The Chilean AIDS Cohort ChiAC: Impact of an expanded access program to HAART in survival and risk fa

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The Chilean AIDS Cohort (ChiAC) Impact of an
expanded access program to HAART in survival and
risk factors for mortality in a treatment naïve
population

• Beltrán C., Wolff M. , Vásquez P., Berna L.,
  Carreño J., Toro C., Chahín C.
• Chilean AIDS Study Group, Santiago, Chile

mwolff_at_sidachile.cl cabel_at_sidachile.cl
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• This work has been financed by grants from the
  Global Fund to Fight AIDS, Tuberculosis and
  Malaria and the National Fund for Health Research
  (FONIS)

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• Expanded access program (EAP) to AIDS therapy is
  being implemented worldwide.
• Chile has such a program since 2001
• and as of 7/2004 4,452 patients had begun
  HAART 100 coverage was reached in late 2003 in
  the Public Health System (PHS).
• By 7/2005 6,000 are in HAART under EAP
• A new law guaranties universal access
• regardless of the health care system in charge
  of the assistance

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The Expanded Access Program to ART
The Model
National Commission of AIDS CONASIDA
ARV resolution
ARV orders
Advisory group
Pharmaceutical companies
ARV requests
Na tional AIDS Treatm ent
Guidelines
ARV shipment
AIDS Center 1
AIDS Center 2
AIDS Center 3
AIDS Center 32
ARV delivery
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The Chilean AIDS Cohort ChiAC

• A network of health care providers from AIDS care
  centers from the PHS contributes to homogeneous
  follow up of these patients in an observational
  prospective cohort (ChiAC).
• Information is exchanged through internet
• By 7/2004 CHiAC-1 had enrolled 4,365 pts (98 of
  all those under HAART in the PHS at that time)
  from 29/32 centers

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Chilean AIDS Cohort ChiAC
29/32 AIDS centers in the public health system
are participating (Chilean AIDS Study
Group) 98 (4,365) of all patients treated under
the Expanded Access Program have been
enrolled (ChiAC) 2/3 of patients are from the
Central Metropolitan Area (Santiago) 30
of centers are staffed by especialists
(infectious disease physicians or
immunologists Patients who have received at
least 1 dose of HAART under the EAP
are members of ChiAC
Punta Arenas
www.sidachile.cl
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Objective

• To assess the survival impact of the Expanded
  Access Program to HAART in a treatment naïve (Tx
  nv) population from a national cohort and to
  evaluate baseline characteristics as risk factors
  for mortality.

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Methods

• Prospective follow up and review of ChiAC
  database.

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Population composition
?
?
Tx naïve 2,103
Presented here
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Baseline AIDS defining events (ADE) rate
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Treatment naïve patients Baseline information
N 2,103
Median age group 35-39 years 15 women
94 acquired by sexual transmission
Clinical AIDS
CD4 12
Treatment regimens in 2,103 treatment naïve
patients

• Backbone therapy
• AZT 3TC 83.9
• 3TC d4T or ddI or abacavir 10.1

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Results

• Median follow up time 784 days
• 322 patients had endpoints
• 143 (6.8) died (2/3 of them in the first 6
  months)
• 179 (8.5) discontinued initial therapy
• By 12/31/2004
• 1,781 patients had completed 6 months of therapy
• 1,685 patients had completed 12 months of
  therapy
• 976 patients had completed 24 months of therapy
• 1,341 (of those still in treatment remained on
  the initial regimen

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Time to death after starting HAART
61,5 of deaths within first 6 monts, 15 after 12
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Survival of treatment-naïve patients
Percent
Months
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Global mortality according to baseline CDC stage
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Global mortality according to baseline immune
status
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Conclusions

• Expanded access program to state of the art
  antiretroviral therapy in a middle-income country
  has been successful in terms of survival in an
  advanced-disease population.
• Significant higher mortality was observed only in
  clinically severe disease (AIDS) or severe
  immunodepression.
• A national cohort model may contribute both, to
  the evaluation of such a program and to its
  overall success

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Our sincere and deep recognition to the members
of the Chilean AIDS Study Group

• Carlos Gallo, Roxana Galvez, David Wachter,
  Patricia Sarabia, Marcela de Andraca, Patricia
  Pavez, Patricia Carrasco,Lorena Berna, Carmen
  Aguayo, Marisol Ayala, Viviana Turi, Luis Montes,
  Eduardo Hermosilla, Gladys Varela, M. Eugenia
  Madariaga, Erna Ripoll, Elizabeth Barthel, M.
  Inés Sánchez, M. Teresa de Mateo, Werner Jensen,
  Rodrigo Ahumada, Alvaro Covarrubias, Luis
  Bavestrello, Sylvia Gómez, A. Burdiles, P.
  Rodas, Katty Zúñiga, Marcelo Wolff (coordinator),
  Rebeca Northland, Teresa Bidart, Jeanette
  Dabanch, Claudia Bustamante, Patricia Alvarez,
  Ingrid Flores, Patricia Vásquez, Marisol Bustos,
  Claudia Ledesma, Juan Ballesteros, Alexis
  Diomedi, Rinna Ortega, Jeannette Sobarzo, Jorge
  Pérez, Martín Lasso, Ana M. Fernández, Aurora
  Garín, Enna Zunino, Laura Bahamondes, Patricia
  Olea, Lucía Aguad, M. Moreno, Cristian
  Montenegro, C. Valdés, Margarita Enberg, J. López
  de Maturana, R. Pizarro, M. Quezada, Gregorio
  Ramírez, Johanna Bravo, Erika Molina, Carlos
  Beltrán (coordinator), Ricardo Morales, David
  Gallardo, J.M.Arancibia, Amalia Adasme, Miguel
  Valenzuela, Johanna Huerta, Diana Yanine, Silvia
  Arredondo,Manuel Amigo, Mauricio Maturana, M.
  Angélica Olivares, Luis Uribe, Eugenia Rodríguez,
  Ricardo Vásquez, Eva Woldarsky, Elizabeth Daube,
  Rodrigo Blamey, M. Eugenia Cancino, M. Elena
  Novoa, José Carreño, M. Isabel Mendoza, Carolina
  Chahín, Claudia Molina, Mario Calvo, Mónica
  Hering, Alicia Rebolledo, Jorge Mardones, Sara
  Villalobos, Iván Becerra, Ana M. Sáez, Carmen
  Toro, Lucía Atala, Stanko Karelovic and Tatiana
  Navarro.
• Alejandra Valdovinos, Angélica Carrasco, Luis
  Villarroel and Omar Morales (staff)

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Our sincere and deep recognition to the members
of the Chilean AIDS Study Group
www.sidachile.cl
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Our major recognition and appreciation

• To the 4,365 patients in the 5,000 kilometer
  long network
• Thanks

Punta Arenas