European Commission Approves Labelling Update For REYATAZ® (atazanavir sulfate) in Pregnant Women Living With HIV

drugs may be prescribed during pregnancy to reduce the mother’s viral load, although their optimal dosage is mostly unknown. As pregnancy can reduce the serum levels of many ARVs, it is important to know the optimal dosage. Margaret Johnson, Clinical Director of HIV Services, Royal Free NHS Trust, London.

This label update is based on a multicentre, open-label, prospective, single-arm pharmacokinetic study (Study AI424-182*). The study evaluated 41 pregnant women living with HIV, between 12 to 32 weeks gestation (second and third trimester of gestation) with CD4 ≥ 200 cells/mm3...HIV.2

Secondary outcomes of the study evaluated antiviral efficacy and safety in pregnant women and their infants. Among the 39 women who completed the trial, 38 achieved an HIV RNA

A moderate amount of data in pregnant women (between 300-1,000 pregnant outcomes) indicates no malformative toxicity of atazanavir. Animal studies do not indicate reproductive toxicity...In the prepartum period, additional monitoring should be considered.

Breast-feeding
It is unknown whether atazanavir or atazanavir metabolites are excreted in human milk. Studies in rats have demonstrated that atazanavir is excreted in the milk. PI with labelling that allows for co-administration with an oral contraceptive.

About Pregnancy and HIV
Globally, the number of women living with HIV is on the rise. , The prevalence of pregnant women living with HIV in Europe has increased significantly in recent years, with a high proportion of women diagnosed during antenatal testing. This rate is increasing due to the growing influx of people living with HIV immigrating to Europe. In developing countries, many more pregnant women are also living with HIV. For example, in parts of Africa, the prevalence is about 30%.8

About Bristol-Myers Squibb Company
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

Media Contacts:
Annie Simond, office: + 33 01 58 83 65 66
Joanna Ritter, office: + 33 01 58 83 65 09

References
1...Safety and exposure of once-daily ritonavir-boosted atazanavir in HIV-infected pregnant women. HIV Medicine...Summer 2009. Available at http://aidsetc.org/aidsetc?page=hmq-0908-00. Accessed 22 November 2011.
6...Available at http://www.thebody.com/content/art38572.html...Available at http://data.unaids.org/pub/Report/2009/2009_epidemic_update_en.pdf...Available at http://data.unaids.org/pub/epislides/2007/2007_epiupdate_en.pdf...HIV infection in Central and Eastern European pregnant women living in the UK/Ireland: data from national surveillance 1992-2007. University College London, Institute of Child Health Institute of Child Health. For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2011/11/prweb8992584.htm