The promises & challenges of universal ART for women in southern Africa: Option B+ and beyond. Landon Myer

Transcription

1 The promises & challenges of universal ART for women in southern Africa: Option B+ and beyond Landon Myer 6 th International Workshop on HIV & Women 21 February 2015

2 Overview 1) Background Where are we? 2) The promise of universal ART views from Option B+ 3) The challenges of Option B+ 4) Looking forward where we need to go

3 1. Background Where are we?

4 Where are we? Several years experience implementing policies of lifelong ART for all HIV+ pregnant & postpartum women ( Option B+ ) in southern Africa Malawi 2011 South Africa 2015 New global policies calling for universal ART for all HIV+ individuals (women, children & men) What are the lessons from Option B+ implementation that may foreshadow universal ART?

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6 Total population (millions) Adult general population HIV+ (%) HIV+ pregnant women annually (n) Maternal mortality ratio (per ) Infant mortality rate (per 1000) Health expenditure per capita (US$) Swaziland % Lesotho % South Africa 54 16% Zambia 15 12% Namibia % Botswana % Zimbabwe 14 17% * Mozambique 25 11% Malawi 18 10% UK % USA % Sources: UNICEF; World Bank

7 ART PMTCT PMTCT Guidelines have evolved weeks AZT; AZT+ 3TC, or SD NVP No recommendation AZT from 28wks + SD NVP AZT from 28wks + SD NVP + AZT/3TC for 7 days Option A (AZT + infant NVP) or Option B (triple ARVs) Option B or Option B+ ART for all PW/BF Option B+ (ART for all) CD4 < 200 CD4 < 200 CD4 < 350 CD4 < 500 ART for all Over time shift towards: more effective ARV regimens, extending coverage throughout MTCT risk period, and recognising ART for the mother s health

8 . and lifelong ART for all pregnant & postpartum women is standard policy UNAIDS 2015

9 Universal ART access for all HIV+ individuals is around the corner.

10 2. The promise of universal ART - views from Option B+

11 Numbers of women starting ART in pregnancy increase CDC MMWR 2013

12 Magnitude of increase varies Keiffer JAIDS 2014

13 ART initiation simplifies & Delays to initiation decrease Malawi Zimbabwe South Africa Malawi Kim JAIDS 2015 Tenthani AIDS 2015 Dzangare TM&IH 2016 Myer JAIDS 2015

14 P r o p o r tio n o f a ll p o s itiv e te s ts fr o m d iffe r e n t s e ttin g s O v e r a ll % o f in fa n ts n e w ly d ia g n o s e d H IV + Mother to child transmission drops Proportion of all positive HIV PCR tests from different clinical settings and decreasing HIV positivity rate in the Western Cape province, South Africa, % % a ll n e w H IV + fro m ro u tin e p rim a r y c a re E ID % a ll n e w H IV + fr o m h o s p ita l p r e s e n ta tio n p o s t-b ir th % o f a ll n e w H IV + fr o m b irth te s tin g P e rc e n t n e w ly d ia g n o s e d H IV % Option B+ Begins in the Western Cape mid % 8 % 6 0 % 6 % 4 0 % 4 % 2 0 % 2 % 0 % 0 % Y e a r Maritz CROI 2016 #782 CROI 2016 oral LB#35

15 % 90% 80% 70% 60% 50% 40% 30% 20% 10% In SA: up to 80% of HIV+ women will enter antenatal care previously initiated on ART under Option B+ by 2020 Increasing population coverage of ART in women of reproductive age 0% Gugulethu data Current guidelines, pessimistic Current guidelines, optimistic Option B+ Option B+, WHO guidelines Universal ART Johnson, personal communication

16 Long-term maternal health should improve across CD4+ cell counts ANRS TEMPRANO NEJM 2015 INSIGHT START NEJM 2015

17 Declines in maternal mortality Tanzania: 8% reduction in maternal mortality for each additional month on ART before pregnancy Malawi & Mozambique: increasing duration of pre-pregnancy ART use reduces postnatal mortality independent of CD4 & BMI Li AOGS 2014 Liotta PLoS ONE 2013

18 Health systems costs & sexual transmission should be reduced * * Not much empirical data (understandably) * Many modelling efforts; all assumption-laden Ishikawa PLoS ONE 2014 Khanna PLoS ONE 2015 Van Deusen BMC ID 2015 Gopalappa AIDS 2014 Binghwayo PloS ONE 2013 Ciaranello CID 2013

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21 3. The challenges of implementing Option B+

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23 ART adherence may decline postpartum Pregnancy status Antepartum Postpartum 75.7% (71.5,79.7) 53.0% (32.8,72.7) Antiretroviral therapy ZDV sdnvp cart 79.0% (70.2,86.6) 78.6% (73.5,83.4) 63.5% (55.8,70.8) Adherence measure Pharmacy Pill count Self-report Blood drug concentration 73.0% (20.4,70.4) 73.0% (60.7,83.7) 72.2% (70.2,78.1) 72.6% (66.6,78.2) Proportion adherent (%) Nachega AIDS 2012

24 MCH-ART cohort (n=620) 28% of women missed dose in pregnancy under Option B+ ART side effects in pregnancy are common and strong predictors of non-adherence Side effect (SE) Frequency in pregnancy (%) OR for nonadherence P-value Any SE 95% GIT SE 77% 2.42 <0.001 CNS SE 82% Skin/mucosal SE 29% Systemic SE 75% 2.75 <0.001 Phillips CROI 2015

25 Increased disengagement from ART programmes after delivery Under Option A Common finding that women initiating ART in pregnancy more likely to be lost to follow-up vs nonpregnant women starting ART for their own health Rotheram-Borus AIDS 2015 Kaplan AIDS 2010 Phillips JIAS 2014 Clouse TM&IH 2013

26 Retention in care may worsen under universal ART Malawi: ~ women starting ART, Compare women starting ART (Option B+) while pregnant vs breastfeeding, vs ART initiation own health Pregnant and breastfeeding women more likely to be lost to programmes vs women starting ART for own health Jahn IAS 2015 Abrams CROI 2016 #34

27 What patient factors contribute to non-adherence & loss to follow-up? Risk factor data heterogeneous, highly contextual Younger, recent HIV diagnosis, unintended pregnancy ART readiness? Partner involvement? Disclosure? Qualitative evidence more insightful Policies may be universal, but patients are not Tweya TM&IH 2014 Mattheson JIAS 2014 Clouse JAIDS 2014 Price STI 2014 Hoffman CROI 2016 #792

28 How to provide universal ART Surging interest in models of care for delivering universal ART during pregnancy & postpartum What features of services can address women s needs & promote adherence/retention? How to deliver ART at scale & with efficiency in severely resource-limited health systems? Tailoring services to women s needs Health systems constraints

29 Ideas galore Enhanced patient education & counselling? Ongoing engagement of women in MCH setting? Enhanced peer support on ART? Increased male partner involvement? Integration of MCH and ART services? Text message reminders / mhealth? Multicomponent intervention packages? Conditional cash transfers? Case manager systems? Foster JAIDS 2014 Mwapasa JAIDS 2014 Schwartz MCHJ 2015 Yotebieng Lancet HIV 2015 Herlihy JAIDS 2015 Rosenberg Lancet HIV 2015 Aliyu CROI 2016 #790 Fayorsey CROI 2016 #791

30 Example: Impact of service delivery model on retention Health facility survey in facilities with integrated HIV services in South East Health Zone, Malawi pregnancies annually, 15% HIVinfected Aims: Describe the diversity of approaches to service organization (models of care) for the delivery of Option B+ Explore associations between the model of care and program indicators at health facility level, including retention on ART Van Lettow JIAS 2014

31 Van Lettow JIAS 2014

32 Design of services impacts on outcomes 10-20% of women defaulted Option B+ before 6 months postpartum Defaulting associated with District location Patient volume Model of Care Option B+ retention is lowest in facilities with ART initiation in ANC, then referral for separate follow-up Van Lettow JIAS 2014

33 4. Looking forward where do we go from here?

34 Promises & challenges Policies for universal ART carry massive opportunities to alter the impact of HIV in southern Africa Potential benefits unravelled by long-term non-adherence & disengagement from care Preliminary data from Option B+ suggests retention may be low, at least in high burden settings

35 Researchers will always recommend more research Individual-level questions Why do some patients disengage from care, and others are retained over the long-term? What factors can we promote through interventions? Health systems & services issues What approaches to delivering care maximise health outcomes with lowest cost and greatest coverage? Balance individualised vs public health approaches

36 We know that implementation matters

37 We know that implementation matters Policy Implementation Policies for universal ART are only as useful as the programmes and services that implement them

38 With thanks to. Elaine Abrams Leigh Johnson Jean Maritz James McIntyre Lynne Mofenson Tamsin Phillips Thank you!