pediatric hiv treatment guidelines update
DESCRIPTION
Pediatric HIV Treatment Guidelines Update. Ana M. Puga, MD Comprehensive Family AIDS Program Children’s Diagnostic & Treatment Center Fort Lauderdale, FL Faculty, Florida/Caribbean AETC. Disclosures of Financial Relationships. - PowerPoint PPT PresentationTRANSCRIPT
Pediatric HIV Treatment Guidelines Update
Ana M. Puga, MD
Comprehensive Family AIDS Program
Children’s Diagnostic & Treatment Center
Fort Lauderdale, FL
Faculty, Florida/Caribbean AETC
Disclosures of Financial Relationships
This speaker has the following significant financial relationships with commercial entities to disclose:•Speaker’s Bureau: Abbott, Boehringer-Ingelheim, Gilead
This speaker will discuss off-label use or investigational product during the program:•Unlabeled use of drugs in pediatrics if pertinent to discussion for all ARVs
This slide set has been peer-reviewed to ensure that there are no conflicts of interest represented in the presentation.
Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
• August 16, 2010 guidelines updated August 11, 2011
• For full set of guidelines, visit the AIDSinfo website at http://aidsinfo.nih.gov/guidelines
What’s New in the Pediatric Guidelines?
• When to Start Antiretroviral Therapy (ART)– Recommendations for naïve infants
< 12 months and those older than 1 year
• What to Start; pediatric trial updates
• Monitoring updates for blips and lab evaluations
• Toxicity management table updated
What’s New in the Pediatric Guidelines?
• Treatment Failure with focus on adherence assessment/management
• Resistance Testing section expanded
• Pediatric Antiretroviral Drug Information section reorganized and updated
At what ages should an exposed infant be tested for HIV?
A. Birth, 1m, 2m, 3m
B. 2m, 4m, 6m, 18m
C. 14 days, 1m, 4m
D. Birth, 1m 4m, 6m
E. Birth, 14 days, 3m, 6m
A. B. C. D. E.
0% 0% 0%0%0%
ART Initiation: Infants <12 Months
• Youngest children are at high risk of rapid disease progression.
• Clinical and laboratory markers are poor indicators of risk of rapid progression in infants.
• RCT and observational data suggest early ART reduces risk of HIV progression and death.
• Limited information on appropriate ARV dosing.
August 2011 AETC National Resource Center, www.aidsetc.org
Indications for Initiation of ART in Children <12 Months of Age
Criteria Recommendation
Treat all, regardless of clinical symptoms, immune status, or viral load
Assess and discuss issues associated with adherence before therapy is initiated (AIII)
Treat (AII)
August 2011 AETC National Resource Center, www.aidsetc.org
ART: Age ≥12 Months
• Children with AIDS or significant symptoms are at high risk of disease progression and death; in them, treatment should be initiated regardless of immunologic or virologic status (AI)
August 2011 AETC National Resource Center, www.aidsetc.org
ART: Age ≥12 Months (2)
• Asymptomatic or mildly symptomatic children are at lower risk of disease progression; CD4 count and VL may be useful in determining need for ART.
• Younger age at initiation of therapy has been associated with improved immune response and rapid growth reconstitution.
• Higher CD4 count or % is associated with better immune response to ART.
August 2011 AETC National Resource Center, www.aidsetc.org
ART: Age ≥12 Months (3)
• For asymptomatic children, ART now recommended at higher CD4 count or %, though few data available to define optimal CD4 threshold for starting ART.
• At lower CD4 levels, recommendation to treat is stronger (and supporting data are more substantial)
August 2011 AETC National Resource Center, www.aidsetc.org
ART: Age ≥12 Months (4)
• Factors to consider in deciding when to initiate therapy in asymptomatic children >12 mos
– Increasing HIV RNA levels (e.g., approaching 100,000 copies/mL)
– CD4 count or percentage values approaching age-related threshold for treatment
– Development of clinical symptoms
– Ability of caregiver and child to adhere to regimen
August 2011 AETC National Resource Center, www.aidsetc.org
At what age can you use the CD4 cut off used for adults to start HAART in
asymptomatic children?
A. 6
B. 5
C. 12
D. 4
E. 13
A. B. C. D. E.
0% 0% 0%0%0%
What is the CD4 cut off used in adults?
A. 350
B. 200
C. 500
D. 450
E. 600
A. B. C. D. E.
0% 0% 0%0%0%
Indications for Initiation of ART in Children ≥1 - <5 Years of Age
Criteria Recommendation
AIDS or significant HIV-related symptoms (Clinical
Category C or most Clinical Category B
conditions) regardless of CD4 percentage/count
or plasma HIV RNA level
Treat (AI*)
CD4 <25% regardless of symptoms or HIV RNA Treat (AII*)
Asymptomatic or mild symptoms plasma RNA ≥100,000 copies/mL regardless of CD4 percentage/count
Treat (BII)
Asymptomatic or have mild symptoms with a plasma RNA <100,000 copies/mL and CD4 percentage >25%
Consider treatment
(CIII)
August 2011 AETC National Resource Center, www.aidsetc.org
Indications for Initiation of ART in Children >5 Years of Age
Criteria Recommendation
AIDS or significant HIV-related symptoms (Clinical Category C or most Clinical Category B conditions) regardless of CD4 percentage/count or plasma HIV RNA level
Treat (AI)
CD4 ≤500, regardless of symptoms or HIV RNA Treat
(AI forCD4 count <350 and BII*
for CD4 count 350–500)
Asymptomatic or have mild symptoms with a plasma RNA ≥100,000 copies/mL regardless of CD4 percentage/count
Treat (BII)
Asymptomatic or have mild symptoms with a plasma RNA <100,000 copies/mL and CD4 percentage >25%
Consider treatment
(CIII)
August 2011 AETC National Resource Center, www.aidsetc.org
Initial Combination Therapyfor ARV-Naïve Children
• Initial therapy should include at least 3 ARVs, from at least 2 drug classes, to include:– Either an NNRTI or a PI (boosted or
unboosted), plus
– A dual-NRTI backbone (AI)
August 2011 AETC National Resource Center, www.aidsetc.org
Which ARV was most recently FDA approved for children?
A. Rilpivirine
B. Efavirenz
C. Raltegravir
D. Etravirine
E. Tenofovir
A. B. C. D. E.
0% 0% 0%0%0%
Current ARV MedicationsNRTI Abacavir (ABC) Didanosine (ddI) Emtricitabine (FTC) Lamivudine (3TC) Stavudine (d4T) Tenofovir (TDF) Zidovudine (AZT,
ZDV)
NNRTI Efavirenz (EFV) Etravirine (ETR) Nevirapine (NVP) Rilpivirine (RPV)
PI Atazanavir (ATV) Darunavir (DRV) Fosamprenavir (FPV) Indinavir (IDV) Lopinavir (LPV) Nelfinavir (NFV) Ritonavir (RTV, /r) Saquinavir (SQV) Tipranavir (TPV)
Fusion Inhibitor Enfuvirtide (ENF, T-20)
CCR5 Antagonist Maraviroc (MVC)
Integrase Inhibitor Raltegravir (RAL)
= FDA approved for pediatric treatment
August 2011 AETC National Resource Center, www.aidsetc.org
NNRTI-Based Regimens
Advantages
• Lower risk of dyslipidemia and fat maldistribution than seen with PIs
• PI sparing• More palatable • Lower pill burden
Disadvantages
• Risk of virologic failure if exposed to single-dose NVP as part of PMTCT
• Single mutation can confer high-level resistance; cross-resistance between EFV and NVP
• Risk of serious or life-threatening rash and hepatitis (rare)
• Potential for multiple drug interactions
August 2011 AETC National Resource Center, www.aidsetc.org
PI-Based Regimens
Advantages• NNRTI-sparing
• Efficacy well documented
• Resistance requires multiple mutations
• Targets HIV at 2 steps of viral replication
Disadvantages
• Metabolic complications
• Potential for multiple drug interactions
• Higher pill burden
• Poor palatability of liquid formulations
August 2011 AETC National Resource Center, www.aidsetc.org
Initial Treatment: Preferred Regimens
1 LPV/r should not be given to neonates before a postmenstrual age (first day of the mother’s last menstrual period to birth plus time elapsed after birth) of 42 weeks and a postnatal age of at least 14 days.
² EFV is currently available only in capsule and tablet form and should be used only in children age >3 years who weigh >10 kg. Not recommended for adolescent females who are sexually active and may become pregnant unless adequate contraception can be ensured.
Children age >14 days and <3 years1
2 NRTIs + LPV/r1 AI
Children age >3 years 2 NRTIs + EFV2
2 NRTIs + LPV/r
Children age >6 years 2 NRTIs + ATV (with low-dose RTV)
2 NRTIs + EFV2
2 NRTIs + LPV/r AI
August 2011 AETC National Resource Center, www.aidsetc.org
Initial Treatment: Alternative Regimens
Children of any age
2 NRTIs + NVP3
Children age >6 years
2 NRTIs + DRV (with low-dose RTV) AI2 NRTIs + FPV (with low-dose RTV)
3 NVP should not be used in postpubertal girls with CD4 count >250, unless the benefit clearly outweighs the risk
August 2011 AETC National Resource Center, www.aidsetc.org
Initial Treatment: Regimens for Use in Special Circumstances
2 NRTIs + ATV unboosted (for treatment-naïve adolescents age >13 years and body weight >39 kg) 2 NRTIs + FPV unboosted (for children age >2 years) 2 NRTIs + NFV (for children age >2 years) ZDV + 3TC + ABC*
* Test for HLA-B*5701 before initiation of ABC; do not give ABC to children who are HLA-B*5701 positive. (AII*).
August 2011 AETC National Resource Center, www.aidsetc.org
Initial Treatment: 2-NRTI Backbone Options
Preferred ABC* + (3TC or FTC) (age >3 mos) TDF + (3TC or FTC) (adolescents age >12 years and Tanner 4 or 5 only) ZDV + (3TC or FTC)
Alternative ddI + (3TC or FTC) BI TDF + (3TC or FTC) (adolescents age >12 years and Tanner 3) BI ZDV + ABC* ZDV + ddI
Use in special circumstances
d4T + (3TC or FTC) TDF + (3TC or FTC) (adolescents age >12 years and Tanner 2)
* Test for HLA-B*5701 before initiation of ABC; do not give ABC to children who are HLA-B*5701 positive. (AII*).
August 2011 AETC National Resource Center, www.aidsetc.org
Initial ARV Therapy: Components Not Recommended
Insufficient Data for use in Initial Therapy
Triple-class regimens, including NRTI + NNRTI + PI
Maraviroc Etravirine Raltegravir Tenofovir (Insufficient data in children<12
years or children >12 and Tanner 1)
Enfuvirtide EFV for children age <3 Rilpivirine and rilpivirine-containing
regimens
August 2011 AETC National Resource Center, www.aidsetc.org
Initial ARV Therapy: Components Not Recommended (2)
Potential toxicity, inferior potency,or inconvenient dosing
ATV (unboosted) in children<13 years and/or <39 kg
IDV PTV NFV in children <2 years SQV RTV (full dose) EFV in first trimester of pregnancy or in
girls of childbearing potential NVP initiation in girls with CD4 >250 or
boys >400 Dual PI regimens (full dose) NLF in age <2 years
August 2011 AETC National Resource Center, www.aidsetc.org
ARV Components Never Recommended as Part of an ARV Regimen for Children
Components Rationale Exception
EFV in 1st trimester of pregnancy or if adequate contraception cannot be assured
Potential for teratogenicity
When no other ARV option is available and potential benefits outweigh risks
NVP in adolescent girls with CD4 >250 or adolescent boys with CD4 >400
Increased incidence of symptomatic hepatic events
Only if benefit clearly outweighs the risk
Unboosted SQV, DRV or TPV
Poor bioavailability
Inferior virologic activity
Only if benefit clearly outweighs the risk
August 2011 AETC National Resource Center, www.aidsetc.org
ARV Components Never Recommended as Part of an ARV Regimen for Children
Components Rationale Exception
ATV plus IDV Potential additive risk of hyperbilirubunemia
No exceptions
Dual-NNRTI combinations
Enhanced toxicity No exceptions
Dual NRTI combinations: d4T plus ZDV
Antagonistic effect on HIV
No exceptions
Dual NRTI combinations: 3TC plus FTC
Similar resistance profile and no additive benefit
No exceptions
August 2011 AETC National Resource Center, www.aidsetc.org
ARV Regimens Never Recommended for Children
Regimen Rationale Exceptions
Single-drug therapy Rapid development of resistanceInferior antiviral activity
Prophylaxis for HIV-exposed infants3TC or FTC “bridging regimen”
Two NRTIs alone Rapid development of resistanceInferior antiviral activity
Not recommended for initial therapyIn a child on 2 NRTIs with good virological response
TDF plus ABC plus (3TC or FTC)
High rate of early viral failure No exceptions
TDF plus ddI plus (3TC or FTC)
High rate of early viral failure No exceptions
August 2011 AETC National Resource Center, www.aidsetc.org
How often should you monitor labs in HIV infected children?
A. Every 2 months
B. Every 4-6 months
C. Every 1-2 months
D. Every 3-4 months
E. Every 6-12 months
A. B. C. D. E.
0% 0% 0%0%0%
Monitoring of Children on ART
• Baseline (before ART)– Clinical history, CBC and diff, chemistries
(incl. electrolytes, creatinine, calcium, phosphorus, hepatic transaminases), glucose, lipid panel and u/a.
– Urinalysis- NEW at baseline and reevaluate every 6-12 months
– Genotype
August 2011 AETC National Resource Center, www.aidsetc.org
Monitoring of Children on ART(2)
• Within 1-2 weeks of starting new ARV regimen– Screen for side effects, assess adherence (AIII)
• Within 4-8 weeks (AIII)
– Screen for side effects, evaluate virologic response (AIII)
– CD4/%, HIV RNA, CBC, chemistries (incl. renal panel and liver function tests)
• For stable patients, follow up at least every 3-4 months (AII*)
– Monitor adherence, toxicity, efficacy (AII*)
• More frequent evaluation may be needed following initiation or change in therapy (AIII)* For children receiving nevirapine, serum transaminase levels should be measured every 2
weeks for the first 4 weeks of therapy, then monthly for 3 months, followed by every 3 to 4 months.
August 2011 AETC National Resource Center, www.aidsetc.org
Monitoring Viral Loads
– Panel noted that temporary viral load elevations between the level of detection and 1,000 copies/ml are often detected in children and are blips.
– “Blips”: Isolated episode of viremia <1000 copies/mL followed by return to viral suppression. Common and not generally reflective of virologic failure.
Toxicities and their management
• New sections added to table 17 on CNS toxicity, gastrointestinal effects, nephrotoxicity and peripheral nervous system toxicity
• CNS: LPV/r EFV, RAL, TPV
• GI: Nausea/vomiting, diarrhea, pancreatitis
• Renal: IDV, ATV, TDF
• Peripheral Nervous System : d4T, ddI
Overview of Treatment Failure (2)
– Evaluate the cause of treatment failure, especially adherence (the #1 cause of treatment failure)
– Not all ART failures require immediate change in therapy (AII)
– Manage treatment failure in collaboration with pediatric HIV specialist (AI*)
• Bridging regimens
August 2011 AETC National Resource Center, www.aidsetc.org
Virologic Failure
– Incomplete virologic response to therapy or viral rebound after achieving virologic suppression
• Incomplete response to therapy: – <1.0 log10 decline in HIV RNA from baseline after 8-12
weeks of ART; or– HIV RNA >200 copies/mL after 6 months of ART; or– Repeated HIV RNA above the level of detection after
12 months of therapy using most sensitive assay
August 2011 AETC National Resource Center, www.aidsetc.org
13 yr. old in clinic has viral load of 1975 copies/ml after 5 years of undetectable viral loads.
What would you do next?
A. Discuss adherence and follow up in 1 month.
B. Discuss adherence, adjust doses, test for resistance and follow up in 2-4 weeks.
C. Discuss adherence, adjust doses and follow up in 3 months.
D. Change medications and discuss adherence. A. B. C. D.
0% 0%0%0%
Resistance Testing• Recommended :
– Before initiation of ART for all treatment-naive children (AII) (genotype preferred) (AIII)
– Before changing ART in patients with treatment failure (AI*)
• In setting of viral failure, ensure patient is on current regimen or within 4 weeks of discontinuation (AII*)
August 2011 AETC National Resource Center, www.aidsetc.org
Resistance Testing
– Use phenotype (usually in addition to genotype) for known or suspected complex drug resistance (BIII)
• Absence of detectable resistance to a drug does not insure its success
– Current assays are not sensitive enough to exclude the presence of resistant virus
– ARVs history and previous resistance tests should be reviewed when choosing new ART after virologic failure (AII)
August 2011 AETC National Resource Center, www.aidsetc.org
Tropism (Viral Coreceptor) Assays
• Detects presence of CCR5 and CXCR4 coreceptors
• Standard test is phenotypic assay, requires HIV RNA >1,000 copies/mL
– Genotypic assay available; few clinical data
• Should be performed before starting patient on CCR5 antagonist (CCR5 antagonists not effective in patients with CXCR4 virus) (AI*)
• Consider for patients who have virologic failure on a CCR5 inhibitor (AI*)
August 2011 AETC National Resource Center, www.aidsetc.org
Pediatric Antiretroviral Drug Information
• Abacavir: Once daily dosing 16mg/kg/day max 600mg; in clinically stable undetectable children
• Lamivudine: Once daily (300mg daily) for youth ≥16 yrs who weigh ≥ 50kg
• Stavudine: Use only 30mg dose in adolescents
• Tenofovir: Bone Mineral Density effects and renal function effects updated in children
Pediatric Antiretroviral Drug Information
• Efavirenz: Interpatient variabiltiy due to CYP450 genes, TDM discussed.
• Nevirapine: Extended release not approved for <18 yr.
• Rilpivirine: No pediatric data.
Pediatric Antiretroviral Drug Information
• Darunavir: Once daily only for naïve 12-18 yrs if >40kg Dose at (800/100 mg).
• Lopinavir/ritonavir: Cardiovascular toxicity in preterm infants- use only after postmenstrual age of 42 weeks and a postnatal age of at least 14 days.
• Saquinavir: Pretherapy ECG recommended due to prolonged PR and QT; do not use if has prolonged QT or on meds that effect QT.
References• Most slides in this presentation were
prepared by Mary Jo Hoyt, MSN; Carolyn K Burr, EdD, RN; and Susa Coffey, MD for the AETC National Resource Center in August 2011.
• Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, August 11, 2011; Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PediatricGuidelines.pdf (Accessed10-14-2012).
Perinatal HIV Treatment Guidelines Update
Ana M. Puga, MD
Comprehensive Family AIDS Program
Children’s Diagnostic & Treatment Center
Fort Lauderdale, FL
DHHS Guidelines • September 2011 guidelines updated July
31, 2012, including supplement update on Safety & Toxicity of Individual Antiretroviral Agents in Pregnancy
• For full set of guidelines, visit the AIDSinfo website at http://aidsinfo.nih.gov/guidelines
When do you test a pregnant woman for HIV?
A. When she starts prenatal care.
B. When she has an STI.
C. When she gets sick.
D. At entry into Prenatal Care and at 28-32 weeks or at delivery if not done in third trimester
E. Every trimester.
A. B. C. D. E.
0% 0% 0%0%0%
What’s New in the Perinatal Guidelines?
• New Clinical Trial results• More info on Preconception Counseling,
including drug interactions and contraceptives • Antepartum care expanded, including
management of naïve pregnant women and those already on ARVs
• New ARVs recommended in preferred category and category changes for other ARVs
What’s New in the Perinatal Guidelines?
• Intrapartum care changes- no IV ZDV needed if woman is undetectable (BII)
• Postpartum care updates for infant prophylaxis and monitoring
• Discussion of premastication
Strength of Recommendations
A: Strong recommendation for the statementB: Moderate recommendation for the statementC: Optional recommendation for the statement
I: One or more randomized trials with clinical outcomes and/or validatedlaboratory endpointsII: One or more well-designed, nonrandomized trials or observationalcohort studies with long-term clinical outcomesIII: Expert opinion
Lesson Learned from Clinical Trials• Breastfeeding and Nutrition (BAN) study
– Postpartum maternal triple drug prophylaxis vs. infant NVP in women with CD4-cell counts ≥ 250 cells/mm3
– Arm 1 (control):• Maternal ZDV/3TC for 1 week; infant single dose NVP +
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 AETC National Resource Center, www.aidsetc.org
You have a 26 year old female who wants to start ARVs with a “one pill a day” regimen. What do you discuss with her?
A. Proper dosing, side effects, adherence, resistance and cost
B. Proper dosing, side effects, adherence, and resistance
C. Proper dosing, side effects, adherence, resistance, and preconception counseling, including contraception
D. Proper dosing, side effects, adherence and birth control
A. B. C. D.
0% 0%0%0%
Preconception Counseling
• 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-cell counts ≤550 cells/mm3 (AI)
• For CD4-cell counts >550 cells/mm3 (BIII)
August 2012 AETC National Resource Center, www.aidsetc.org
Preconception Counseling (2)
• Pre-exposure 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 AETC National Resource Center, 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 AETC National Resource Center, 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 due to toxicity concerns
– Atazanavir• Preferred due to increased information on safety
– Darunavir• Alternative PI for use in ARV-naïve pregnant women
– Raltegravir• Use in special circumstances when preferred or
alternative agents cannot be used
August 2012 AETC National Resource Center, www.aidsetc.org
ARV-Naïve HIV-Infected Pregnant Women
• 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 AETC National Resource Center, 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 or 6 weeks of pregnancy• Most pregnancies are not recognized before 4 to
6 weeks
– ARV changes can lead to loss of viral control and increased risk of perinatal transmission
August 2012 AETC National Resource Center, 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 AETC National Resource Center, www.aidsetc.org
ARVs and Pregnancy Outcome• Guidelines include a table of studies assessing
the association between ART and preterm delivery (Table 7)
• 17 studies reviewed from sites throughout the globe
• 10 associated with Preterm Delivery• 7 Not associated with Preterm Delivery• Association not yet confirmed given variability of
study data and results • All but one US study (patients with advanced
disease) did not show an association
What is the recommended delivery option for a 30 y/o HIV+ G3P2 on ARVs with a viral load of 1800c/ml?
A. Vaginal delivery at term
B. C-section at term
C. Vaginal delivery at 38 weeks
D. C-section at 38 weeks
E. C-section at 38 weeks with 3 hours of ZDV prior to procedure
A. B. C. D. E.
0% 0% 0%0%0%
When can IV ZDV be omitted in the delivery process?
A. When the viral load near delivery is <1000 copies/ml
B. When the viral load near delivery is < 48 (<20) copies/ml
C. When the viral load near delivery is < 48 (<20) copies/ml and a C-section is planned
D. When a woman on combination ARVs has undetectable viral load near delivery
A. B. C. D.
0% 0%0%0%
Intrapartum Care
• IV zidovudine is no longer required for HIV-infected women receiving combination ARV regimens who have HIV RNA <400 copies/ml near delivery (BII)
• HIV-infected women with HIV RNA ≥400 copies/ml (or unknown) near 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 AETC National Resource Center, 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 AETC National Resource Center, www.aidsetc.org
All these are ways HIV can be transmitted?
A. Blood contact, exchange of sexual fluids, during pregnancy and labor/delivery
B. Blood contact, exchange of sexual fluids, during pregnancy and labor/delivery, and breastfeeding
C. Blood contact, exchange of sexual fluids, during pregnancy and labor/delivery, breastfeeding and premastication
A. B. C.
0% 0%0%
Postpartum Care (2)
• Management of the HIV-exposed infant– Infants receiving zidovudine/lamivudine-
containing prophylaxis (AI)• Higher risk for 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 AETC National Resource Center, www.aidsetc.org
References• Most slides from the National AETC Resource
Center, What’s New in Perinatal Guidelines?, August 2012, www.aidsetc.org (Accessed 10/14/2012).
• Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. 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. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/PerinatalGL.pdf (Accessed 10/14/2012).