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Kaletra in Women
Reported by Jules Levin
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Abbott reported at the conference on an analysis of the response of women to Kaletra in the study (M98-863) which compared it to nelfinavir (Viracept). In the M98-863 study 653 treatment-naive patients received either Kaletra twice daily or Viracept three times daily (this was before Viracept was approved to be taken twice daily), plus d4T and 3TC. After the FDA approved Viracept to be taken twice daily patients could switch to twice daily dosing. The study investigators concluded that viral effectiveness was similar between men & women in this study; and while differences in rates of certain adverse events and lab abnormalities were noted, overall safety and tolerability were equal between men & women Kaletra treated patients.
Average age of women was 41. Female patients in the study had lower weight than the men (68 kg vs 75 kg, 2.2 lbs per kg). Most women in the study were Black: 50% of females were Black vs 18% of the men. Most (62%) of the men were White.
There were 66 women enrolled in study vs 260 men. There wasnąt much difference in the discontinuation rate between women (26%) & men (21%). 8% of women discontinued study drug due to drug-related adverse events vs 3% for men. There was no real difference in discontinuation for viral failure between women & men (0% vs 1%). There was no real difference in discontinuation for noncompliance (2% vs 3%).
A similar viral response was seen between women & men: 65% of men had <50 copies/ml of viral load vs 61% of women after 60 weeks of therapy in the study (ITT, noncompleter=failure). The time to loss of viral response through week 60 was similar (17% of women lost viral suppression by week 60 vs 15% of men). The CD4 response was also similar: 257 Cd4 increase by women at week 60 vs 242 for men.
No Kaletra treated patient (0/10 females & 0/41 men) with viral load >400 copies and an available genotype resistance test between week 24 & 60 developed detectable protease inhibitor resistance. But several women & men developed 3TC resistance.
SAFETY
Moderate to severe nausea and dyspepsia (GI) was reported more often by women than men through week 60 (nausea: 14% vs 6%; dyspepsia: 8% vs 2%). Diarrhea was reported equally by men & women: about 15%. Investigators suggested the observed higher rate of nausea in female patients does not appear to be related to lower body weight.
Investigators reported females receiving Kaletra had a significantly lower incidence of grade 3/4 triglyceride elevations (>750) through week 60, consistent with previous reports of gender differences in triglyceride increases, particularly in d4T regimens. Men had significantly higher triglycerides before starting the study (171 vs 141). Other grade 3/4 lab tests reported did not show differences between men & women: glucose, liver enzymes, cholesterol). Investigators did report lab abnormalities less than grade 3/4.
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