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THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND AFTER PREGNANCY Alison Drake, MPH, PhD University of Washington

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Page 1: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND AFTER PREGNANCY

Alison Drake, MPH, PhDUniversity of Washington

Page 2: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

I have nothing to disclose.

Disclosure

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Outline

3. Preventing MTCT

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Novel testing strategies When to test How to test

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Acute maternal infections contribute substantially to mother-to-child HIV transmission (MTCT)

UNAIDS Global Plan, 2016; Johnson LF, JAIDS 2012.

150,000New infections 2015

MTCT 2-23%UNAIDS 2015

50% MTCT2010-2015

46,000-69,00030 - 46%

MTCT attributed to acute maternal HIV

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Temporal shift in MTCT: Increasingly attributed to acute maternal HIV

Figure 2: Johnson LF, JAIDS 2012.

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MTCT: 22.7%

Higher MTCT rates attributed to incident infection in era of ART

Drake AL, PLoS Med 2014.

Low rates in chronic infection

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MTCT rates are underestimated due to acute maternal infections

CHRONIC

ACUTE & MISSED

33% 45%

Njuguna IN, AIDS Patient Care and STDs 2016.

78%

Attend ANC

HIV test

Pregnancy PostpartumPre-conception

+ =

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Contributions to MTCT due to acute infections are high, but relatively small proportion of mothers have new infections

Dinh TH,. PLOS ONE 2015; 10(5): e0125525.

South Africa 2011-2012

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Long cumulative duration for maternal HIV risk

Average life expectancy (yrs) 63

Total fertility rate (per woman)3.9

Years pregnant/lactating (per preg.)1.75

Total years pregnant/lactating6.8

= woman year

= pregnant/lactating

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High maternal HIV incidence rates

INCIDENCEAuthor, year Country Pregnancy Postpartum OverallKinuthia & Drake, 2015 Kenya 3.4 1.4 2.3De Schact, 2014 Mozambique 4.3Dinh, 2015 S. Africa 3.3%

Drake AL, PLoS Med 2014.

Page 11: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

Outline

3. Preventing MTCT Novel testing strategies

When to test How to test

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

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Guidance on timing of repeat testing lacks specificity

Labor

Pregnancy

3rd

trimester

Postpartum

Retesting criteria Concentrated epidemic

Generalized epidemic

3rd trimester, labor, or postpartum

Serodiscordant couple

Member of key population

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Country specific guidelines focus on retesting during late pregnancy and early postpartum

Delivery

Pregnancy

3rd

trimester

1st ANC

Postpartum

2, 6, 10, 14 weeks

6 months 9

months

Page 14: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

No clear “best” time to test based on prospective research

Delivery

Pregnancy Postpartum

3rd

trimester2, 6, 10, 14

weeks6

months 9 months

EnrollmentKinuthia & Drake, AIDS 2015.

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Long potential duration of breastfeeding warrants guidance on postnatal testing

Postnatal transmission (maternal seroconversion)

Antenatal transmission (maternal seroconversion)

Postnatal transmission (maternal chronic infection)

Antenatal transmission (maternal chronic infection)

Adapted from Figure 3b: Johnson LF, JAIDS 2012.

Acute infection: postnatal

transmission contributes

disproportionately to MTCT

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Timing of repeat testing will require balancing maternal and infant risks vs. benefits

Delivery

Pregnancy

3rd

trimester

1st ANC

Postpartum

2, 6, 10, 14 weeks

6 months 9

months

Late favors maternal benefit• detection• prevention

Early favors infant benefit• detection • prevention

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Implementation science approach to determining optimal timing of repeat testing

Delivery (n=930)

Pregnancy Postpartum

3rd trimester(n=930)

6 weeks (n=930)

6 months (n=930)

9 months (n=930)

NIH/NIAID K01 AI116298 (Drake, PI) Retest 4650 women

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Model parameters Country scenarios: Kenya, South Africa, Belarus, Cuba HIV prevalence / incidence Repeat testing: timing, guidelines, practices Behaviors: breastfeeding, condom use, ART initiation/

adherence Assays PrEP

Modeling impact and cost-effectiveness of repeat maternal testing for PMTCT

Page 19: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

Outline

3. Preventing MTCT Novel testing strategies

When to test How to test

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

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Barriers to repeat implementation of repeat testing

Rogers AJ, BMC Pregnancy and Childbirth 2016.

Individual

Late ANC presentation

Low ANC completion rates

Provider

Heavy workload

Time constraints

Difficulty checking repeat test eligibility

Facility

Inconsistent ANC volume

Lack of private space for testing

Alternative delivery systems may expand coverage and

reach

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What approaches are acceptable and feasible for repeat maternal testing?

Choose:Home, self test

ORClinic, blood test

Follow-up

Pregnancy Postpartum

3rd trimester OR 6 weeks 14 weeks1st ANC

RETEST

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Thirumurthy H, Lancet HIV 2016.

Peripartum women are willing to distribute self-tests to male partners

Half of women self-tested with their partner

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Kenya first country to nationally roll-out self-testing

Resources to support roll-out Hotline Website

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WHO endorses self-testing

Page 25: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

Delivery approaches in use for PMTCT Partner-

delivered

Service delivery approaches for self-testing

Integrated (reproductive

health)

PrEP

Facility (pick-up

/self-test)

Vending machines /

kiosks

Workplace

Adapted from Figure 2.5, 2016 WHO self-testing guidelines

Pharmacy

Community (door to

door)Internet

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Outline

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Novel testing strategies When to test How to test

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Safety data on tenofovir suggest PrEP is safe during pregnancy and lactation

Page 28: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

WHO technical brief on PrEP during pregnancy and breastfeeding

Population Additional considerations

Pre-conception for women:• Serodiscordant relationships• Unknown partner status• Partner unwilling to test

• “Bridge to partner viral suppression”

Adolescents•Requires additional supportfor information & adherence

•Consent may be barrier

Pregnant and postpartum women with substantial HIV risk

PrEP is safe and effective

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Outline

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Novel testing strategies When to test How to test

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PrEP implementation should maximize prevention while minimizing unnecessary exposure

Sero-discordance

Risk based

Universal (Opt-in)

Conservative

Anti-conservative

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Potential strategies to identify PrEP eligibility during pregnancy and lactation

100

2613

100

37 37

61

130

0

20

40

60

80

100

Universal HIV prevalence based Risk based

%

PrEP CoverageOffered PrEP (All)

Offered PrEP (high-risk)

Unnecessary

Universal HIV prevalence Risk

Pintye J, CROI 2017.

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Kenya well poised to evaluate PrEP during pregnancy and lactation

Page 33: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

Outline

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Novel testing strategies When to test How to test

Page 34: THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING ...regist2.virology-education.com/2017/9HIVped/24_Drake.pdf · THE FINAL FRONTIER FOR eMTCT: ACUTE HIV INFECTION DURING AND

PrEP screening tools

Pintye J, CID 2017.

Rapid Assessment Screening Tool (RAST)

Partner• HIV status• Violence

Sex• Unprotected• Forced• Trade

STI

Post-exposure prophylaxis

Sharing needles

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Outline

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Safety and efficacy Eligibility Screening tools Innovative evaluations

Background on impact of acute maternal HIV on efforts to achieve eMTCT

Novel testing strategies When to test How to test

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Ongoing evaluations testing approaches to PrEP delivery in Kenya

PrEP counseling guided by risk score in high prevalence

Universally offer

(including age 15-17)Offer PrEP based on partner self-test

PrEP counseling guided by risk score in high prevalence

Universally offer

Offer PrEP based on partner self-test

+ risk score

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Conclusions

3. Preventing MTCT

1. Primary prevention in women

Novel testing strategies can help, but need: Guidance on timing of retesting Evaluations of new delivery systems

Oral self-, partner, and home-based testing

Increasing need to focus upstream on PrEP Safe and effective to use Current projects will guide implementation

Acute maternal HIV contributes substantially to MTCT

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Future directions

3. Preventing MTCT

1. Primary prevention in women

Pre-exposure prophylaxis (PrEP) Counseling messages & tools Maternal adherence support Female controlled prevention

Acute maternal HIV contributes substantially to MTCT and must be addressed to achieve eMTCT

Novel testing strategies Counseling messages & tools Delivery systems & task-shifting Economic evaluations

4. Preventing unintended pregnancies

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2015Cuba

2016ArmeniaBelarusThailand

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Acknowledgements

Grace John-StewartKenneth SherrAnjuli Wagner David KatzRuanne BarnabasCarol LevinJillian PintyeShiza Farid

NIH/NIAID K01 AI116298UW CFAR NIA P30 AI27757Global Center for Integrated Health of Women, Adolescents, and Children (Global WACh)Kenya Research & Training Center (KRTC)World Health Organization (WHO)

John KinuthiaDaniel MatemoRuth NduatiPeter Cherutich