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1.  Sociodemographic Factors Predict Early Discontinuation of HIV Non-Nucleoside Reverse Transcriptase Inhibitors and Protease Inhibitors 
Background/Objective
HIV infection has a devastating impact on individual and public health, and affects populations disproportionately. Treatment with antiretroviral therapy (ART) saves lives, but long-term adherence to ART is critical to its success. We performed an observational cohort study to determine the influence of race, sex and other sociodemographic factors on early ART discontinuations among HIV-infected persons.
Methods
TennCare-enrolled adults of black or white non-Hispanic race beginning ART with either a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) between 1996–2003 (N=3,654) were assessed for early discontinuation. A subgroup of discontinuations was validated using the primary medical record.
Results
Blacks were more likely than whites to discontinue NNRTIs (37 vs. 28%; P=0.003) and PIs (36 vs. 25%; P≤0.001). In multivariable models adjusting for race, sex, age, early HIV-related medical encounter, urban residence and TennCare enrollment category, black race, female sex and younger age were independent predictors of discontinuation among those starting PIs. Among persons starting NNRTIs, black race, younger age and a disability-based enrollment category predicted early drug discontinuation, but female sex did not.
Conclusions
Our results suggest that sociodemographic factors were associated with early NNRTI and PI discontinuation in this population, and some factors were ART class specific.
PMCID: PMC3816354  PMID: 19110909
HIV/AIDS; treatment; health insurance
2.  Tuberculosis Risk Before and After Highly Active Antiretroviral Therapy Initiation: Does HAART Increase the Short-term TB Risk in a Low Incidence TB Setting? 
Objective
To evaluate the short- and long-term effects of highly active antiretroviral therapy (HAART) on tuberculosis (TB) risk, compared to risk without HAART in a low TB incidence setting.
Design
An observational cohort study among HIV-infected persons in care at the Comprehensive Care Center (Nashville, TN) between January 1998 and December 2008.
Methods
A marginal structural model was used to estimate the effect of HAART on short- (≤180 days) and long-term (>180 days) TB risk, with CD4+ lymphocyte count incorporated as a time-updated covariate.
Results
Of 4,534 HIV-infected patients, 34 developed TB (165/100,000 p-y; 20,581 person-years [p-y] of follow-up). Seventeen cases occurred among persons not on HAART or >30 days after HAART discontinuation (212/100,000 p-y; 8,019 p-y of follow-up). Seventeen occurred among persons on HAART (135/100,000 p-y; 12,562 p-y of follow-up); ten in the first 180 days (402/100,000 p-y; 2,489 p-y of follow-up) and 7 after more than 180 days (69/100,000 p-y; 10,073 p-y of follow-up). After adjusting for the most recent CD4+ lymphocyte count, the risk of TB in the first 180 days of HAART exposure relative to no HAART was 0.68 (0.14–3.22, p=0.63).
Conclusions
In this low TB incidence setting, the TB rate in the first 180 days of HAART was almost twice as high as persons not on HAART. However, after adjusting for most recent CD4+ count there was no significant difference in TB risk between these two groups. This suggests that low recent CD4+ lymphocyte count influences TB risk during the first 180 days of HAART.
doi:10.1097/QAI.0b013e3182182e2d
PMCID: PMC3141096  PMID: 21423024
tuberculosis; M. tuberculosis infection; tuberculosis risk; human immunodeficiency virus; highly active antiretroviral therapy
3.  Cross-cohort heterogeneity encountered while validating a model for HIV disease progression among antiretroviral initiators 
Journal of clinical epidemiology  2008;62(7):729-737.
Objective
To evaluate a model for predicting time to AIDS or death among HIV-infected persons initiating highly active antiretroviral therapy (HAART).
Study Design and Setting
The model was constructed from 1,891 HAART initiators in the Collaborations in HIV Outcomes Research/US (CHORUS) cohort. The model's predictive ability was assessed using internal bootstrap validation techniques and data from 716 HAART initiators at Johns Hopkins HIV Clinical Cohort (JHHCC) in whom HIV disease was, in general, more advanced.
Results
The estimated concordance statistic was 0.632 with the bootstrap method and 0.625 in JHHCC. Mean predicted and observed 3-year AIDS-free survival for JHHCC was 0.76 and 0.73 (95% CI 0.69−0.77), respectively; mean predicted and observed 5-year AIDS-free survival was 0.69 and 0.57 (95% CI 0.52−0.62). Sensitivity analyses showed that the discrepancy between predicted and observed AIDS-free survival after 3 years could be due to differences in lost-to-follow-up rates between cohorts.
Conclusion
The model was fair at using baseline characteristics to order patients’ risk of disease progression, but did not accurately predict AIDS-free survival >3 years after HAART initiation. Different variable definitions, patient characteristics, and loss-to-follow-up highlight the challenges of using data from one cohort to predict AIDS-free survival in an independent cohort.
doi:10.1016/j.jclinepi.2008.09.002
PMCID: PMC2747519  PMID: 19108987
AIDS; Antiretroviral therapy; Bootstrap; CD4 lymphocyte percent; Loss-to-follow-up; Validation; Heterogeneity
4.  Antiretroviral Therapy Initiation Before, During, or After Pregnancy in HIV-1-Infected Women: Maternal Virologic, Immunologic, and Clinical Response 
PLoS ONE  2009;4(9):e6961.
Background
Pregnancy has been associated with a decreased risk of HIV disease progression in the highly active antiretroviral therapy (HAART) era. The effect of timing of HAART initiation relative to pregnancy on maternal virologic, immunologic and clinical outcomes has not been assessed.
Methods
We conducted a retrospective cohort study from 1997–2005 among 112 pregnant HIV-infected women who started HAART before (N = 12), during (N = 70) or after pregnancy (N = 30).
Results
Women initiating HAART before pregnancy had lower CD4+ nadir and higher baseline HIV-1 RNA. Women initiating HAART after pregnancy were more likely to receive triple-nucleoside reverse transcriptase inhibitors. Multivariable analyses adjusted for baseline CD4+ lymphocytes, baseline HIV-1 RNA, age, race, CD4+ lymphocyte count nadir, history of ADE, prior use of non-HAART ART, type of HAART regimen, prior pregnancies, and date of HAART start. In these models, women initiating HAART during pregnancy had better 6-month HIV-1 RNA and CD4+ changes than those initiating HAART after pregnancy (−0.35 vs. 0.10 log10 copies/mL, P = 0.03 and 183.8 vs. −70.8 cells/mm3, P = 0.03, respectively) but similar to those initiating HAART before pregnancy (−0.32 log10 copies/mL, P = 0.96 and 155.8 cells/mm3, P = 0.81, respectively). There were 3 (25%) AIDS-defining events or deaths in women initiating HAART before pregnancy, 3 (4%) in those initiating HAART during pregnancy, and 5 (17%) in those initiating after pregnancy (P = 0.01). There were no statistical differences in rates of HIV disease progression between groups.
Conclusions
HAART initiation during pregnancy was associated with better immunologic and virologic responses than initiation after pregnancy.
doi:10.1371/journal.pone.0006961
PMCID: PMC2734183  PMID: 19742315
5.  Increased Detectability of Plasma HIV-1 RNA after Introduction of a New Assay and Altered Specimen-Processing Procedures 
After changes to assay and specimen-processing methods, plasma human immunodeficiency virus type 1 (HIV-1) RNA was frequently detectable in patients who previously had well-suppressed HIV-1 RNA levels. This artifact is attributable to shipping frozen plasma in primary plasma preparation tubes and is not caused by the HIV-1 RNA detection assay; it can be avoided by shipping plasma in a secondary tube.
doi:10.1086/592693
PMCID: PMC2605467  PMID: 18922071

Results 1-5 (5)