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 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a
Generic Name
(Abbreviation)
Trade Name		 Formulation Dosing Recommendations Use in Pregnancy
Lopinavir/Ritonavir
(LPV/r)
Kaletra

LPV/r (Kaletra) 
Tablets (Coformulated):
  • LPV/r 200 mg/50 mg
  • LPV/r 100 mg/25 mg
Oral Solution:
  • LPV/r 400 mg/100 mg/5 mL
 Standard Adult Dose:
  • 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 (PI-Naive or PI-Experienced Patients):
  • LPV/r 500 mg/125 mg tablets twice daily without regard to meals (use a combination of 2 LPV 200-mg plus RTV 50-mg tablets and 1 LPV 100-mg plus RTV 25-mg tablet), or
  • LPV/r 520 mg/130 mg oral solution (6.5 mL) twice daily with food
PK in Pregnancy:
  • With twice-daily dosing, LPV exposure is reduced in pregnant women receiving standard adult doses; increasing the dose by 50% results in exposure equivalent to that seen in non-pregnant 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.
  • If standard dosing is used, monitor virologic response and, if available, 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 dosages may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 8).
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 to Acronyms: EFV = efavirenz; LPV = lopinavir; LPV/r = lopinavir/ritonavir; NVP = nevirapine; PI = protease inhibitor; PK = pharmacokinetic; RTV = ritonavir

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