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Revised Guidelines for PMTCT and Infant Feeding in the Context of HIV

Revised Guidelines for PMTCT and Infant Feeding in the Context of HIV. Dr. A.K.GUPTA, MD (PEDIATRICS) OFICER ON SPECIAL DUTY DELHI STATE AIDS CONTROL SOCIETY. “We have effective drugs. There is no reason why any mother should die of AIDS.

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Revised Guidelines for PMTCT and Infant Feeding in the Context of HIV

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  1. RevisedGuidelines forPMTCTandInfant FeedingintheContextofHIV Dr.A.K.GUPTA, MD (PEDIATRICS) OFICER ON SPECIAL DUTY DELHI STATE AIDS CONTROL SOCIETY

  2. “We have effective drugs. There is no reason why any mother should die of AIDS. There is no cause for any child to be born with HIV If we work hard enough we can virtually eliminate mother-to-child transmission.” Ban Ki Moon UN Secretary-General

  3. Risk of Mother-to-Child HIV Transmission Background transmission risk:15-45% 15-30% Risk during pregnancy and delivery 10-20% Additional risk postpartum via breastfeeding Transmission risk with interventions: 20-30% No breastfeeding 15-25% Short-course ARV + breastfeeding 5-15% Short-course ARV, no BF <5% 2010 interventions, BF <2% 2010 interventions, no BF

  4. Duration, timing and complexity of ARV regimens to reduce MTCT sd-NVP sc AZT + sd-NVP Maternal therapeutic ART sc AZT + sd-NVP Daily Infant NVP Maternal triple ARV prophylaxis

  5. Estimated number of new pediatric infections with and without PMTCT prophylaxis globally, 1996-2008 70,000 infections averted in 2008 UNAIDS, AIDS Epidemic Update2009

  6. Rationale for Development of New 2010 PMTCT Recommendations New evidence on: Optimal timing and eligibility for ART initiation in HIV positive pregnant women Benefits of earlier initiation of ARV prophylaxis for PMTCT during pregnancy Effectiveness of different ARV prophylaxis strategies Effectiveness of ARV prophylaxis to mother or infants in reducing risk of HIV transmission during breastfeeding

  7. Benefit and Impact of Providing ART to Eligible Pregnant Women 8 • Pregnant women with CD4 <350: • About 40% of HIV+ pregnant women • Account for >75% of MTCT risk • Account for >80% of postpartum transmission • Account for 85% of maternal deaths within 2 years of delivery • Strong benefit from initiating ART for maternal health and PMTCT during pregnancy, labour and delivery and breastfeeding

  8. High MTCT Risk with CD4 <350ZEBS study, Thea et al. 2008 3.9 4.5 1.9 84% of maternal deaths 82% of postnatal infections 3.5 2.3 7.4 7.3 7.6 13.3 20.8 7.6 15.5

  9. 1. PregnantWomen EligibleforART (CD4<350) Shouldbe initiatedonlifelongARTassoonaspossible BabyreceivesdailyNVPfor6 weeks after birth (breastfeedingorreplacementfeeding)

  10. ARV prophylaxis to the mother or the baby from 1-6 weeks until 6-7 months post partum prevents HIV breastfeeding transmission Maternal Postpartum ART Infant Postpartum ARV Mom AZT/3TC Mom AZT/ddI Mom AZT/3TC sdNVP Adapted from Lynne Mofenson

  11. 1.PMTCTRegimensforpregnantwomen eligibleforART IfapregnantwomenhasCD4≤350,orisStageIIIorIV,sheshouldbe initiatedonlifelongARTassoonaspossible BabyreceivesdailyNVPfor6 weeks after birth (breastfeedingorreplacementfeeding) Note:ItisgenerallybettertouseNVPinsteadofEFVinpregnantwomen(unlessthereare toxicities).ThesewomenareonARTforlifeandmostwillbecomepregnantagain---ifon EFVin1sttrimesterthereisariskofbirthdefects

  12. Whyitisimportanttoensurethateligiblepregnant women(<350)areinitiatedonART 11 Pregnant women with CD4 ≤ 350 may account for: Approximately40%ofallHIV+pregnantwomen Contributetogreaterthan75%ofoveralltransmission andgreaterthan80%ofpostpartumtransmission 85%ofmaternaldeathswithin2yearsofdelivery Duethehighviralloads

  13. ARV Prophylaxis in Pregnant Women Not eligible for ART (CD4 > 350) **sd-NVP and AZT+3TC can be omitted if mother receives > 4 wks AZT antepartum

  14. Option A or Option B? • Both recommended options A and B provide significant reduction of the MTCT risk • There are advantages and disadvantages of both options, in terms of feasibility, acceptability and safety for mothers and infants, as well as cost • The choice for a preferred option should be made at a country level, after considering these advantages and disadvantages

  15. ARV Prophylaxis Options ( India will soon adopt Option B) *sd-NVP and AZT+3TC can be omitted if mother receives > 4 wks AZT antepartum

  16. RationaleofthenewGuidelines NewGuidanceisbasedonnewevidenceon: •Benefitsofearlier initiation of ARV prophylaxis during pregnancyin reducingmother-to-childtransmission •EffectivenessofARV prophylaxis provided during breastfeedingin reducingmother-to-child-transmission •Effectivenessofdifferent ART regimens for children and adults •OptimaltimingandcriteriaforARTinitiationinchildren&adults Inresponsetothisevidence,theWorldHealthOrganization(WHO) releasednewguidanceforPMTCT,EID,ART&InfantFeeding,which the NACO , MinistryofHealth, GOI hasadapted for 40 districts

  17. SummaryofnewChanges PreventionofMother-to-ChildTransmission(PMTCT): 1.ARVusefortheHIVpositivepregnantwomen RecommendinitiationofARVsearlierduringpregnancyfrom 14weekofgestation 2.ARVuseduringBreastFeeding; RecommendARVprophylaxistoeitherthebabyormotherup totheendofallbreastfeeding 3.InfantandYoungChildFeeding(IYCF): RecommendHIVpositivemotherstobreastfeedforatleast 12monthsaslongasthebabyormotherisreceivingARV’s

  18. BenefitsoftheNewPMTCTpolicyguidelines • • • • AZTnowstartedearlierinpregnancy—significantlyreduces ratesofintrauterinetransmission •Womenreceiveprophylaxisformoreofthetransmissionperiod AZTcannowbestartedatthewoman’sfirstvisit •Currentlymanywomencomebefore28weeksbutdon’tevercomebackasa resulttheyneverreceiveARVsforPMTCT Transmissionthroughbreastfeedingwilldecreasebecausethe babyormotherwillreceivingARVprophylaxisdaily Motherscanbreastfeedforalongertimebecausethebabyis receivingNVP;hencecontributingto“increasedHIVfree survival”throughreducedHIVriskaswellasmorbidityand mortalityfrommalnutrition

  19. DosingscheduleforinfantNVPprophylaxis

  20. “AFASS”criteriaisusedtodeterminewhethera motherisabletoreplacementfeed AFASSCriteriaforReplacementFeeding NOTE:Currentlyoptionsforreplacementfeedingincludecommercial infant formulaandmodified animal milk However,WHOrecommendedthatanimalmilkshouldnolongerbeusedfor infantsbelow6months.

  21. Inthecurrentfeedingguidelines,HIV-positivemothers stopbreastfeedingexposedinfantsat6months CurrentFeedingGuidelines(2006-2009) MothersencouragedtoEXCLUSIVELYBREASTFEEDuntil6 months of ageif replacementfeedingisnotAFASS Mothersshouldweanoverthecourseof2weeks IfmotherscannotprovideSufficientanimalmilkat6months,theycancontinueto breastfeedwhilealsointroducingcomplementaryfeeds IfmothersareabletomeettheAFASScriteriaatanytime,encourage replacementfeeding InfantsconfirmedHIV-positiveshouldbreastfeedexclusivelyfor6months,& complementaryfeeduntil24months

  22. HIV+mothersarenowurgedtobreastfeedfor12monthswhile theexposedbaby(unknownstatus)receivesARVprophylaxis NewFeedingGuidelines(2010) Mothers stronglyrecommendedtoexclusivelybreastfeedinguntil 6 months of age,andcontinuebreastfeedingwhileintroducingcomplementaryfeedsuntil 12 months of age Ifmotherscannotprovidesufficientanimalmilkat12months,theycancontinueto breastfeeduntilable ExposedinfantsreceivedailyNVPprophylaxisuntil1weekaftercessationof breastfeeding Breastfeedingisthepreferredfeedingmethod.However,ifmothersstill desiretoreplacementfeed,theycan,ifabletomeettheAFASScriteria InfantsconfirmedHIV-positiveshouldbreastfeedexclusivelyfor6months,& continuebreastfeedingwhileaddingincomplementaryfeedsuntil24months

  23. Rationaleforthenewinfantfeedingguidelines Challengesofthe2006-2009Guidelines Whenmothersbreastfeedfor6months,andwithoutARVprophylaxis: Risk of HIV transmission is high,especiallysincemanymothersmixedfeed. However,ifmothersreplacementfeeditwillleadtomalnutritionsincemost cannotmeetAFASScriteria Risk of malnutrition after 6 months is highbecausemanymotherscan’tgive theirbabiesanadequatesubstitute However,ifmothercontinuebreastfeedingbeyond6months,lengthofexposure toHIVisincreased Benefitsof2010Guidelines Whenmothersbreastfeedfor12monthsandwithARVPROPHYLAXIS: Risk of HIV transmission is reducedbecauseARVprophylaxisisprovided throughoutthebreastfeedingperiod Risk of malnutrition is greatly reducedbecausebabiesarereceivingbreast milkfor12months—bythatagethebabyhasgrownandthemalnutritionriskisless

  24. Thecounselingmessagesgiventomothersduring antenatalchangeswiththenewguidelines Inthecurrentguidelines(2006-2009): Mothers are encouraged to breastfeed exclusively for 6 months andthenstop;unlessreplacementfeedingifAFASS Inthenewguidelines(2010): HIV+ mothers arestronglyencouraged to breastfeed their exposed infants for 12 months while on ARV’s ExclusiveBFuntil6months,complementaryfrom6-12months BreastfeedingisnolongerJust“necessary”but“critical” becauseofthenutritionalneedandbecauseARVprophylaxis nowlimitstheriskoftransmission However,ifthemotherstillpreferstoreplacementfeedafter counseling,shecandosoifAFASScriteriaismet

  25. Comprehensive approach to virtual elimination Prevent new infections Childbearing Women Avoid unintended pregnancies Women living with HIV Prevent MTCT Pregnant women living with HIV HIV-infected children

  26. Estimated number of new pediatric infections with and without PMTCT prophylaxis globally, 1996-2008 70,000 infections averted in 2008 UNAIDS, AIDS Epidemic Update2009

  27. 3 Sets of Rapid Advice, Nov 2009

  28. New 2010 WHO Guidelines Adult ART; PMTCT; HIV and Infant Feeding http://www.who.int/hiv/en/

  29. Risk of Mother-to-Child HIV Transmission Background transmission risk:15-45% 15-30% Risk during pregnancy and delivery 10-20% Additional risk postpartum via breastfeeding Transmission risk with interventions: 20-30% No breastfeeding 15-25% Short-course ARV + breastfeeding 5-15% Short-course ARV, no BF <5% 2010 interventions, BF <2% 2010 interventions, no BF

  30. PMTCT ARV Recommendations Refer to Two Key Approaches • Lifelong ART for HIV-positive pregnant women in need of treatment • Prophylaxis, or short-term provision of ARV's, to prevent HIV transmission from mother to child • During pregnancy • During breastfeeding (if breastfeeding is the best infant feeding option)

  31. How long to breastfeed? In the presence of ARV interventions breastfeeding can continue to 12 months • avoids many of the complexities associated with stopping breastfeeding • provides a safe and adequate diet for infants 6-12 months of age

  32. Research Questions Important operations research needed in the context of the new guidelines • Safety of starting and stopping triple ARV prophylaxis • Safety of extended prophylaxis during breastfeeding • Comparison of Option A and Option B • Improved access to CD4 testing • Improved monitoring of regimens • Assessment of proposed strategies to provide ART (lifelong) to all HIV-infected pregnant women • Outcome measures, PMTCT impact at national level

  33. Implementation Challenges • Successful implementation of the new guidelines depends on: • Universal HIV testing and counseling for pregnant women • Availability of CD4 testing and ARVs at primary care level and in ANC where most maternal-child health care takes place, not just in specialized clinics • Integration of PMTCT and MNCH; PMTCT and ART • Improved follow-up of pregnant women antenatally and of mothers and HIV-exposed infants after birth • Ability to provide prophylaxis to the mother or baby throughout breastfeeding • Health systems strengthening • Enhanced M&E, including impact assessment

  34. Support for Country Implementation New guidelines need to be linked with active support for country adaptation, implementation and evaluation • Regional workshops • Support through Global Fund and PEPFAR • Active IATT partner support at country level • Tools for adaptation and implementation: Adaptation guide, FAQs, core slide set, M&E guide, monitoring of country progress, sharing of country guidelines, IMAI/IMPAC

  35. Guiding Principles • Women (including pregnant women) in need of ARV for their own health should get life-long ART • Antenatal CD4 is critical for decision-making about ART eligibility • Interventions should maximize reduction of vertical transmission, minimize side effects, and preserve future HIV treatment options • Unify antepartum and postpartum approaches; strengthen mother and infant follow up • Effective postpartum ARV-based interventions for all women will allow safer breastfeeding practices • Different options may be appropriate in different settings

  36. Summary: Benefits and Opportunities • Revised 2010 guidelines – new norms and standards for highly effective interventions to: • Improve health of the mother • Decrease mother-child HIV transmission • Improve HIV-free survival • Reduce transmission to <5% in breastfeeding populations and <2% in non-breastfeeding populations • Make significant progress towards virtual elimination of paediatric HIV

  37. THANK YOU • WHO:Tin TinSint, Ying-Ru Lo, Nigel Rollins, Gottfried Hirnschall, MTCT Unit • UN partner agencies: UNICEF, UNAIDS, UNFPA • Expanded IATT partners: PEPFAR (CDC, USAID), GFATM, EGPAF, ICAP, FHI, CHAI, and many others New recommendations available at: http://www.who.int/hiv/en/

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