FDA classification: Antiretroviral toxicity of third agents1

FDA categories

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  1. Adequate and well-controlled studies of pregnant women fail to demonstrate a risk to the fetus
  2. Animal reproduction studies fail to demonstrate a risk to the fetus, and adequate but well-controlled studies of pregnant women have not been conducted
  3. Safety in human pregnancy has not been determined; animal studies are either positive for fetal risk or have not been conducted
  4. Positive evidence of human fetal risk that is based on adverse reaction data from investigational or marketing experiences
  5. Contraindicated

*ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2

1. Public Health Service Task Force Perinatal GL 2009. Available at: http://aidsinfo.nih.gov/contentfiles/PerinatalGL.pdf Accessed March 2011
2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



Antiretroviral pregnancy registry1

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ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2

1. The Antiretroviral Pregnancy Registry Interim report, 1 January 1989 –31 January 2010 (published December 2010). Available at http://www.apregistry.com/forms/interim_report.pdf. Accessed March 2011;
2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



No difference in prevalence of birth defects for infants exposed prenatally to ATV to that of the general population1

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Note: The number of defects represents the number of outcomes with at least 1 defect. An outcome is defined as a live or stillborn infant, or a spontaneous or induced abortion. Excludes reported defects in pregnancy losses <20 weeks.

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ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2

1. Esker S, et al. HIV10 2010. Glasgow, UK. Poster 113; 2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



Preterm delivery and ART (1)

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ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2

1. Sibiude J, et al. 18th CROI 2011. Abstract 743; 2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



Preterm delivery and ART (2)


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MoCHiV, Swiss Mother and Child HIV Cohort Study; SHCS, Swiss HIV Cohort Study. ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk6

Aebi-Popp et al. JPerinatMed 2010;38:353-8;
2. Rudin C, et al. HIV Med 2011;12:228–35;
3. González-Tomé MI, et al. 18th CROI 2011. Abstract 744;



Kesho Bora study: Low toxicity among mothers and children

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ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk3

1. Kesho Bora Study Group,.Lancet Infect Dis.2011;11:171–80;
2. Kesho Bora Study Group. International AIDS Society Conference on HIV Treatment, Pathogenesis and Prevention, Cape Town 2009. Abstract eLBPeC01;
3. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



SQV/r has a favourable safety and tolerability profile1

ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2
1. van der Lugt J, et al. Antivir Ther.2009;14:443–50; 2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



BMS 182 Study: Tolerability profile of ATV/r in mothers1

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aThe proportion of SAEs are based on enrolled subjects; Drug-related SAEs: bAnaemia (n=1); cAnaemia (n=2) and hyperbilirubinemia (n=1); dBased on AE reports not laboratory values; eALT elevation and AST elevation (>5 x ULN) occurred in 0 and 1 (5%) of patients receiving ATV/r 300/100 mg and ATV/r 400/100 mg, respectively; fTotal cholesterol (≥240 mg/dL) occurred in 1/14 (7%) and 3/16 (19%) of patients receiving ATV/r 300/100 mg and ATV/r 400/100 mg, respectively; Fasting lipids were measured at screening and at post-partum Week 4 only; gReported during episode of pre-eclampsia

ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2 1. Hardy H, et al. 1st International Workshop on HIV and Women, 2011. Poster 016;
2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011



BMS 182 Study: Tolerability profile of ATV/r in newborns1

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aDrug-related SAEs: three infants (with mothers on ATV/r 300/100 mg) had SAEs considered related to AZT, overdose, anaemia and restrictive cardiomyopathy; bInfant born at 35 weeks following premature rupture of membranes; maternal bilirubin 2.3 g/dL on day of delivery; birth weight 1.8 kg; infant bilirubin 13 mg/dL on Day 3; received 3 days of phototherapy; discharged well; cValues for Grade 3-4 abnormalities not provided as thresholds vary with age of newborn; dSix infants received phototherapy; eMaximum individual level: 8.5 mg/dL at Day 15

ARVs used during pregnancy should be selected only if potential benefit justifies the potential risk2 1. Hardy H, et al. 1st International Workshop on HIV and Women, 2011. Poster 016; 2. SmPCs. Available at http://www.ema.europa.eu Accessed March 2011