Effect of twice-daily nevirapine on adherence in HIV-1-infected patients: a randomized controlled study.
OBJECTIVE
For optimal adherence, once-daily dosing is best. Whether this applies to antiretroviral therapy is unknown. We thus aimed to determine the effect of once-daily dosing on adherence to nevirapine.


METHODS
A three-phase (3-month observational, 4-month randomized, 5-month interventional) open-label, clinical trial at four French academic medical centres during 2005-2006 among 62 chronically HIV-1-infected subjects with long-lasting viral suppression under a twice-a-day nevirapine-based antiretroviral combination.


METHODS
Adherence was measured using electronic monitoring devices and validated by sequential plasma drug levels. Participants were randomly assigned to switch to nevirapine 400 mg once-daily (n = 31) or continue nevirapine 200 mg twice-a-day (n = 31). After the randomized phase, participants had an opportunity to choose their antiretroviral dosage. Primary outcome was the mean percentage of adherence.


RESULTS
Fifty-two patients qualified for electronic data analysis. During the randomized phase, the mean adherence rate was non-significantly superior by 0.5% in once-daily versus twice-a-day dosing (P = 0.68), adjusting for previous twice-a-day adherence rate (P < 0.0001). Once-daily group increased days without dose [odds ratio (OR) 1.7; 95% confidence interval (CI) 1.0, 2.8; P = 0.04], adjusting for previous drug interruptions (P < 0.0001). In the longitudinal analysis, once-daily dosing was significantly associated with at least two consecutive days without dose (OR 4.4; 95% CI 1.9, 10.3; P < 0.001).


CONCLUSIONS
Changing from twice to once-daily nevirapine does not improve adherence. Supporting continuous adherence to antiretroviral therapy in the 'once-a-day era' remains a challenge, even if more potent regimens can achieve viral suppression at lower adherence levels.
Parienti
Jean-Jacques
JJ
INSERM U707, Epidémiologie, Systèmes d'informations, Modélisation, Paris, F-75012, France. parienti-jj@chu-caen.fr
Massari
Véronique
V
Reliquet
Véronique
V
Chaillot
Fabien
F
Le Moal
Gwenaël
G
Arvieux
Cédric
C
Vabret
Astrid
A
Verdon
Renaud
R
D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000523:psychology*; D015497:HIV-1; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D019829:Nevirapine / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D010349:Patient Compliance / Q000523:psychology*; D017060:Patient Satisfaction; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D019562:Viral Load
D018894:Reverse Transcriptase Inhibitors; D019829:Nevirapine