- Poster presentation
- Open Access
Adherence with lopinavir/ritonavir (LPV/r) tablet and SoftGel (SGC) capsule based antiretroviral regimens and predictors of early treatment compliance
© Podsadecki et al; licensee BioMed Central Ltd. 2008
- Published: 10 November 2008
- Electronic Monitoring
- Correct Dose
- Great Adherence
- Infected Subject
- Compliance Measure
Simplified antiretroviral (ARV) regimens may promote adherence and improve outcomes in HIV-1 infected patients. Clinical studies have previously demonstrated greater adherence with LPV/r SGC when dosed once-daily (QD) compared to twice-daily (BID). The objectives of the current analysis are to compare adherence when LPV/r tablets and SGC are dosed QD and BID and to assess predictors of early adherence.
M05-730 is an ongoing Phase III, open-label, randomized, multicenter, multicountry study designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of LPV/r tablets dosed QD or BID through 48 and 96 weeks in combination with TDF and FTC (both QD) in ARV naïve HIV-1 infected subjects. In addition, the study compared safety, tolerability, and pharmacokinetics of LPV/r tablets with LPV/r SGC over the first 8 weeks of administration. Electronic monitoring (MEMS®) allowed for computation of three LPV/r compliance measures through week 12: taking (TAC; prescribed doses taken), correct dosing (COD; days with correct number of doses taken), and timing (TIC; doses taken within ± 3 hrs of prescribed interval) compliance. Using longitudinal mixed models, demographic and baseline characteristics were examined for possible associations with compliance through week 12.
A total of 606 subjects were included in the analysis. Adherence was similar for subjects taking LPV/r tablets compared to SGC. Adherence to LPV/r dosed QD was statistically significantly greater than BID (p < 0.001). Adherence declined significantly over time (p < 0.001), but between-arm differences remained consistent over 12 weeks (p = 0.353). Week 48 clinical outcomes did not differ for subjects receiving LPV/r QD or BID. Demographic and baseline characteristics significantly associated with early compliance included sex, age, race, tobacco use, HIV/AIDS risk factors, HIV-1 RNA, and CD4 and CD8+ T-cell count (p = 0.20). The strongest associations were for TIC and sex (M>F), age (older>younger) and race (white>black) (p ≤ 0.003); however, the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at week 48 did not differ by sex (p = 0.622), race (p = 0.724) or age (p = 0.610).
In this large study of LPV/r, QD dosing resulted in higher levels of adherence than BID dosing. Adherence to LPV/r tablets and SGC were similar. Sex, age and race were predictors of early adherence. Differences in early adherence did not predict clinical outcomes in this study.
This article is published under license to BioMed Central Ltd.