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 (< 50 a...
| Authors: | ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; |
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| Format: | Article |
| Publication date: | 2024 |
| Country: | España |
| Institution: | Universidad Autónoma de Madrid |
| Repository: | Biblos-e Archivo. Repositorio Institucional de la UAM |
| Language: | English |
| OAI Identifier: | oai:repositorio.uam.es:10486/724160 |
| Online Access: | https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 |
| Access Level: | Open access |
| Keyword: | Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| _version_ | 1878741971164463105 |
|---|---|
| author | Walmsley, Sharon |
| 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 |
| author_browse | Ait-Khaled, Mounir Bontempo, Gilda Cahn, Pedro E. Clark, Andrew Grove, Richard Górgolas Hernández-Mora, Miguel Jones, Bryn Kisare, Michelle Kumar, Princy N. Lacombe, Karine Lutz, Thomas Moodley, Riya Okoli, Chinyere Smith, Don E. Walmsley, Sharon Wynne, Brian |
| 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 |
| collection | Biblos-e Archivo. Repositorio Institucional de la UAM |
| 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 |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_ee2ec4136a26b0d1c4e82cf8ecfda287 |
| identifier_str_mv | 38515183 |
| institution | Universidad Autónoma de Madrid |
| instname_str | Universidad Autónoma de Madrid |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:repositorio.uam.es:10486/724160 |
| publishDate | 2024 |
| publishDateSort | 2024 |
| publisher | Springer Nature |
| publisherStr | Springer Nature |
| reponame_str | Biblos-e Archivo. Repositorio Institucional de la UAM |
| spelling | 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 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 Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina 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 These studies were funded by ViiV Healthcare Springer Nature https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 38515183 |
| 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 | 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_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_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 |
| topic | Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| topic_facet | Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen Suppressed switch ≥ 50 years Medicina |
| url | https://hdl.handle.net/10486/724160 https://dx.doi.org/10.1186/s12981-024-00604-9 |