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Structured Treatment Interruptions Workshop Summary

January 31, 2001

Progress in STI Research:
Outstanding Clinical Issues

Clinical Risks
  • The risks of clinical events during treatment interruption (TI) are small if CD4+ counts remain above 200 cells/mm3. For those with lower CD4+ counts, good medical practice is crucial to prevent breakthrough infections.
  • The risk of developing resistance during interruption is very low but cases have been observed.
  • The risk of viral transmission during interruption is of concern but not quantified.
  • The risk of affecting the pharmacokinetics of other drugs by inducing or inhibiting liver enzymes after starting or stopping certain antiretrovirals could be significant.
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  • Recrudescence of an acute retroviral syndrome (ARS) during viral rebound may require clinical attention.
  • Discontinuous treatment schedules may undermine adherence habits.
  • Pulsed therapy may have risks of toxicity different from those seen with chronic dosing.
  • Some patients may experience rashes or other drug sensitivity reactions when restarting therapy.

Relief of Toxicity and Other Possible Benefits

  • Preventing metabolic toxicity: It may be possible to delay but not prevent toxicity. (It's still not clear if the drugs are responsible for all of the toxicity -- some of it may be due to HIV.)

  • Reducing or reversing lipodystrophy: Hatano, et al. (and Lori, et al. in SIV monkeys) observed improvement in blood lipid levels but not in insulin resistance profiles or body shape measurements. Muscle cell abnormalities appear early with drug exposure.

  • Improving quality of life (QOL): QOL is difficult to assess, available instruments are not used in a standard way, and cultural variables are uncertain. QOL measures are not routinely performed and there is little accepted data on which QOL deficits are a problem and when they resolve. For example, many patients note the reduction of fatigue following TI although some complain of headaches and increased fatigue for a few weeks after interruption, possibly due to a recurrence of acute retroviral syndrome (ARS).

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