July 9, 2001
For several years, it has become clear that patients with high viral loads and low CD4 counts are at increased risk of virologic failure, even during a first regimen. It is likely that many of our current regimens are only marginally potent for these difficult patients. A four-drug regimen is often used in this setting, but this usually increases the pill burden and complexity.
This small pilot single armed study explored the use of Combivir, abacavir and efavirenz in treatment-naive patients with >50,000 copies. The study was later amended to include anyone with over 1000 copies. With the release of Trizivir, this regimen would consist of one pill in the morning and four at night yet deliver four active drugs while sparing protease inhibitors as a class.
Thirty-eight patients were enrolled. The median viral load in this study was 5.1 log (a little over 100,000) and the median CD4 count was 285, so perhaps many of the patients were not actually those for whom the regimen would be most appealing. Nonetheless, viral load decline was very rapid and the results are impressive with 68% of patients being suppressed to less than 50 copies by 24 weeks in an ITT NC=F analysis.
Three of 38, (9%) had hypersensitivity reactions to abacavir. One patient had suicidal ideation due to efavirenz. These are not unexpected, and as often happens when NNRTIs are started with abacavir, rash may have led to some over diagnosis of hypersensitivity. This regimen, or perhaps nevirapine plus Trizivir, are tempting options for increasing potency while maintaining simplicity. A reasonable population to consider such an approach, in the absence of controlled trials, might be naive patients who have low CD4 counts, and/or high viral loads.
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