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Detrimental effect of current patient-reported drug holidays on long-term sub-optimal treatment out-come in advanced naive subjects initiating cART
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Reported by Jules Levin
EACS Nov 11-14 2009
Cologne Germany
M.P. Trotta1, A. Ammassari1, M. Zaccarelli1, P. Marconi1, P. Sette1, M.L. Giancola1, P. Pierro1, V. Neri1, R.A. Acinapura1, A. Antinori1
1INMI L Spallanzani, Rome, Italy
Objectives: To study the relationship between different non-adherence behaviours and long-term viro-immunological success in patients with CD4-
nadir < 200 cell/mmc.
Methods: Long-term viro-immulogical optimal response (=HIV-RNA< 50 cp/ml and CD4>500 cell/mmc) was investigated in 235 subjects with CD4-
nadir < 200 cell/mmc who received cART for least 4 years. Self-reported non-adherence patterns were: < 95% of therapy taken in the last month; <
100% doses taken over the last week; timing deviation; drug holidays over the last month; interruption in drug refill over last 3 months.
Results: 235 patients were included in the analysis. The mean values of viro-immunological parameters were: HIV-RNA 2.00 log10/ml (range 1.70-
5.70) and CD4 539/mmc (IQR 324-715). Current regimen contained PI-boosted in 62%, and a NNRTI in 29%. Viro-immulogical optimal response was
recorded in 96 (41%) subjects.
Prevalence of reported deviations in adherence were: 25.0% for < 95% of therapy taken in the last month; 26.6% for < 100% doses taken over the last
week; 43.8% for timing deviation; 16.2% for drug holidays, and 13.2% for interruption in drug refill.
At univariate, all non-adherence behaviours were significantly associated with treatment success, and for each adherence deviation more a 60% lower
probability of response was found.
At multivariate model adjusted for type of regimen, time of treatment, and HIV risk factor, number of non-adherence behaviours remained the strongest variable associated with treatment success (OR:0.56 for each more deviation; 95%CI:0.42-0.74). In particular, including all non-adherence patterns in the model, only self-reported drug holidays had an independent effect on optimal viro-immunological response (OR:0.16; 95%CI:0.04-0.61: this means there was a 16% chance for virologic success when patients reported drug holidays).
Conclusions: Substantial CD4 gains are possible among highly advanced adherent patients. Patterns of incomplete adherence, namely unplanned
short treatment interruptions, may have a detrimental effect on immunorecovery. To optimize viro-immunological response in advanced subjects, a comprehensive investigation of all non-adherence behaviours is needed in clinical practice.
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