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48-week efficacy and safety of transitioning virologically stable HIV-1 patients from nevirapine IR 200 mg BID to nevirapine XR 400 mg QD (TRANxITION)
Journal of the International AIDS Society volume 13, Article number: P45 (2010)
Wk 24 TRANxITION study data showed patients transitioned from immediate release nevirapine (NVP IR) twice daily (BID) to NVP extended release (NVP XR) once-daily (QD) demonstrated non-inferior efficacy to patients continuing on IR NVP BID . Similar safety was reported for NVP XR and NVP IR in the VERxVE study 2. Wk 48 efficacy/safety data from TRANxITION study are presented here.
Open label, randomized (2:1), non-inferiority, parallel group study comparing NVP XR 400 mg QD with NVP IR 200 mg BID in HIV-1 patients >18 years receiving IR NVP plus one of three NRTI combinations, with viral load (VL) <50 copies/mL. Patients remained on their previous background therapy for treatment duration. Sustained virologic response (VL <50 copies/mL) was assessed at Wk 48 using a time-to-loss of virologic response (TLOVR) algorithm.
426 patients completed 48 wks of treatment. 94.9% of NVP XR and 91.9% of NVP IR patients. Mean baseline CD4+ counts: 557.7 cells/mm3 and 569.7 cells/mm3, respectively. 48 Wk data are reported in Table 1. Non-inferiority of virologic suppression was achieved using a TLOVR and snapshot analysis.
At Wk 48, non-inferiority between the NVP XR 400 mg QD and NVP IR 200 mg BID groups was sustained. No unexpected AEs were observed at Wk 48. These data support transition from NVP IR to NVP XR in patients stable on the former formulation.
Arasteh K, et al: Presented at ICAAC 2010, Boston, USA. Abst: 2148
Gathe J, et al: Presented at XVIII International AIDS Conference, Vienna, Austria. Abst: THLBB202
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Arastéh, K., Ward, A., Plettenberg, A. et al. 48-week efficacy and safety of transitioning virologically stable HIV-1 patients from nevirapine IR 200 mg BID to nevirapine XR 400 mg QD (TRANxITION). JIAS 13 (Suppl 4), P45 (2010). https://doi.org/10.1186/1758-2652-13-S4-P45
- Viral Load
- Sustained Virologic Response
- Virologic Response
- Extended Release