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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Protease Inhibitors

Lopinavir/Ritonavir (Kaletra, LPV/r)

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
Lopinavir/Ritonavir
(LPV/r)
Kaletra
LPV/r (Kaletra)
Tablets:
  • LPV/r 200 mg/50 mg
  • LPV/r 100 mg/25 mg
Oral Solution:
  • Each 5 mL contains LPV/r 400 mg/100 mg
Standard Adult Doses:
  • LPV/r 400 mg/100 mg twice daily, or
  • LPV/r 800 mg/200 mg once daily
Tablets:
  • Take without regard to food.
Oral Solution:
  • Take with food.
With EFV or NVP in PI-Naive or PI-Experienced Patients:
  • LPV/r 500 mg/125 mg tablets twice daily without regard to meals (use a combination of two LPV/r 200 mg/50 mg tablets and one LPV/r 100 mg/25 mg tablet), or
  • LPV/r 520 mg/130 mg oral solution (6.5 mL) twice daily with food

Pregnancy

PKs in Pregnancy:
  • With twice-daily dosing, LPV exposure is reduced in pregnant women who receive standard adult doses; increasing the dose by 50% results in exposure equivalent to that seen in nonpregnant adults receiving standard doses.
  • No PK data are available for once-daily dosing in pregnancy.
Dosing in Pregnancy:
  • Once-daily dosing is not recommended during pregnancy.
  • Some experts recommend that an increased dose (i.e., LPV/r 600 mg/150 mg twice daily without regard to meals or LPV/r 500 mg/125 mg twice daily without regard to meals) should be used in the second and third trimesters, especially in PI-experienced pregnant women and women who start treatment during pregnancy with a baseline viral load >50 copies/mL.
  • When standard dosing is used, monitor virologic response and, if possible, LPV drug levels.
Low placental transfer to fetus.b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects).

Oral solution contains 42% alcohol and 15% propylene glycol and is not recommended for use in pregnancy.

Once-daily LPV/r dosing is not recommended during 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: EFV = efavirenz; FDC = fixed-dose combination; LPV = lopinavir; LPV/r = lopinavir/ritonavir; NVP = nevirapine; PI = protease inhibitor; PK = pharmacokinetic; RTV = ritonavir

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