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Fat Loss: efavirenz + AZT/3TC vs indinavir AZT/3TC in study 006
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This was a report by K Tashima and DuPont Pharma on lipodystrophy development
for patients in the efavirenz 006 study. The 006 study was conducted a few
years ago. Study 006 compared EFV + AZT/3TC to indinavir + AZT/3TC to EFV
+IDV in treatment naive patients. Tashima reported on willing subjects from
006 who underwent an abdominal CT-scan at their next scheduled visit with a 1
year follow-up scan. An independent, central reader read all scans in a
blinded fashion.
373 subjects enrolled in this substudy. authors reported there were no
significant differences in arms in demographics or baseline characteristics.
The median time from study start to first scan was 738 days and to the
follow-up scan, 1106 days.
The median subcutaneous fat at first scan ranged from 254 to 331 cm2, not a
significant difference between arms. The authors reported the median change
between scans was -87.6, -128.5, and -117.5 cm2 for the EFV/AZT/3TC,
IDV/AZT/3TC, and IDV/EFV arms, respectively (significant changes between
scans within all arms, p<0.05 EFV + AZT/3TC vs IDV + AZT/3TC). In other words
there was a loss in subcutaneous fat in the EFV/AZT/3TC arm (-87.6) but the
loss in subcutaneois fat was greater in the patients taking IDV/AZT/3TC.
Suggesting that lipoatrophy was greater in the patients receing the
IDV/AZT/3TC arm than in the patients receiving EFV/AZT/3TC.
The median change in visceral fat (belly paunch) at the first scan ranged
from 123.6 to 150.4 cm2 (not significant). The median change in visceral fat
was -6.7, -13.7, and -7.6, for the 3 arms, respectively. But the differences
were not significant.
The authors summed: in this post hoc (substudy conducted after the main 006
study) assessment of fat redistribution measured by abdominal cat scan
significantly more subcutaneous fat loss was noted in subjects receiving
IDV/AZT/3TC than in patients receiving EFV/AZT/3TC. However, significant
subcutaneous fat loss between scans was noted in all arms. In other words,
fat loss occurred in patients receiving all 3 regimens.
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