Title: The Challenge of HAART in the Caribbean Eyes Wide Shut or Eyes Wide Open
1The Challenge of HAART in the Caribbean Eyes
Wide Shut or Eyes Wide Open
- Bernard Liautaud, Moïse Desvarieux, Roland
Landman, André Cabié, Sylvie Abel et Pierre Marie
Girard
Intrepide Group Centre Hospitalier
Universitaire de Fort de France Division of
Epidemiology, School of Public Health,University
of Minnesota Institut de Médecine et
dÉpidémiologie Africaine, Hôpital Bichat/Claude
Bernard, Paris Service de Maladies Infectieuses
et Tropicales, Hôpital St Antoine, Paris
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6Once-a-day HAART in treatment-naïve HIV-infected
adults in Senegal
- Feasibility of antiretroviral evaluation in
Senegal - Long term efficacy with high rate of virological
and immunological responses in a population of
patients with advanced immune deficiency and high
viral load at baseline. - High compliance as assessed by PK study and
patient questionnaire and virological success
Roland Landman et al, AIDS, 17, 1017-1022, 2003
7The gap between access and need
8Declaration of President Nelson Mandela
We have failed to translate our scientific focus
into action where it is most needed in the
communities of the developing world, the poorIts
our belief that the single most imporant step we
must now take is to provide access to treatment
throughout the developing world. There is no
excuse for delay !!!!
Opening ceremony, IAS, 2nd Conference on AIDS,
July 13-16 , 2003 Paris, France
930.000 deaths/year people in need of HAART
10ART in the Caribbean Bahamas
- Prevalence 3,5, urbanized p. 89
- 2002 350 HIV under bi-therapy Only mother
and children and costs 3600/pt/year - 2003 1200/6000 HIV under triple therapy Cost
of Triple therapy 200/pt/year, provided free
of charge
Perry Gomez, a success story, 2002 Laurie
Garet, Newdays.com, 2004
11ART in the Caribbean Bahamas
12ART in the Caribbean Barbados
- Prevalence 1,2
- 106 new cases (57,1 B or C) in 2002
- Reinforcement Aids program 2001
- Financing World Bank
- Modern ambulatory care unit Ladymead Reference
Unit (LRU) - Comprehensive care (including ART, Counselling,
Adherence)
N. Adomakoh, SA Adomakoh et al TC Roach et al
IAS, 2nd Conference on AIDS, July 13-16 , 2003
Paris, France
13ART in the Caribbean Barbados
- ART started in 2002
- April 2003 236 beneficiaries
- Included for evaluation 83
- Median cell CD 4 183/µl (52lt200)
- AZT/3TC/EFV 60,5
- AZT/3TC/IDV 12,8
N. Adomakoh, SA Adomakoh et al TC Roach et al
IAS, 2nd Conference on AIDS, July 13-16 , 2003
Paris, France
14ART in the Caribbean Barbados
- Adherence rate gt95 at 28 week 85
- 69 viral load ND at 4-6months
- Median cell CD4 100 cell/ml
N. Adomakoh, SA Adomakoh et al TC Roach et al
IAS, 2nd Conference on AIDS, July 13-16 , 2003
Paris, France
15ART in the Caribbean Barbados
Results 2002 vs 2001 43 Aids related
mortality 59 number of hospital
admissions/year 40,8 hospitalization
cost/pt 29,9 hospital days 27,8
days Outpatient visits 128
N. Adomakoh, SA Adomakoh et al TC Roach et al
IAS, 2nd Conference on AIDS, July 13-16 , 2003
Paris, France
16GHESKIO Research-based Model
17THE PROBLEM
- Estimated Haitian Population 8.500.000
inhabitants - 652 health facilities with the 1/3 in capital
periphery. - HIV national prevalence 4.5 (2000)
- ( rural 2.91 urban 6.74)
- 300.000 PLWHIV 160.000 AIDS orphans
- GHESKIO unique urban VCT with free services for
STI/AIDS
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19The GHESKIO VCT urban model with integrated
services
STI Management
Post-HIV exposure Counseling and HAART
Pre-test Counseling HIV, Syphilis, Tuberculosis
Post-Test Counseling
Same day TB screening / Rx / Px
Reproduction Health Services (family planning and
prenatal care) HIV women Prevention HIV MTCT
with HAART
- Care to HIV infected individual/ affected family
- OI Rx/Px
- HAART to HIV positive women in MTCT with
- CD4 count ? 200
- Nutritional support
- Psychosocial support
Rx Treatment Px Prophylaxis
20GHESKIOs population for HAART (2002)
- Already requiring treatment 600
- New persons coming for HIV testing 3000/year
- New population requiring HAART 1017
- Total adult population requiring HAART 1617
patients
21The MSPP/GHESKIO extension project to small
cities
- Develop with Ministry of Health 27 VCT centers
throughout the country (15 from public / 12 from
private sector), 10 being centers of excellence - Association public sector / private sector.
- Availability of integrated services
STI/HIV/TB/FP - Direct beneficiaries 250.000 persons
22Interaction of VCT in health facilities
GHESKIO / MSPP
Groupe III
9
8
Groupe I
10
Groupe II
7
(Zami la sante)
6
5
4
3
NIPPES
1
2
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24 Zami la Sante Rural Model Project
Boucan Carré Clinic, before extension of DOT-HAART
Boucan Carré Clinic, after extension
25DOT-HAART Model Zami la Sante Directly
observed therapy for HIV/AIDS
- 450 patients under HAART with everyday
follow-up - One accompagnateur attached to every patient
- The accompagnateur (commonly a community health
promotor) observe all drug take - Triage of patients priority to who were most
seriously ill
Paul Farmer et al, 2nd Conference on AIDS, 10th
Conf on Retroviruses d Opportunistic Infections,
Febr 2003
26DOT-HAART Model Zami la Sante Directly
observed therapy for HIV/AIDS
- 2 year mortality rates (100 patients, 1999-2003)
Paul Farmer brought immense hope among the rural
patients with no access to ARV treatment
Paul Farmer et al, 2nd Conference on AIDS, 10th
Conf on Retroviruses d Opportunistic Infections,
Febr 2003
27CISIH
28Comprehensive Health Care Management
MARTINIQUE/French Hospital-based Model
AIDS hot line 24/24hrs
The Patient
Domestic chores and home help
Regular in-patient hospitalisation
29EVOLUTION DES STRATÉGIES THÉRAPEUTIQUESCISIH
Martinique
30SURVIVAL RATES AFTER AIDSCISIH Martinique
Before 1996 (n 254) 24 months Survival
0.452 Since 1996 (n 161) 24 months Survival
0.734 LOGRANK p lt 0.0001
SINCE 1996
Before 1996
(months)
31Why HAART in the Caribbean? Ethical principles
of justice and equity
- But how will justice be respected on launching
HAART programs urban vs rural population on
which criteria should patients be selected for
treatment, lottery or positive discrimination - HIV pregnant women ?
- patients participating in research ?
- patients eating at least 2 times a day ?
- patients living not too far from medical sites ?
- Patients prone to adherence ?
- What clinical/lab criteria should be use to
qualify patients for HAART if lacking basic
health care facilities?
32Why HAART in the Caribbean Ethical principles
of justice
- But allocating resources, do justice should
refer only to HIV? What about malnutrition,
diarrheal diseases, mother and child mortality,
vaccinations programs... ? - Should not each country/territory participate in
protecting its own future (Incoming generations)
as well as other peoples future against
developpement of HIV resistant variants to ARV ?
33Resistance to ARV in developed Countries (1995-199
8 compared to 1999-2000 S. Little et al)
- frequency of high-level resistance to one or more
drugs increased from 3.4 to 12.4
- frequency of multidrug resistance increased from
1.1 to 6.2 - frequency of resistance mutations detected by
sequence analysis increased from 8.0 to 22.7
S. Little, S. Holte, JP Routy et al. N Engl J
Med, Vol. 347, No. 6 August 8, 2002
34Resistance to ARV in France (1996-2000, Chaix et
al, AIDS, 17, 2635-2643, 2003)
- genotypic drug resistance mutations in primary
HIV infections stable around 10 - (vs British cohort with resistance mutations
detected in 27 in 2000) - increase of non B subtypes from 10.6 to 19
35Resistance to ARV in developing Countries
- Ivory Cost 57 of resistance to at least one
drug among 68 patients with prior exposure to ARV
(Adje C. Et al, 2001) - 19 to gt40 of resistance mutations associated
to Nevirapine 6-8 weeks after exposure to single
dose of Nevirapine for MTCT prevention (Eshleman
S. et al, 2001 Martinson et al, 2004)
36Resistance to ARV in the Caribbean
- In Martinique primary resistance documented (gt
10) and transmission of up to 8 drug-resistant
viruses observed (G. Dos Santos) 1.5 to 2 of
patients in therapeutic deadlock - Barbados experiencing first virological failures
on 2nd and 3rd line therapy (16 drugs available)
37Robert Gallo director of the U.S.-based Institute
of Human Virology
- Obviously it is critical to get available drugs
to developing nations as quickly as possible, but
not just to throw this at them," Gallo,, told
Reuters. ...the danger of failure is very real in
a few years if the drugs are just dumped there," - "We've got to have infrastructure created at the
same time because we are going to create
multi-drug resistant mutants if we don't."
"Nobody talks about that...the danger of failure
is very real in a few years if the drugs are just
dumped there," - "There'll be great happiness with the drugs being
made available, as I would see the future, for
two to five years and then we're going to start
seeing problems if it is not done right."
(Reuters, 2003)
38Bill Blattner Institute of Human Virology,
University of Maryland
The epidemic of drug resistance may rob mankind
of its best hope and create an even greater
tragedy
CREDHAC meeting, Ponce, Puerto-Rico, Feb 29-30,
2004
39How Much Adherence is enough? Correlation
Between Adherence and Virologic Failure
(n) patients with virologic failure
gt95 90-95 80-90 70-80 lt70
Adherence ()
D Paterson et al. 6th Conference on Retroviruses
and OIs, Chicago, February 1999 Abstract 092.
40Why HAART in the Caribbean? Increasing of Local
and International funding Global Funds WHO 3x5
Target, Pres. Bush initiative
- But 95 price reduction is still too high for
majority of patients, and reduction do not
include other costs lab tests for follow-up,
medication for OI, nutrition supplementation.... -
41Why HAART in the Caribbean? Increasing of funding
- But How Health care authorities will manage the
discrepancy between the budet dedicated to
HIV/STI programs and others aimed at other public
health priority programs emerging problems with
disparity of salaries between Aids and non-AIDS
health care workers in Haiti (VCT workshop,
P-au-P, Nov 5-7 and Nouvelliste, Nov 11, 2003) - which proportion of STI/HIV budget will stay
attributed to prevention programs and to
treatment and care? -
42Why HAART in the Caribbean? Increasing of funding
- But Promoting VCT must benefit patients how
long can we be waiting between promoting HIV
screening in all sites and availability of HAART?
- Improving lab facilities for diagnosis and
follow-up of ARTshould be balanced with
investments necessary in basic laboratories
(hematology, biochemistry, immunology) they are
necessary for detection of side effects of HAART
as well as for improving general care to all
patients with or without AIDS
43Determinants of therapy outcomeDiscontinuation
of HAART in naive patients (n862)
Toxicity 58.3
Failure 14.1
Non-adherence 19.6
Italian Cohort
Other 8.0
I
C
O
N
A
Naive Antiretroviral
Monforte et al. AIDS 200014499-507
44- ARV prescription must be limited to care
centers possessing the necessary technical means
(drug logistics, trained staff, laboratory
facilities...).
Dakar 2000 recommendations
45- ARV Treatment and follow-up Minimum .Blood
cell count .Transaminase .Serum
creatinine .Urinary strip . CD4 cell
count
Dakar 2000 recommendations
46Why HAART in the Caribbean? Increasing of funding
- But Necessity to take into account the lack of
electrical power in some country and related
expenses - Refrigeration is required not only for lab
reagents but also for storage of some ARV
(Ritonavir, Lopinavir/r) which should not be
prohibited in developing countries, since they
appear to be a key power-related factor in
prevention of drug resistance
47Why HAART in the Caribbean? Centers of Excellence
- Among the best research and care centers in the
Americas in the field of STI/HIV prevention
programs and care of opportunistic infections
(Gheskio Centers, Zanmi la Sante in Haïti) - Same for Puerto Rico, the French territories
(DFA), Barbados, Bahamas, Trinidad and Tobago,
Cuba, Dominican Republic, Jamaica - They can exchange experiences and provide Help to
other countries
48Why HAART in the Caribbean? Centers of Excellence
- But limited application of research outputs on
the general population (for ex TB prevention) - Human resources too scare regarding the national
challenge lack or training programs to cope with
this public health disaster - Clinics already overwhelmed with number of
patients and lack of space to deliver acceptable
quality of care to patients
49HAART in the Caribbean some conditions for succes
- Access to HAART is ethically mandatory and should
be free of charge - No way Caribbean peoples should be deprived of
ARV because developed countries fear the increase
of HIV variants resistant to ARV - Imperious necessity to set up a national team
with the highest technical expertise
50HAART in the Caribbean some conditions for succes
- 4. Strategies for preserving the future (1) a
common ethical issue for all neighbouring
countries - appropriate management of ARV strong procurement
storage plans for continuous availability of
medications (first and second line is a minimum) - design of locally adapted guidelines for
efficient ARV regimens
51HAART in the Caribbean some conditions for succes
- 4. Strategies for preserving the future (2)
- Specific plans for adherence a condition for
funding ART programs - Monitoring of drug resistance at the population
level (sequential samplings)
52HAART in the Caribbean some conditions for succes
- 5. Implementation of HAART can and must be done
in a phased approach first in limited pilot sites
with qualified human ressources, then expanded
ASAP today it is still a technical and complex
issue - 6. A switch from individual and hospital-based
approach to public mass therapy program
clinical/community based approach may fit some
places
53HAART in the Caribbean some conditions for succes
- 7. Implementation must be carefully monitored
through reliable reports of outcomes and ensure
that a policy for drug disappearance is not
substituted to a policy of treatment - 8. Take steps now to launch infrastructures and
training programs necessary to extend HAART
through the National VCT programs and open access
to all persons in need as quickly as possible.
Improve now access to palliative care and OI
treatment (reduction of costs)
54HAART in the Caribbean some conditions for succes
- 9. Special programs promoting confidentiality
and compassion to every PLHIV and fighting
stigmatisation clearly informing population that
ARV access do not resolve the HIV epidemic - Sustainability of national programs should depend
on economical growth of the country and
comprehensive development of health care
facilities. - In 1989, L. Manigat one Haitian Candidate to the
Presidency promised to every haitian access to
one full meal a day....How will we manage to
promote 95 compliance to ARV regimen?
55Non! Fok je nou toujou byin Kalé
?
56EYES WIDE SHUTby Stanley Kubrick
Alice (Nicole Kidman) to Bill Hartford (Tom
Cruise) The Important thing is were awake
now, and hopefully for a long time to
come Limportant est que nous soyons maintenant
réveillés, et espérons le pour très longtemps