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ARTwith Indinavir Ritonavir (400 mg/100 mg Twice Daily)-containing Regimen in HIV-1-infected Pregnant Women
Roland Tubiana*1, S Dominguez1, C Perot1, C Cornelie1, A Marcelin1, M Pauchard1, Z Ouagari1, J Ghosn1, G Peytavin2, I De Montgolfier1, R Agher1, V Calvez1, F Bricaire1, M Dommergues1, and C Katlama1
1Hosp Pitie-Salpetriere, Paris, France and 2Hosp Bichat-Claude Bernard, Paris, France
Background: Indinavir (IDV)/ritonavir (RTV) is a simple, potent, well-tolerated regimen
in HIV patients. Whether this regimen could be safely used in pregnant women
remains to be determined. Our objective
was to evaluate the safety and efficacy of IDV/RTV-based therapy in HIV+
pregnant women
Methods: An observational study
including pregnant women attending our unit and receiving a
IDV/RTV-containing regimen. Plasma HIV-1 RNA, CD4 count, chemistry, Cmin plasma IDV and RTV were measured and
adverse effects recorded monthly until delivery.
Results: A total of 32 women received ART
with IDV/RTV (400/100 mg twice daily) and a backbone of zidovudine
(AZT)/lamivudine (3TC) (n = 30), stavudine
(d4T)/3TC (n = 1), AZT/didanosine (ddI) (n = 1). At baseline, the first visit during
pregnancy, the median term was 9 weeks, median age was 32 years; 21 patients
were on ART with 14 receiving
IDV/RTV for a median of 9 months (1 to 16). For the 11 ART-naļve, the median time of RTV/IDV
initiation was 20 weeks of gestation (3 to 30). For these 11, median baseline
HIV RNA was 9265 copies/mL (261 to 50,800), CD4 count
was 193/µL (112 to 395). Median exposure to IDV/RTV during pregnancy was 24
weeks (5 to 40). In 4 of 32 patients IDV/RTV was discontinued before delivery,
1 for virologic failure and 3 for intolerance: 2 xerosis
and 1 ingrowing toenail. No nephrolithiasis,
grade 2 hyperbilirubinemia, hyperglycemia,
or elevated creatinine were observed. Median Cmin
was 208 ng/mL (0 to 10,665)
for IDV in the third trimester .(n = 27), 1 patient
was overdosed for IDV and one non-observant. At delivery, 28 of 31 (90%) had an HIV RNA < 400 copies/mL.
The 3 detectable value: 1200, 1870, and 3100 copies/mL were related to patients poor adherence. The pregnancies
ended with 1 spontaneous miscarriage at 11 weeks and the birth of 33 infants (2
set of twins). Mode of delivery was vaginal for 12 patients, elective caesarean
section for18 and 1 emergency caesarean section. Median term of delivery was 38
weeks (33 to 42) with premature delivery < 37 weeks in 4 of 31 patients. None of the 32 infants reaching 3 months was infected using
HIV RNA and DNA PCR. The median birth weight was 3000 g (2100
to 4600), 5 were hypotrophic including 3 of 4 twins (1600
to 2500 g). At 4 days, median hemoglobin was 14 g
(10.4 to 18.7), median bilirubin 115 (14 to 223),
SGOT 45 (22 to 71) all within the normal range.
Conclusions: At
delivery, 90% of pregnant women assigned to
IDV/RTV-containing ART showed an undetectable plasma HIV RNA with an overall adequate IDV Cmin and good tolerance for the mothers and
infants suggesting that this simple boosted protease inhibitor regimen could be
used in HIV+ pregnant women.
Keywords: pregnancy; antiretroviral therapy; ritonavir-indinavir
