title: Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice-daily in treatment-naive HIV-1-infected patients.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  ClinicalTrials (NCT): NCT00561925.
authors.affiliation: Therapeutic Concepts, Houston, Texas, USA. drgathe@josephgathe.com
authors.forename: Joseph
authors.initials: J
authors.lastname: Gathe
authors.forename: Jaime
authors.initials: J
authors.lastname: Andrade-Villanueva
authors.forename: Steven
authors.initials: S
authors.lastname: Santiago
authors.forename: Andrzej
authors.initials: A
authors.lastname: Horban
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Pedro
authors.initials: P
authors.lastname: Cahn
authors.forename: Johannes
authors.initials: J
authors.lastname: Bogner
authors.forename: David
authors.initials: D
authors.lastname: Spencer
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.forename: Chan-Loi
authors.initials: CL
authors.lastname: Yong
authors.forename: Thuy
authors.initials: T
authors.lastname: Nguyen
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Murray
authors.initials: M
authors.lastname: Drulak
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Quinson
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D024882:Drug Resistance, Viral / Q000235:genetics; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D038622:Internationality; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine