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Leonardo Palombi and Maria Cristina Marazzi
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Transcript of Leonardo Palombi and Maria Cristina Marazzi
TAP Program Mozambique TAP Program Mozambique DREAM, DREAM, Experience under the TAP:
ART regimen for PMTCT and PMTCT+
Treatment Acceleration ProgramTreatment Acceleration ProgramLearning from the experiences gained and the challenges Learning from the experiences gained and the challenges
aheadaheadNovember 30, 2006November 30, 2006
Leonardo Palombi and Maria Cristina Marazzi
The Central Question:Are optimal standards of care unsustainable?
816
2863
5037
6669
0
1000
2000
3000
4000
5000
6000
7000
2002 2003 2004 2005-2006*
Enrolled patients by year in MozambiqueTotal: 15,385
* March 2006
TAP Cohort
548
1592
26673062
0
500
1000
1500
2000
2500
3000
3500
2002 2003 2004 2005-2006*
Patients receiving HAART in Mozambique by year
TOTAL 7,869
* March 2006
TAP Cohort
DREAM FrameworkDREAM Framework
Nationwide Public Health program encouraging cooperation with Nationwide Public Health program encouraging cooperation with faith-based NGOs and local NGOs faith-based NGOs and local NGOs
Full package of care, free – of - charge: Full package of care, free – of - charge: Educational and social supportEducational and social support VCTVCT HAART (from late Feb 2002)HAART (from late Feb 2002) treatment of OI, STI, Malariatreatment of OI, STI, Malaria nutritional evaluation & supplementationnutritional evaluation & supplementation Mother & Child Prevention & Care (MCPC)Mother & Child Prevention & Care (MCPC) Overall Informatics ManagementOverall Informatics Management
run by Community of Sant’ Egidio, comprehensive agreement run by Community of Sant’ Egidio, comprehensive agreement with Ministry of Healthwith Ministry of Health
Training courses locally and internationally for M.D.s, Training courses locally and internationally for M.D.s, technicians, biologists, nurses, social workers, activiststechnicians, biologists, nurses, social workers, activists
The African patient profileThe African patient profile
•Malnourishment•TB•Malaria•Anemia•Parasitosis
•Poverty•Poor access to health centers
•HIV Clade C
People in sub-Saharan Africa on antiretroviral People in sub-Saharan Africa on antiretroviral treatment treatment
as percentage of those in need, 2002–2005as percentage of those in need, 2002–2005
20022003
2004
2005
7.2Source: WHO/UNAIDS (2005). Progress on global access to HIV antiretroviral therapy: An update on “3 by 5.”
Achieving AdherenceAchieving Adherence
Predisposing Cultural FactorsPredisposing Cultural Factors Increasing patient knowledge about the disease and treatment, etc. Increasing patient knowledge about the disease and treatment, etc.
Enabling – Organizational FactorsEnabling – Organizational Factors Free access to HAARTFree access to HAART and to OI treatment and to OI treatment
Reinforcing – Participative FactorsReinforcing – Participative Factors Employment of activists in the programmeEmployment of activists in the programme
Achieving AdherenceAchieving Adherence
77,4%
22,6%
<18,5>18,5
90,9%
9,1%
<18,5>18,5
Day Hospital of Machava (Matola, Mozambique)
BMI distribution patterns in 296 patients along 24 months
93,9%
6,1%
<18,5>18,5
18 months T1 BMI<18.5: 9.1%
6 months T2 BMI<18.5: 6.1%
Observation T0 BMI<18.5: 22.6%
70,3%
2,7%
27,0%
<88<10>10
91,2%
8,4%0,3%
<88 < 10>10
Day Hospital of Machava (Matola, Mozambique)
Hb levels in the same cohort
95,9%
4,1%0,0%
<88 < 10>10
HB<8: 2.7%HB<10: 27%
HB<8: 0.3%HB<10: 8.4%
HB<8: /HB<10: 4.1%
6,8%
93,2%
<400>400
< 400 copies/ml< 400 copies/ml >400 copies/ml>400 copies/ml
276276 2020
Day Hospital of Machava (Matola, Mozambique)
Viral load at the final observation
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5
10
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2002 2003 2004 2005 2006
TestEquipment
Cost of Viral Load (b-DNA) unit analysis by year
USD
Involving patients in the care process….
Mulheres para o dream
Major limitations of an Major limitations of an exclusively preventive approach exclusively preventive approach
- MTCT- MTCT High refusal and drop out High refusal and drop out
ratesrates Severe limitations Severe limitations
resulting from low access resulting from low access rate to health centersrate to health centers
Unsafe breastfeedingUnsafe breastfeeding Increased number of viral Increased number of viral
resistance mutationsresistance mutations No protection for mothersNo protection for mothers
23/704 (3.2%) 1 month after delivey
11/704 (1.5%) 1-6 months
after delivery
Refused: 83/999 (8.2%)
65/916 (7.1%)Before delivery
Refusal - Drop outRefusal - Drop out
Accomplished the protocol: 81.2%)
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
0
10
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%
plasma breast milk plasma breast milk
T0 (delivery) T7 (7 days postpartum)
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
Non-HAART Group B
HAART Group A
1,7
2,7
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dia
n H
IV R
NA
log
/ml
plasma whole milk milk lipid layer skim milk
T0 (delivery)
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dia
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IV R
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log
/ml
plasma whole milk milk lipid layer skim milk
T7 (7 days postpartum)
Viral load in breast milk: comparison of HAART (A) and non-HAART (B) Groups at delivery and after 1 week
Non-HAART Group B
HAART Group A
Breastfeeding vs FormulaBreastfeeding vs Formula
Evaluation at first monthEvaluation at first month
HIV+HIV+
N.(%)N.(%)
HIV-HIV-
N.(%)N.(%)
TotalTotal
BreastfeedingBreastfeeding 2 (0.6)2 (0.6) 339 (99.6)339 (99.6) 341341
FormulaFormula 7 (0.9)7 (0.9) 802(99.1)802(99.1) 809809
A new approach – Month 1
Breastfeeding vs FormulaBreastfeeding vs Formula
Evaluation at sixth monthEvaluation at sixth month
HIV+HIV+
N.(%)N.(%)
HIV-HIV-
N.(%)N.(%)
BreastfeedingBreastfeeding 0(/)0(/) 78(100)78(100) 7878
FormulaFormula 15(1,8)15(1,8) 794 (98,2)794 (98,2) 809809
A new approach – Month 6
HIV status by parity at 1 HIV status by parity at 1 monthmonth
ParityParity
TotalTotal P1P1 P2P2 P3 P3
HIV+HIV+ 22 00 00
22
HIV-HIV- 286286 5050 33
339339
TotalTotal
288288 5050 33
341341
Malnourished and anemic children in the Malnourished and anemic children in the breastfed cohortbreastfed cohort
0
1020
3040
5060
7080
90100
YES NO
MalnourishedAnemic
NVP Toxicity in the DREAM CohortNVP Toxicity in the DREAM Cohort
NN IncidenceIncidence
Hepatic Hepatic reaction reaction
38/606*38/606* 6,3%6,3%
SJSSJS 8/7788/778 1.1%1.1%
Skin RushesSkin Rushes 17/77817/778 2.2%2.2%
NVP Toxicity in the DREAM CohortNVP Toxicity in the DREAM Cohort
* Women with at least 2 ALT/AST results available
ResistancesResistances
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 detectableCROI, Boston 2005
Distribution by HAART lineDistribution by HAART line
First line: First line: 4,855 (87,08%)4,855 (87,08%) First line Tox.mod:First line Tox.mod: 316 (5,66%) 316 (5,66%) Second line:Second line: 405 (7,26%) 405 (7,26%)
92,74% of patients are still in first line 92,74% of patients are still in first line with a median time of more than 2 with a median time of more than 2 yearsyears
DREAM costsDREAM costs
Total program: 4,350,000 USD
Cost per patient per year: 540 USD
DREAM costsDREAM costsHAART Population last update 2006HAART Population last update 2006
Cost distributionCost distribution::
ItemsItems TotTotPer Per paxpax Perc.Perc.
ARV TreatmentARV Treatment$1,999,6$1,999,6
8080 250250 46%46%
ARV Treatment 1° lineARV Treatment 1° line$1,540,7$1,540,7
2525 $204.5$204.5
ARV Treatment 2° lineARV Treatment 2° line $458,955$458,955 $987$987
ReagentsReagents $684,800$684,800 $86$86 16%16%
PersonnelPersonnel $662,200$662,200 $83$83 15%15%
FoodFood $400,000$400,000 $50$50 9%9%
Fixed costsFixed costs $245,000$245,000 $31$31 6%6%
Expatriate personnelExpatriate personnel $120,000$120,000 $15$15 3%3%
Training of personnelTraining of personnel $80,000$80,000 $10$10 2%2%
Administrative and logistical costsAdministrative and logistical costs $75,000$75,000 $9$9 2%2%
Testing ActivitiesTesting Activities $48,000$48,000 $6$6 1%1%
$4,314,6$4,314,6
8080 $539$539
Cost-effectiveness of PMTCT Cost-effectiveness of PMTCT programprogram
Premise:Premise:
Data gathered at the DREAM centre for PMTCT of Matola in MozambiqueDuration of program: 3 yearsWomen tested: 6175HIV-positive women: 1862 (30%)Women who joined the program: 1594Protocol followed: HAART from 25° week to six months after deliveryAll costs are considered, including ARV treatment just for the period from initiation of therapy to six months after deliveryUNAIDS indications for cost-effective analysis were followed
Results:Results:Total cost of 3 year programTotal cost of 3 year program $333,774,48$333,774,48
Reduction of riskReduction of risk 71.89%71.89%
Cost per infection avertedCost per infection averted $486,19$486,19
Cost per DALY savedCost per DALY saved $17,83$17,83
Public sector perspectivePublic sector perspective
Total cost of 3 year programTotal cost of 3 year program $58,593,46$58,593,46
Cost per infection avertedCost per infection averted $123,51$123,51
Cost per DALY savedCost per DALY saved $4,53$4,53
Cost-effectiveness of PMTCT Cost-effectiveness of PMTCT programprogram
Results:Results:Total cost of 3 year programTotal cost of 3 year program $333,774,48$333,774,48
Reduction of riskReduction of risk 71.89%71.89%
Cost per infection avertedCost per infection averted $486,19$486,19
Cost per DALY savedCost per DALY saved $17,83$17,83
Public sector perspectivePublic sector perspective
Total cost of 3 year programTotal cost of 3 year program $58,593,46$58,593,46
Cost per infection avertedCost per infection averted $123,51$123,51
Cost per DALY savedCost per DALY saved $4,53$4,53
Cost-effectiveness of PMTCT Cost-effectiveness of PMTCT programprogram
Variables considered in the model
Sensitivity analysis
Cost-effectiveness of PMTCT Cost-effectiveness of PMTCT programprogram
Independent variables inserted in the Independent variables inserted in the modelmodel
Life expectancy without AIDS in MozambiqueLife expectancy without AIDS in Mozambique 52.652.6
Discount rate on future benefits (DALY saved)Discount rate on future benefits (DALY saved) 3%3%
Discount rate on future costsDiscount rate on future costs 3%3%
Postnatal transmission rate of HIV without Postnatal transmission rate of HIV without interventionintervention 0.3590.359
DREAM transmission rate at one monthDREAM transmission rate at one month 0.0380.038
Discount on costs due to further benefits of VCT*Discount on costs due to further benefits of VCT* 30%30%
* 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.
Sensitivity analysis:Sensitivity analysis:
Cost-effectiveness of PMTCT Cost-effectiveness of PMTCT programprogram
BaseBaseRate discount Rate discount DALY 0%-6%DALY 0%-6%
Rate discount Rate discount costs 0%-6%costs 0%-6%
Rate discount VCT Rate discount VCT 15%-45%15%-45%
Cost per infection Cost per infection avertedaverted $486,19$486,19 $486,19$486,19 $486,19$486,19 $500,63$500,63 $472,83$472,83 $590,38$590,38
$382,0$382,011
Cost per DALYCost per DALY $17,83$17,83 $9,72$9,72 $28,22$28,22 $18,36$18,36 $17,34$17,34 $21,65$21,65 $14,01$14,01
Savings sick Savings sick children public children public sectorsector
Cost per infection Cost per infection avertedaverted $123,51$123,51 $123,51$123,51 $123,51$123,51 $138,14$138,14 $109,98$109,98 $229,05$229,05 $17,98$17,98
Cost per DALYCost per DALY $4,53$4,53 $2,47$2,47 $7,17$7,17 $5,07$5,07 $4,03$4,03 $8,40$8,40 $0,66$0,66
HAART in pregnancy...HAART in pregnancy...
Is effective and the results are Is effective and the results are independent from the setting of independent from the setting of deliverydelivery
Makes possible the breastfeadingMakes possible the breastfeading Present a very limited life-Present a very limited life-
threatening risk and the hepatic threatening risk and the hepatic toxicity seems, in a large cohort, to toxicity seems, in a large cohort, to be limitedbe limited
HAART in pregnancy...HAART in pregnancy... Is well accepted by the patients: Is well accepted by the patients:
80% of the invited women 80% of the invited women completed the protocolcompleted the protocol
Is associated with a decreased rate Is associated with a decreased rate of viral resistance compared with of viral resistance compared with single dose nevirapinesingle dose nevirapine
Is cost-effectiveIs cost-effective