Kaplan-Meier survival curve for time from HIV diagnosis to viral suppression, by baseline CD4 count.

<p>Kaplan-Meier survival curve for time from HIV diagnosis to viral suppression, by baseline CD4 count.</p

Kaplan-Meier survival curve for time from HIV diagnosis to viral suppression, by entry to care within 3 months of HIV diagnosis.

<p>Kaplan-Meier survival curve for time from HIV diagnosis to viral suppression, by entry to care within 3 months of HIV diagnosis.</p

Factors associated with viral suppression^a among adolescents and adults diagnosed with HIV infection^b, 2009, 19 U.S. jurisdictions.

<p>^a Viral suppression defined as < = 200 copies/ml.</p><p>^b 17,028 adolescents and adults (aged >12 years) diagnosed in 2009, with followed up through December 31, 2011; 7, 324 censored (43.01%).</p><p>^c A hazard ratio >1 indicates a higher rate of viral suppression per unit time among the group of interest (e.g., those with early care entry vs. those who did not). Hazard ratio is adjusted for all other covariates in the table.</p><p>^d Includes 5,648 persons with unknown transmission category.</p><p>^e CD4 test result or opportunistic illnesses within 3 months of diagnosis; persons without a CD4 test result or OI within 3 months of diagnosis are classified as “unknown”.</p><p>^f Defined as ≥1 CD4 or VL test result within 3 months of diagnosis.</p><p>^g The number of care visits is a time-updated covariate in the model because it accumulates over time. Hazard ratio per additional visit.</p

Characteristics of adolescents and adults^a diagnosed with HIV infection, 2009, 19 U.S. jurisdictions.

<p>^a 17028 adolescents and adults (aged >12 years) diagnosed in 2009, with followed up through December 31, 2011.</p><p>^b Percentage reflects the column percentage; numerator is the number of persons in the group and denominator is the total number of persons diagnosed with HIV in 2009. Mean (standard deviation) was also calculated for age at HIV diagnosis.</p><p>^c Had a viral load (VL) test within follow-up period. Percentage reflects number of persons with a VL test among the total population.</p><p>^d Had a suppressed VL within follow-up period. For percentage among total population, the denominator is the total population (number of persons diagnosed with HIV in that group). For the percentage among persons with VL test, the denominator is the number of persons with a VL test in that group.</p><p>^e Includes 5,648 persons with unknown transmission category.</p><p>^f CD4 test result or opportunistic illnesses within 3 months of diagnosis; persons without a CD4 test result or OI within 3 months of diagnosis are classified as “unknown”.</p

A Comparison of Methods for Analyzing Viral Load Data in Studies of HIV Patients

<div><p>HIV RNA viral load (VL) is a pivotal outcome variable in studies of HIV infected persons. We propose and investigate two frameworks for analyzing VL: (1) a single-measure VL (SMVL) per participant and (2) repeated measures of VL (RMVL) per participant. We compared these frameworks using a cohort of 720 HIV patients in care (4,679 post-enrollment VL measurements). The SMVL framework analyzes a single VL per participant, generally captured within a “window” of time. We analyzed three SMVL methods where the VL binary outcome is defined as suppressed or not suppressed. The omit-participant method uses a 8-month “window” (-6/+2 months) around month 24 to select the participant’s VL closest to month 24 and removes participants from the analysis without a VL in the “window”. The set-to-failure method expands on the omit-participant method by including participants without a VL within the “window” and analyzes them as not suppressed. The closest-VL method analyzes each participant’s VL measurement closest to month 24. We investigated two RMVL methods: (1) repeat-binary classifies each VL measurement as suppressed or not suppressed and estimates the proportion of participants suppressed at month 24, and (2) repeat-continuous analyzes VL as a continuous variable to estimate the change in VL across time, and geometric mean (GM) VL and proportion of participants virally suppressed at month 24. Results indicated the RMVL methods have more precision than the SMVL methods, as evidenced by narrower confidence intervals for estimates of proportion suppressed and risk ratios (RR) comparing demographic strata. The repeat-continuous method had the most precision and provides more information than other considered methods. We generally recommend using the RMVL framework when there are repeated VL measurements per participant because it utilizes all available VL data, provides additional information, has more statistical power, and avoids the subjectivity of defining a “window.”</p></div

The predicted geometric mean (GM) by characteristic using the pdf-cdf random effects model plotted on the VL and log₁₀(VL) scales.

<p>The horizontal line is the defined level of suppression (<200 copies/mL).</p

The retention in care (RIC) study distribution of each participant’s closest VL copies/mL to month 24, where zero represents month 24.

<p>There are 551 (76.5%) participants who have their closest VL within 6 months of month 24 and 232 (32.2%) whose closest VL is within 30 days.</p

Box plots by characteristic for the participants predicted VLs at month 24 and rate of change (slope).

<p>The shaded box represents the 25^th and 75^th percentiles, while the vertical line and diamond within the shaded box are the median and mean, respectively. The upper and lower arms, represented by vertical lines, are the 2.5 and 97.5 percentiles, and dots outside these arms are considered outliers.</p

The baseline calculated geometric mean (GM) viral load (VL), GM VL 95% confidence interval (CI), and proportion of all visits for all participants with VL <200 (suppressed) after baseline for each characteristic.

<p>The baseline calculated geometric mean (GM) viral load (VL), GM VL 95% confidence interval (CI), and proportion of all visits for all participants with VL <200 (suppressed) after baseline for each characteristic.</p

An example of log₁₀(VL) copies/mL collected over time from baseline (month zero) and at subsequent follow-up visits for four participants.

<p>The triangles and squares represent the closest VL to month 24 for each of the four participants.</p