Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials
Background: Older adults living with HIV (OALWH) are a growing population facing unique challenges to successful antiretroviral therapy. Objective: To assess efficacy and safety profiles of antiretroviral regimens, including those containing dolutegravir, in OALWH. Methods: Combined data from 6 phas...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2021-07-01
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| Series: | HIV Research & Clinical Practice |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/25787489.2021.1941672 |
| _version_ | 1797661047122821120 |
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| author | Frank Spinelli Manyu Prakash Jill Slater Mike van der Kolk Niccolò Bassani Richard Grove Brian Wynne Jean van Wyk Andrew Clark |
| author_facet | Frank Spinelli Manyu Prakash Jill Slater Mike van der Kolk Niccolò Bassani Richard Grove Brian Wynne Jean van Wyk Andrew Clark |
| author_sort | Frank Spinelli |
| collection | DOAJ |
| description | Background: Older adults living with HIV (OALWH) are a growing population facing unique challenges to successful antiretroviral therapy. Objective: To assess efficacy and safety profiles of antiretroviral regimens, including those containing dolutegravir, in OALWH. Methods: Combined data from 6 phase III/IIIb trials in treatment-naive (ARIA, FLAMINGO, SINGLE, SPRING-2; N = 2634) and treatment-experienced (DAWNING, SAILING; N = 1339) participants receiving dolutegravir- or non–dolutegravir-based regimens were analyzed by age (<50, ≥50 to <65, and ≥65 years). Baseline data included comorbidities and numbers of concomitant medications. Week 48 efficacy outcomes included virologic response (HIV-1 RNA <50 copies/mL) and CD4+ cell count change from baseline. Safety outcomes included incidence of adverse events (AEs), serious AEs, and AE-related withdrawals. Results: Use of ≥5 concomitant medications was more frequently reported among treatment-naive and treatment-experienced participants aged ≥50 to <65 (30% [90/296] and 25% [57/227], respectively) and ≥65 years (43% [10/23] and 29% [4/14]) than among those aged <50 years (13% [310/2315] and 11% [118/1098]). Comorbidities were more prevalent in the older age groups. For dolutegravir-based regimens, Week 48 rates of virologic response and change in CD4+ cell count were similar across age groups (treatment naive, 80–87% and 234–251 cells/mm3; treatment experienced, 70–100% and 105–156 cells/mm3, respectively). There were no major differences in safety outcomes in each age group. Conclusions: In these analyses of combined phase III/IIIb trial data, efficacy and safety of dolutegravir-based regimens were generally similar across age groups in treatment-naive or treatment-experienced participants. Polypharmacy and comorbidities were more common among OALWH than those aged <50 years. |
| first_indexed | 2024-03-11T18:39:41Z |
| format | Article |
| id | doaj.art-4176bce433b2463580ff6ef6d2dfbc94 |
| institution | Directory Open Access Journal |
| issn | 2578-7470 |
| language | English |
| last_indexed | 2024-03-11T18:39:41Z |
| publishDate | 2021-07-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | HIV Research & Clinical Practice |
| spelling | doaj.art-4176bce433b2463580ff6ef6d2dfbc942023-10-12T13:43:53ZengTaylor & Francis GroupHIV Research & Clinical Practice2578-74702021-07-01222465410.1080/25787489.2021.19416721941672Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trialsFrank Spinelli0Manyu Prakash1Jill Slater2Mike van der Kolk3Niccolò Bassani4Richard Grove5Brian Wynne6Jean van Wyk7Andrew Clark8ViiV Healthcare, Research Triangle ParkViiV HealthcareViiV Healthcare, Research Triangle ParkViiV HealthcareQuanticateGlaxoSmithKlineViiV Healthcare, Research Triangle ParkViiV HealthcareViiV HealthcareBackground: Older adults living with HIV (OALWH) are a growing population facing unique challenges to successful antiretroviral therapy. Objective: To assess efficacy and safety profiles of antiretroviral regimens, including those containing dolutegravir, in OALWH. Methods: Combined data from 6 phase III/IIIb trials in treatment-naive (ARIA, FLAMINGO, SINGLE, SPRING-2; N = 2634) and treatment-experienced (DAWNING, SAILING; N = 1339) participants receiving dolutegravir- or non–dolutegravir-based regimens were analyzed by age (<50, ≥50 to <65, and ≥65 years). Baseline data included comorbidities and numbers of concomitant medications. Week 48 efficacy outcomes included virologic response (HIV-1 RNA <50 copies/mL) and CD4+ cell count change from baseline. Safety outcomes included incidence of adverse events (AEs), serious AEs, and AE-related withdrawals. Results: Use of ≥5 concomitant medications was more frequently reported among treatment-naive and treatment-experienced participants aged ≥50 to <65 (30% [90/296] and 25% [57/227], respectively) and ≥65 years (43% [10/23] and 29% [4/14]) than among those aged <50 years (13% [310/2315] and 11% [118/1098]). Comorbidities were more prevalent in the older age groups. For dolutegravir-based regimens, Week 48 rates of virologic response and change in CD4+ cell count were similar across age groups (treatment naive, 80–87% and 234–251 cells/mm3; treatment experienced, 70–100% and 105–156 cells/mm3, respectively). There were no major differences in safety outcomes in each age group. Conclusions: In these analyses of combined phase III/IIIb trial data, efficacy and safety of dolutegravir-based regimens were generally similar across age groups in treatment-naive or treatment-experienced participants. Polypharmacy and comorbidities were more common among OALWH than those aged <50 years.http://dx.doi.org/10.1080/25787489.2021.1941672integrase strand transfer inhibitorvirologic suppressionantiretroviral therapycomorbiditiespolypharmacyolder adults living with hiv |
| spellingShingle | Frank Spinelli Manyu Prakash Jill Slater Mike van der Kolk Niccolò Bassani Richard Grove Brian Wynne Jean van Wyk Andrew Clark Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials HIV Research & Clinical Practice integrase strand transfer inhibitor virologic suppression antiretroviral therapy comorbidities polypharmacy older adults living with hiv |
| title | Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials |
| title_full | Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials |
| title_fullStr | Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials |
| title_full_unstemmed | Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials |
| title_short | Dolutegravir-based regimens in treatment-naive and treatment-experienced aging populations: analyses of 6 phase III clinical trials |
| title_sort | dolutegravir based regimens in treatment naive and treatment experienced aging populations analyses of 6 phase iii clinical trials |
| topic | integrase strand transfer inhibitor virologic suppression antiretroviral therapy comorbidities polypharmacy older adults living with hiv |
| url | http://dx.doi.org/10.1080/25787489.2021.1941672 |
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