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Effect of Protease Inhibitor-based ARTon Glucose Tolerance in Pregnancy: ACTG A5084
Jane Hitti*1, J Andersen2, G McComsey3, T Liu2, A Melvin1, A Stek4, J Aberg5, A Hull6, B Alston-Smith7, E Livingston8, and ACTG A5084 Study Team
1Univ of Washington, Seattle, US; 2Harvard Sch of Publ Hlth, Boston, MA, US; 3Case Western Reserve Univ, Cleveland, OH, US; 4David Geffen Sch of Med, Univ of California, Los Angeles Med Ctr, US; 5New York Univ, NY, US; 6Univ of California, San Diego, US; 7NIH, DHHS, Bethesda, MD, US; and 8Duke Univ Sch of Med, Durham, NC, US
Background: Since
protease inhibitor (PI) use can result in insulin resistance and hyperglycemia,
we hypothesized that PI use would also be associated with an increase in
glucose intolerance in pregnancy.
Methods: AIDS
Clinical Trials Group Protocol A5084 was a prospective observational study of
161 HIV-infected pregnant women at 20 to 34 weeks’ gestation, on stable ART or
no ART for ≥8 weeks prior to entry. Equal numbers were on PI-containing
and PI-sparing or no ART. Serum glucose was measured 1 hour after an oral 50-g
glucose load. Impaired glucose tolerance (IGT) was defined as a 1-hr glucose
>130 mg/dL. Among subjects with IGT, gestational
diabetes (GD) was determined with a 100-g, 3-hour glucose tolerance test
interpreted by the Carpenter and Coustan criteria.
Subjects without GD repeated entry evaluations at 8 weeks if still pregnant. Glucose
tolerance was categorized as always normal, at least IGT, or GD. Subjects with
IGT and incomplete GD testing were classified as IGT. Statistical significance
was determined using χ2 test for trend and Mann-Whitney or T-tests.
Results: Of the total, 149 (93%) of subjects had
evaluable data; 76 (51%) on PI and 73 (49%) not on PI, including 4 subjects not
on ART. The most frequently used PI were nelfinavir (n = 44) and lopinavir/ritonavir
(n = 25). Subjects’ race was: 55% African American, 25% Hispanic, 15% white,
and 5% from other groups. Median entry body mass index was 30.8 kg/m2.
There were no significant differences between the PI and no-PI groups in
demographics or body mass index. Subjects with IGT or GD had a trend
toward higher body mass index
than those with normal glucose tolerance (p
= 0.06). PI use was not associated with IGT or GD, gestational age at delivery,
infant birth weight, mode of delivery, congenital abnormalities,
or other adverse neonatal diagnoses.
|
Outcome
|
PI (n = 76)
|
No PI (n = 73)
|
p value
|
|
Glucose tolerance:
Always normal
At least IGT
GD
|
45
25
6
|
(59%)
(33%)
( 8%)
|
47
19
7
|
(64%)
(26%)
(10%)
|
0.65
|
|
Gestational age at delivery
(weeks, mean ±SD)
|
38.0 ±2.0
|
38.4 ±1.8
|
0.20
|
|
Infant birth weight (g,
mean ±SD)
|
3106 ± 540
|
3146 ± 649
|
0.68
|
|
|
|
|
|
|
Conclusions: In this cohort, PI-containing ART was not associated
with an increased risk of glucose intolerance in pregnancy, or with the
sequelae of glucose intolerance. PI use was also not associated with an
increase in preterm birth. These data add to the consensus that PI use, in
general, appears to be a safe antiretroviral strategy for HIV-infected pregnant
women.
|
