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
Abstract 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 ag...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | AIDS Research and Therapy |
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| Online Access: | https://doi.org/10.1186/s12981-024-00604-9 |
| _version_ | 1827309942786228224 |
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| author | Sharon Walmsley Don E. Smith Miguel Górgolas Pedro E. Cahn Thomas Lutz Karine Lacombe Princy N. Kumar Brian Wynne Richard Grove Gilda Bontempo Riya Moodley Chinyere Okoli Michelle Kisare Bryn Jones Andrew Clark Mounir Ait-Khaled |
| author_facet | Sharon Walmsley Don E. Smith Miguel Górgolas Pedro E. Cahn Thomas Lutz Karine Lacombe Princy N. Kumar Brian Wynne Richard Grove Gilda Bontempo Riya Moodley Chinyere Okoli Michelle Kisare Bryn Jones Andrew Clark Mounir Ait-Khaled |
| author_sort | Sharon Walmsley |
| collection | DOAJ |
| description | Abstract 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. Trial registration number: TANGO, NCT03446573 (February 27, 2018); SALSA, NCT04021290 (July 16, 2019). |
| first_indexed | 2024-04-24T19:51:47Z |
| format | Article |
| id | doaj.art-7b821da8aae94b9ea95b9b1b7ced2c3e |
| institution | Directory Open Access Journal |
| issn | 1742-6405 |
| language | English |
| last_indexed | 2024-04-24T19:51:47Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | AIDS Research and Therapy |
| spelling | doaj.art-7b821da8aae94b9ea95b9b1b7ced2c3e2024-03-24T12:34:30ZengBMCAIDS Research and Therapy1742-64052024-03-012111910.1186/s12981-024-00604-9Efficacy 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 studiesSharon Walmsley0Don E. Smith1Miguel Górgolas2Pedro E. Cahn3Thomas Lutz4Karine Lacombe5Princy N. Kumar6Brian Wynne7Richard Grove8Gilda Bontempo9Riya Moodley10Chinyere Okoli11Michelle Kisare12Bryn Jones13Andrew Clark14Mounir Ait-Khaled15University Health NetworkAlbion CentreFundación Jiménez Díaz, Universidad Autónoma de MadridFundación HuéspedInfektiologikumHôpital Saint-AntoineGeorgetown University Medical CenterViiV HealthcareGSKViiV HealthcareViiV HealthcareViiV HealthcareViiV HealthcareViiV HealthcareViiV HealthcareViiV HealthcareAbstract 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. Trial registration number: TANGO, NCT03446573 (February 27, 2018); SALSA, NCT04021290 (July 16, 2019).https://doi.org/10.1186/s12981-024-00604-9AgingComorbidityDTG/3TCHIV-1PolypharmacySingle-tablet regimen |
| spellingShingle | Sharon Walmsley Don E. Smith Miguel Górgolas Pedro E. Cahn Thomas Lutz Karine Lacombe Princy N. Kumar Brian Wynne Richard Grove Gilda Bontempo Riya Moodley Chinyere Okoli Michelle Kisare Bryn Jones Andrew Clark Mounir Ait-Khaled 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 AIDS Research and Therapy Aging Comorbidity DTG/3TC HIV-1 Polypharmacy Single-tablet regimen |
| 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 |
| url | https://doi.org/10.1186/s12981-024-00604-9 |
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