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FDA: Prezista Label Revised
 
 
  The Prezista (darunavir) label was recently revised:
 

label

To update USE IN SPECIFIC POPULATIONS, Pregnancy subsection
with information from a clinical trial as follows:
 
Data
Human Data
 
PREZISTA/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 34 pregnant women during the second and third trimesters, and postpartum. Seventeen subjects were enrolled in each BID and QD treatment arms. Twenty-seven subjects completed the trial through the postpartum period (6 12 weeks after delivery) and 7 subjects discontinued before trial completion, 5 subjects in the BID arm and 2 subjects in the QD arm.
 
The pharmacokinetic data demonstrate that exposure to darunavir and ritonavir as part of an antiretroviral regimen was lower during pregnancy compared with postpartum (6-12 weeks). Exposure reductions during pregnancy were greater for the once daily regimen as compared to the twice daily regimen [see Clinical Pharmacology (12.3)].
 
Virologic response was preserved. In the BID arm, the proportion of subjects with HIV 1 RNA <50 copies/mL were 35% (6/17) at baseline, 59% (10/17) through the third trimester visit, and 59% (10/17) through the 6-12 week postpartum visit. Virologic outcomes during the third trimester visit showed HIV-1 RNA ≥50 copies/mL for 12% (2/17) of subjects and were missing for 5 subjects (1 subject discontinued prematurely due to virologic failure). In the QD arm, the proportion of subjects with HIV-1 RNA <50 copies/mL were 59% (10/17) at baseline, 82% (14/17) through the third trimester visit, and 82% (14/17) through the 6 12 week postpartum visit. Virologic outcomes during the third trimester visit showed HIV-1 RNA ≥50 copies/mL for none of the subjects and were missing for 3 subjects (1 subject discontinued prematurely due to virologic failure).
 
PREZISTA/ritonavir was well tolerated during pregnancy and postpartum. There were no new clinically relevant safety findings compared with the known safety profile of PREZISTA/ritonavir in HIV-1-infected adults.
 
Among the 29 infants with HIV test results available data, born to the 29 HIV-infected pregnant women who completed trial through delivery or postpartum period, all 29 infants had test results that were negative for HIV-1 at the time of delivery and/or through 16 weeks postpartum. All 29 infants received antiretroviral prophylactic treatment containing zidovudine.

 
 
 
 
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