Long-term efficacy and safety of once-daily nevirapine in combination with tenofovir and emtricitabine in the treatment of HIV-infected patients: a 72-week prospective multicenter study (TENOR-trial).
BACKGROUND
There is an unmet medical need for simplified antiretroviral therapy regimens to improve patient's compliance and quality of life. The purpose of this study was to evaluate the efficacy and safety of a once-daily regimen with Tenofovir (TDF), Emtricitabine (FTC) and Nevirapine (NVP) for adult patients with HIV-1 infection.


METHODS
70 patients were enrolled in a prospective, multicenter, non-randomized, single arm, open-label cohort study. Patients were either naive or had problems with their current ART and needed to be changed to another regimen. Daily drug dosage was 300 mg Tenofovir, 200mg Emtricitabine and 400 mg Nevirapine once daily. Follow-up was performed over 72 weeks.


RESULTS
After 72 weeks, the regimen was still continued by 52 patients (74,3%). Of these, 44 patients (84,6%) had a viral load below detection limit. The median viral load had decreased by 2,5 log and the median CD4 cell count had increased by 44,8%. Most side-effects occurred at an early stage during the study. Resistances were rare (only two resistances were considered as newly developed) and occurred rather late during the study.


CONCLUSIONS
A once-daily regimen of Tenofovir, Emtricitabine and Nevirapine is an attractive treatment option since it is safe, effective, and well tolerated.
Weberschock
T
T
Department of Dermatology, University of Heidelberg, Heidelberg, Germany. tanja.sehr@med.uni-heidelberg.de
Gholam
P
P
Hueter
E
E
Flux
K
K
Hartmann
M
M
D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D000068698:Tenofovir; D016896:Treatment Outcome
D019380:Anti-HIV Agents; D063065:Organophosphonates; D003841:Deoxycytidine; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine