Pediatric HIV Treatment Guidelines Update

1
Pediatric HIV Treatment Guidelines Update

• Ana M. Puga, MD
• Comprehensive Family AIDS Program
• Childrens Diagnostic Treatment Center
• Fort Lauderdale, FL
• Faculty, Florida/Caribbean AETC

2
Disclosures of Financial Relationships

• This speaker has the following significant
  financial relationships with commercial entities
  to disclose
• Speakers 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.

3
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

4
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Whats New in the Pediatric Guidelines?

• When to Start Antiretroviral Therapy (ART)
• Recommendations for naïve infants lt
  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

6
Whats 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

7
At what ages should an exposed infant be tested
for HIV?

1. Birth, 1m, 2m, 3m
2. 2m, 4m, 6m, 18m
3. 14 days, 1m, 4m
4. Birth, 1m 4m, 6m
5. Birth, 14 days, 3m, 6m

8
ART Initiation Infants lt12 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
9
Indications for Initiation of ART in Children
lt12 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
10
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
11
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
12
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
13
ART Age 12 Months (4)

• Factors to consider in deciding when to initiate
  therapy in asymptomatic children gt12 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
14
At what age can you use the CD4 cut off used for
adults to start HAART in asymptomatic children?

1. 6
2. 5
3. 12
4. 4
5. 13

15
What is the CD4 cut off used in adults?

1. 350
2. 200
3. 500
4. 450
5. 600

16
Indications for Initiation of ART in Children 1
- lt5 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 lt25 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 lt100,000 copies/mL and CD4 percentage gt25 Consider treatment (CIII)
August 2011
AETC National Resource Center, www.aidsetc.org
17
Indications for Initiation of ART in Children gt5
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 lt350 and BII for CD4 count 350500)
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 lt100,000 copies/mL and CD4 percentage gt25 Consider treatment (CIII)
August 2011
AETC National Resource Center, www.aidsetc.org
18
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
19
Which ARV was most recently FDA approved for
children?

1. Rilpivirine
2. Efavirenz
3. Raltegravir
4. Etravirine
5. Tenofovir

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Current ARV Medications
NRTI 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
21
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
22
PI-Based Regimens

• Disadvantages
• Metabolic complications
• Potential for multiple drug interactions
• Higher pill burden
• Poor palatability of liquid formulations

• Advantages
• NNRTI-sparing
• Efficacy well documented
• Resistance requires multiple mutations
• Targets HIV at 2 steps of viral replication

August 2011
AETC National Resource Center, www.aidsetc.org
23
Initial Treatment Preferred Regimens
Children age gt14 days and lt3 years1 2 NRTIs LPV/r1 AI
Children age gt3 years 2 NRTIs EFV2 2 NRTIs LPV/r
Children age gt6 years 2 NRTIs ATV (with low-dose RTV) 2 NRTIs EFV2 2 NRTIs LPV/r AI
1 LPV/r should not be given to neonates before a
postmenstrual age (first day of the mothers 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 gt3 years who weigh gt10 kg.
Not recommended for adolescent females who are
sexually active and may become pregnant unless
adequate contraception can be ensured.
August 2011
AETC National Resource Center, www.aidsetc.org
24
Initial Treatment Alternative Regimens
Children of any age 2 NRTIs NVP3
Children age gt6 years 2 NRTIs DRV (with low-dose RTV) AI 2 NRTIs FPV (with low-dose RTV)
3 NVP should not be used in postpubertal girls
with CD4 count gt250, unless the benefit clearly
outweighs the risk
August 2011
AETC National Resource Center, www.aidsetc.org
25
Initial Treatment Regimens for Use in Special
Circumstances
2 NRTIs ATV unboosted (for treatment-naïve adolescents age gt13 years and body weight gt39 kg) 2 NRTIs FPV unboosted (for children age gt2 years) 2 NRTIs NFV (for children age gt2 years) ZDV 3TC ABC
Test for HLA-B5701 before initiation of ABC
do not give ABC to children who are HLA-B5701
positive. (AII).
August 2011
AETC National Resource Center, www.aidsetc.org
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Initial Treatment 2-NRTI Backbone Options
Preferred ABC (3TC or FTC) (age gt3 mos) TDF (3TC or FTC) (adolescents age gt12 years and Tanner 4 or 5 only) ZDV (3TC or FTC)
Alternative ddI (3TC or FTC) BI TDF (3TC or FTC) (adolescents age gt12 years and Tanner 3) BI ZDV ABC ZDV ddI
Use in special circumstances d4T (3TC or FTC) TDF (3TC or FTC) (adolescents age gt12 years and Tanner 2)
Test for HLA-B5701 before initiation of ABC
do not give ABC to children who are HLA-B5701
positive. (AII).
August 2011
AETC National Resource Center, www.aidsetc.org
27
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 childrenlt12 years or children gt12 and Tanner 1) Enfuvirtide EFV for children age lt3 Rilpivirine and rilpivirine-containing regimens
August 2011
AETC National Resource Center, www.aidsetc.org
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Initial ARV Therapy Components Not Recommended
(2)
Potential toxicity, inferior potency, or inconvenient dosing ATV (unboosted) in childrenlt13 years and/or lt39 kg IDV PTV NFV in children lt2 years SQV RTV (full dose) EFV in first trimester of pregnancy or in girls of childbearing potential NVP initiation in girls with CD4 gt250 or boys gt400 Dual PI regimens (full dose) NLF in age lt2 years
August 2011
AETC National Resource Center, www.aidsetc.org
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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 gt250 or adolescent boys with CD4 gt400 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
30
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
31
ARV Regimens Never Recommended for Children
Regimen Rationale Exceptions
Single-drug therapy Rapid development of resistance Inferior antiviral activity Prophylaxis for HIV-exposed infants 3TC or FTC bridging regimen
Two NRTIs alone Rapid development of resistance Inferior antiviral activity Not recommended for initial therapy In 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
32
How often should you monitor labs in HIV
infected children?

1. Every 2 months
2. Every 4-6 months
3. Every 1-2 months
4. Every 3-4 months
5. Every 6-12 months

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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
34
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
35
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 lt1000
  copies/mL followed by return to viral
  suppression. Common and not generally reflective
  of virologic failure.

36
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

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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
38
Virologic Failure

• Incomplete virologic response to therapy or viral
  rebound after achieving virologic suppression
• Incomplete response to therapy
• lt1.0 log10 decline in HIV RNA from baseline after
  8-12 weeks of ART or
• HIV RNA gt200 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
39
13 yr. old in clinic has viral load of 1975
copies/ml after 5 years of undetectable viral
loads. What would you do next?

1. Discuss adherence and follow up in 1 month.
2. Discuss adherence, adjust doses, test for
   resistance and follow up in 2-4 weeks.
3. Discuss adherence, adjust doses and follow up in
   3 months.
4. Change medications and discuss adherence.

40
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
41
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
42
Tropism (Viral Coreceptor) Assays

• Detects presence of CCR5 and CXCR4 coreceptors
• Standard test is phenotypic assay, requires HIV
  RNA gt1,000 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
43
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

44
Pediatric Antiretroviral Drug Information

• Efavirenz Interpatient variabiltiy due to CYP450
  genes, TDM discussed.
• Nevirapine Extended release not approved for lt18
  yr.
• Rilpivirine No pediatric data.

45
Pediatric Antiretroviral Drug Information

• Darunavir Once daily only for naïve 12-18 yrs if
  gt40kg 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.

46
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 (Accessed
• 10-14-2012).

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Perinatal HIV Treatment Guidelines Update

• Ana M. Puga, MD
• Comprehensive Family AIDS Program
• Childrens Diagnostic Treatment Center
• Fort Lauderdale, FL

48
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

49
When do you test a pregnant woman for HIV?

1. When she starts prenatal care.
2. When she has an STI.
3. When she gets sick.
4. At entry into Prenatal Care and at 28-32 weeks or
   at delivery if not done in third trimester
5. Every trimester.

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Whats 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

51
Whats 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

52
Strength of Recommendations

A Strong recommendation for the statement B Moderate recommendation for the statement C Optional recommendation for the statement I One or more randomized trials with clinical outcomes and/or validated laboratory endpoints II One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes III Expert opinion
53
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
54
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?

1. Proper dosing, side effects, adherence,
   resistance and cost
2. Proper dosing, side effects, adherence, and
   resistance
3. Proper dosing, side effects, adherence,
   resistance, and preconception counseling,
   including contraception
4. Proper dosing, side effects, adherence and birth
   control

55
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 gt550 cells/mm3 (BIII)

August 2012
AETC National Resource Center, www.aidsetc.org
56
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
57
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
58
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
59
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
60
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
61
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
62
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

63
What is the recommended delivery option for a 30
y/o HIV G3P2 on ARVs with a viral load of
1800c/ml?

1. Vaginal delivery at term
2. C-section at term
3. Vaginal delivery at 38 weeks
4. C-section at 38 weeks
5. C-section at 38 weeks with 3 hours of ZDV prior
   to procedure

64
When can IV ZDV be omitted in the delivery
process?

1. When the viral load near delivery is lt1000
   copies/ml
2. When the viral load near delivery is lt 48 (lt20)
   copies/ml
3. When the viral load near delivery is lt 48 (lt20)
   copies/ml and a C-section is planned
4. When a woman on combination ARVs has undetectable
   viral load near delivery

65
Intrapartum Care

• IV zidovudine is no longer required for
  HIV-infected women receiving combination ARV
  regimens who have HIV RNA lt400 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
66
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
67
All these are ways HIV can be transmitted?

1. Blood contact, exchange of sexual fluids, during
   pregnancy and labor/delivery
2. Blood contact, exchange of sexual fluids, during
   pregnancy and labor/delivery, and breastfeeding
3. Blood contact, exchange of sexual fluids, during
   pregnancy and labor/delivery, breastfeeding and
   premastication

68
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
69
References

• Most slides from the National AETC Resource
  Center, Whats 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).