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Leonardo Palombi and Maria Cristina Marazzi

TAP Program Mozambique DREAM, Experience under the TAP: ART regimen for PMTCT and PMTCT+ Treatment Acceleration Program Learning from the experiences gained and the challenges ahead November 30, 2006. Leonardo Palombi and Maria Cristina Marazzi. The Central Question:

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Leonardo Palombi and Maria Cristina Marazzi

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  1. TAP Program Mozambique DREAM, Experience under the TAP: ART regimen for PMTCT and PMTCT+Treatment Acceleration ProgramLearning from the experiences gained and the challenges aheadNovember 30, 2006 Leonardo Palombi and Maria Cristina Marazzi

  2. The Central Question: Are optimal standards of care unsustainable?

  3. Enrolled patients by year in Mozambique Total: 15,385 TAP Cohort * March 2006

  4. Patients receiving HAART in Mozambique by year TOTAL 7,869 TAP Cohort * March 2006

  5. DREAM Framework • Nationwide Public Health program encouraging cooperation with faith-based NGOs and local NGOs • Full package of care, free – of - charge: • Educational and social support • VCT • HAART (from late Feb 2002) • treatment of OI, STI, Malaria • nutritional evaluation & supplementation • Mother & Child Prevention & Care (MCPC) • Overall Informatics Management • run by Community of Sant’ Egidio, comprehensive agreement with Ministry of Health • Training courses locally and internationally for M.D.s, technicians, biologists, nurses, social workers, activists

  6. The African patient profile • Malnourishment • TB • Malaria • Anemia • Parasitosis • Poverty • Poor access to health centers • HIV Clade C

  7. People in sub-Saharan Africa on antiretroviral treatment as percentage of those in need, 2002–2005 2005 2002 2003 2004 Source: WHO/UNAIDS (2005). Progress on global access to HIV antiretroviral therapy: An update on “3 by 5.” 7.2

  8. Achieving Adherence

  9. Achieving Adherence Predisposing Cultural Factors • Increasing patient knowledge about the disease and treatment, etc. Enabling – Organizational Factors • Free access to HAART and to OI treatment Reinforcing – Participative Factors • Employment of activists in the programme

  10. BMI distribution patterns in 296 patients along 24 months Observation T0 BMI<18.5: 22.6% 18 months T1 BMI<18.5: 9.1% 6 months T2 BMI<18.5: 6.1% Day Hospital of Machava (Matola, Mozambique)

  11. Hb levels in the same cohort HB<8: 2.7% HB<10: 27% HB<8: 0.3% HB<10: 8.4% HB<8: / HB<10: 4.1% Day Hospital of Machava (Matola, Mozambique)

  12. Viral load at the final observation Day Hospital of Machava (Matola, Mozambique)

  13. Cost of Viral Load (b-DNA) unit analysis by year USD

  14. Involving patients in the care process….

  15. Mulheres para o dream

  16. Major limitations of an exclusively preventive approach - MTCT • High refusal and drop out rates • Severe limitations resulting from low access rate to health centers • Unsafe breastfeeding • Increased number of viral resistance mutations • No protection for mothers

  17. Refusal - Drop out Accomplished the protocol: 81.2%)

  18. TRIPLE ANTIRETROVIRAL PROPHYLAXIS ADMINISTERED DURING PREGNANCY AND AFTER DELIVERY SIGNIFICANTLY REDUCES BREASTMILK VIRAL LOAD • A STUDY WITHIN THE DREAM PROGRAM – • Marina Giuliano, MD,* Giovanni Guidotti, MD, Mauro Andreotti, B.Sc.,* Amerigo Assane, XX, + Maria F. Pirillo, B.Sc.,* Paola Villani, B.Sc.,° Giuseppe Liotta, MD, § Maria Cristina Marazzi, XX, # Maria Grazia Mancini, B. Sc.,* Maria Cusato, Pharm D., ° Paola Germano, XX, ^ Sandra Loureiro, MD, & Susanna Ceffa, B. Sc., @, Mario Regazzi, Pharm D., ° Stefano Vella, MD,* Leonardo Palombi, MD,§ In press

  19. HAART Group A Non-HAART Group B Risk of having a detectable viral load in milk in Non-HAART Group Delivery: OR = 4.8, [CI] : 1.7-13.6 1° Week:OR = 11.7, [CI] = 3.9-34.1

  20. HAART Group A Non-HAART Group B Viral load in breast milk: comparison of HAART (A) and non-HAART (B) Groups at delivery and after 1 week

  21. A new approach – Month 1

  22. A new approach – Month 6

  23. HIV status by parity at 1 month

  24. Malnourished and anemic children in the breastfed cohort

  25. NVP Toxicity in the DREAM Cohort

  26. NVP Toxicity in the DREAM Cohort * Women with at least 2 ALT/AST results available

  27. Resistances 42 unselected women that completed the protocol were assessed for genotypic resistance, in a time period of between 2-6 months after therapy was interrupted: All carried a subtype C strain (more prone to resistance to Nevirapine compared to subtype A and B) 37 (88.1%) showed no mutations associated with resistance 5 (11.9%) carried mutations associated with resistance to Nevirapine 3 : K103N 2 : G190S Resistance to 3TC and AZT-D4T was not detectable CROI, Boston 2005

  28. Distribution by HAART line • First line: 4,855 (87,08%) • First line Tox.mod: 316 (5,66%) • Second line: 405 (7,26%) • 92,74% of patients are still in first line with a median time of more than 2 years

  29. DREAM costs • Total program: 4,350,000 USD • Cost per patient per year: 540 USD

  30. DREAM costsHAART Population last update 2006 Cost distribution:

  31. Cost-effectiveness of PMTCT program Premise: • Data gathered at the DREAM centre for PMTCT of Matola in Mozambique • Duration of program: 3 years • Women tested: 6175 • HIV-positive women: 1862 (30%) • Women who joined the program: 1594 • Protocol followed: HAART from 25° week to six months after delivery • All costs are considered, including ARV treatment just for the period from initiation of therapy to six months after delivery • UNAIDS indications for cost-effective analysis were followed

  32. Cost-effectiveness of PMTCT program Results: Cost-effectiveness of PMTCT program Results: Variables considered in the model Sensitivity analysis

  33. Cost-effectiveness of PMTCT program Independent variables inserted in the model * VCT has benefits that go beyond the birth of children without HIV. Consequently costs sustained that do not influence the results being assessed should be deducted from program costs in the calculation of indicators examined.

  34. Cost-effectiveness of PMTCT program Sensitivity analysis:

  35. HAART in pregnancy... • Is effective and the results are independent from the setting of delivery • Makes possible the breastfeading • Present a very limited life-threatening risk and the hepatic toxicity seems, in a large cohort, to be limited

  36. HAART in pregnancy... • Is well accepted by the patients: 80% of the invited women completed the protocol • Is associated with a decreased rate of viral resistance compared with single dose nevirapine • Is cost-effective

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