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Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide Pregnancy and Breastfeeding Warnings

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide is also known as: Genvoya

Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: B Comments: -A pregnancy exposure registry is available. -Use of effective contraception during therapy has been recommended.

Animal studies have failed to reveal evidence of teratogenicity, embryolethality, embryofetal toxicity, or an effect on reproductive function. Data in pregnant women (between 300 to 1000 outcomes) showed no malformations, fetotoxicity, or neonatal toxicity with emtricitabine and tenofovir disoproxil fumarate (DF). There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com Insufficient first-trimester exposures to cobicistat and elvitegravir have been monitored in the APR to determine birth defect risk. The APR has received prospective reports of over 2900 exposures to emtricitabine-containing regimens (over 1900 exposed in the first trimester; over 900 exposed in the second/third trimester) and over 3800 exposures to tenofovir DF-containing regimens (over 2600 exposed in the first trimester; over 1200 exposed in the second/third trimester) resulting in live births; there was no difference between emtricitabine or tenofovir DF and overall birth defects compared with the background birth defect rate of 2.7% in the reference population. The prevalence of defects in the first trimester was 2.4% for emtricitabine and 2.3% for tenofovir DF. The prevalence of defects in the second/third trimester was 2.1% for emtricitabine and 2.1% for tenofovir DF. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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Cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide Breastfeeding Warnings

EMTRICITABINE: Samples of breast milk obtained from 5 HIV-1-infected women show that emtricitabine is secreted in human milk. Average peak and trough drug levels in breast milk were 679 and 177 mcg/L, respectively. An exclusively breastfed infant would receive about 2% of the proposed emtricitabine dose for infants (estimated). Breastfeeding infants whose mothers are treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. TENOFOVIR DF: Samples of breast milk obtained from 5 HIV-1-infected mothers show that tenofovir is secreted in human milk. Average peak and trough drug levels in breast milk were 14.1 and 6.8 mcg/L, respectively. An exclusively breastfed infant would receive about 0.03% of the proposed tenofovir dose for infants (estimated) and attain trivial infant serum levels. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. In a multicenter study, a single 600 or 900 mg tenofovir dose was administered to mothers during labor; samples of breast milk were collected at various times postpartum. In 75% of samples obtained from 25 mothers during the first 2 days postpartum, tenofovir was detected (greater than 2.5 mcg/L); levels ranged from 6.3 to 17.8 mcg/L. Only 1 of 21 milk samples had detectable tenofovir level (15.7 mcg/L) at 4 to 6 days postpartum. Tenofovir (dose not provided; presumed 300 mg/day), lamivudine, and efavirenz were administered daily (between 6 and 8 PM) for prevention of mother-to-child HIV transmission. At 1 month postpartum, milk samples were collected in the morning from 33 women; tenofovir level was 5 mcg/L (interquartile range [IQR]: 0 to 6.1 mcg/L). At 12 months postpartum, milk samples were collected in the morning from 47 women; tenofovir level was 2.5 mcg/L (IQR: 0 to 5.5 mcg/L). Blood samples were obtained from 25 of their breastfed infants; the morning infant plasma level of tenofovir at 6 and 12 months of age was 24 mcg/L (IQR: 0 to 51.6 mcg/L) and 0 mcg/L, respectively. Serum tenofovir levels were measured in 5 infants exclusively breastfed by 4 mothers using tenofovir 245 mg daily; infant age averaged 1.8 months. In 4 infants, serum tenofovir was undetectable (less than 0.005 mg/L); in 1 infant, the serum tenofovir was 0.0055 mg/L. At 4 months of age, no adverse outcomes (on standard developmental parameters) were observed in 2 of the infants exclusively breastfed for 3 months.

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred. Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: -Excreted into human milk: Yes (emtricitabine); Unknown (cobicistat, elvitegravir, tenofovir alafenamide) -Excreted into animal milk: Yes (cobicistat, elvitegravir, tenofovir) Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF): -Excreted into human milk: Yes (emtricitabine, tenofovir); Unknown (cobicistat, elvitegravir) -Excreted into animal milk: Yes (cobicistat, elvitegravir) Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.

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References for pregnancy information

  1. "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/perin" ([2016, Apr 29]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/perin" ([2016, Apr 29]):

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