Slide 7 of 76
Notes:
- Anecdotal data show that high exposure to indinavir is associated with an increased risk for urological complaints (flank pain, haematuria, renal colic).
- Hypothesized that Cmax of indinavir is correlated with renal toxicity.
- Data from the BEST trial suggest that renal toxicity is more often encountered when used in a RTV/IDV 100/800 mg bid regimen as compared to IDV 800 mg tid alone, suggesting that AUC or time > certain concentration rather than Cmax might be the main determinant of renal toxicity
- High ritonavir exposure has been associated with increased risk for gastrointestinal and neurological complaints. These associations have been reported for AUC, Cmax and Cmin (all correlated).
Nelfinavir and Saquinavir:
- High drug exposure has been associated with increased risk for gastrointestinal complaints such as abdominal pain, distension, and nausea to both nelfinavir and saquinavir. NB: in this study, the incidence/severity of diarrhea was not correlated to drug exposure.
