Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients

Simple item page
dc.contributor.authorGathe, Joseph
dc.contributor.authorAndrade-Villanueva, Jaime
dc.contributor.authorSantiago, Steven
dc.contributor.authorHorban, Andrzej
dc.contributor.authorNelson, Mark
dc.contributor.authorCahn, Pedro
dc.contributor.authorBogner, Johannes
dc.contributor.authorSpencer, David
dc.contributor.authorPodzamczer, Daniel
dc.contributor.authorChan-Loi, Yong
dc.contributor.authorThuy, Nguyen
dc.contributor.authorWei, Zhang
dc.contributor.authorMurray, Drulak
dc.contributor.authorQuinson, Anne-Marie
dc.date.accessioned2024-05-23T18:53:33Z
dc.date.available2024-05-23T18:53:33Z
dc.date.issued2011
dc.description.abstractBackground: This study (VERxVE) compared the efficacy and safety of the new nevirapine extended-release (NVP XR) formulation dosed once daily with NVP immediate release (IR) twice daily in treatment-naive patients. Methods: Randomized, double-blind, double-dummy, parallel group study of HIV-1-infected adult patients with baseline viral load (VL) ≥ 1,000 copies/ml and CD4(+) T-cell count of >50-<400 (males) and >50-<250 cells/mm(3) (females). Patients stratified by baseline VL (≤ 100,000/>100,000 copies/ml) were randomized 1:1 to NVP XR 400 mg once daily (plus placebo) or NVP IR 200 mg twice daily (plus placebo), both combined with tenofovir disoproxil fumarate (TDF) 300 mg and emtricitabine 200 mg once daily. Primary endpoint was sustained virological response (<50 copies/ml) through week 48 using the time to loss of virological response algorithm. Non-inferiority of NVP XR to NVP IR was tested using Cochran's statistic incorporating baseline VL stratum with pre-specified, non-inferiority margin of -10%. Results: Among 1,011 patients randomized and treated, virological response at week 48 was 81.0% (409/505) for NVP XR and 75.9% (384/506) for NVP IR with adjusted difference of 4.9% in favour of NVP XR (95% CI -0.1-10.0%), demonstrating non-inferiority of NVP XR to NVP IR. This finding was supported by secondary endpoints. The safety profile of NVP XR was similar to NVP IR, but showed numerically fewer treatment-related adverse events. Conclusions: NVP XR in combination with TDF and emtricitabine was shown to be non-inferior in efficacy to NVP IR with a similar safety and adverse event profile, with the potential for the added convenience of once-daily dosing. Trial registration: ClinicalTrials (NCT): NCT00561925.
dc.identifier.citationGathe, J., Andrade-Villanueva, J., Santiago, S., Horban, A., Nelson, M., Cahn, P., ... Quinson, A.-M. (2011). Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients. Antiviral Therapy.
dc.identifier.otherDOI: 10.3851/IMP1803
dc.identifier.urihttps://repositorio.huesped.org.ar/handle/123456789/1092
dc.relation.ispartofseriesAntiviral Therapy
dc.subjectNevirapine extended-release
dc.subjectnevirapine immediate-release
dc.subjectHIV-1-infected patients
dc.titleEfficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
140_2011_Gathe_Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients.pdf
Size:
323 KB
Format:
Adobe Portable Document Format
Download

Collections

Articulos científicos