Title:HIV Infection and Pregnancy Managing Mother and Baby
Description:
Breastfeeding and HIV Infection. Women with HIV infection in the U.S. should not breastfeed ... Husband has AIDS. This is a planned pregnancy. ... – PowerPoint PPT presentation
Maternal Viral Load (VL) ZDV Treatment and the Risk of Perinatal HIV Transmission
Correlation between high maternal VL and transmission
Transmission observed at every VL level including undetectable levels
No HIV RNA threshold below which there was no risk of transmission
ZDV decreases transmission regardless of HIV RNA level
Recommendation Initiate maternal ZDV regardless of plasma HIV RNA or CD4 counts
23 What have we learned
Interrupting Perinatal HIV Transmission
Study Results
24
ACTG 076
A phase III randomized placebo-controlled trial of zidovudine (ZDV) for the prevention of maternal-fetal HIV transmission
Treatment Regimen
Antepartum 100 mg ZDV po 5x day started at 14 34 weeks gestation
IntrapartumDuring labor 1- hour initial dose 2 mg/kg IV followed by continuous infusion of 1 mg/kg until delivery
Postpartum/Infant Regimen2 mg/kg po q 6 hr for 6 weeks to start 8 12 hours after birth
25 Results of ACTG 076 30 This represents a 66 reduction in risk for transmission (P lt0.001) Efficacy was observed in all subgroups 20 22.6 Transmission Rate () 10 7.6 ZDV Group Placebo 26
Follow-up of Uninfected Infants in ACTG 076 ZDV versus Placebo
No significant difference in growth
No difference in CD4 and CD8 counts between groups
No other safety abnormalities have been identified
No differences in Bayley developmental scores in uninfected infants in ACTG 219
Follow-up of infants with exposure to nucleoside analogues is ongoing due to the potential for mitochondrial toxicity
In the U.S. no cases of mitochondrial toxicity have been identified
27
Follow-Up of Women in ACTG 076
Median follow-up 4.2 years
No substantial differences in CD4 count time to progression to AIDS or death in women who received ZDV compared to those who received placebo
28
Reducing Intrapartum HIV Transmission
Studies of Short Course Therapy
Oral ZDV in a non-breastfeeding population (Thailand) from 36 weeks and during labor
Transmission rate 9.4 ZDV vs 18.9 placebo
Petra study intrapartum/postpartum oral ZDV/3TC in a breast-feeding population (Uganda S. AfricaTanzania)
Transmission rate 10 ZDV/3TC vs 17 placebo
HIVNet 012 intrapartum/postpartum/neonatal nevirapine (NVP) vs short course/neonatal ZDV in a breast-feeding population (Uganda)
Transmission rate 12 NVP vs 21 ZDV
29
Reducing HIV Transmission with
Suboptimal Regimens
Partial ZDV regimens (New York cohort)
Transmission rates
6.1 with prenatal intrapartum and infant ZDV
10 with only intrapartum ZDV
9.3 if only infant ZDV started within first 48 hours
26.6 with no ZDV
30 Treating Women with HIV Infection in Pregnancy
31
Goals of Antiretroviral Therapy
To prolong life and improve quality of life
To suppress HIV to below the limits of detection or as low as possible for as long as possible
To preserve or restore immune function
32
When Should an Adult be Treated
Clinical Category CD4 count HIV RNA Recommendations Symptomatic Asymptomatic Asymptomatic Any value CD4 T cells lt200/mm3 HIV RNA any value CD4 T cells gt200/mm3 but lt350 /mm3 HIV RNA any value CD4 T cells gt350/mm3 HIV RNA gt30000 (bDNA) or gt55000 (RT-PCR) CD4 T cells gt350/mm3 HIV RNA lt30000(bDNA) or lt55000 (RT-PCR) Treat Treat Offer treatment if pt willing to accept Some experts would treat Many experts would delay therapy observe 33
Guidelines for Care of All Pregnant Women with HIV Infection
Provide standard clinical evaluation HIV disease stage
Provide standard immunologic evaluation absolute CD4 CD4
Provide standard virologic evaluation HIV-RNA copy number (viral load)
Discuss known or unknown risks/benefits of therapy during pregnancy
Develop strategy for long term evaluation and management of mother/infant
34
Guidelines for Antiretroviral Drugs in Pregnancy Concepts
Use optimal ARV for the womans health
Add ZDV regimen for reducing perinatal HIV transmission
Discuss preventable risk factors for perinatal transmission
Counsel on cesarean delivery
Support decision-making by woman following discussion of known and unknown benefits and risks
Acceptance or refusal of ARV or ZDV should not result in denial of care or punitive action
35
Guidelines for Antiretroviral Drugs in Pregnancy Clinical Scenario 1
Women without prior antiretroviral therapy
Recommend
Standard combination therapy for women with high viral load low CD4 count
Combination therapy for women with viral load 1000 regardless of clinical or immunologic status
3-part ZDV regimen to reduce perinatal transmission for all HIV-infected pregnant women regardless of antenatal viral load
Consider delaying therapy until completion of first trimester
Offer scheduled cesarean delivery for women with viral loads gt1000 (based on most recent VL results)
36
Clinical Scenario 2
Women currently on antiretroviral therapy
Discuss benefits and potential risks of her current regimen during pregnancy
Add or substitute ZDV at 14 weeks
Recommend intrapartum and neonatal ZDV
Discontinue teratogenic drugs
Consider continuing or stopping current therapy based on gestational age (lt14 weeks)
If therapy is stopped stop and restart all ARV simultaneously
Resistance testing for suboptimal viral suppression or failure
37
Clinical Scenario 3
Women with HIV infection and present in labor with no previous treatment
Discuss benefits of treatment during intrapartum and neonatal period
Four treatment options
Single dose nevirapine for mother at onset of labor followed by single dose of nevirapine for the newborn at age 4872 hrs
Oral ZDV/3TC for mother during labor followed by one week oral ZDV/3TC to the newborn
Intrapartum IV ZDV followed by six weeks ZDV for the newborn
The two-dose nevirapine regimen as above combined with intrapartum IV ZDV and six week ZDV for the newborn
38
Clinical Scenario 4
Infant whose mother did not receive prenatal or intrapartum ZDV
Offer the six-week neonatal ZDV component
Initiate therapy as soon as possible after maternal consent (preferably within 6 12 hours of birth)
Begin diagnostic testing of the infant
Refer to pediatric HIV specialist for long-term care
39
Assessment of the Pregnant Woman with HIV Infection
Initial Assessment Desires Antiretroviral Therapy Yes No Treat according to clinical immunologic status Monitor for HIV disease progression Recommend ZDV Recommend combination therapy if VL gt1000 Discuss C/S Wants to perinatal transmission 40
Follow-Up Assessment of Pregnant Woman with HIV
4 weeks after initiation of treatment then q 3 months if viral load stable
Fetal assessment based on gestational age
CD4 and viral load response
New onset of symptoms
Side effects or toxicities
Adherence to therapy
Long-range planning for continuity of medical care
41
Changing HIV Therapy During Pregnancy
Poor CD4 response
Drugs with potential teratogenicity
Poor viral load response
Poor adherence to regimen
Evidence of viral resistance
42
Cesarean Section to Reduce Perinatal HIV Transmission
Pregnant women with VL gt1000 should be counseled re potential benefit of scheduled C/S to reduce perinatal transmission
Unknown whether scheduled C/S offers any benefit to women on HAART with low or undetectable VL given the low transmission rate
Complications of C/S similar to HIV uninfected women
Patients decision should be respected and honored
43
Preterm Labor and the Use of Combination Antiretroviral Therapy
A Swiss study reported a possible association between combination ARV therapy and preterm births
Preliminary review of U.S. cohorts has not supported the association
Patients should be educated and cautioned about signs of preterm labor
44
Antiretroviral Pregnancy Registry
A collaborative project managed by PharmaResearch Corporation on behalf of an advisory committee (specialists in OB/Gyn ID teratology epidemiology and CDC and NIH members) and sponsored by
Abbott Laboratories Agouron Pharmaceuticals Inc. Boehringer Ingelheim Company Bristol-Myers Squibb Co. DuPont Pharmaceuticals Company GlaxoSmithKline F. Hoffmann-LaRoche Ltd. Merck Co. Inc.
Purpose To assess safety of antiretroviral drugs during pregnancy
Telephone (800) 258-4263 Fax (800) 800-1052
45
Comprehensive Care of Women Postpartum
Primary and HIV specialty care
Ob/gyn and family planning services
Mental health and substance abuse treatment as needed
Coordination of care through case management for the woman and her family
Support services for the family
46
Evaluation and Follow up of Infants
HIV diagnostic testing to establish or rule-out HIV infection as early as possible
Referral to an HIV specialist
PCP prophylaxis initiated at 6 weeks of age
Long-term follow-up of HIV- and ARV-exposed infants
Support services for the family
47 Case Studies 48 Case Study 1
Angela 41 y.o. first prenatal visit approximately 19 weeks gestation tested HIV 2 months ago. CD4 725 HIV-1 RNA 600 copies/ml. This is her 4th pregnancy she has no children.
What recommendations for antiretroviral therapy apply in this case
What questions will you ask what options to present
What OB condition may complicate this case
Follow-up after delivery for the woman and infant
49 Case Study 2
Maria 27 y.o. at 35 weeks gestation requested HIV test. Former boyfriend died of AIDS. Test is positive CD4 350 HIV-1 RNA 120000 husband and child test negative. Refuses ZDV. It made my boyfriend worse. Wants the cocktail that Magic Johnson uses.
What are the recommendations for this woman
Psychological issues Related to community beliefs
What counseling will you do
50 Case Study 3
Ellen 32 y.o. 9 10 weeks gestation tested positive on voluntary prenatal screening. A former heroin user she is now on methadone. CD4 198. HIV-1 RNA is 100000. Under stress. Wants HAART therapy and aC-section. Wants to know what else she can do to stay well. Heard that ritonavir is a good drug.
What are the recommendations for this woman
Screening for other infectious complications
Options for reducing perinatal transmission
What management issues does this case present
51 Case Study 4
Heather 14 weeks gestation HIV for 5 years stage B2 (mild dysplasia) CD4 220 HIV-1 RNA is 5000. Shes on ZDV ddI and nelfinavir. Shes anemic. Husband has AIDS. This is a planned pregnancy. Office staff feel this couple is irresponsible for having a baby.
What are the recommendations for this woman
What information does this couple need
What are other options for this woman Should she be referred
How are you going to deal with the office staff
52 Case Study 5
Joan G8P3222 HIV for 3 years admitted with ruptured membranes. No prenatal care. Lost 2 children to HIV. Urine for cocaine GB strep (urine cervix) other STDs negative. CD4 845.
What are the recommendations for this mother and infant
How will you present the 076 regimen to this woman
What alternative therapies can she choose to decrease perinatal transmission
What should follow-up care include
53 Case Study 6
Twelve hours after the birth of her infant Angela Gs HIV test comes back positive. She tested negative early in her pregnancy but the test was repeated on admission to L D because she reported that her husband was back to using IV drugs. She did not have any antenatal or intrapartum antiretroviral therapy.
What are the recommendations for this mother and infant
How will you present the 076 regimen to this woman and what are the options
What follow-up care is needed for Angela and her baby
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