Antiretroviral Therapy During Pregnancy: Risk of Adverse Outcome

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Antiretroviral Therapy During Pregnancy: Risk of Adverse Outcome

Risk of premature delivery and other adverse outcomes of pregnancy associated

with the use of antiretroviral agents was assessed in pregnant women with HIV-1

infection who were enrolled in 7 clinical studies and who delivered their

infants from 1990 through 1998 (Tuomala RE, Shapiro DE, Mofenson LM, et al. N

Engl J Med. 2002;346:1863-1870). The cohort comprised 2123 women who received

antiretroviral therapy during pregnancy (monotherapy in 1590, combination

therapy without protease inhibitors [PIs] in 396, and combination therapy with

PIs in 137) and 1143 women who did not receive antiretroviral therapy.

Unadjusted rates of very premature delivery, low birth weight, very low birth

weight, abnormal Apgar scores, and stillbirth did not differ significantly

between the treated and untreated groups; however, unadjusted rates of premature

delivery were significantly lower among treated women. The rates of each of

these outcomes were also similar among the women who received monotherapy and

those who received combination therapy.

After standardization for the CD4+ cell count and use or nonuse of tobacco,

alcohol, and illicit drugs, the rate of premature delivery (less than 37 weeks'

gestation) was similar among the women who received antiretroviral therapy and

those who did not (16% and 17%, respectively); the rate of low birth weight

(less than 2500 g) was 2% for the group that received antiretroviral therapy and

1% for the group that did not. The rates of low Apgar scores (below 7) and

stillbirth were also similar or the same in the 2 groups. Rates of premature and

very premature delivery did not differ significantly according to whether the

antiretroviral regimen included PIs.

After adjustment for multiple risk factors, combination antiretroviral therapy

was not associated with an increased risk of premature delivery or with

increased risk of low birth weight compared with monotherapy. Seven of the women

who received combination therapy with PIs (5%) had infants with very low birth

weight, compared with 34 women who received monotherapy (2%) and 9 women who

received combination therapy without PIs (2%); however, these results were not

statistically significant.

Data on all assessed risk factors for adverse outcomes were available for 1598

women, and data on all risk factors except previous premature delivery were

available for 1936 treated women. After adjustment for covariates other than, or

including, previous premature delivery, the risk of premature and very premature

delivery among women who received combination therapy with PIs compared with

those who received combination therapy without PIs was not elevated. Combination

therapy that included PIs was associated with higher risks of low and very low

birth weight than was combination therapy without PIs. However, when the

analysis was also adjusted for previous premature delivery, only the risk of

very low birth weight remained significantly elevated.

Compared with monotherapy or no antiretroviral therapy, combination therapy for

HIV-1 infection in pregnant women is not associated with increased rates of

premature delivery or stillbirth or with low birth weight or low Apgar scores.

The association between combination therapy with PIs and an increased risk of

low birth weight requires confirmation. [CDC HIV/STD/TB Prevention News Update,

Monday, June 24, 2002]

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Section 3 of 3

AIDS Read 12(8):325, 343, 370, 2002. © 2002 Cliggott Publishing, Division of SCP

Communications

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