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Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.

ABSTRACT: OBJECTIVE:To evaluate factors affecting antiretroviral therapy (ART) start time when triggered by a CD4 count <350 cells/?L while monitoring counts over time. Measurement frequency, requirement for confirmatory counts, and precision and accuracy of CD4 enumeration technology were considered. METHODS:Using a model of CD4 count trajectories among seroconverters in the Multicenter AIDS Cohort Study, sequences of counts were simulated for a large hypothetical population monitored for 5 years from seroconversion. Time of first count <350 cells/?L was defined as ART start time. The simulation was adapted to evaluate the effect of the above factors on these times. ART initiation was considered "very late" among patients whose underlying trajectory declined less than 200 cells/?L during the period simulated if no previous observed count was <350 cells/?L. RESULTS:For 12-, 6-, 4-, and 3-monthly measurements, median start time was 48, 36, 32, and 30 months after seroconversion and proportion of patients starting ART very late was 11.5%, 1.6%, 0.2%, and 0.1%. For 6-monthly measurements, requiring confirmation increased the median to 49 months and proportion to 8.9%. Changes in standard deviation of short-term variability in counts of 25% and measurement bias for a novel technology of ±10% changed median time by ±6 months with modest change in the proportion very late (range, 0.5%-3.2%). CONCLUSION:: 6-monthly measurements appear adequate in achieving low rates of very late ART whereas confirmation affects rates adversely. Studies comparing new versus standard measurement technologies should focus on ruling out modest bias, particularly proximal to important thresholds for treatment management.

SUBMITTER: Noubary F

PROVIDER: S-EPMC3649850 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.

Noubary Farzad F Hughes Michael D MD

Journal of acquired immune deficiency syndromes (1999) 20121101 3

<h4>Objective</h4>To evaluate factors affecting antiretroviral therapy (ART) start time when triggered by a CD4 count <350 cells/μL while monitoring counts over time. Measurement frequency, requirement for confirmatory counts, and precision and accuracy of CD4 enumeration technology were considered.<h4>Methods</h4>Using a model of CD4 count trajectories among seroconverters in the Multicenter AIDS Cohort Study, sequences of counts were simulated for a large hypothetical population monitored for ...[more]

PMID: 22878419

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Project description:HIV infection and certain antiretroviral therapy (ART) medications increase atherosclerotic cardiovascular disease risk, mediated, in part, through traditional cardiovascular disease risk factors. We studied cardiovascular disease risk factor changes in the START (Strategic Timing of Antiretroviral Treatment) trial, a randomized study of immediate versus deferred ART initiation among HIV-positive persons with CD4+ cell counts >500 cells/mm3. Mean change from baseline in risk factors and the incidence of comorbid conditions were compared between groups. The characteristics among 4685 HIV-positive START trial participants include a median age of 36 years, a CD4 cell count of 651 cells/mm3, an HIV viral load of 12 759 copies/mL, a current smoking status of 32%, a median systolic/diastolic blood pressure of 120/76 mm Hg, and median levels of total cholesterol of 168 mg/dL, low-density lipoprotein cholesterol of 102 mg/dL, and high-density lipoprotein cholesterol of 41 mg/dL. Mean follow-up was 3.0 years. The immediate and deferred ART groups spent 94% and 28% of follow-up time taking ART, respectively. Compared with patients in the deferral group, patients in the immediate ART group had increased total cholesterol and low-density lipoprotein cholesterol and higher use of lipid-lowering therapy (1.2%; 95% CI, 0.1-2.2). Concurrent increases in high-density lipoprotein cholesterol with immediate ART resulted in a 0.1 lower total cholesterol to high-density lipoprotein cholesterol ratio (95% CI, 0.1-0.2). Immediate ART resulted in 2.3% less BP-lowering therapy use (95% CI, 0.9-3.6), but there were no differences in new-onset hypertension or diabetes mellitus. Among HIV-positive persons with preserved immunity, immediate ART led to increases in total cholesterol and low-density lipoprotein cholesterol but also concurrent increases in high-density lipoprotein cholesterol and decreased use of blood pressure medications. These opposing effects suggest that, in the short term, the net effect of early ART on traditional cardiovascular disease risk factors may be clinically insignificant." URL: http://www.clinicaltrials.gov. Unique identifier: NCT00867048.

Project description:The rates of death are high among patients with coinfection with tuberculosis and the human immunodeficiency virus (HIV). The optimal timing for the initiation of antiretroviral therapy in relation to tuberculosis therapy remains controversial.In an open-label, randomized, controlled trial in Durban, South Africa, we assigned 642 patients with both tuberculosis and HIV infection to start antiretroviral therapy either during tuberculosis therapy (in two integrated-therapy groups) or after the completion of such treatment (in one sequential-therapy group). The diagnosis of tuberculosis was based on a positive sputum smear for acid-fast bacilli. Only patients with HIV infection and a CD4+ cell count of less than 500 per cubic millimeter were included. All patients received standard tuberculosis therapy, prophylaxis with trimethoprim-sulfamethoxazole, and a once-daily antiretroviral regimen of didanosine, lamivudine, and efavirenz. The primary end point was death from any cause.This analysis compares data from the sequential-therapy group and the combined integrated-therapy groups up to September 1, 2008, when the data and safety monitoring committee recommended that all patients receive integrated antiretroviral therapy. There was a reduction in the rate of death among the 429 patients in the combined integrated-therapy groups (5.4 deaths per 100 person-years, or 25 deaths), as compared with the 213 patients in the sequential-therapy group (12.1 per 100 person-years, or 27 deaths); a relative reduction of 56% (hazard ratio in the combined integrated-therapy groups, 0.44; 95% confidence interval, 0.25 to 0.79; P=0.003). Mortality was lower in the combined integrated-therapy groups in all CD4+ count strata. Rates of adverse events during follow-up were similar in the two study groups.The initiation of antiretroviral therapy during tuberculosis therapy significantly improved survival and provides further impetus for the integration of tuberculosis and HIV services. (ClinicalTrials.gov number, NCT00398996.)

Project description:BackgroundPapua Province, Indonesia is experiencing an on-going epidemic of Human Immunodeficiency Virus (HIV) infection, with an estimated 9-fold greater prevalence than the overall national rate. This study reviewed the treatment outcomes of an HIV-infected cohort on Antiretroviral Therapy (ART) and the predictors in terms of immunological recovery and virological response.MethodsART-naïve individuals in a workplace HIV program in southern Papua were retrospectively analyzed. Patients were assessed at 6, 12 and 36 months after ART initiation for treatment outcomes, and risk factors for virological suppression (viral load (VL) <1,000 copies/ml), poor immune response (CD4 <200 cells/mm3) and immunological failure (CD4 <100 cells/ mm3) after at least 6 months on ART, using a longitudinal Generalized Estimating Equations multivariate model.ResultsAssessment of 105 patients were included in the final analysis with a median age of 34 years, 88% male, median baseline CD4 236 cells/ mm3, and VL 179,000 copies/ml. There were 74, 73, and 39 patients at 6, 12, and 36 months follow-up, respectively, with 5 deaths over the entire period. For the three observation periods, 68, 80, and 75% of patents achieved virological suppression, poor immune responders decreased from 15, 16 to 10%, whilst 15, 16, 10% met the immunological failure criteria, respectively. Using multivariate analysis, the independent predictor for viral suppression at 12 and 36 months was ≥1 log decrease in VL at 6 months (OR 19.25, p<0.001). Higher baseline CD4 was significantly correlated with better immunological outcomes, and lower likelihood of experiencing immunological failure (p <0.001).ConclusionVirological response at six months after beginning ART is the strongest predictor of viral suppression at 12 and 36 months, and may help in identifying patients needing additional adherence therapy support. Higher baseline CD4 positively affects the immunological outcomes of patients. The findings indicate HIV control programs should prioritize the availability of VL testing and begin ART regardless of CD4 counts in infected patients.

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Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.

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Factors affecting timing of antiretroviral treatment initiation based on monitoring CD4 counts.

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