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)
Peds needing ART (2012):
Adult HIV prevalence has gone up-maybe due to the effect of ART on mortality-and increased survival of PLHIV
New pediatric HIV infections are going down due to scale-up of PMTCT services
Sour11 & MOHCW HIV estimates 2012 3

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
2001
2004
2006
2010
Launch
July 2013
PMTCT
4 weeks AZT; AZT+ 3TC, or SD NVP
AZT from 28 wks + SD NVP
AZT from 28wks + sdNVP +AZT/3TC 7days
Option A
(AZT +infant NVP)
Option B
(triple ARVs)
Option B or B+
Moving to ART for all PW/BF
ART
No recommendation
CD4 <200
CD4 <350
CD4 <500
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