Objectives
To test and characterize the dependence of viral load on gender in different countries and racial groups as a function of CD4 T‐cell count.
Methods
Plasma viral load data were analysed for >30 000 HIV‐infected patients attending clinics in the USA [HIV Insight™ (Cerner Corporation, Vienna, VA, USA) and Plum Data Mining LLC (East Meadow, NY, USA) databases] and the Netherlands (Athena database; HIV Monitoring Foundation, Amsterdam, Netherlands). Log‐normal regression models were used to test for an effect of gender on viral load while adjusting for covariates and allowing the effect to depend on CD4 T‐cell count. Sensitivity analyses were performed to test the robustness of conclusions to assumptions regarding viral loads below the lower limit of quantification (LLOQ).
Results
After adjusting for covariates, women had (nonsignificantly) lower viral loads than men (HIV Insight™:−0.053 log10 HIV‐1 RNA copies/mL, P=0.202; Athena: −0.005 log10 copies/mL, P=0.667; Plum:−0.072 log10 copies/mL, P=0.273). However, further investigation revealed that the gender effect depended on CD4 T‐cell count. Women had consistently higher viral loads than men when CD4 T‐cell counts were at most 50 cells/μL, and consistently lower viral loads than men when CD4 T‐cell counts were greater than 350 cells/μL. These effects were remarkably consistent when estimated independently for the racial groups with sufficient data available in the HIV Insight™ and Plum databases.
Conclusions
The consistent relationship between gender‐related differences in viral load and CD4 T‐cell count demonstrated here explains the diverse findings previously published.
We analyse data on patient adherence to prescribed regimens and surrogate markers of clinical outcome for 168 human immunodeficiency virus infected patients treated with antiretroviral therapy. Data on patient adherence consisted of dose-timing measurements collected for an average of 12 months per patient via electronic monitoring of bottle opening events. We first discuss how such data can be presented to highlight suboptimal adherence patterns and between-patient differences, before introducing two novel methods by which such data can be statistically modelled. Correlations between adherence and subsequent measures of viral load and CD4 C T-cell counts are then evaluated. We show that summary measures of short-term adherence, which incorporate pharmacokinetic and pharmacodynamic data on the monitored regimen, predict suboptimal trends in viral load and CD4 C T-cell counts better than measures based on adherence data alone.
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.
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