Background of study: Although current recommendations do not include specific guidelines on the use of combination anti-HIV therapy in pregnancy, peculiar issues do exist.
Objective: 1. To examine the reasons of therapeutical choices in HIV infected pregnant women; 2. To evaluate the short term effects of combination antiretroviral therapy on mother and baby.
Design: Thirty-two HIV infected women who received combination therapy were included (all delivered at Gemelli Hospital, Rome from September 1998 to February 2001). We reviewed all records (medical, obstetrical and neonatal) of these mother-baby pairs.
Results: Ten out of 32 women were not aware of HIV seropositivity before pregnancy. Five were out of therapy (no criteria for therapy in three cases, no stable follow up in two cases); one stopped therapy more then 1 year before pregnancy; 16 were on therapy as detailed in the table below.
| Therapy before pregnancy |
Cases |
Therapy during pregnancy |
Cases |
| 2 NRTIs |
4 |
ZDV + 3TC + IDV |
4 |
| 2 NRTIs + 1 NNRTI |
4 |
ZDV + 3TC+ NFV |
2 |
| |
|
D4T + 3TC+ NFV |
1 |
| |
|
ZDV + 3TC + NVP |
1 |
| 2 NRTIs + 1 PI |
7 |
ZDV + 3TC+ IDV |
1 |
| |
|
ZDV + 3TC+ NFV |
4 |
| |
|
ZDV + DDI + NFV |
1 |
| |
|
ZDV + 3TC+ RTV + NFV |
1 |
| 1 NRTI + 1 NNRTI + 2 Pis |
|
ZDV + 3TC+RTV+ NFV |
1 |
Fifteen women stopped therapy between 1-9 w of gestation; one, with overt AIDS, did not stopped. Therapy was started between 16-34 w (median 21). At the delivery, HIV RNA was <1000 copies/ml in 24/31 women. It was <50 copies/ml in 15 women. Fourteen out of 16 “drug experienced” women had <1000 copies/ml (<50 copies/ml in 9 cases). In particular, 5 out of 7 women who changed therapy (1 for anemia, 2 for rash, 4 for nausea/vomiting) had HIV viremia detectable at delivery. We did not observe any major adverse event during pregnancy although we had quite a large number of minor adverse events. All women delivered by caesarean section (30-40 w, median 38 w). No statistical differences were observed in auxologic parameters
comparing babies exposed to combination therapy to those exposed to ZDV alone or not exposed to anti-HIV drugs. A women out of two who used EFV during the first trimester delivered a baby with cystomielomeningoceles. No infected baby (at 6 months) were observed.
Conclusion: Therapeutical choices in pregnancy should be tailored considering both the efficacy for the HIV infected mother (during pregnancy and future options) and safety for the baby. In particular, long time effects should be carefully considered, and a follow up is ongoing on this issue. The use of combined protocols seems well responsive to these two issues.
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