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FOCUS Study: 24-week interim analysis
Reported by Michael Norton, PA-C, Boriken Health Center, East Harlem NYC
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Study Design:
- Open label
- Randomized
- Multi-centered
- 48 week in length
Entry Criteria:
- Antiretroviral naive
- HIV viral load > 5000 copies/ml.
Patients were randomized to either Fortovase/r 1600/100 qd plus 2 nucs or Efavirenz 600 qd plus 2 nucs.
Total enrolled = 161
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Baseline T-cells were approximately 350 cells/mm3 in both arms.
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Adverse Events:
- FTV/r arm reported predominantly GI complaints such as nausea, vomiting, and diarrhea.
- EFV arm reported predominantly CNS and skin (rash).
Lab Abnormalities:
Slight increase in total cholesterol and in LDL cholesterol was reported in the FTV/r arm.
Discussion:
This study, confirmed now in patients', earlier modeling data presented by Saag at the 1999 ICAAC. That modeling work suggested that with 100mg of RTV, SQV could remain at therapeutic levels for at least 24 hours thus making once a day dosing plausible. Patients in the FTV/r arm complained of GI side effects at a higher rate then seen in a previous study of FTV 1000mg bid with RTV 100mg bid. It was suggested that the higher GI side effects seen in the FTV/r arm are attributable to the FTV capsule or possibly cypiate formulation of FTV. The makers of FTV, Roche Pharmaceuticals, are examining whether taking SQV in its older formulation, Invirase hard gel capsules, should be utilized when taking SQV/r at this dose and frequency. They also reported that Invirase 1600mg/RTV 100mg qd has the same PK parameters as FTV 1600mg/RTV 100mg qd. It was suggested that this substitution could decrease these high level GI side effects. Stay tuned...
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