Antiretroviral Treatment of Mothers: interrupting vertical

transmission

Dr Angela MushaviNational PMTCT and Pediatric HIV Care and Treatment

CoordinatorMinistry of Health and Child Care, Zimbabwe

Antiretroviral Treatment in RLSIAS, Melbourne

21/07/2014

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

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

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

Evolution of WHO PMTCT ARV Recommendations

2001 2006 20102004 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 <200 CD4 <350 CD4 <500

Move towards: more effective ARV drugs, extending coverage throughout MTCT risk period, and ART for the mother’s health

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

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

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

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)

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

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

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

Phasing of ImplementationPhased 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 deliveryi. Early sites: those already delivering ART (n~700)ii. Late sites: those not yet delivering ART (n~860)

Option B+ Implementation Phasing

Launch Event: November 2013

Interim Review and Program Adjustment

Post-Rollout Review

Early Implementation Phase (500 sites By February 2014)

Late Implementation Phase(All sites by November 2014)

Preparation Phase: September 2013

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

Acknowledgements

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