The Body Covers: The 12th International AIDS Conference
Poster Session 22343: A Phase III, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Effectiveness and Tolerability of the Combination of Efavirenz and Indinavir (IDV) versus Indinavir in HIV-1 Infected Patients Receiving Nucleoside Analogue (NRTI) Therapy at 24 Weeks
June 30, 1998
This study of 300 patients with at least 8 weeks of experience with nucleoside reverse transcriptase inhibitor (NRTI) therapy compared the three drug combination of IDV plus 2 NRTIs (patient's choice) with the FOUR drug combination of efavirenz, plus IDV and two NRTIs. 180 patients had reached the 24 week analysis point, and results were reported on those patients in Geneva. This study, unlike some other efavirenz studies, was blinded.
Not surprisingly, the four drug combination was more effective than the three drug regimen at reducing viral load. After 24 weeks, 85.3% of the 4-drug patients had viral load levels under 400 copies, while 66.2% of patients on the 3-drug arm were <400 copies. This second number is less impressive than viral load reductions seen in other trials, a fact that could be attributed to the amount of NRTI experience among the patients. Benefit was seen in patients with baseline viral loads both above and below the100,000 copies per mL level, and both study arms saw significant increases in CD4 cell count, in the 100-120 cell range.
The study drugs were well-tolerated in both arms, but one must wonder whether a four-drug regimen (and its inherent adherence and side effect challenges) is an attractive option when some 2-drug regimens are showing equally impressive viral load reductions.
Authored by: W. Jeffrey Fessel
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