Baseline characteristics of the 775 HIV-infected and 205 HIV-uninfected women included in this analysis are shown in . HIV-infected women weighed less than HIV-uninfected women and had lower percent total body fat. Arm, hip, and thigh circumference measurements were also smaller for HIV-infected than for HIV-uninfected women. Among HIV-infected women, 70% reported ARV use and 55% were on HAART. The body composition characteristics between HIV-infected women on HAART and those not on HAART, as well as between HIV-infected women on any ARV and those not on ARV at the index visit were similar (data not shown). Two thirds of those who were not on an ARV at the index visit started therapy during the study period.
Characteristics of Nine Hundred Eighty Women at the Index Visit, Between April and October 1999
Average 6-month changes in weight, percent total body fat, and circumferences are shown in . HIV-infected women demonstrated decreases on average in weight and percent total body fat, while HIV-uninfected women showed increases. Circumference measures showed similar patterns of decrease in HIV-infected and gain in HIV-uninfected women. Similar results were observed when circumference measures were expressed as the percent of the baseline circumference measure for each regional site in HIV-infected and uninfected women (data not shown).
Table 2 Average Six-Month changes in Weight, Percent Body Fat, Fat Free mass, and Circumference Measurements for the Seven Hundred Seventy-Five HIV-Infected and Two Hundred Five HIV-Uninfected Women from April 1999–April 2003 and 95% Confidence Intervals (more ...)
NRTIs were the drug class participants most reported taking with 3TC reported in 45% of the 1852 person-visits, D4T in 24% of 1087 person-visits, AZT in 19% of 892 person-visits, ABC in 7% of 378 person-visits and DDI in 6% of 314 person-visits. The percentage of women using D4T halved during the study period. The percentage of person-visits with reported use of an individual NNRTI and an individual PI on three consecutive visits ranged from 7% to 9% for NNRTI and 5% to 10% for PI.
shows the estimate for the average 6-month change in weight and percent body fat, and the 95% confidence intervals (95% CI) for HIV-uninfected versus HIV-infected women, and for HIV-infected women reporting exposure to each of the 11 ARV medications on 3 consecutive visits versus those not taking the specific ARV in any of the same 3 visits.
FIG. 1 Estimate for the average 6–month change in weight and percent body fat, and the 95% confidence intervals (95% CI) for HIV-infected versus HIV-uninfected women; and for HIV-infected women exposed and unexposed to each specific antiretroviral (ARV) (more ...)
Participants taking DDI for 3 consecutive visits showed a significant reduction on weight (−0.63 kg; 95% CI: −1.10, −0.16; p = 0.01) and on percent body fat (−0.59%; 95% CI: −1.14, −0.04; p = 0.03). Participants taking ABC for 3 consecutive visits showed a significant reduction on weight only (−0.48 kg; 95% CI: −0.89, −0.08; p = 0.02) and participants taking SQV showed a significant reduction in percent body fat only (−0.39%, 95% CI: −0.74, −0.03; p = 0.04).
When the average 6-month change in circumference measurements were compared between those on an ARV drug and those not on the ARV drug for 3 consecutive visits, a difference was observed only for DDI. shows the estimate for the average 6-month change in regional circumference measures, and the 95% CI for HIV-infected women exposed to DDI on 3 consecutive visits versus those not taking DDI in any of the same 3 visits. HIV-infected women exposed to DDI demonstrated a significant average 6 month reduction in the hip, waist, and chest. A reduction was also observed in the arm although not statistically significant. There was no difference observed for the thigh. Similar findings were observed when women not taking any ARV for 3 consecutive visits were excluded from the unexposed group.
FIG. 2 Estimate for the average 6–month change in regional body circumference, and the 95% confidence intervals (95% CI) for HIV-infected exposed and unexposed to DDI, in three consecutive visits. The effect of the comparison (cm), and the p values for (more ...)
Because DDI is often used in conjunction with D4T, we analyzed the association of DDI and D4T use in body composition at baseline and during the study period. At the index visit in 1999, approximately 75% of women exposed to DDI for at least 3 consecutive visits, were also on D4T and approximately one third of women not exposed to DDI for at least 3 consecutive visits, were on D4T. During the study period from 1999 to 2003, a combination of D4T and DDI was reported in 55% of the 314 person-visits in which participants reported taking DDI on 3 consecutive visits. Among the 1087 person-visits where participants reported taking D4T on 3 consecutive visits, the combination of D4T and DDI was reported in only 16% of those person-visits.
At the index visit in 1999, there was no difference in the body composition characteristics between women exposed to DDI and those not exposed to DDI for 3 consecutive visits, including weight (67 kg versus 68 kg, respectively p = 0.56) and percent body fat (37% versus 39%, respectively, p = 0.23). However, the body composition characteristics were different between women on D4T and those not on D4T for 3 consecutive visits. D4T users had lower weight (66 kg versus 70 kg, p = 0.01), percent body fat (36% versus 40%, p < 0.01), and decreased arm (28 cm versus 29 cm, p = 0.03), hip (93 cm versus 98 cm, p < 0.01), and thigh circumferences (47 cm versus 50 cm, p < 0.01). During the 4-year study period, the average 6-month decrease in weight and percent body fat in women on a combination of D4T and DDI for 3 consecutive visits appeared greater than women on D4T without DDI, although not statistically different (data not shown).
When exploring the effect of at least 12 months of exposure to the other individual ARV medications on circumference measures, a significant 6-month average increase in the arms was observed in women exposed to D4T (0.20 cm increase, 95% CI: 0.07, 0.35; p < 0.01) and to NFV (0.18 cm increase, 95% CI: 0.03, 0.39; p = 0.04). No other significant differences were noted for circumference measures in patients on the other ARV medications.