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TheBody.com/TheBodyPRO.com covers The 18th Conference on Retroviruses and Opportunistic Infections (CROI 2011)

Maternal Risk Following Short Course HAART

March/April 2011

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Roger Shapiro and colleagues from the Mma Bana Study, Botswana looked at maternal and infant outcomes among women receiving short course HAART for PMTCT during pregnancy and breastfeeding.1

In Mma Bana, pregnant women with CD4 counts >200 cells/mm3 (n=560) were randomised to receive regimens of either abacavir+AZT+3TC (arm A) or LPV/r+AZT+3TC (arm B) from week 26 to 34 gestation until the infants were weaned at 6 months post partum.2 The study also included an observational arm (n=170) in which women indicated for HAART according to local guidelines received lifelong NVP+AZT+3TC. Participants were followed for 24 months post partum.

Randomised women re-started HAART with NVP+AZT+3TC when indicated for treatment (at a CD4 count of 200 cells/mm3 at the beginning and changed to 250 cells/mm3 during the course of the study). This occurred in 9% of randomised women and 25% overall (randomised and observational) continued HAART past 6 months for treatment.

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At 24 months, there were 14 (1.9%) maternal deaths: 2 during pregnancy following HAART initiation (1 arm A, 0 arm B, 1 observational), 2 from delivery to 6 months postpartum (0 arm A, 0 arm B, 2 observational), and 10 from 6 to 24 months postpartum (5 arm A, 3 arm B, 2 observational).

There were deaths across all baseline CD4 strata among randomised women (4, 2, and 3 with baseline CD4 200 to 350, >350 to 500, and >500 cells/mm3, respectively). In this group, 8 of 9 deaths were from 6 to 24 months; and 5 of these women had not re-started HAART as treatment.

There was a mean CD4 increase from baseline to 24 months in all treatment arms (15% of randomised women re-started HAART): 68 cells/mm3, 98 cells/mm3, and 283 cells/mm3 in arms A, B and observational respectively. Among women with baseline CD4 >250 cells/mm3, there was a significantly higher CD4 increase in arm B vs A (86 vs 46 cells/mm3, p=0.04).

Data were available for 96% of 709 live-born infants at 24 months of follow up. The majority (97%) of infants were breastfed for a median of 5.8 months. Nine deaths occurred before breastfeeding was initiated (7 <3 days of age, 3 arm A, 2 arm B, 4 observational). There was an increase in infant mortality after weaning, only 5 (0.7%) deaths were during breastfeeding (0 arm A, 2 arm B, 3 observational), compared to 23 (3.2%) after weaning (10 arm A, 11 arm B, and 2 observational). Of these, •14 (2.0%) deaths occurred less than 3 months from weaning which accounted for 38% of all infant deaths in the study. The death rate during breastfeeding was 1.76/100 person-years compared to 5.71/100 person-years within 6 months post-weaning, p=0.02.

Eight children (1.1%) were HIV-infected at 24 months, which did not change from 6 months. HIV infection or death occurred in 6.1% of infants (6.4% arm A, 5.9% arm B, 5.8% observational)..

Causes of maternal and infant deaths are shown in Table 1.


Table 1: Causes of Maternal and Infant Deaths at 24 Months in Mma Bana
Maternal Infant
Arm A

Extrapulmonary TB (3)

Postpartum hemorrhage

Bleeding disorder/hemorrhage

Diarrhoea/sepsis

Vulvar cancer

Drowning

Diarrhoea (13)

Pneumonia (5)

Neonatal sepsis (5)

Meconium aspiration (3)

Respiratory failure/? aspiration (2)

Pulmonary TB (suspected)

Prematurity/respiratory distress

Fever/respiratory failure

Birth asphyxia

Meningitis

Hydrocephaly

Car accident

Unknown (weakness/lethargy)

Unknown (no information)

Arm B

Pulmonary TB

Diarrhoea/hepatic/renal failure

Unknown (febrile illness, back pain)

Observational

Toxoplasmosis

PCP

Stevens Johnson Syndrome

Bowel obstruction Congestive heart failure


The authors concluded that maternal HAART from pregnancy through 6 months of breastfeeding was associated with low overall maternal and infant mortality at 24 months. They noted that this study found similar maternal mortality/lower infant mortality than in Mashi, a previous Botswana non-HAART MTCT intervention study. Following their observation of a trend for increased maternal mortality after stopping HAART for PMTCT they suggest that 24-month mortality may be higher when stopping HAART in this situation than if it is continued.

Increased infant mortality among weaned infants has been seen previously and later weaning is now recommended by WHO but MTCT and mortality tradeoff are unstudied.

A related poster from the MTCT-Plus Initiative also looked at the impact of stopping HAART used during pregnancy for PMTCT on maternal HIV disease progression.2 This study evaluated maternal CD4 count decline after MTCT prophylaxis.

MTCT-Plus was a multi-country HIV care programme for women, children, and families in eight African countries and Thailand.

ART-naive, HIV-positive pregnant women with CD4 count >400 cells/mm3 at enrollment were included in the analysis.

The majority of the women evaluated received single-dose nevirapine (sdNVP) or short-course ARV prophylaxis with AZT or AZT+3TC. HAART (AZT+3TC+NVP or nelfinavir) was initiated during pregnancy in programmes in Thailand and Kenya. All regimens were stopped shortly after delivery with a median duration of 10 weeks.

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 


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