Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial
Background. An exploratory subanalysis of the ODIN trial was performed to evaluate the efficacy of darunavir/ritonavir (DRV/r) 800/100 mg OD versus 600/100 mg BID in patients who were NNRTI-experienced but PI-naïve. Methods. ODIN was a phase III, 48-week study comparing DRV/r OD versus BID in 590 tr...
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| Format: | Article |
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Wiley
2015-01-01
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| Series: | AIDS Research and Treatment |
| Online Access: | http://dx.doi.org/10.1155/2015/962574 |
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| author | Anna Maria Geretti Mathe Moeketsi Ralph Demasi Yvon van Delft Perry Mohammed |
| author_facet | Anna Maria Geretti Mathe Moeketsi Ralph Demasi Yvon van Delft Perry Mohammed |
| author_sort | Anna Maria Geretti |
| collection | DOAJ |
| description | Background. An exploratory subanalysis of the ODIN trial was performed to evaluate the efficacy of darunavir/ritonavir (DRV/r) 800/100 mg OD versus 600/100 mg BID in patients who were NNRTI-experienced but PI-naïve. Methods. ODIN was a phase III, 48-week study comparing DRV/r OD versus BID in 590 treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Patients received DRV/r 800/100 mg OD or DRV/r 600/100 mg BID plus ≥2 NRTIs. Of the 590 patients randomized, 272 (46%) were NNRTI-experienced but PI-naïve. Results. Overall, 272 patients received DRV/r OD n=135 or BID n=137 plus ≥2 optimised NRTIs. The mean age was 39 years; 35% were female; 27% were Black, 24% Caucasian, 26% Oriental/Asian, and 23% other races; 17% were recruited in South Africa; and 48% had non-B HIV-1 subtypes. Mean baseline plasma HIV-1 RNA load was 4.10 log10 copies/mL; median CD4 cell count was 258 cells/μL. At week 48, 111/135 (82%) of DRV/r OD and 109/137 (80%) of DRV/r BID patients achieved an HIV-1 RNA load <50 copies/mL. No patient developed primary PI RAMs. Conclusion. DRV/r 800/100 mg OD in combination with ≥2 optimised NRTIs led to virological suppression <50 copies/mL in 82% of NNRTI-experienced, PI-naïve patients by week 48. |
| format | Article |
| id | doaj-art-c90bebc0cfe747638d2893a8d0204b57 |
| institution | Kabale University |
| issn | 2090-1240 2090-1259 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
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| series | AIDS Research and Treatment |
| spelling | doaj-art-c90bebc0cfe747638d2893a8d0204b572025-02-03T01:06:43ZengWileyAIDS Research and Treatment2090-12402090-12592015-01-01201510.1155/2015/962574962574Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN TrialAnna Maria Geretti0Mathe Moeketsi1Ralph Demasi2Yvon van Delft3Perry Mohammed4University of Liverpool, Liverpool, UKFolateng Ward, Sebokeng Hospital, Gauteng, South AfricaJanssen Research and Development, LLC, Titusville, NJ, USAJanssen Global Public Health, Tilburg, NetherlandsJanssen Global Public Health, High Wycombe, UKBackground. An exploratory subanalysis of the ODIN trial was performed to evaluate the efficacy of darunavir/ritonavir (DRV/r) 800/100 mg OD versus 600/100 mg BID in patients who were NNRTI-experienced but PI-naïve. Methods. ODIN was a phase III, 48-week study comparing DRV/r OD versus BID in 590 treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening. Patients received DRV/r 800/100 mg OD or DRV/r 600/100 mg BID plus ≥2 NRTIs. Of the 590 patients randomized, 272 (46%) were NNRTI-experienced but PI-naïve. Results. Overall, 272 patients received DRV/r OD n=135 or BID n=137 plus ≥2 optimised NRTIs. The mean age was 39 years; 35% were female; 27% were Black, 24% Caucasian, 26% Oriental/Asian, and 23% other races; 17% were recruited in South Africa; and 48% had non-B HIV-1 subtypes. Mean baseline plasma HIV-1 RNA load was 4.10 log10 copies/mL; median CD4 cell count was 258 cells/μL. At week 48, 111/135 (82%) of DRV/r OD and 109/137 (80%) of DRV/r BID patients achieved an HIV-1 RNA load <50 copies/mL. No patient developed primary PI RAMs. Conclusion. DRV/r 800/100 mg OD in combination with ≥2 optimised NRTIs led to virological suppression <50 copies/mL in 82% of NNRTI-experienced, PI-naïve patients by week 48.http://dx.doi.org/10.1155/2015/962574 |
| spellingShingle | Anna Maria Geretti Mathe Moeketsi Ralph Demasi Yvon van Delft Perry Mohammed Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial AIDS Research and Treatment |
| title | Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial |
| title_full | Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial |
| title_fullStr | Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial |
| title_full_unstemmed | Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial |
| title_short | Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial |
| title_sort | efficacy of once daily darunavir ritonavir in pi naive nnrti experienced patients in the odin trial |
| url | http://dx.doi.org/10.1155/2015/962574 |
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