The Research Question

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The Research Question

• What factors characterize the elite successes
  among HAART recipients in a NYC HIV care clinic?

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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.

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What would it take to do an ideal prospective
study?

• Large prospectively followed cohortat 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

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An Alternative Approach

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

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Definition of Elite Success

• HAART recipient
• All VLslt50 for an entire calendar year (2002)
• At least 3 VLs measured during the calendar year

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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 (n984)
• Query 2 Produce a table of all VLs at MMC in
  2002 (nappx. 10,000)
• Merge tables from Queries 1 and 2

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Methods

• Select all patients from merged table who had at
  least 3 VLs done in 2002 (n375)
• Select all patients who had a max(VL)lt50
  (n69)these are potential cases
• Select all patients who had a max(VL)gt50
  (n306)these are potential controls
• Make a randomly ordered list of potential
  controls

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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

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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

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The Actual Study Sample

• 62 casesHAART recipients throughout 2002 with
  all VLslt50 in 2002 (3 or more measurements)
• 62 controlsHAART recipients throughout 2002 with
  at least one VLgt50 (3 or more measurements)

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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 VLslt50
306 with at least one VLgt50
7 without continuous HAART in 2002
62 controls randomly selected, but matched on
of VL measurements
62 cases on HAART throughout 2002
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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

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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 2002388) and
  virologically (mean VL in 20021049)

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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
  criteriai.e. enrollment in ID Clinic and
  continuous HAART, did well regardless of case or
  control status

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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

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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

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Acknowledgements

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

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