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WHO PMTCT ARV Guidelines 2012 Programmatic Update EFV During Pregnancy Nathan Shaffer PMTCT Technical Lead, WHO IATT Webinar 11 July, 2012.

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Presentation on theme: "WHO PMTCT ARV Guidelines 2012 Programmatic Update EFV During Pregnancy Nathan Shaffer PMTCT Technical Lead, WHO IATT Webinar 11 July, 2012."— Presentation transcript:

1 WHO PMTCT ARV Guidelines 2012 Programmatic Update EFV During Pregnancy Nathan Shaffer PMTCT Technical Lead, WHO IATT Webinar 11 July, 2012

2 PMTCT Programmatic Update April, 2012 http://www.who.int/hiv/en http://www.who.int/hiv/topics/mtct/en/i ndex.html English, French, Spanish, Portuguese NOT formal new guidance, but interim update/ new directions Response to new developments interest by countries in B+ strong interest in streamlining, simplifying, harmonizing PMTCT and ART regimens and programmes

3 Major Changes in Context Global Plan and bold EMTCT targets New evidence for ARV treatment as prevention (TasP) Increasing country experience with operational and programme challenges with both Options A and B, and challenges linking PMTCT and ART Proposal by some countries (eg. Malawi) to move to "Option B+" Launch of Treatment 2.0 Initiative – to simplify and optimize ARV regimens and service delivery Decreasing cost of ARV drugs

4 Comparison of Options A, B and B+

5 What PMTCT ARV Options Have Countries Chosen? Most high burden countries in east and southern Africa initially chose Option A –Cost considerations –Continuity with 2006 approach (short-course AZT prophylaxis) –Limited ability to provide ART in MNCH settings Lower prevalence countries in west Africa tended to choose Option B Option B+ -- Malawi, Rwanda, others In most regions outside Africa: Option B Currently, active reconsideration of options by many countries, especially in east and southern Africa (eg. Kenya, Mozambique, S. Africa, Zambia, et al.)

6 PMTCT Progammatic Update: Key Messages Time to reassess PMTCT options Option B and B+ have key advantages –Better assure women in need of ART receive treatment (not dependent on early CD4 test) –Simplified regimen, same ARVs throughout the PMTCT continuum –Harmonization with ART programmes –Benefits beyond PMTCT, especially B+ –Simpler for programmes, simpler for health care workers, simpler for patients

7 Advantages of B+ Simplification of regimen and service delivery and harmonization with ART programmes Once daily, single-pill, FDC: TDF/3TC/EFV –Need to assure ART delivery in MNCH settings (task-shifting, coordination with ART programmes) –Not dependent on CD4 testing for initial decision: prophylaxis vs. treatment Protection against MTCT in future pregnancies Prevention against sexual transmission to serodiscordant partners Avoiding stopping and starting ARV drugs Benefit to the mother's health of early ART

8 PMTCT Progammatic Update: Key Messages More countries reassessing and moving to B and B+ Key unknowns need further research and implementation experience –Acceptability, adherence, retention, drug resistance, safety (during pregnancy and long-term exposure during BF), impact on prevention… Simpler, but no easy fix

9 Key Issues and Concerns Service delivery in MNCH settings and supply chain –All MNCH/PMTCT sites now become ART sites –Task-shifting for nurse-initiation of ART Adherence and retention –Successful completion of regimen through BF –Linkage and continuation in ART programmes Pharmacovigilance –Safety, especially with EFV, but also TDF –Tolerability Drug resistance Funding, support, sustainability

10 New Guidelines: Couples T&C (2012) Including ARVs for Treatment and Prevention in Serodiscordant Couples ANC and PMTCT setting important entry for couples T&C New evidence from HPTN 052: 96% decrease in transmission in serodiscordant couples High rates of serodiscordance in many settings (10-50%) New Rec: Provide ART, regardless of "eligibility" for the HIV+ partner in serodiscordant couple

11 Technical update on Treatment Optimization Use of Efavirenz During Pregnancy (June 2012) Addresses concerns of EFV safety in pregnancy Overview of key evidence (safety, tolerability and efficacy) Reviews clinical and programmatic advantages compared with NVP; decreasing cost Findings Available safety, efficacy data and programme and operational considerations provide further support for use of EFV as part of first line optimized ART regimen, including for pregnant women Key advantage of EFV as part of FDC: TDF/3TC/EFV

12 Comparison: EFV vs NVP

13 Looking to the (near) Future 2013 Consolidated, Integrated ARV Guidelines WHO reassessing best methods for developing, presenting and supporting normative guidelines for ARVs Key principles: –Unify previously separate guidelines –Normative, clinical, operational, programmatic –Address treatment as prevention Goal: formal guidelines revision mid 2013 Key changes anticipated for pregnant women and PMTCT

14 Looking to the (near) Future: B+ Evidence Needs for WHO 2013 Guidelines Evidence and Lessons for Other Countries Acceptability to women Adherence and retention Linkages with ART Implementability Impact -- –Mother’s health –Vertical transmission –Prevention of sexual transmission

15 Thank You!


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