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Pediatric HIV Treatment Guidelines Update Ana M. Puga, MD Comprehensive Family AIDS Program Children’s Diagnostic & Treatment Center Fort Lauderdale, FL.

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Presentation on theme: "Pediatric HIV Treatment Guidelines Update Ana M. Puga, MD Comprehensive Family AIDS Program Children’s Diagnostic & Treatment Center Fort Lauderdale, FL."— Presentation transcript:

1 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

2 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.

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 http://aidsinfo.nih.gov/guidelines

4

5 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

6 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

7 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

8 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

9 Indications for Initiation of ART in Children <12 Months of Age CriteriaRecommendation 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 >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

14 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

15 What is the CD4 cut off used in adults? A.350 B.200 C.500 D.450 E.600

16 Indications for Initiation of ART in Children ≥1 - <5 Years of Age CriteriaRecommendation 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 RNATreat (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 25% Consider treatment (CIII) August 2011 AETC National Resource Center, www.aidsetc.org

17 Indications for Initiation of ART in Children >5 Years of Age CriteriaRecommendation 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 RNATreat (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 25% Consider treatment (CIII) August 2011 AETC National Resource Center, www.aidsetc.org

18 Initial Combination Therapy for 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? A.Rilpivirine B.Efavirenz C.Raltegravir D.Etravirine E.Tenofovir

20 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 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

23 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 years 1 2 NRTIs + LPV/r 1 AI Children age >3 years2 NRTIs + EFV 2 2 NRTIs + LPV/r Children age >6 years2 NRTIs + ATV (with low-dose RTV) 2 NRTIs + EFV 2 2 NRTIs + LPV/r AI August 2011 AETC National Resource Center, www.aidsetc.org

24 Initial Treatment: Alternative Regimens Children of any age 2 NRTIs + NVP 3 Children age >6 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 >250, 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 >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

26 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

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 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

28 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

29 ARV Components Never Recommended as Part of an ARV Regimen for Children ComponentsRationaleException EFV in 1 st 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

30 ARV Components Never Recommended as Part of an ARV Regimen for Children ComponentsRationaleException ATV plus IDVPotential additive risk of hyperbilirubunemia No exceptions Dual-NNRTI combinations Enhanced toxicityNo 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  RationaleExceptions 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? A.Every 2 months B.Every 4-6 months C.Every 1-2 months D.Every 3-4 months E.Every 6-12 months

33 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 <1000 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

37 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: –<1.0 log 10 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

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? 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.

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 >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

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 <18 yr. Rilpivirine: No pediatric data.

45 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.

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/lvguideli nes/PediatricGuidelines.pdf (Accessed http://aidsinfo.nih.gov/contentfiles/lvguideli nes/PediatricGuidelines.pdf 10-14-2012).

47 Perinatal HIV Treatment Guidelines Update Ana M. Puga, MD Comprehensive Family AIDS Program Children’s 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 http://aidsinfo.nih.gov/guidelines

49 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.

50 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

51 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

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/mm 3 –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? 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

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/mm 3 (AI) For CD4-cell counts >550 cells/mm 3 (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 1 st 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? 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

64 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

65 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

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? 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

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, What’s New in Perinatal Guidelines?, August 2012, www.aidsetc.org (Accessed 10/14/2012).www.aidsetc.org 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). http://aidsinfo.nih.gov/contentfiles/lvguidelines/ PerinatalGL.pdf


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