Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV
Two-drug regimens (2DRs) are emerging in clinical practice guidelines as treatment option for both naive and treatment-experienced people living with HIV (PLHIV). <b>Objectives:</b> To determine the real-life effectiveness of 2DR with 25 mg RPV plus 50 mg DTG in a single-tablet regimen (...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-11-01
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| Series: | Viruses |
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| Online Access: | https://www.mdpi.com/1999-4915/14/12/2626 |
| _version_ | 1797454994103861248 |
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| author | Carmen Hidalgo-Tenorio David Vinuesa Coral García-Vallecillos Leopoldo Muñoz-Medina Sergio Sequera Rosario Javier Miguel Ángel López-Ruz Svetlana Sadyrbaeva-Dolgova Juan Pasquau |
| author_facet | Carmen Hidalgo-Tenorio David Vinuesa Coral García-Vallecillos Leopoldo Muñoz-Medina Sergio Sequera Rosario Javier Miguel Ángel López-Ruz Svetlana Sadyrbaeva-Dolgova Juan Pasquau |
| author_sort | Carmen Hidalgo-Tenorio |
| collection | DOAJ |
| description | Two-drug regimens (2DRs) are emerging in clinical practice guidelines as treatment option for both naive and treatment-experienced people living with HIV (PLHIV). <b>Objectives:</b> To determine the real-life effectiveness of 2DR with 25 mg RPV plus 50 mg DTG in a single-tablet regimen (RPV/DTG<sub>STR</sub>) and its impact on viral and immune status, lipid profile, and inflammatory markers. <b>Methods:</b> This observational study included 291 treatment-experienced PLHIV, starting 2DR with RPV/DTG<sub>STR</sub> between 29 January 2019 and 2 February 2022, who were followed up for at least six months. Participants gave verbal informed consent for the switch in antiretroviral therapy (ART) to RPV/DTG<sub>STR</sub>. <b>Results:</b> The mean age of the 291 participants was 51.3 years; 77.7% were male; and 42.9% were in the AIDS stage with a CD4 nadir of 283.5 ± 204.6 cells/uL. The median time since HIV diagnosis was 19.7 years (IQR: 10.6–27). Before 2DR, patients received a median of five ART lines (IQR: 3–7) for 22.2 years (IQR: 14–26), with 34.4% (<i>n</i> = 100) receiving a three-drug regimen (3DR), 31.3% (<i>n</i> = 91) receiving monotherapy, and 34.4% (<i>n</i> = 100) receiving 2DR. The median time on RPV/DTG<sub>STR</sub> was 14 months (IQR: 9.5–21); 1.4% were lost to the follow-up. Effectiveness was 96.2% by intention-to-treat (ITT) analysis, 97.5% by modified ITT, and 99.3% by per-protocol analysis. Virological failure was observed in 0.69%, blips in 3.5%, and switch to another ART in 1.4%. The mean lipid profile improved, with reductions in TC/HDLc ratio (3.9 ± 0.9 vs. 3.6 ± 0.9; <i>p</i> = 0.0001), LDLc (118.3 ± 32.2 mg/dL vs. 106.2 ± 29.8 mg/dL, <i>p</i> = 0.0001), TG (130.9 ± 73.9 mg/dL vs. 115.9 ± 68.5 mg/dL, <i>p</i> = 0.0001), and CD4/CD8 ratio increase (0.99 ± 0.58 vs. 1.01 ± 0.54; <i>p</i> = 0.0001). The cost-effectiveness of 2DR with RPV/DTG<sub>STR</sub> was similar to that of DTG/3TC and superior to those of BIC/TAF/FTC and DRV/c/TAF/FTC, with higher virological suppression and lower annual costs. <b>Conclusions:</b> The switch to RPV plus DTG in STR is a cost-effective, long-lasting, and robust strategy for PLHIV, with a very long experience of treatment, which improves the lipid profile without affecting inflammatory markers. |
| first_indexed | 2024-03-09T15:45:09Z |
| format | Article |
| id | doaj.art-ca0738d9b9ec405e9150637edeacdf06 |
| institution | Directory Open Access Journal |
| issn | 1999-4915 |
| language | English |
| last_indexed | 2024-03-09T15:45:09Z |
| publishDate | 2022-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Viruses |
| spelling | doaj.art-ca0738d9b9ec405e9150637edeacdf062023-11-24T18:36:46ZengMDPI AGViruses1999-49152022-11-011412262610.3390/v14122626Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIVCarmen Hidalgo-Tenorio0David Vinuesa1Coral García-Vallecillos2Leopoldo Muñoz-Medina3Sergio Sequera4Rosario Javier5Miguel Ángel López-Ruz6Svetlana Sadyrbaeva-Dolgova7Juan Pasquau8Unit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, San Cecilio University Hospital, Biohealth Research Institute, IBS-Granada, 18012 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, San Cecilio University Hospital, Biohealth Research Institute, IBS-Granada, 18012 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainUnit of Infectious Diseases, Virgen de las Nieves University Hospital, Biohealth Research Institute, IBS-Granada, 18014 Granada, SpainTwo-drug regimens (2DRs) are emerging in clinical practice guidelines as treatment option for both naive and treatment-experienced people living with HIV (PLHIV). <b>Objectives:</b> To determine the real-life effectiveness of 2DR with 25 mg RPV plus 50 mg DTG in a single-tablet regimen (RPV/DTG<sub>STR</sub>) and its impact on viral and immune status, lipid profile, and inflammatory markers. <b>Methods:</b> This observational study included 291 treatment-experienced PLHIV, starting 2DR with RPV/DTG<sub>STR</sub> between 29 January 2019 and 2 February 2022, who were followed up for at least six months. Participants gave verbal informed consent for the switch in antiretroviral therapy (ART) to RPV/DTG<sub>STR</sub>. <b>Results:</b> The mean age of the 291 participants was 51.3 years; 77.7% were male; and 42.9% were in the AIDS stage with a CD4 nadir of 283.5 ± 204.6 cells/uL. The median time since HIV diagnosis was 19.7 years (IQR: 10.6–27). Before 2DR, patients received a median of five ART lines (IQR: 3–7) for 22.2 years (IQR: 14–26), with 34.4% (<i>n</i> = 100) receiving a three-drug regimen (3DR), 31.3% (<i>n</i> = 91) receiving monotherapy, and 34.4% (<i>n</i> = 100) receiving 2DR. The median time on RPV/DTG<sub>STR</sub> was 14 months (IQR: 9.5–21); 1.4% were lost to the follow-up. Effectiveness was 96.2% by intention-to-treat (ITT) analysis, 97.5% by modified ITT, and 99.3% by per-protocol analysis. Virological failure was observed in 0.69%, blips in 3.5%, and switch to another ART in 1.4%. The mean lipid profile improved, with reductions in TC/HDLc ratio (3.9 ± 0.9 vs. 3.6 ± 0.9; <i>p</i> = 0.0001), LDLc (118.3 ± 32.2 mg/dL vs. 106.2 ± 29.8 mg/dL, <i>p</i> = 0.0001), TG (130.9 ± 73.9 mg/dL vs. 115.9 ± 68.5 mg/dL, <i>p</i> = 0.0001), and CD4/CD8 ratio increase (0.99 ± 0.58 vs. 1.01 ± 0.54; <i>p</i> = 0.0001). The cost-effectiveness of 2DR with RPV/DTG<sub>STR</sub> was similar to that of DTG/3TC and superior to those of BIC/TAF/FTC and DRV/c/TAF/FTC, with higher virological suppression and lower annual costs. <b>Conclusions:</b> The switch to RPV plus DTG in STR is a cost-effective, long-lasting, and robust strategy for PLHIV, with a very long experience of treatment, which improves the lipid profile without affecting inflammatory markers.https://www.mdpi.com/1999-4915/14/12/26262DRdolutegravirrilpivirinetreatment-experienced PLHIV |
| spellingShingle | Carmen Hidalgo-Tenorio David Vinuesa Coral García-Vallecillos Leopoldo Muñoz-Medina Sergio Sequera Rosario Javier Miguel Ángel López-Ruz Svetlana Sadyrbaeva-Dolgova Juan Pasquau Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV Viruses 2DR dolutegravir rilpivirine treatment-experienced PLHIV |
| title | Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV |
| title_full | Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV |
| title_fullStr | Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV |
| title_full_unstemmed | Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV |
| title_short | Rildo: Real-World Multicenter Study on the Effectiveness and Safety of Single-Tablet Regimen of Dolutegravir plus Rilpivirine in Treatment-Experienced People Living with HIV |
| title_sort | rildo real world multicenter study on the effectiveness and safety of single tablet regimen of dolutegravir plus rilpivirine in treatment experienced people living with hiv |
| topic | 2DR dolutegravir rilpivirine treatment-experienced PLHIV |
| url | https://www.mdpi.com/1999-4915/14/12/2626 |
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