in both treatment groups (≥ 92%), consistent with overall efficacy and similar to observations in participants aged < 50 years (≥ 93%). Regardless of age category, CD4 + cell count increased or was maintained from baseline with DTG/3TC. Change from baseline in CD4 + /CD8 + ratio was similar across age groups and between treatment groups. One CAR participant aged < 50 years had confirmed virologic withdrawal, but no resistance was detected. In the DTG/3TC group, incidence of adverse events (AEs) was similar across age groups. Proportions of AEs leading to withdrawal were low and comparable between age groups. Although drug-related AEs were generally low, across age groups, drug-related AEs were more frequent in participants who switched to DTG/3TC compared with those who continued CAR. While few serious AEs were observed in both treatment groups, more were reported in participants aged ≥ 50 years vs < 50 years. Conclusions Among individuals with HIV-1, switching to DTG/3TC maintained high rates of virologic suppression and demonstrated a favorable safety profile, including in those aged ≥ 50 years despite higher prevalence of concomitant medication use and comorbidities |
| publishDate |
2024 |
| dc.date.none.fl_str_mv |
2024 2024-03-21 |
| dc.type.none.fl_str_mv |
research article http://purl.org/coar/resource_type/c_2df8fbb1 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 38515183 |
| url |
https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 |
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38515183 |
| dc.language.none.fl_str_mv |
Inglés eng |
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Inglés |
| language |
eng |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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application/pdf |
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Springer Nature |
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Springer Nature |
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Universidad Autónoma de Madrid |
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