Impact of the background regimen on virologic response to etravirine : pooled 48-week analysis of DUET-1 and -2
PURPOSE: This subgroup analysis of the phase 3 DUET trials examined the impact of the background regimen on virologic response to etravirine in treatment-experienced patients.
METHODS: Patients received etravirine 200 mg or placebo, both twice daily with a background regimen of darunavir/ritonavir, investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), and optional enfuvirtide. Virologic response at week 48 (viral load <50 HIV-1 RNA copies/mL) was analyzed by the number and activity of background agents.
RESULTS: Baseline phenotypic sensitivity score (PSS), enfuvirtide use, darunavir fold change in 50% effective concentration (FC), and number of baseline darunavir resistance-associated mutations (RAMs) were significant predictors of response to etravirine (P < .0001, P = .0018, P < .0001, and P = .0120, respectively). The number of active NRTIs was not a significant predictor of response (P = .0626). The highest response rates in etravirine-treated patients were associated with PSS ≥2, de novo enfuvirtide use, darunavir FC ≤10, ≤1 darunavir RAM, and ≥2 active NRTIs. Virologic response was consistently higher in etravirine-treated patients than placebo-treated patients, regardless of the activity of the background regimen. Response rates according to baseline PSS were 46% to 79% in the etravirine group versus 6% to 75% in the placebo group.
CONCLUSION: The results of this subanalysis demonstrate higher virologic response rates with increased activity of the background regimen in both treatment groups, with the highest responses achieved in patients using ≥2 active agents in addition to etravirine.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2010 |
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| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
HIV clinical trials - 11(2010), 4 vom: 22. Juli, Seite 175-85 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Trottier, Benoit [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 30.12.2010 Date Revised 09.12.2020 published: Print Citation Status MEDLINE |
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| doi: |
10.1310/hct1104-175 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM202629066 |
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| 024 | 7 | |a 10.1310/hct1104-175 |2 doi | |
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| 041 | |a eng | ||
| 100 | 1 | |a Trottier, Benoit |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Impact of the background regimen on virologic response to etravirine |b pooled 48-week analysis of DUET-1 and -2 |
| 264 | 1 | |c 2010 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 30.12.2010 | ||
| 500 | |a Date Revised 09.12.2020 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a PURPOSE: This subgroup analysis of the phase 3 DUET trials examined the impact of the background regimen on virologic response to etravirine in treatment-experienced patients | ||
| 520 | |a METHODS: Patients received etravirine 200 mg or placebo, both twice daily with a background regimen of darunavir/ritonavir, investigator-selected nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), and optional enfuvirtide. Virologic response at week 48 (viral load <50 HIV-1 RNA copies/mL) was analyzed by the number and activity of background agents | ||
| 520 | |a RESULTS: Baseline phenotypic sensitivity score (PSS), enfuvirtide use, darunavir fold change in 50% effective concentration (FC), and number of baseline darunavir resistance-associated mutations (RAMs) were significant predictors of response to etravirine (P < .0001, P = .0018, P < .0001, and P = .0120, respectively). The number of active NRTIs was not a significant predictor of response (P = .0626). The highest response rates in etravirine-treated patients were associated with PSS ≥2, de novo enfuvirtide use, darunavir FC ≤10, ≤1 darunavir RAM, and ≥2 active NRTIs. Virologic response was consistently higher in etravirine-treated patients than placebo-treated patients, regardless of the activity of the background regimen. Response rates according to baseline PSS were 46% to 79% in the etravirine group versus 6% to 75% in the placebo group | ||
| 520 | |a CONCLUSION: The results of this subanalysis demonstrate higher virologic response rates with increased activity of the background regimen in both treatment groups, with the highest responses achieved in patients using ≥2 active agents in addition to etravirine | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a HIV Protease Inhibitors |2 NLM | |
| 650 | 7 | |a Nitriles |2 NLM | |
| 650 | 7 | |a Pyridazines |2 NLM | |
| 650 | 7 | |a Pyrimidines |2 NLM | |
| 650 | 7 | |a RNA, Viral |2 NLM | |
| 650 | 7 | |a Sulfonamides |2 NLM | |
| 650 | 7 | |a etravirine |2 NLM | |
| 650 | 7 | |a 0C50HW4FO1 |2 NLM | |
| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 650 | 7 | |a Darunavir |2 NLM | |
| 650 | 7 | |a YO603Y8113 |2 NLM | |
| 700 | 1 | |a Di Perri, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Madruga, José Valdez |e verfasserin |4 aut | |
| 700 | 1 | |a Peeters, Monika |e verfasserin |4 aut | |
| 700 | 1 | |a Vingerhoets, Johan |e verfasserin |4 aut | |
| 700 | 1 | |a Picchio, Gaston |e verfasserin |4 aut | |
| 700 | 1 | |a Woodfall, Brian J |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:11 |g year:2010 |g number:4 |g day:22 |g month:07 |g pages:175-85 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1310/hct1104-175 |3 Volltext |
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