Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals; Pregnancy / Obstetrics
Article Date: 28 Nov 2011 - 5:00 PST
email to a friend 
printer friendly 
opinions 
Following new data from study AI424-182 on pregnant women living with HIV, the European Commission approved a labeling update for Reyataz (atazanavir sulfate). The announcement was made by Bristol-Myers Squibb Company. Dosing and medical guidance for Reyataz/ritonavir during pregnancy and postpartum are provided in the updated label. The study assessed the safety, efficacy and the pharmacokinetic parameters of Reyataz/ritonavir in pregnant women living with HIV. The update is based on a multicenter, open-label, prospective, single-arm pharmacokinetic investigation (Study AI424-182*).
Each year around the world over 3 million women living with HIV give birth. According to European AIDS Clinical Society (EACS) treatment guidelines, women with HIV may be prescribed antiretrovial (ARV) drugs during pregnancy in order to reduce their viral load, even though the optimal dosage of these drugs remains largely unknown. It is crucial to know the optimal dosage, since pregnancy can reduce the serum levels of several antiretroviral drugs.
Margaret Johnson, Clinical Director of HIV Services, Royal Free NHS Trust, London, explains:
"This labeling update is important news for both physicians and women with HIV of child-bearing age in that it provides dosing and medical guidance for the use of Reyataz/ritonavir during pregnancy and postpartum."
41 women living with HIV who were between 12 to 32 weeks pregnant (2nd and 3rd trimester of gestation) with CD4 = 200 cells/mm3, were assessed in the investigation. 20 participants received Reyataz with ritonavir 300/100 mg (n=20) and 21 participants received a 400/100 mg dose once daily. In addition they received a combination of zidovudine/lamivudine 300/150 mg twice daily, whilst those in their second trimester were administered with Reyataz/ritonavir 300/100 mg.
The main goal of the investigation was to determine the optimal dosing of Reyataz/ritonavir in pregnant women living with HIV in comparison to previous data in adults with the disease. According to the results, both doses of Reyataz achieved minimum plasma concentrations (24 hours after-dose) during the third trimester, similar to results in prior investigations in adults living with HIV.
Secondary outcomes of the investigation assessed the safety and effectiveness of ARV in pregnant women and their infants. 38 participants out of the 39 women who completed the trial achieved an HIV RNA <50 copies/mL at time of delivery. All 40 infants tested (one patient withdrew) were negative for HIV-1 DNA at time of delivery and/or for the first six months after birth. At the end of the investigation: 30% (6/20) of the participants on Reyataz/ritonavir 300/100 mg experienced grades 3 to 4 hyperbilirubinemia.62% (13/21) of the women on Reyataz/ritonavir 400/100 mg experienced grades 3 to 4 hyperbilirubinemia.3 out of 20 infants (15%) born to participants who received 300/100 and 4 of 20 (20%) infants born to women treated with Reyataz/ritonavir 400/100 mg experienced grade 3-4 bilirubin.In the study there was no evidence of acute or chronic bilirubin or severe hyperbilirubinemia (total bilirubin levels greater than 20 mg/dL) among newborns, and no cases of lactic acidosis were observed. Although animal studies show no indication of reproductive toxidity, a moderate amount of data in pregnant women, i.e. between 300-1,000 pregnant outcomes indicate no malformative toxicity of atazanavir, but given that the studies in humans cannot fully rule out the possibility of harm, Reyataz may be only be considered during pregnancy if the potential benefit outweighs the risk.
Important Information about Reyataz (atazanavir sulfate) for pregnant HIV positive women
Second and third trimesters of pregnancy:
Reyataz/ritonavir 300/100 mg might not provide enough exposure to Reyataz, especially if the activity of the whole administration or Reyataz is compromised as a result of drug resistance. Because of inter-patient variability during pregnancy as well as limited available data, Therapeutic Drug Monitoring (TDM) might be considered to ensure sufficient exposure.
Reyataz taken with medicinal products know to reduce exposure, such as H2-receptor antagonists or tenofovir, increase the risk of further decrease in Reyataz exposure. However, if these medications are needed, a dose increase to Reyataz/ritonavir 400/100 mg with TDM might be considered.
Pregnant patients who take both an H2-receptor antagonist and tenofovir are not recommended to use Reyataz with ritonavir.
During postpartum:
After a potential decrease in Reyataz exposure during the second and third trimester, REYATAX exposures may increase during the initial two months following delivery. It is important postpartum patients are closely monitored in order to check for adverse reactions.
Postpartum patients should take the same dose recommended for non-pregnant patients, including those for co-administration of drugs known to affect the exposure of Reyataz.
It is unclear if Reyataz taken during pregnancy will intensify physiological hyperbilirubinaemia and cause kericterus in neomates and infants. Further monitoring should be considered during the prepartum period.
Breast-feeding:
Investigations in rats have shown that that atazanavir is excreted in the milk. As its unknown if atazanavir or atazanavir metabolites are passed into human milk, it is advised that women with HIV not breast-feed their infants in order to avoid HIV transmission.
About Reyataz
Reyataz (atazanavir sulfate) is an antiviral medication used in conjunction with other drugs in order to treat people infected with HIV-1. In Europe, Reyataz was the first once-daily protease inhibitor launched and has proven safety, efficacy and tolerability in HIV treatment-naive and experienced patients. In addition it is the only boosted PI with labeling that allows for co-administration with an oral contraceptive. Reyataz was developed by Bristol-Myers Squibb.
About Pregnancy and HIV
Worldwide, the number of women infected with HIV is rising. In recent years the prevalence of pregnant HIV-positive women in Europe has considerably increased, with a majority diagnosed during antenatal testing. The rate of HIV is increasing as a result of more individuals living with HIV immigrating to Europe. In developing countries, several more pregnant women are living with HIV, and the prevalence, i.e. in parts of Africa, is approximately 30%.
Written by Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our hiv / aids section for the latest news on this subject. Source: Bristol-Myers Squibb Company Please use one of the following formats to cite this article in your essay, paper or report:
MLA
8 Dec. 2011.
Please note: If no author information is provided, the source is cited instead.
Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.
If you write about specific medications or operations, please do not name health care professionals by name.
All opinions are moderated before being included (to stop spam)
Contact Our News Editors
For any corrections of factual information, or to contact the editors please use our feedback form.
Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.
