Skip to main content

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)

Background

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 [1]. Similar safety was reported for NVP XR and NVP IR in the VERxVE study [2]2. Wk 48 efficacy/safety data from TRANxITION study are presented here.

Methods

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.

Results

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.

Table 1

Conclusions

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.

References

  1. Arasteh K, et al: Presented at ICAAC 2010, Boston, USA. Abst: 2148

  2. Gathe J, et al: Presented at XVIII International AIDS Conference, Vienna, Austria. Abst: THLBB202

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

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, P45 (2010). https://doi.org/10.1186/1758-2652-13-S4-P45

Download citation

  • Published:

  • DOI: https://doi.org/10.1186/1758-2652-13-S4-P45

Keywords

  • Viral Load
  • Sustained Virologic Response
  • Nevirapine
  • Virologic Response
  • Extended Release