HIV and Hepatitis.com Coverage of the
14th Annual Conference on Retroviruses
and Opportunistic Infections (14th CROI)
February 25 - 28, 2007, Los Angeles, CA
Atazanavir (Reyataz) Use during Pregnancy

There are few data available on use of atazanavir (Reyataz) by pregnant women. The main concern is the potential for neonatal hyperbilirubinemia, especially in premature infants. Still, atazanavir is increasingly used in pregnancy, due to its favorable adherence (its once-daily dosing improves convenience), resistance, and tolerability profiles.

As reported at the 14th Conference on Retroviruses and Opportunistic Infections last month in Los Angeles, researchers conducted a retrospective analysis in which they reviewed the case notes of all women who used atazanavir during pregnancy while attending 9 HIV medical centers in London, UK. Data were collected on maternal CD4 counts, viral loads, drug toxicity, and plasma atazanavir concentrations. Infant data included serum bilirubin, use of phototherapy (a treatment for hyperbilirubinemia involving exposure to light), and, if available, HIV serostatus at 3 months.

Results 

  • 31 women with a total of 33 pregnancies while taking atazanavir were identified.

  • At their first prenatal visit, the median CD4 cell count was 270 cells/mm3, 16 women had undetectable HIV viral loads, 3 had low viral loads (98-673 copies/mL), and 1 had a viral load greater than 60,000 copies/mL.

  • 20 women conceived while taking atazanavir.

  • 13 women started atazanavir at a median of 22 weeks into their pregnancies.

  • Pre-treatment serum bilirubin and alanine aminotransferase (ALT) levels were within normal limits for all women.

  • At delivery, the median CD4 count was 260 cells/mm3 and the median viral load was below 50 copies/mL.

  • Median maternal bilirubin level was 1.8 mg/dL and 23 out of 25 mothers had elevated bilirubin.

  • All but 1 of 15 women tested had atazanavir levels above the recommended therapeutic concentration of 100 mg/L.

  • 26 infants were born at a median of 38 weeks gestation.

  • Among the 26 infants born, the mean birth weight was 2894 g and the median bilirubin level was 4.2 mg/dL.

  • No infants required phototherapy and no birth defects were observed.

  • All infants tested so far are HIV-uninfected.

Conclusion

In conclusion, the investigators stated that this is likely the largest reported case series of atazanavir use during pregnancy. “Maternal plasma levels, where measured, were adequate,” they said, adding, “No early infant morbidity as a result of in utero exposure to atazanavir was demonstrated.”

Link to poster PDF

Link to study abstract

St George's Hosp, London, UK; St Mary's Hosp, London, UK; Central Middlesex Hosp, London, UK; Barts and the London NHS Trust, UK; Newham Univ Hosp London, UK; Mayday Univ Hosp, London, UK; North Middlesex Univ Hosp, London, UK; Homerton Univ Hosp London, UK; and St Thomas' Hosp, London, UK.

03/20/07

Reference
M Natha, P Hay, G Taylor, and others. Atazanavir Use in Pregnancy: A Report of 33 Cases. 14th Conference on Retroviruses and Opportunistic Infections. Los Angeles, CA. February 25-28, 2007. Abstract 750 (poster).











































14th croi