Adherence over 48 weeks in an antiretroviral clinical trial: variable within patients, affected by toxicities and independently predictive of virological response
P. Nieuwkerk et al., Adherence over 48 weeks in an antiretroviral clinical trial: variable within patients, affected by toxicities and independently predictive of virological response, ANTIVIR TH, 6(2), 2001, pp. 97-103
Objectives: To investigate adherence to antiretroviral therapy over 48 week
s, to investigate the association between adherence and treatment-related s
ymptoms and to investigate the impact of adherence on virological response
over 48 weeks among established predictors of treatment success.
Methods: One-hundred-and-sixty HIV-1 infected protease inhibitor- and stavu
dine-naive patients participating in a trial of ritonavir/saquinavir versus
ritonavir/saquinavir/ stavudine completed an adherence questionnaire and a
symptom checklist at weeks 12, 24, 36 and 48. We calculated odds ratios be
tween experienced symptoms and non-adherence. Regression models were used t
o determine predictors of HIV-1 RNA below 400 copies/ml at week 48, and of
the area about the change from baseline over 48 weeks (ACFB) in serum HIV-1
RNA.
Results: The percentage of patients reporting missing medication, deviation
from time schedule, and dietary prescriptions at separate time-points rang
ed from 12 to 15%, 32 to 35% and 17 to 22%, respectively. The percentage th
at changed their level of adherence during 48 weeks ranged from 29% for ski
pping medication to 48% for deviation from time-schedule. Experienced side-
effects were associated with an increased likelihood of non-adherence. Not
skipping medication was an independent predictor of both having a serum HIV
-1 RNA below 400 copies/ml at week 48 and the ACFB over 48 weeks in serum H
IV-1 RNA.
Conclusions: Adherence was an independent predictor of virological response
over 48 weeks. The level of adherence is variable within patients over tim
e. This suggests the need for continued adherence monitoring in all patient
s as part of standard medical practice.