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Background

Background. Appropriate time to start HAART is still debatable 1995: “Time to hit HIV, early and hard” Eradication thought to be possible Early regimens had a lot of toxicity: CD4 200 Not 500, not 200, 350 than. Study outline. Study Design: cohort/observational

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Background

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Presentation Transcript

  1. Background • Appropriate time to start HAART is still debatable • 1995: “Time to hit HIV, early and hard” Eradication thought to be possible • Early regimens had a lot of toxicity: CD4 200 • Not 500, not 200, 350 than.

  2. Study outline • Study Design: cohort/observational Patients stratified according to CD4 count at baseline. Two groups of interest CD4 350-500 and CD4 > 500. Early –therapy: HAART started within 6 months of CD4 count within prespecified range Deferred-therapy: HAART started after transition into lower CD4 count range

  3. Study outline • Setting: Patients from 60 sites managed by 22 research groups based in Canada and US • Participants: 17,517 asymptomatic patients with HIV infection who received care during the period of 1996-2005 and were therapy naïve. • Data Collection: methods are not uniform. Some site collect prospectively, others retrospectively. • Main Outcome: death from any cause

  4. Results

  5. Results • Patients in deferred groups more likely to have HCV and hx of IVDU. • Patients with CD4 > 500 that deferred Rx were less likely to have HIV RNA < 500 copies/ml 12 after initiation of Rx.

  6. Results • Adjustments also made for HCV status and Hx of IVDU • Analysis done with exclusion of data from each cohort

  7. Results

  8. Strengths • Feasible study design/External validity • Death from all causes as end point • Sample size • Good vital systems: decrease in ascertainment bias • Data available before intervention: decrease in lead time bias • All strategies possible tested: interruption is bad • Sophisticated analytical methods

  9. Weaknesses • Is intervention a marker for good outcome? • Differences in exposure to health care and follow-up not addressed Health-seeking behavior (e.g., dif in viral suppresion) “Good Dr.” effect • ~45% did not change CD4 stratum and not analyzed= slow progressors? • Cause of death known in only 16% • No KM curve. • Lack of central lab • Effects of resistance and long term toxicity not addressed (and maybe not possible addressed)

  10. Preliminary discussion points: • Making decision on treatment based on observational data: The HRT example • When decision to treat is marker for good outcomes or a marker for bad outcomes • Can we or should we have a RCT for each and every intervention?

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