1. Integrating ART/PMTCT services into MNCH services to enhance test & treat strategy for HIV infected pregnant and lactating women (Option B+) WHO Satellite Symposium

2. Rationale for Option B+ As a resource limited country, we had challenges with WHO options A & B: Lack of CD4 capacity in most health facility High fertility levels in Malawi (5.6) – will lead to stop start strategy for ART High postpartum mortality in HIV infected women and hence their children, even with CD4>350 compared to non-infected women 1 HPTN 052 study results supported the Malawi strategy as it is part of treatment as prevention (TasP) strategy to reduce transmission between discordant couples 2 1 Hargrove et al., Declining HIV prevalence and incidence in perinatal women in Harare, Zimbabwe, Epidemics. 2011 June 2 HPTN 052 and the future of HIV treatment and prevention, Lancet. 2011 Jul 16

3. Implications of scaling up integrated PMTCT/ART (Option B+)

4. Option 1: Full Implementation from July 2011 1.Universal ART (TDF/3TC/EFV) for HIV infected pregnant/lactating women (Option B+) 2.Raise CD4 count threshold from 250 to 350 3.Move all children to new paediatric regimen (AZT/3TC/NVP) 4.Move all adults from d4T/3TC/NVP to TDF/3TC/EFV 5.Provide Depo-Provera and condoms in ART/PMTCT clinics

5. Option 2: Phased Approach Provide TDF for certain groups of people with proven benefits (an option due to lack of funds): 1. New HIV infected Pregnant & lactating women not on ART (Option B+) 2. New TB/HIV co-infected patients not previously on ART 3.Current patients on d4T (30 mg)/3TC/NVP, who have developed severe lipodystrophy 4.General population continue to initiate on d4T/3TC/NVP

6. Phased approach Cont’d 1.Raise CD4 count threshold from 250 to 350 2.Move all children to new paediatric regimen: AZT/3TC/NVP 3.Phase out d4T/3TC/NVP Junior & Baby in children 4.Provide Depo-Provera and condoms in integrated ART/PMTCT clinics

7. Total GF Phase 2 Budget Ceiling = $177.3 M AVAILABLE RESOURCES Area OPTION 1 Year 1-2 OPTION 2 Year 1-2 OPTION 3 Year 1-3 ARVs 160.892.497.1 OI/STI/Lab 16.8 25.4 Other 60.0 Total 237.6169.2182.5 RCC Phase 2 177.3 Variance -60.3+8.1-5.2

8. Interventions 1.Integrate ART services into the MCH services using option B+ (ART for life using TDF/3TC/EFV regardless of CD4/WHO staging for pregnant & lactating women – target 750 sites) 2.Integrate Family planning into ART/PMTCT services (prong 2 of PMTCT strategy) i.e. Depo-Provera & condoms Integration of ART and PMTCT services has simplified and streamlined the Procurement and Supply Management system in terms of training providers, ART forecasting, quantification, procurement, distribution, supervision as well as M& E

9. Progress so far At National level: - Integrated the National ART & PMTCT technical working groups (TWGs) to plan the integration - The TWG developed new integrated ART/PMTCT policy guidelines, approved by MOH - The TWG developed integrated ART/PMTCT guidelines & curriculum for training of providers - The TWG developed a National integrated ART/PMTCT clinical mentoring programme.

10. Mile stones for integrated PMTCT/ART implementation Policy guideline developed & approved by MOH New integrated ART/PMTCT Guidelines developed (including Pre-ART, EID & T, exposed infant follow up) Training curriculum developed and trainings started (120 TOT trained & over 4,250 current providers trained so far) Procurement & distribution of new ARVs (TDF/3TC/EFV & AZT/3TC/NVP pediatric formulation) started August 2011 Clinical mentoring program developed and 356 clinical mentors trained

11. Achievements Over 323,638 (73%) are alive & on ART out of 443,594 ever initiated on ART 25,161 (8%) are on 5A (TDF/3TC/EFV) 81% of our patients are still on Triomune (d4T/3TC/NVP) 3,894 pregnant and lactating women were initiated on TDF/3TC/EFV in Q3 2011, and 14,017 in Q4 2011 as per new guidelines (Option B+). 10,865 HIV exposed children and 14,609 pre-ART patients enrolled for follow-up in HIV Care clinics

12. 323,504

15. Challenges Human Resources: Only about 20% of sites fulfill minimum staffing norm despite task shifting Infrastructure: Lack of adequate and secure storage space for drugs and test kits, consultancy rooms, etc. Supply chain management: Increased number of sites to quantify and distribute HIV commodities (including ARVs is a major challenge) Adherence: Counseling of same intensity as for ART is required in option B+ Funding: Inadequate funding for full implementation of the guidelines

16. Key Considerations Integration of ART and PMTCT services has simplified and streamlined the PSM system in terms of training, forecasting, Quantification, procurement, distribution, supervision and M& E The health systems are strengthened by removing differences between PMTCT and ART providers, and increasing provider flexibility Integration of ART & PMTCT at all levels simplifies the implementation of Option B+