What’s New in the Perinatal Guidelines Updates from July 31, 2012

Lesson Learned from Clinical Trials Breast-feeding and Nutrition (BAN) study Postpartum maternal triple-drug prophylaxis vs infant NVP in women with CD4 cell counts ≥250 cells/µL Arm 1 (control): Maternal ZDV/3TC for 1 week; infant sdNVP + ZDV/3TC for 1 week Arm 2: Control as above, then Maternal ZDV/3TC/LPV/r for 6 months Arm 3: Control as above, then Infant NVP for 6 months Results No significant difference between maternal triple-drug prophylaxis (Arm 2) and infant NVP (Arm 3) at 28 and 48 weeks August 2012 www.aidsetc.org

Preconception Counseling (1) Contraception Updated information on hormonal contraceptive interactions with ARVs Reproductive options for serodiscordant couples Use of ART is recommended for the HIV-infected partner, with maximal viral suppression achieved prior to attempting conception For CD4 counts ≤550 cells/µL (AI) For CD4 counts >550 cells/µL (BIII) August 2012 www.aidsetc.org

Preconception Counseling (2) Preexposure prophylaxis (PrEP) Recommendations Periconception administration of ARV PrEP may offer an additional tool to reduce the risk of sexual transmission. (CIII) The utility of PrEP of the uninfected partner when the infected partner is receiving ART has not been studied. Discussion on PrEP includes information on: Studies Counseling Laboratory testing Monitoring individuals on PrEP August 2012 www.aidsetc.org

Antepartum Care Initial assessment of HIV-infected pregnant women should include: Screening for hepatitis C and tuberculosis infection A history of side effects or toxicities from prior ARV regimens Use of effective ART to reduce transmission to uninfected partners Discussion of HPTN 052 trial August 2012 www.aidsetc.org

Antiretroviral Drugs during Pregnancy Modified drug categories: Preferred Alternative Use in special circumstances Drugs that have changed categorization: Didanosine and stavudine Use in special circumstances owing to toxicity concerns Atazanavir Preferred owing to increased information on safety Darunavir Alternative PI for use in ARV-naive pregnant women Raltegravir Use in special circumstances when preferred or alternative agents cannot be used August 2012 www.aidsetc.org

HIV-Infected Pregnant Women Who Are ARV Naive The decision to initiate an ARV drug regimen in the 1st trimester or after 12 weeks’ gestation depends on (AIII) CD4 cell count HIV RNA levels Maternal conditions Earlier initiation of ARV combination therapy may be more effective in reducing transmission but risks and benefits must be weighed August 2012 www.aidsetc.org

HIV-Infected Pregnant Women Receiving ARV Therapy Women receiving efavirenz as part of an effective ART regimen may continue it during pregnancy (CIII) The risk of neural tube defects is limited to the first 5-6 weeks of pregnancy Most pregnancies are not recognized before 4-6 weeks ARV changes can lead to loss of viral control and increased risk of perinatal transmission August 2012 www.aidsetc.org

Failure of Viral Suppression Discussion of the use of raltegravir in late pregnancy for women with high viral loads Efficacy and safety of this approach has not been evaluated Concerns that the addition of a single agent to a failing regimen may: Increase resistance Decrease future effectiveness August 2012 www.aidsetc.org

ARVs and Pregnancy Outcome Guidelines include a table of studies assessing the association between ART and preterm delivery See Table 7 August 2012 www.aidsetc.org

Intrapartum Care IV zidovudine is no longer required for HIV-infected women receiving combination ARV regimens who have HIV RNA <400 copies/mL near time of delivery (BII) HIV-infected women with HIV RNA ≥400 copies/mL (or unknown) near time of delivery should be administered IV zidovudine during labor regardless of mode of delivery (AI) IV is the recommended route of zidovudine administration Oral administration may be considered if IV is not possible August 2012 www.aidsetc.org

Postpartum Care Neonatal dosing recommendations for Zidovudine Nevirapine Neonatal prophylaxis regimens Discussion on the NICHD-HPTN 040 study Concerns about lopinavir/ritonavir in neonates Pharmacokinetic data on nevirapine in preterm infants August 2012 www.aidsetc.org

Postpartum Care (2) Management of the HIV-exposed infant Infants receiving zidovudine/lamivudine-containing prophylaxis (AI) Higher risk of hematological toxicity (vs zidovudine alone) Recheck hemoglobin and neutrophil counts at 4 weeks after initiation of prophylaxis Health care providers should routinely inquire about premastication of food fed to infants, instruct HIV-infected caregivers to avoid this practice, and advise on safer feeding options (AII) August 2012 www.aidsetc.org