Antiretroviral Treatment of Mothers: interrupting vertical transmission

1. Antiretroviral Treatment of Mothers: interrupting vertical transmission Dr Angela Mushavi National PMTCT and Pediatric HIV Care and Treatment Coordinator Ministry of Health and Child Care, Zimbabwe Antiretroviral Treatment in RLS IAS, Melbourne 21/07/2014

2. Outline of Presentation • Background data for Zimbabwe • About the PMTCT Program • Choice of PMTCT regimen • The process of regimen selection for PMTCT • Transition to Option B+ • Summary

3. Background of Zimbabwe Total population: 13mil (2012) PLHIV: 1,4mil; of whom 156, 718 are children 0-14years* Adult HIV prevalence 15%* ANC HIV prevalence 16.1%*MTCT rate: 18% (Spectrum 2011); 8.8% from 2012 survey New pediatric HIV infections are estimated at 6,843* (90% from MTCT) Adult need for ART (2014) 955 922 Peds needing ART (2012): 100 561 Sour11 & MOHCW HIV estimates 2012

4. The National PMTCT Program • PMTCT started as a 3 site pilot in 1999 • PMTCT program rolled-out in 2002-to date 1560 sites (95%) offer PMTCT services • Initially using only single dose of Nevirapine • Transitioned to 2006 WHO guidelines in 2009 • Implementing Option A of the 2010 WHO guidelines since 2011 • February 2013: Stakeholders’ Consultation recommends Option B+-fully adopted after country WHO guideline adaptation process • Roll-out ongoing since late 2013

5. Evolution of WHO PMTCT ARV Recommendations Launch July 2013 2001 2004 2006 2010 Move towards: more effective ARV drugs, extending coverage throughout MTCT risk period, and ART for the mother’s health

6. Choosing a PMTCT Regimen: B or B+ • WHO PMTCT Programmatic Update released in April 2012 • MOHCC convened Stakeholder Consultation on B/B+ Feb 2013 • Consultation attended by Dr Chirwa from Malawi MOH (B+) and Dr Martha from EGPAF Rwanda-started on B; now moving to B+ • Participants were unanimous in recommending Option B+ • These included the Director AIDS and TB Unit, Director Family Health, D/Director SRH, program managers and officers from the AIDS and TB Program, Nutrition, Directorate of Pharmacy, Provincial and District staff, City Health Directorates, Academics, PLWHIV, Civil society, donors and implementing partners

7. Consolidated guidelines development process • Process led by National Medicines and Therapeutics Policy Advisory Committee (NMTPAC)-responsible for Essential Medicines List for Zimbabwe (EDLIZ) including ARVs • Following attendance of the WHO 2013 Guideline Dissemination Meeting in Pretoria, the AIDS and TB Unit and NMTPAC constituted a WHO 2013 National Adaptation Steering Committee (multidisciplinary including PLHIV) • The Steering committee had 3 sub-committees • Adult and Adolescent ART • eMTCT and Pediatric HIV • HIV Prevention including HTC • Stakeholder consultations and consensus building workshops • National guidelines produced and launched Nov 2013

8. Adapting WHO 2013 Guidelines on PMTCT • Option B+ is lifelong ART for HIV positive pregnant and lactating women irrespective of clinical stage or CD4 count • Benefits of B+ • No need for CD4 count before starting B+ • No interruption of triple ART ‘’avoid a start-stop-start-stop approach’’ • Simpler to implement • One regimen for all-non-pregnant populations and pregnant women • Easier to harmonize with the treatment program • Covers future pregnancies esp with high fertility

9. Advantages of Option B+ • More paediatric HIV infections are averted-cost saving • Better health outcomes for the mother-through earlier ART • Prolonging the life of the mother improves the chances of survival for her HIV exposed infant (irrespective of HIV status) • Benefits in the case of sero-dicordant couple (TasP)

10. Issues of to address • Readiness and willingness to adhere to lifelong ART throughout ANC, delivery and beyond • Tracking of M-B pairs and keeping them in care • Inconvenience of lifelong treatment • What happens to HIV positive male partners of women on Option B+?? • Costs associated with FDC-TDF/3TC/EFV • Risks of ART-toxicity, resistance and drug interactions

11. Policy questions for Option B+ • Review scope of practice of nurses to allow ART initiation • ART within MCH and not just at specific OI/ART clinics to minimize delays and missed opportunities • ART decentralization for adults and children, and moving to family centred care • Storage and distribution of ART drugs

12. Summary of Key Issues for Option B+ • Effectively integrating ART/PMTCT/MNCH at all levels • Preparing sites rapidly while retaining quality • Adequate training/supervision to decentralize ART • Newly engaging communities to support retention • Adapting existing distribution systems to Option B+ • Meeting new data needs including revision of tools to become B+ compliant

13. Phasing of Implementation Phased approach • Preparation and two implementation phases • Necessary to manage existing Option A stocks • Timing of implementation dependent on site readiness as determined at provincial level • Timing of ART initiation generally based on current status of ART delivery • Early sites: those already delivering ART (n~700) • Late sites: those not yet delivering ART (n~860)

14. Option B+ Implementation Phasing Preparation Phase: September 2013 Launch Event: November 2013 Early Implementation Phase (500 sites By February 2014) Interim Review and Program Adjustment Late Implementation Phase (All sites by November 2014) Post-Rollout Review

15. Summary • Option B+ adopted in Zimbabwe-rapid roll-out to all sites by end 2014 • Benefits for women and children, towards eMTCT by 2015 • Equity issues for male partners who test HIV positive-proposed ‘’Option B+M’’; and for women who opt-out of Option B+ • Pharmacovigilance critical

16. Acknowledgements • MOHCC and AIDS and TB Unit • Provincial and District Officers • NAC • Implementing partners • Multilateral agencies • Donors • CSOs and PLHIV