2016 Perinatal Treatment Guidelines Update

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1 Mountain West AIDS Education and Training Center 2016 Perinatal Treatment Guidelines Update Shireesha Dhanireddy, MD Associate Professor of Medicine, University of Washington 2 November 2016 This presentation is intended for educational use only, and does not in any way constitute medical consultation or advice related to any specific patient.

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3 Objectives Review updates to pre-conception counseling Review guidelines for use or PrEP peri-conception Review preferred ART regimens in pregnancy Review peri-partum management of HIV+ woman

4 Pre-Conception Counseling Discuss childbearing intentions with all women of childbearing age on an ongoing basis Provide information about contraceptive methods Discuss safe sex practices and offer counseling on cessation of alcohol, tobacco, and other drugs referal to treatment (ie methadone) should be provided Immunize! influenza, penumococcus, Hep B, Tdap (each pregnancy) All women contemplating pregnancy should be on ART and have an undetectable HIV RNA

5 Drug-Drug Interactions Between Contraceptives and ART New data on contraceptive efficacy - Levonorgesterol (jadelle) implants Study of 570 HIV+ women on NVP or LPV/r-based regimens VS EFV-based regimen 0 pregnancies with NVP or LPV/r compared to 15 in EFV group New table on drug interactions between ART and hormonal contraceptives - DTG (and RAL) no additional contraceptive is needed when using any of the hormonal options - Atazanavir increase in estrogren / estradiol AUC, can consider alternative (such as progesterone only if concerned about safety of increased estrogen) - COBI may increase estrogen and progesterone but data lacking - Rilpivirine no change in progesterone, mild increase in estrogen (AUC 14%)

6 Reproductive Options For discordant couples: - HIV+ should be on ART and suppressed before attempting to conceive - PrEP 30 days before and 30 days after for HIV negative partner may be offered especially if HIV+ partner is NOT suppressed Unknown if PrEP offers additional benefit if HIV+ partner suppressed

7 PARTNER Study Multicenter, prospective, observational study 1166 HIV sero-different couples (heterosexual and MSM), HIV+ partner on ART and < 200 copies/ml having condomless sex No cases of within-couple HIV transmission Rodger AJ et al. JAMA 2016;316:

8 ART Initiation in Pregnancy Start ART as early as possible in pregnancy (don t wait for genotype resistance testing results) Counsel patients about intrapartum and postpartum considerations such as mode of delivery, maternal lifelong HIV therapy, postpartum contraception, infant feeding (avoiding breast feeding and premastication of food), infant prophylaxis and testing as well as neonatal circumcision Screening for intimate partner violence Referral of partners for testing and prophlaxis ART does NOT increase of birth defects

9 HHS Perinatal Treatment Guidelines: 2016 Preferred Agents Preferred NRTI ABC/3TC TDF/FTC or TDF/3TC PLUS Preferred PI Atazanavir + ritonavir Darunavir + ritonavir OR Preferred INSTI Raltegravir

10 HHS Perinatal Treatment Guidelines: 2016 Alternative Agents Alternative NRTI ZDV/3TC BID, hematologic toxicity Alternative PI - Lopinavir + ritonavir BID, nausea, drug interactions NNRTI Efavirenz concern for birth defects, drug interactions Rilpivirine not recommended if baseline VL > 100K * ZDV monotherapy no longer recommended

11 HHS Perinatal Treatment Guidelines: 2016 ARVs with Limited or No Data NRTI TAF*; TAF/FTC: No data on use in pregnancy Booster COBI: Limited data INSTI EVG/COBI: Limited data DTG: Limited data * No evidence of teratogenicity in rats (insufficient data in humans)

12 What about TAF? No data on placental transfer of TAF No evidence of teratogenicity in rats (insufficient data in humans)

13 HIV/HBV Co-Infection in Pregnancy Use medication active against HBV: ie TDF/ FTC Continue through pregnancy and indefinitely after Every 12 week HBV DNA level testing Infant should receive HBV immune globulin and 1 st dose of HBV vaccine within 12 hours of birth

14 Peripartum Management & Antiretroviral Therapy Women on ART with < 1000 copies/ml no increase in perinatal transmission with duration of ruptured membranes à vaginal delivery is recommended Artificial rupture of membranes okay

15 Infant ART Prophylaxis 4-week ZDV for full-term infants when mother is on ART and suppressed 6-week course of ART with higher risk Mother received no ART or intrapartum ART only Mother without sustained virologic suppression No consensus on specific regimen 6 weeks ZDV + 3 doses of NVP during 1 st week of life (NICHD-HPTN/PACTG) 3-drug regimen: ZDV (6 weeks) + 3TC + NVP (6mg/ kg bid duration 2 weeks vs 6 weeks)

16 Question A 32 year old woman presents after missed menses and home pregnancy test is positive. You confirm pregnancy. Estimated gestational age by LMP is 10 weeks. She is currently suppressed on EVG/COBI/ FTC/TDF. Based on the perinatal guidelines for ART use in pregnancy you advised her to: 1. Change her ART regimen to a preferred regimen in pregnancy 2. Continue current regimen

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