Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors

Tenofovir Alafenamide (Genvoya, Odefsey, Descovy, TAF)

Last Updated: November 14, 2017; Last Reviewed: November 14, 2017

Tenofovir alafenamide (TAF), an orally bioavailable form of tenofovir, has insufficient data on human use in pregnancy to inform a drug-associated risk determination for birth defects or miscarriage.

Animal Studies

Carcinogenicity
Because TAF is rapidly converted to tenofovir, and tenofovir exposure in rats and mice is lower after TAF administration compared to tenofovir disoproxil fumarate (TDF) administration, carcinogenicity studies were performed with TDF. Long-term oral carcinogenicity studies of tenofovir in mice and rats were carried out at 167 times (mice) and 55 times (rats) tenofovir exposure compared to that seen after TAF administration at recommended doses in humans. In female mice, liver adenomas were increased. In rats, no carcinogenic findings were observed.1,2

Reproduction/Fertility
Reproduction studies have been performed in rats and rabbits at exposures similar to and 53 times higher than human exposure, respectively, and revealed no evidence of impaired fertility or mating performance associated with TAF administration.1-3

Teratogenicity/Adverse Pregnancy Outcomes
No effects on early embryonic development were seen when TAF was administered to male or female rats at 62 times the human therapeutic exposure.1-3

Placental and Breast Milk Passage
Rat studies demonstrated secretion of tenofovir in breast milk after administration of TDF; whether TAF is present in animal milk is unknown.1,3

Human Studies in Pregnancy

Pharmacokinetics
No pharmacokinetic studies of TAF have been reported in pregnant women.

Placental and Breast Milk Passage
No data are available on placental or breast milk passage of TAF in humans.

Teratogenicity/Adverse Pregnancy Outcomes
In the Antiretroviral Pregnancy Registry, only 3 cases of exposures to TAF have been reported so far; therefore, no conclusions can be made about risk of birth defects.4

Excerpt from Table 9a
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Tenofovir Alafenamide
(TAF)
Vemlidyd

(TAF/FTC/EVG/COBI)
Genvoya

(TAF/FTC/RPV)
Odefsey

(TAF/FTC)
Descovy
Vemlidy
  • TAF 25-mg tablet
Genvoya:
  • TAF 10 mg plus FTC 200 mg plus EVG 150 mg plus COBI 150 mg tablet
Odefsey:
  • TAF 25 mg plus FTC 200 mg plus RPV 25-mg tablet
Descovy:
  • TAF 25 mg plus FTC 200-mg tablet
Standard Adult Dose
Vemlidy:
  • 1 tablet once daily with food
Genvoya, Odefsey:
  • 1 tablet once daily with food
Descovy:
  • 1 tablet once daily with or without food
  • Same dose (TAF 25 mg) can be used with or without pharmaco-enhancers

PK in Pregnancy:
  • No PK studies in human pregnancy.

Dosing in Pregnancy:
  • Insufficient data to make dosing recommendation
No data are available on placental transfer of TAF.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats.

Renal function should be monitored because of potential for renal toxicity.
a Individual antiretroviral drug dosages may need to be adjusted in renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 7).
b Placental transfer categories—Mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3
c See Teratogenicity section for discussion of EFV and risks in pregnancy.
d Only indicated for use in chronic hepatitis B virus infection in adults
e Generic formulation available

Key to Acronyms: COBI = cobicistat; EFV = efavirenz; EVG = elvitegravir; FTC = emtricitabine; PK = pharmacokinetic; RPV = rilpivirine; TAF = tenofovir alafenamide

References

  1. Odefsey [package insert]. Food and Drug Administration. 2016. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208351s000lbl.pdf.
  2. Genvoya [package insert]. Food and Drug Administration. 2016. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf.
  3. Descovy [package] insert. Food and Drug Administration. 2016. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf. 2016. Available at
  4. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry international interim report for 1 January 1989 - 1 January 2017. Wilmington, NC: Registry Coordinating Center. 2017. Available at http://APRegistry.com

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