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The Research Question

The Research Question. What factors characterize the elite successes among HAART recipients in a NYC HIV care clinic?. The Problem.

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The Research Question

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  1. The Research Question • What factors characterize the elite successes among HAART recipients in a NYC HIV care clinic?

  2. The Problem • The medical literature describing response to HAART is dominated by reports of efficacy at a single time point (usually 24 or 48 weeks), but the real goal of HAART is to achieve sustained virologic suppression.

  3. What would it take to do an “ideal” prospective study? • Large prospectively followed cohort—at least several hundred patients, eg MACS, HOPS, etc. • At least two years • A price tag in the millions • There would still be serious biases limiting the generalizability of findings • Sociodemographic constitution of cohort • Study patients differ from “real world” patients

  4. An Alternative Approach • Virtually all modern medical establishments have visit and laboratory information stored in databases • The use of IT to create study cohorts

  5. Definition of Elite Success • HAART recipient • All VLs<50 for an entire calendar year (2002) • At least 3 VLs measured during the calendar year

  6. Methods • All patient visits and VL measurements are available in a CIS replicate at MMC • Query 1: Produce a table of all patients who had new patient visits in the ID Clinic in 1999 or 2000 (n=984) • Query 2: Produce a table of all VLs at MMC in 2002 (n=appx. 10,000) • Merge tables from Queries 1 and 2

  7. Methods • Select all patients from merged table who had at least 3 VLs done in 2002 (n=375) • Select all patients who had a max(VL)<50 (n=69)—these are potential cases • Select all patients who had a max(VL)>=50 (n=306)—these are potential controls • Make a randomly ordered list of potential controls

  8. Chart Review • Two investigators performed preliminary chart reviews to eliminate subjects who were not on continuous HAART throughout 2002 • Once the final study cohort was assembled, a more detailed chart review was conducted to collect medical and sociodemographic information

  9. Minimization of Bias • All study patients must have enrolled in the ID Clinic in calendar year 1999 or 2000 • Controls matched to cases on frequency of VL measurement in 2002

  10. The Actual Study Sample • 62 cases—HAART recipients throughout 2002 with all VLs<50 in 2002 (3 or more measurements) • 62 controls—HAART recipients throughout 2002 with at least one VL>=50 (3 or more measurements)

  11. The Numbers 984 new patients 1999-2000 375 with 3 or more VLs in 2002 609 with fewer than 3 VLs in 2002 69 with all VLs<50 306 with at least one VL>=50 7 without continuous HAART in 2002 62 controls randomly selected, but matched on # of VL measurements 62 cases on HAART throughout 2002

  12. Results • No difference in age, gender, or ethnicity between groups • No difference in enrollment CD4 or VL measurement. No difference in nadir CD4. • No significant differences in HAART regimens • Cases were more likely to report MSM and less likely to report hetero-sex or IDU as risk behavior • Cases less likely to smoke, more likely to have hepatitis C • Cases had a greater rise in CD4 count in 2002 than controls

  13. Results • On multivariate analysis, having HIV risk behavior other than hetero-sex or IDU, and having hepatitis C were independently associated with being a member of the “elite success” group • Control patients did relatively well immunologically (mean CD4 in 2002=388) and virologically (mean VL in 2002=1049)

  14. Lessons Learned • There is no specific demographic group to target for intervention • We may need to work harder to achieve optimal outcomes in patients who acquired HIV from heterosexual contact or IDU • The average patient who met eligibility criteria—i.e. enrollment in ID Clinic and continuous HAART, did well regardless of case or control status

  15. Lessons Learned • The majority of patients enrolled as new patients in ID Clinic in 1999-2000 did not have 3 VL measurements in that same clinic in 2002

  16. Other Projects • Use of computer generated prompts to improve PAP smear rates • Comparison of outcomes between HIV and uninfected individuals undergoing cardiothoracic surgery • Patients who walk in to clinic frequently: Factors associated with frequent walk-in patients and performance indicators • Modeling of total lymphocyte count guided discontinuation of PCP prophylaxis: A strategy for resource constrained countries

  17. Acknowledgements • Faisal Wasi, MD • Tania Purkayastha, MD • Bristol-Myers Squibb Virology HIV Fellowship Research Program • AECOM/MMC Center for AIDS Research

  18. For more HIV-related resources, please visit www.hivguidelines.org

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