skip navigation

Skip Nav

Clinical Guidelines Portal

Clinical Guidelines Portal

Table of Contents

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

Entry Inhibitors

Maraviroc (Selzentry, MVC)

(Last updated: August 6, 2015; last reviewed: August 6, 2015)

Maraviroc is classified as Food and Drug Administration Pregnancy Category B.

Animal Studies 

Maraviroc was neither mutagenic nor clastogenic in a series of in vitro and animal in vivo screening tests. Long-term animal carcinogenicity studies of maraviroc showed no drug-related increases in tumor incidence.

Reproductive toxicity has been evaluated in rats and rabbits. Maraviroc produced no adverse effects on fertility of male or female rats at doses with exposures (area under the curve [AUC]) up to 20-fold higher than in humans given the recommended 300-mg, twice-daily dose. 

Teratogenicity/Developmental Toxicity
The incidence of fetal variations and malformations was not increased in embryo-fetal toxicity studies in rats at AUC approximately 20-fold higher (and in rabbits at approximately 5-fold higher) than human exposures at the recommended 300-mg, twice-daily dose (up to 1000 mg/kg/day in rats and 75 mg/kg/day in rabbits).

Placental and Breast Milk Passage
Minimal placental passage was demonstrated in a study of single-dose maraviroc in rhesus macaques that showed poor placental transfer and rapid clearance from infant monkeys’ blood.2 Studies in lactating rats indicate that maraviroc is extensively secreted into rat milk. 

Human Studies in Pregnancy 

Data on the use of maraviroc in human pregnancy are limited to a small pharmacokinetic study that found exposure to maraviroc was 21% lower during the third trimester than postpartum.

Placental and Breast Milk Passage
An ex vivo human placental cotyledon perfusion model demonstrated minimal placental passage of maraviroc.4 In a study in humans of six mother/infant pairs, the median ratio of cord blood-to-maternal-plasma drug concentrations was 0.33 (0.03–0.56).3 Whether maraviroc is secreted into human milk is unknown.

Teratogenicity/Developmental Toxicity
In the Antiretroviral Pregnancy Registry, insufficient numbers of first-trimester exposures to maraviroc in humans have been monitored to be able to make a risk determination.5,6


Excerpt from Table 7a
Generic Name
Trade Name
Formulation  Dosing Recommendations Use in Pregnancy

  • 150 mg
  • 300 mg
Standard Adult Dose:
  • 300 mg twice daily with or without food
  • Maraviroc must be used in combination with other ARVs in HIV-1-infected adults with only CCR5-tropic virus.
Dose Adjustments:
  • Increase to 600 mg BID when used with potent CYP3A inducers: EFV, ETR, and rifampin.
  • Decrease to 150 mg BID when used with CYP3A inhibitors: all PIs except tipranavir/ritonavir, itraconazole.
PK in Pregnancy:
  • No PK studies in human pregnancy
Dosing in Pregnancy:
  • Insufficient data to make dosing recommendation. 
No evidence of teratogenicity in rats or rabbits.

a Individual antiretroviral drug dosages may need to be adjusted in renal or hepatic insufficiency (for details, see Adult Guidelines, Appendix B, Table 7).

Key to Abbreviations: ARV = antiretroviral; BID = twice daily; MVC = maraviroc; PI = protease inhibitor; PK = pharmacokinetic


  1. Maraviron (Selzentry [package insert]. Food and Drug Administration. 2014. Available at Accessed July 10, 2015. 
  2. Winters MA, Van Rompay KK, Kashuba AD, Shulman NS, Holodniy M. Maternal-fetal pharmacokinetics and dynamics of a single intrapartum dose of maraviroc in rhesus macaques. Antimicrob Agents Chemother. 2010;54(10):4059-4063. Available at
  3. Colbers A, Best B, et al. A comparison of the pharmacokinetics of maraviroc during pregnancy and postpartum. Abstract 931. Presented at: 20th Conference on Retroviruses and Opportunistic Infections. 2013. Atlanta, GA.
  4. Vinot C, Gavard L, Treluyer JM, et al. Placental transfer of maraviroc in an ex vivo human cotyledon perfusion model and influence of ABC transporter expression. Antimicrob Agents Chemother. 2013;57(3):1415-1420. Available at
  5. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry international interim report for 1 Jan 1989–31 July 2014. Wilmington, NC: Registry Coordinating Center. 2014. Available at
  6. Floridia M, Mastroiacovo P, Tamburrini E, et al. Birth defects in a national cohort of pregnant women with HIV infection in Italy, 2001-2011. BJOG. 2013;120(12):1466-1475. Available at

Back to Top