[Viva] Fwd: FW: CATIE News - FDA revises instructions on the use of atazanavir during pregnancy and after birth

[Tami Starlight]

** <cosmictami at shaw.ca>
*Subject:* CATIE News - FDA revises instructions on the use of atazanavir
during pregnancy and after birth



*CATIE News - FDA revises instructions on the use of atazanavir during
pregnancy and after birth*

The use of potent anti-HIV therapy (commonly called ART or HAART) has
greatly extended the survival of HIV-positive people by helping to lower
production of HIV and allowing the immune system to partially repair itself.
ART has additional benefits: for instance, HIV-positive women who take ART
during pregnancy can significantly reduce the amount of HIV in their blood
(viral load) and, therefore, the risk of transmitting HIV to the fetus.
These additional steps also help reduce the risk of transmitting HIV to the
infant:

   - intravenous AZT (Retrovir, zidovudine) during delivery
   - delivery of the baby via cesarian section
   - oral AZT for the baby for the first six weeks of life
   - use of baby formula rather than breastfeeding (as breast milk can
   transmit HIV)

In high-income countries today, among women who take ART exactly as directed
and whose viral load is suppressed, who also receive prenatal counselling
and care and take the steps outlined above the chance of transmitting HIV to
the fetus can be reduced to less than two percent.
Enter atazanavir

Leading American HIV treatment guidelines, produced by the Department of
Health and Human Services suggest that the preferred regimen for pregnant
HIV-positive women is:

lopinavir-ritonavir (Kaletra) + AZT (Retrovir, zidovudine) + 3TC
(lamivudine).

This combination of drugs has been taken by many people living with HIV and
its safety during pregnancy for the mother as well as the fetus is well
established. Treatment-experienced women who develop drug resistance may
need to use other anti-HIV drugs. One potential alternative to Kaletra that
is being tested in pregnant HIV-positive women is the combination of
atazanavir (reyataz) and ritonavir (Norvir).

The U.S. Food and Drug Administration (FDA) has recently changed the
prescribing information for the use of atazanavir in HIV-positive
treatment-experienced women who are pregnant. Below are key points from the
FDA’s update.

Dosing during pregnancy and postpartum:

   - Atazanavir should only be taken with ritonavir.
   - Atazanavir should only be taken by pregnant women whose strain of HIV-1
   is susceptible to atazanavir.

Acid-reducing agents, such as cimetidine (Tagamet) and ranitidine (Zantac),
belong to a class of drugs called histamine2-receptor antagonists (H2-receptor
antagonists). For pregnant HIV-positive women who use H2-receptor
antagonists with atazanavir *or* the anti-HIV drug tenofovir (Viread, also
in Truvada and Atripla), the FDA recommends the following dose:

   - atazanavir 400 mg and ritonavir (Norvir) 100 mg once daily.

The FDA does not have sufficient information to make a dose and schedule
recommendation for the use of antazanavir-ritonavir when *both* an H2-receptor
antagonist and tenofovir are also used in pregnancy by treatment-experienced
women.

The FDA notes that no dose adjustment is required during the first two
months after the baby is delivered. However, the agency does state that
women “should be closely monitored for adverse events because [the
concentration of atazanavir] could be higher during the first two months
after delivery.”
Risk summary

The FDA states that atazanavir has been “evaluated in a limited number of
women during pregnancy and postpartum. Available human data suggest that
atazanavir does not increase the risk of major birth defects overall
compared to the background rate. Nevertheless, because studies in humans
cannot rule out the possibility of harm, atazanavir should be used during
pregnancy only if clearly needed.”

The FDA will eventually post this and other updates about the use of
atazanavir in pregnant HIV-positive women at this location:

www.accessdata.fda.gov/scripts/cder/drugsatfda/
In Canada

Bristol-Myers Squibb, the manufacturer of atazanavir, has submitted similar
changes for the prescribing information of this drug to Health Canada for
approval.


*—Sean R. Hosein*

REFERENCES:

1.     Klein R and Struble K. HIV/AIDS Update – Reyataz (atazanavir) label
revised, adding dosing recommendations for pregnancy and postpartum period.
*HIV/AIDS Update*. U.S. Food & Drug Administration. 4 February, 2011.

2.     Panel on Antiretroviral Guidelines for Adults and Adolescents.
*Guidelines
for the use of antiretroviral agents in HIV-1-infected adults and
adolescents*. Department of Health and Human Services. January 10, 2011;
1–166. Available at
www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 7
February, 2011.

3.     von Linstow ML, Rosenfeldt V, Lebech AM, et al. Prevention of
mother-to-child transmission of HIV in Denmark, 1994-2008. *HIV Medicine*.
2010 Aug;11(7):448-56. Epub 2010 Feb 8.

4.     Townsend CL, Cortina-Borja M, Peckham CS, et al. Low rates of
mother-to-child transmission of HIV following effective pregnancy
interventions in the United Kingdom and Ireland, 2000-2006. *AIDS*. 2008 May
11;22(8):973-81.



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-- 
Thank you/Merci
Tami M. Starlight
Vancouver, Canada
tamistarlight at gmail.com
604-200-2445home
604-790-9943cell
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