Progress Realized: Trends in HIV-1 Viral Load and CD4 Cell Count in a Tertiary-Care Center from 1999 through 2011

<div><p>Background</p><p>HIV-1 RNA and CD4 cell counts are important parameters for HIV care. The objective of this study was to assess the overall trends in HIV-1 viral load and CD4 cell counts within our clinic.</p> <p>Methods</p><p>Patients with at least one of each test performed by the Infectious Diseases Laboratory from 1999 through 2011 were included in this analysis. By adapting a novel statistical model, log₁₀ HIV-1 RNA means were estimated by month, and log₁₀-transformed HIV-1 RNA means were estimated by calendar year. Geometric means were calculated for CD4 cell counts by month and calendar year. Log₁₀ HIV-1 RNA and CD4 cell count monthly means were also examined with polynomial regression.</p> <p>Results</p><p>There were 1,814 individuals with approximately 25,000 paired tests over the 13-year observation period. Based on each patient's final value of the year, the percentage of patients with viral loads below the lower limit of quantitation rose from 29% in 1999 to 72% in 2011, while the percentage with CD4 counts <200 cells/µL fell from 31% to 11%. On average annually, the mean HIV-1 RNA decreased by 86 copies/mL and the mean CD4 counts increased by 16 cells/µL. For the monthly means, the correlations (R²) from second-order polynomial regressions were 0.944 for log₁₀ HIV-1 RNA and 0.840 for CD4 cell counts.</p> <p>Conclusions</p><p>Marked improvements in HIV-1 RNA suppression and CD4 cell counts were achieved in a large inner-city population from 1999 through 2011. This success demonstrates that sustained viral control with improved immunologic status can be a realistic goal for most individuals in clinical care.</p> </div

Distribution of final HIV-1 RNA and CD4 cell counts.

<p>(<b>A</b>) Final HIV-1 RNA and (<b>B</b>) final CD4 cell counts by calendar year for 1,814 unique patients tested for both parameters at least once from 1999 through 2011. The number of individuals each year ranged from 575 in 1999 to 854 in 2011. The HIV-1 RNA lower limit of quantitation was 50 copies/mL from 1-1-99 to 10-17-02, 75 copies/mL from 10-18-02 to 3-4-08 and 40 copies/mL from 3-5-08 to 12-31-11.</p

Annual and monthly means of HIV-1 RNA and CD4 cell counts.

<p>(<b>A</b>) Annual log₁₀-transformed HIV-1 RNA means and CD4 cell count geometric means calculated from each patient's final values by calendar year. (<b>B</b>) Monthly log₁₀ HIV-1 RNA means and (<b>C</b>) CD4 cell count geometric means calculated from all testing in a given month which represented 21–24% of that year's number of patients (575 persons in 1999 to 854 in 2011). Two-limit Tobit, censored regression models were used to estimate the true mean log₁₀ HIV-1 RNA values by month and year. CD4 cell counts of 0 were assigned the value of 1 cell/µL.</p

Distribution of viral load results at enrollment by time on ART.

<p>(A) Time on ART for all study women with duration and VL information available. (B) Time on ART only for study women on ART < 4 months with VL results available. Both figure parts exclude one woman with an outlying VL result of 900,000 copies/ml and <1 month on ART for ease of viewing.</p

Kabeho Study Cohort Screening and Enrollment Diagram.

<p>Kabeho Study Cohort Screening and Enrollment Diagram.</p

Unadjusted and adjusted odds ratios from GEE models—examining the likelihood of detectable viral load at enrollment in pregnant and postpartum Kabeho Study participants.

<p>Unadjusted and adjusted odds ratios from GEE models—examining the likelihood of detectable viral load at enrollment in pregnant and postpartum Kabeho Study participants.</p

Conventional early infant diagnosis in Lesotho from specimen collection to results usage to manage patients: Where are the bottlenecks?

<div><p>Introduction</p><p>Early infant diagnosis is an important step in identifying children infected with HIV during the perinatal period or in utero. Multiple factors contribute to delayed antiretroviral treatment initiation for HIV-infected children, including delays in the early infant HIV diagnosis cascade.</p><p>Methods</p><p>We conducted a retrospective study to evaluate early infant diagnosis turnaround times in Lesotho. Trained staff reviewed records of HIV-exposed infants (aged-6-8 weeks) who received an HIV test during 2011. Study sites were drawn from Highlands, Foothills and Lowlands regions of Lesotho. Central laboratory database data were linked to facility and laboratory register information. Turnaround time geometric means (with 95% CI) were calculated and compared by region using linear mixed models.</p><p>Results</p><p>1,187 individual infant records from 25 facilities were reviewed. Overall, early infant diagnosis turnaround time was 61.7 days (95%CI: 55.3–68.7). Mean time from specimen collection to district laboratory was 14 days (95%CI: 12.1–16.1); from district to central laboratory, 2 days (95%CI 0.8–5.2); results from central laboratory to district hospital, 23.3 days (95%CI: 18.7–29.0); from district hospital to health facility, 3.2 days (95%CI 1.9–5.5); and from health facility to caregiver, 10.4 days (95%CI, 7.9–13.5). Mean times from specimen transfer to the central laboratory and for result transfer from central laboratory to district hospital were significantly shorter in the Lowlands Region (0.9 and 16.2 days, respectively), compared to Highlands Region (6.0 [P = 0.030] and 34.3 days [P = 0.0099]. Turnaround time from blood draw to receipt of results was significantly shorter for HIV infected infants compared to HIV uninfected infants [p = 0.0036] at an average of 47.1 days (95%CI: 38.9–56.9) and 62 days (95%CI: 55.9–68.7) respectively. Of 47 HIV-infected infants, 36 were initiated on antiretroviral therapy at an average of 1.3 days (95%CI: 0.3, 5.7) after caregiver received the result.</p><p>Conclusion</p><p>HIV-infected infants received results earlier and were rapidly initiated on antiretroviral therapy once the result was delivered to caregiver. However, average early infant diagnosis turnaround time was two months; the longest period of delay was transfer of results from central laboratory to district hospital. Turnaround time of results based on geographical regions or between hospitals and health centres varied but did not reach statistical significance.</p></div

Turnaround time (TAT) for the stages in the EID cascade calculated from linear mixed models.

<p>Turnaround time (TAT) for the stages in the EID cascade calculated from linear mixed models.</p

Summary of barriers, motivators of accessing HIV testing by male partners.

<p><i>MCH – Mother and Child Health.</i></p><p>Summary of barriers, motivators of accessing HIV testing by male partners.</p

Baseline characteristics of the study population (n = 1230).

<p>Baseline characteristics of the study population (n = 1230).</p