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

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Pharmacoenhancers

Cobicistat (Tybost, COBI)

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Excerpt from Table 8

Note: When using FDC tablets, refer to other sections in Appendix B and Table 8 for information about the dosing and safety of individual drug components of the FDC tablet during pregnancy.

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Cobicistat
(COBI)
Tybost

(ATV/c)
Evotaz

(EVG/c/FTC/TAF)
Genvoya

(DRV/c)
Prezcobix

(EVG/c/FTC/TDF)
Stribild

(DRV/c/FTC/TAF)
Symtuza
COBI (Tybost)
Tablet:
  • COBI 150 mg
ATV/c (Evotaz):
  • ATV 300 mg/COBI 50 mg tablet
EVG/c/FTC/TAF (Genvoya):
  • EVG 150 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg tablet
DRV/c (Prezcobix):
  • DRV 800 mg/COBI 150 mg tablet
EVG/c/FTC/TDF (Stribild):
  • EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg tablet
DRV/c/FTC/TAF (Symtuza):
  • DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg tablet
Standard Adult Doses
COBI (Tybost):
  • When used as an alternative PK booster with ATV or DRV, the dose is one tablet once daily with food
ATV/c (Evotaz):
  • One tablet once daily with food
EVG/c/FTC/TAF (Genvoya):
  • One tablet once daily with food
DRV/c (Prezcobix):
  • One tablet once daily with food
EVG/c/FTC/TDF (Stribild):
  • One tablet once daily with food
DRV/c/FTC/TAF (Symtuza):
  • One tablet once daily with food
Pregnancy
PKs in Pregnancy:
  • Based on limited data, COBI exposure and its pharmaco-enhancing effect on ATV, DRV, and EVG are markedly reduced in pregnancy.
  • When coadministered with COBI, TAF exposure is not significantly different between pregnancy and the postpartum period.
Dosing in Pregnancy:
  • While COBI exposure is markedly reduced during pregnancy, higher-than-standard doses have not been studied. The Panel recommends RTV as the preferred pharmaco-enhancer for PIs and INSTIs during pregnancy until more data are available on COBI activity during pregnancy.
For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., FTC, TAF, TDF, ATV, DRV, EVG).
Low placental transfer to fetus.b

No evidence of human teratogenicity (can rule out two-fold increase in overall birth defects).

Use of COBI-boosted ATV, DRV, or EVG is not recommended in pregnancy.
a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Antiretroviral Guidelines, Appendix B, Table 10).

b Placental transfer categories are determined by mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

Key:
ARV = antiretroviral; ATV/c = atazanavir/cobicistat; COBI = cobicistat; DRV/c = darunavir/cobicistat; EVG/c = elvitegravir/cobicistat; FDC = fixed-dose combination; FTC = emtricitabine; INSTIs = integrase strand transfer inhibitors; PIs = protease inhibitors; PK = pharmacokinetic; RTV = ritonavir; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

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