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A comparison of WHO and HHS Pediatric HIV recommendations for 2010.

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  • Preferably < 36 weeks Behaviors: Sex, drugs (>1 sex partner during pregnancy -or- NEW STD in pregnancy) (1 HIV-infected pregnant woman/1000 women screened is HIGH-prevalence) (+) Pos Rapid tests to be followed with WESTERN OR IFA. AND IMMEDIATE antiretroviral prophylaxis with NO breastfeeding in both while pending results of confirmatory test.
  • HIV DNA PCR and HIV RNA assays are preferred. DNA PCR requires Whole blood, DBS RNA PCR requires Plasma, DBS
  • Virologic testing at 4-6 weeks will identify 95% of infants exposed in utero/itrapartum.
  • Because of maternal antibodies 18 months is our cutoff date for serology. Nucleic acid amplification tests should have a Sens and Spec of 95 and 98 respectively. P24 – South Africa used heat shock method to optimize p24 dipsticks and got good results in 40 minutes with only 25 microliters plasma. Up24 Ag should NOT be used in areas where HIV SUBTYPE D is common (Central/East Africa)
  • By age 2, over half of HIV-infected kids will die w/o tx. WHO Stage 3 : unexplained fever, weight loss, diarrhea. Oral hairy leukoplakia, candidiasis and TB in last two (2) years. WHO Stage 4: Wasting syndrome, PCP, EXTRAPULMONARY TB , KS, Toxo, Encephalopathy
  • Some similarities, some mild distinctions/departures
  • “ Exposed” means to Nevirapine or other NNRTI's used for PMTCT (LOPINAVIR/RITONAVIR) a PI In order to preserve a potent new class for second-line regimens, PI's are not usually used in first-line therapy, unless exposure to NNRTI's has occured.
  • There is no established dosing for Efavirenz in kids <3 and it has CNS tox. Efavirenz would otherwise be preferred. (Tenofovir and emtricitabine) Heart of it in this order: You want to use 3TC (Lamivudine) and AZT or 3TC and abacavir or 3TC and Stavudine Triple regimen might be: NELFINAVIR plus 2 NRTI's (safe but only tested in kids with PRIOR NRTI tx). -->in HHS, Nelfinavir has been removed as an initial tx
  • HLA-B*5701 (South Africa, India, Spain) drug-induced inflammatory skin reactions (also ½ the combo of “KIVEXA”, so Epzicom may not be right for everybody) No tenofovir (TDF) in Tanner Stages 1-3 (Bone tox) Triple class not tested as initial tx No PK/safety data in kids for these newer drugs (an entry, integrase and fusion inhibitor)
  • Differences: 2 NRTI's plus NEVIRAPINE is being suggested as an ALTERNATIVE regimen. US experts state LVP/r is less hepatotoxic than NVP and that NVP has a higher failure rate, they admit studies are lacking however. R-Ritonavir is a booster – you can use lower amounts of others drugs often as it is a STRONG 3A4 inhibitor.
  • CD4 (Strong recommendation, low quality of evidence), pretty much same for HHS (AIII) for they are on par with WHO on CD4 situation except for timeframe. If CD4 is limited in its availability, then save it for sudden clinical changes. Routine Labs WBC's and Hb. Any labs for tox. Strong rec, Very Low quality of evidence
  • In children younger than 5 y/o, CD4 PERCENTAGE is preferred. There are 5 FDA approved VL assays The one with the lowest Lower Limit of Detection is the Abbot Real Time HIV-1 test <40 copies/mL. They say use the same assay consistently however due to variability... .
  • First few weeks are particularly difficult.: 1-2 weeks quick assessment of Effectiveness, Adherence, Tolerability Rx like DIDANosine require Pancreatic enzymes too. Kids on Nevirapine need LFT's every 2 weeks (1 st month), monthly (3 months) then q3-4 months.
  • Who suggests potentially more frequent follow-ups.
  • Treatment failure as defined as VIROLOGIC, IMMUNOLOGIC or CLINICAL failure VIRO: Incomplete viral response or viral rebound IMMUNO: Failure to improve or sustained decline in CD4 cells. CLINICAL: Neurodevelopmental deterioration. Growth Failure New OI's MUST Rule out IRIS (Immune Reconstitution Inflammatory Syndrome) (There may be lag in immune functions improvement or even a seemingly paradoxical decrease in immune function.) ADHERENCE is the MCC of treatment failure. FOR EXAMPLE: “ Poor adherence and limited levels of success in adolescents due to local site reactions “ ARV DRT: 1. prior to starting tx, 2. prior to changing tx, 3. for virologic failure while pt is still on failing regimen, 4. Tropism assays (Phen oscrtipt or Trofile) for those on CCR5antagonists like maraviroc)
  • TB is the MC OI-treatment ASSOCIATED with IRIS children. Do not get confused! LVP/r was their best-evidence recommendation.
  • A quick aside, page 68 in the WHO document.
  • Tenofovir causes loss of bone density in kids. Drug substitution may not be possible in resource-limited settings Say NVP-induced SJS would mean not switching to another NNRTI (due to class-specific tox but switching to say a TRIPLE REGIMEN or substituting a PROTEASE INHIBITOR for NVP). .
  • Similar to WHO
  • TB exposure? As evidenced by: Poor weight gain/cough/fever/TB contacts? Isoniazid Preventative Therapy for all: STRONG REC BUT VL Qual of Evidence IPT as a package of care= 6 Months INH EVEN if unexposed and no active dz. Greater quality of evidence for children getting IPT than infants NOT getting IPT. Nothing about B6 supplementation...?
  • Guidances

    1. 1. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection A comparison of WHO and HHS recommendations for 2010 . Robert D. Johnson
    2. 2. Summary <ul><li>Summer 2010 WHO and HHS released updated guidelines. </li></ul><ul><li>• Both guidelines describe “When to Start” ART </li></ul><ul><ul><li>With emphasis on Earlier initiation of therapy. </li></ul></ul><ul><li>• Both describe “What to Start” </li></ul><ul><ul><li>With attention to ART-naive and NVP-exposed children. </li></ul></ul><ul><li>• Both introduced a Rating-System to indicate Quality of Evidence. </li></ul><ul><ul><li>(HHS: A, B, C // I, II, III) -vs- (WHO: H, M, L, VL // S, C) </li></ul></ul><ul><li>WHO: New guidance on HIV/TB Co-infection and IPT </li></ul><ul><li>HHS: Virological Dx at Birth for High-risk newborns, lots Rx/ADE's </li></ul>
    3. 3. ID of PERINATAL HIV Exposure (HHS) <ul><li>Panel's Recommendations (AII): </li></ul><ul><ul><li>• Voluntary HIV test in Early pregnancy, Opt-OUT focus. </li></ul></ul><ul><ul><li>• Third-trimester screens for high-risk behavior or high-prevalence area. </li></ul></ul><ul><ul><li>• Rapid HIV Ab test for Undocumented women seen at labor. -or- </li></ul></ul><ul><ul><li>• In Immediate post-partum period: Rapid HIV Ab test for Mom OR Newborn </li></ul></ul>
    4. 4. Dx of HIV Infants (HHS) <ul><li>Panel's Recommendations: </li></ul><ul><ul><li>• Virologic assays MUST be used to Dx <18 months. </li></ul></ul><ul><ul><ul><li>(>18 months Ab assay alone adequate.) </li></ul></ul></ul><ul><ul><li>• Virologic testing in infants with KNOWN Peri-natal exposure (x3) at: </li></ul></ul><ul><ul><ul><li>2-3 weeks, 1-2 months -and- 4-6 months </li></ul></ul></ul><ul><ul><li>• Confirmation = two (2) separate (+) virologic samples. </li></ul></ul><ul><ul><li>• Definitive Exclusion = two (2) separate (-) virologic samples. </li></ul></ul><ul><ul><ul><li>At > 1 month AND at > 4 months.(AII) </li></ul></ul></ul><ul><ul><li>*Some feel exclusion includes (-) Ab assay at 12-18 months w/ prior (-) virologic test (BIII) . </li></ul></ul><ul><ul><li>PCP prophylaxis at 4-6 weeks for exposed, until HIV status determined. </li></ul></ul>
    5. 5. Dx of HIV Infants (WHO) <ul><li>Recommendations: </li></ul><ul><ul><li>• All infants need HIV EXPOSURE status determined at first contact with health system. First via Mom, then infant but always < 6 weeks. </li></ul></ul><ul><ul><li>• Exposed infants tested at 4-6 weeks via virology </li></ul></ul><ul><ul><ul><li>If (-), then serology at 9 months. </li></ul></ul></ul><ul><ul><ul><li>If (+), then Start ART, and repeat test to confirm. </li></ul></ul></ul><ul><ul><li>• Identify patient(s) as a “mother-baby pair”. </li></ul></ul><ul><ul><li>• 12-18 month olds: dx by virology if possible. </li></ul></ul><ul><ul><ul><li>Otherwise Virology to confirm initial AB assays ( a theme ) </li></ul></ul></ul><ul><ul><li>(>18 months Ab assay alone adequate.) </li></ul></ul><ul><ul><li>PCP, Candida spp., LIP, KS, Crypto. Spp. = Serology stat. </li></ul></ul>
    6. 6. On Assays <ul><li>• HIV Serology </li></ul><ul><ul><li>Should have Sens: 99% and Spec: 98% for use. </li></ul></ul><ul><ul><li>Children may serovert between 12 and 24 months. </li></ul></ul><ul><li>• DNA </li></ul><ul><ul><li>Whole Blood or DBS / Sensitivity increases quickly with age (Sens: 96% and Spec: 99%) at 28 days. </li></ul></ul><ul><li>• RNA </li></ul><ul><ul><li>Plasma or DBS / Can assess baseline Viral Load. </li></ul></ul><ul><ul><li>HHS: RNA better for Non-B Subtypes </li></ul></ul><ul><li>• Up24Ag </li></ul><ul><ul><li>DBS also very practical here. </li></ul></ul><ul><ul><li>HHS : Not recommended (Sens/Spec too low) </li></ul></ul><ul><ul><li>WHO: Can be used. </li></ul></ul><ul><ul><ul><li>J Acquir Immune Defic Syndr. 2010 Aug 31. </li></ul></ul></ul><ul><ul><ul><li>Sens: 95% and Spec 99% </li></ul></ul></ul>
    7. 7. When to Start ART in infants, children (WHO) <ul><li>Recommendations: </li></ul><ul><ul><li>• Infants: ART for all HIV(+) irrespective of CD4 count. </li></ul></ul><ul><ul><li>• 12 – 24 mo: ART for all HIV(+) irrespective of CD4 </li></ul></ul><ul><ul><li>• 24-59 mo: ART if CD4 <750 cells/m3 -or- %CD4 <25% </li></ul></ul><ul><ul><li>• 5 y/o+: ART if CD4 <350 (as in adults) </li></ul></ul><ul><ul><li>Strong recommendations with low evidence quality: </li></ul></ul><ul><ul><li>• ART in any HIV(+) child in WHO clinical stages 3 and 4. </li></ul></ul><ul><ul><li>• ART in any child <18 mo with presumptive clinical Dx </li></ul></ul>
    8. 8. “ When to Initiate Therapy in Antiretroviral-Naive Children” (HHS) <ul><li>Panel's Recommendations: </li></ul><ul><ul><li>• Infants: ART for all HIV(+) irrespective of CD4 count. </li></ul></ul><ul><ul><li>• ART for children >1 yr with AIDS/symptoms </li></ul></ul><ul><ul><li>• ART for children >1 yr with single episode of: </li></ul></ul><ul><ul><ul><li>Serious Bacterial infxn </li></ul></ul></ul><ul><ul><ul><li>LIP </li></ul></ul></ul><ul><ul><li>• ART for children >1 yr who have met age-related CD4 threshold criteria: </li></ul></ul><ul><ul><ul><li>1-5 y/o: CD4 < 25% </li></ul></ul></ul><ul><ul><ul><li>5+ y/o: CD4 <350 cells/mm3 </li></ul></ul></ul><ul><ul><li>• ART may be deferred or considered (CIII): </li></ul></ul><ul><ul><ul><li>>1 y/o and Asymptomatic w/ > 25% CD4 </li></ul></ul></ul><ul><ul><ul><li>1-5 y/o w/ >350 cells/mm3 </li></ul></ul></ul><ul><ul><ul><li>> 5 y/o: w/ plasma HIV RNA < 100k copies </li></ul></ul></ul>
    9. 9. First-line ART for Infants (WHO) <ul><li>What to start: </li></ul><ul><li>ARV-naive infants (or Unk(?) exposure): NVP + 2 NRTI's </li></ul><ul><li>Exposed-infants: LVP/r + 2 NRTI's </li></ul><ul><li>This regimen is same for children 12-24 months . </li></ul>
    10. 10. First-line ART for Children (WHO) <ul><li>What to start: </li></ul><ul><ul><li>2-3 y/o: NVP + 2 NRTI's </li></ul></ul><ul><ul><li>3+ y/o: NVP -or- EFV + 2 NRTI's </li></ul></ul><ul><ul><li>Special Considerations: </li></ul></ul><ul><ul><li>• w/ anemia/neutropenia: No AZT. </li></ul></ul><ul><ul><li>• >12 y/o with Hep B: TDF + FTC -or- 3TC + NNRTI </li></ul></ul><ul><ul><li>• w/ TB: </li></ul></ul><ul><ul><ul><li><3 y/o = NVP + 2 NRTI's (or a triple regimen) </li></ul></ul></ul><ul><ul><ul><li>>3 y/o = EFV + 2 NRTI's </li></ul></ul></ul>
    11. 11. First-line ART for Children (HHS) General Considerations <ul><li>Panel's Recommendations: </li></ul><ul><ul><li>• D/C chemoprophylaxis if infant tests (+), start Combo tx. </li></ul></ul><ul><ul><li>• ARV Drug Resistance Testing recommended prior to initiating tx in naïve children. </li></ul></ul><ul><ul><li>• Combo tx should be at least three (3) drugs: </li></ul></ul><ul><ul><li>An NNRTI -or- PI plus 2 NRTI's </li></ul></ul><ul><ul><li>• HLA-B*5701 genetic testing prior to abacavir </li></ul></ul><ul><ul><li>• No tenofovir (TDF) in Tanner Stages 1-3 </li></ul></ul><ul><ul><li>• No triple-class regimens as initial tx. </li></ul></ul><ul><ul><li>• No Maraviroc (Pfizer), No Raltegravir (Merck), No Enfuvirtide (Roche) as initial tx. </li></ul></ul>
    12. 12. First-line ART for Children (HHS) <ul><li>Preferred Regimens: </li></ul><ul><ul><li>Children <3 y/o: LVP/r + 2 NRTI's -or- NVP + 2 NRTI's (if no peripartum exposure) </li></ul></ul><ul><ul><li>Children > 3 y/o: LVP/r + 2 NRTI's -or- EFV + 2 NRTI's </li></ul></ul><ul><li>Alternative Regimens: </li></ul><ul><ul><li>Children 3-6 y/o: NVP + 2 NRTI's </li></ul></ul><ul><ul><li>Children > 6 y/o: 2 NRTI's + LOW-DOSE LVP/r + : </li></ul></ul><ul><ul><ul><li>Atazanavir -or- darunavir -or- fosamprenavir </li></ul></ul></ul>
    13. 13. ARV Regimens that should NEVER be offered <ul><li>• Monotherapy </li></ul><ul><li>• Two NRTI's alone </li></ul><ul><li>• Two NNRTI's </li></ul><ul><li>• Certain Two-NRTIS combinations: </li></ul><ul><ul><li>Lamivudine + Emtricitabine </li></ul></ul><ul><ul><ul><li>(Same resistance, no added benefit) </li></ul></ul></ul><ul><ul><li>Zidovudine + Stavudine </li></ul></ul><ul><ul><ul><li>(Antagonism) </li></ul></ul></ul><ul><li>• Saquinavir, darunavir or tipranavir without ritonavir “boosting”. </li></ul><ul><li>• Three NRTI-regimen of: </li></ul><ul><ul><li>Tenofovir + (Didanosine or abacavir) + (lamivudine or emtricabine) </li></ul></ul><ul><ul><li>Early non-response in adults, not to be tried in kids. </li></ul></ul>
    14. 14. Clinical and Laboratory Monitoring (WHO) <ul><li>Recommendations: </li></ul><ul><li>CD4 </li></ul><ul><ul><li>At time of Dx, then every 6 mo </li></ul></ul><ul><ul><li>Prior to initiating ART, then every 6 mo </li></ul></ul><ul><ul><li>Where staging events or clinical changes occur </li></ul></ul><ul><li>Viral Load </li></ul><ul><ul><li>Desirable but not essential </li></ul></ul><ul><ul><li>To confirm failure, prior to switching regimens </li></ul></ul><ul><li>Routine Labs </li></ul><ul><ul><li>WBC's and Hb. Any labs for tox. (i.e.; full chem but not at baseline) </li></ul></ul><ul><li>Baseline Clinical Assessment </li></ul><ul><ul><li>Malaria, TB Dz or exposure , OI's, Hepatitis, nutrition, pregnancy </li></ul></ul>
    15. 15. Clinical and Laboratory Monitoring (HHS) <ul><li>Panel's Recommendations: </li></ul><ul><li>CD4 </li></ul><ul><ul><li>At time of Dx, then every 3-4 mo (more frequently in infants) </li></ul></ul><ul><ul><li>Where staging events or clinical changes occur </li></ul></ul><ul><ul><li>When initiating or changing therapy </li></ul></ul><ul><li>Viral Load </li></ul><ul><ul><li>At time of Dx, then every 3-4 mo </li></ul></ul><ul><ul><li>An “ultrasensitive viral load assay” should be used to confirm maximal suppression of viremia. </li></ul></ul>
    16. 16. Routine Clinical Monitoring Recommendations (HHS) <ul><li>On-phone or in-person interview 1-2 weeks after initiation. </li></ul><ul><ul><li>Some suggest “adherence screen at 1-2 weeks” via RNA. </li></ul></ul><ul><li>Evaluate at 4-8 weeks for AE via full chemistries. </li></ul><ul><li>Q 3-4 Months for Tox Screen, should become routine. </li></ul><ul><ul><li>Lipid panel q6-12 months for all. </li></ul></ul>
    17. 17. Routine Clinical Monitoring Recommendations (WHO) <ul><li>Infants: Follow-up at weeks 2, 4, 8 then monthly. </li></ul><ul><li>Children: Follow-up at weeks 2, 4, 8, 12 then q2-3 months. </li></ul><ul><li>At visits: </li></ul><ul><ul><li>Review interim medical Hx including TB Exposure. </li></ul></ul><ul><ul><li>Consider as response to therapy: </li></ul></ul><ul><ul><ul><li>Improved growth </li></ul></ul></ul><ul><ul><ul><li>Overcoming development delays </li></ul></ul></ul><ul><ul><ul><li>Decreased OI's </li></ul></ul></ul>
    18. 18. Treatment Failure (HHS) <ul><li>Panel's Recommendations: </li></ul><ul><ul><li>Assess barriers to adherence. </li></ul></ul><ul><ul><li>Consider individual PK differences. </li></ul></ul><ul><ul><li>Perform ART-resistance testing. </li></ul></ul><ul><ul><ul><li>(Including tropism assays potentially). </li></ul></ul></ul><ul><ul><li>Collaborate with a pediatric HIV specialist. </li></ul></ul><ul><ul><li>Exclude also when considering failure: </li></ul></ul><ul><ul><ul><li>Non-B subtypes? </li></ul></ul></ul><ul><ul><ul><li>Protein-calorie malnutrition </li></ul></ul></ul><ul><ul><ul><li>Untreated Tuberculosis </li></ul></ul></ul><ul><ul><ul><li>Malignancy </li></ul></ul></ul>
    19. 19. Treatment Failure (WHO) <ul><li>WHO Stage 3 or 4, after 24 weeks of adherent ART is treatment failure. </li></ul><ul><li>“ National programmes need to provide standard second-line regimens that are expected to be potent and well tolerated,” </li></ul><ul><li>Early switching = Increased cost </li></ul><ul><li>Late switching = Resistance development </li></ul><ul><ul><li>*LPV/r is the preferred boosted PI for 2nd-line ART after NNRTI failure (Strong, high) </li></ul></ul><ul><li>WHO also reminds us that: </li></ul><ul><ul><li>Clinical “deterioration” may be due to IRIS, ex TB* was subclinical. </li></ul></ul><ul><ul><li>BCG-associated IRIS is very common. </li></ul></ul><ul><ul><li>Also, Tx of OI's, INCLUDING TB can unmask IRIS. </li></ul></ul><ul><ul><li>Time is required to reverse catabolic state. </li></ul></ul><ul><ul><li>. </li></ul></ul>
    20. 20. WHO Proposal for Clinical Case Definition of Paradoxical TB-associated IRIS <ul><li>One (1) Major plus Two (2) minor criteria w/i 3 mo of ART. </li></ul><ul><li>Meintjes, G., et al., Tuberculosis-associated immune reconstitution inflammatorysyndrome: Case definitions for use in resource-limited settings. Lancet Infect Dis , 2008. 8: p. 516-23. </li></ul>
    21. 21. ARV Drug Toxicity (WHO) <ul><li>Principles: </li></ul><ul><ul><li>AE differ somewhat between adults/kids. </li></ul></ul><ul><ul><li>WHO requests increased: </li></ul></ul><ul><ul><ul><li>Pharmacovigilance </li></ul></ul></ul><ul><ul><ul><li>Post-marketing surveillance </li></ul></ul></ul><ul><ul><li>EFV-related rash, TDF-related osteopenia, higher in peds. </li></ul></ul><ul><ul><li>Tox: Mild, Mod. Severe, Life-threatening </li></ul></ul><ul><ul><ul><li>Mod, Severe require substitution, not d/c. </li></ul></ul></ul><ul><ul><ul><li>Life-threatening requires temporary d/c. (Hepatotox w/ NVP) </li></ul></ul></ul>
    22. 22. WHO <ul><li>Pg 49 </li></ul>
    23. 23. Management of Toxicity or Intolerance (HHS) <ul><li>Panel's Recommendations: </li></ul><ul><ul><li>D/C all components in life-threatening reactions. </li></ul></ul><ul><ul><li>Document and relate to caregiver the TOXICITY profile, not just the offending drug, for future care. </li></ul></ul><ul><ul><li>Dose-reduction not recommended. </li></ul></ul><ul><ul><ul><li>Therapeutic drug monitoring is not routine. </li></ul></ul></ul><ul><ul><ul><li>Might be used if excess dose was suspected. </li></ul></ul></ul>
    24. 24. (HHS) ARV AE and Management Recommendations
    25. 25. Considerations for Infant and Children With Tuberculosis and HIV (WHO) <ul><li>EVERY visit requires evaluation for TB exposure. </li></ul><ul><li>“ ALL HIV-infected infants and children exposed to TB through household contacts , but with no evidence of active disease should begin IPT ”. (Strong, VL q of e) </li></ul><ul><ul><ul><li>INH 10mg/kg day (300 mg/day max) </li></ul></ul></ul><ul><li>Children w/ HIV should get 6 mo IPT </li></ul><ul><li>as part of a “package” of HIV care. </li></ul><ul><li>(Infants should not (unless household contact).) </li></ul><ul><li>All Infants and children should get </li></ul><ul><li>c o-trimoxazole tx, especially HIV/TB coinfected. </li></ul>
    26. 26. Diagnosis of TB <ul><li>Interferon-ɣ release assays. </li></ul><ul><ul><li>- May be more sensitive than TST. </li></ul></ul><ul><ul><li>- Unaffected by prior BCG vaccination. </li></ul></ul><ul><li>Co-infected children may have Neg (-) TST. </li></ul><ul><li>Diagnosis is presumptive often in young people. </li></ul><ul><li>If TB is dx'd while child is on ART, must review the regimen to optimize tx of BOTH. </li></ul>
    27. 27. ARV Regimens in TB <ul><li>Rifampin reduces levels of NVP (CYP3A). </li></ul><ul><li>< 3 y/o : </li></ul><ul><ul><li>-> 2 NRTI's + NVP (unless< 2 y/o w/ prior exposure) </li></ul></ul><ul><ul><li>-or- 3 NRTI's: (d4T/AZT) + 3TC + ABC </li></ul></ul><ul><li>>3 y/o: </li></ul><ul><ul><li>-> 2 NRTI's + EFV </li></ul></ul><ul><ul><li>(- or- 3 NRTI's: (d4T/AZT) + 3TC + ABC) </li></ul></ul><ul><ul><li>Nelfinavir should not be given w/ rifampicin. </li></ul></ul>
    28. 28. Review <ul><li>1. Rapid antibody screen for undocumented mom-baby pair. </li></ul><ul><li>2. Virologic assay to confirm, and to test in age < 18 months. </li></ul><ul><li>3. PCP prophylaxis until HIV status determined in exposed baby. </li></ul><ul><li>4. WHO for -vs- HHS against Up24 Antigen assay. </li></ul><ul><li>5. ART for all HIV(+) irrespective of CD4 (WHO) for some -vs- more stringent threshold criteria in HHS guidance. (12-24 mo./old) </li></ul><ul><li>6. Some regimens: </li></ul><ul><ul><ul><li>NVP + 2 NRTI's </li></ul></ul></ul><ul><ul><ul><li>LVP/r + 2 NRTI's </li></ul></ul></ul><ul><ul><ul><li>EFV + 2 NRTI's </li></ul></ul></ul><ul><ul><ul><li>TDF + FTC -or- 3TC + NNRTI </li></ul></ul></ul><ul><ul><ul><li>2 NRTI's + LOW-DOSE LVP/r + : ATV -or- DRV -or- FPV </li></ul></ul></ul>
    29. 29. Review <ul><li>7. CD4: q 3 mo (HHS) -vs- q 6 mo (WHO) </li></ul><ul><li>8. VL: at Dx and q 3 mo (HHS) -vs- to confirm tx failure (WHO) </li></ul><ul><li>9. Clinical Monitoring: q 3-4 mo (HHS) -vs- q 2-3 mo (WHO) </li></ul><ul><li>10. Watch for toxicity within classes of Rx. </li></ul><ul><li>11. Look for, and treat TB actively , adjust ART appropriately. </li></ul><ul><li>12. Prophylaxis with INH for the exposed. </li></ul>
    30. 30. Sources <ul><ul><li>Antiretroviral Therapy for HIV Infection in Infants and Children: Towards Universal Access. Recommendations for a public health approach. 2010 Revision. WHO HIV/AIDS Programme </li></ul></ul><ul><ul><li>Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. August 16, 2010. HHS Panel on Antiretroviral Therapy and Medical Management in HIV-Infected Children </li></ul></ul>