icon_folder.gif   Conference Reports for NATAP  
  3rd International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV
Athens, Greece - October 2001
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Fat Loss: efavirenz + AZT/3TC vs indinavir AZT/3TC in study 006
  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.