ART-LINC: Background

Background

The Benefits of Antiretroviral Treatement

Antiretroviral therapy, or modern HIV treatment (also called HAART, or Highly Active Antiretroviral Treatment), has prolonged and improved the lives of hundreds of thousands people in the world. Its benefits are now finally starting to be extended to resource-constrained settings where 90% of people living with HIV/AIDS live. However, in spite of massive scale-up efforts, as of June 2005, only an estimated 12% of people in urgent medical need were receiving treatment. Nevertheless, this represents roughly one million people, and monitoring the effectiveness and safety of antiretroviral medications is crucial, both for the best clinical management of patients, and on a programmatic level to best inform the continued roll-out of treatment.

New Research Collaboration

In 2003, funding was provided by the National Institutes of Health (NIH) Office of AIDS Research and the French Agence National de Recherches sur le SIDA (ANRS) to set up a research collaboration among HIV treating clinics in Africa, Latin America, and Asia. The purpose of this ‘operational research collaboration’ is to identify what works, what doesn’t work, and why, with regards to the delivery and consumption of antiretrovirals. The Principal Investigators are Prof. Francois Dabis (University of Bordeaux, France), Prof. Matthias Egger (University of Bern, Switzerland), and Prof. Mauro Schechter (Universidad de Rio de Janeiro, Brazil).

Definition of the participating Countries

The specific objectives of the collaboration are to define the effect on survival in people initiating HAART in resource-constrained settings, to compare that effect with survival in high income settings, and to describe program-level factors that influence survival. The main criterion for participating in the ART-LINC Collaboration was that a clinic had to be in a low or middle income country, treating people with HIV, and prospectively and electronically be collecting basic clinical data on their patients. Potential sites were identified through contacting people presenting research at international conferences, and through personal contacts of the PI’s. A total of 31 centres in 18 lower income settings were contacted. Twenty-three agreed to participate and 18 sent data, together representing 8714 patients from Africa (Botswana, Burundi, Cameroon, Democratic Republic of the Congo, Cote d’Ivoire, Kenya, Malawi, Morocco, Nigeria, Rwanda, Senegal, South Africa, and Uganda), Brazil (2 centres), Thailand and India. The database was closed at the end of 2004, and the data are from the period 2003 and before.

Introduction of HAART

HAART was introduced earliest in Brazil and India (1996), then West and North Africa (1997-1999), Thailand (2000), and East and Southern Africa (2001). Most of the centres (n=9, 39%) were publicly funded clinics or clinics set up by a non-governmental organization (NGO) (40%). The remaining sites were private-for-profit clinics. The average number of patients being treated with HAART in a clinic was 542, although it ranged from 70-3,000. Most treated children as well as adults. In nine centres treatments were paid for by the government; 16 reported having access to generics. How much patients had to pay, if anything varied. 12 programmes (52%) charged an average of $31 US per month, 14 for CD4 counts at an average cost of $23.5 US; while viral load testing was available in 17 (74%) of centres, it was expensive. As a result, only 22% of patients in ART-LINC had both a CD4 and viral load measure both at baseline and at 6-months following HAART initiation. Eleven centres provided completely free treatment and care (or charged a locally minimal fee).

Eligibility criteria and treatment regimens were generally consistent with the guidelines of the World Health Organization. 41% of all prescriptions were for d4T, 3TC, and nevirapine, but were given as separate drugs (i.e. not in a fixed dose regimen) is 22% of all prescriptions.

Patients Data

Of the 8,734 patients for whom any data were transferred, only 81% had completely recorded age and sex, start of HAART date, and had at least one follow-up visit. The vast majority of patients (92%) were treatment naïve when they started HAART (i.e. they had never before received any antiretroviral treatment). Compared to treatment naive patients, those people who had previously received antiretroviral treatment were more likely to be male, to have received treatment before 2002, and to have gone to private clinics.

Only 75% of people had a documented baseline CD4 count. People with a CD4 measure at baseline were more likely to be women, and to be attending public clinics and receiving free care.

One of the key findings is that the more recently people start treatment, the less likely they are to have a documented baseline CD4, the less likely they are to have any follow-up, and the more likely they are to be lost to follow-up. These data suggest that clinic infrastructures (including laboratory processing, data entry, and following up missing patients) may not be able to keep up with the rate that new patients are starting HAART.

Follow up

There is much that the ART-LINC Collaboration may be able to contribute. The current phase of the collaboration (November, 2005) has over 40 centres participating, including the MTCT+ Network, and over 40,000 patients from roughly 20 countries. Although large, it may not be representative. For example, there are few clinics from rural areas participating, and in order to participate in the collaboration, clinics had already to be electronically collecting data, and so may overrepresent ‘centres of excellence’. There are approximately 15% of patients who are lost-to-follow-up; not knowing what is happening to patients makes it impossible to conduct high impact research into clinical outcomes.

For more information, please contact ART-LINC-Info.

	Antiretroviral Treatment in Lower Income Countries Collaboration A collaboration of the International epidemiological Databases to Evaluate AIDS
	Background The Benefits of Antiretroviral Treatement Antiretroviral therapy, or modern HIV treatment (also called HAART, or Highly Active Antiretroviral Treatment), has prolonged and improved the lives of hundreds of thousands people in the world. Its benefits are now finally starting to be extended to resource-constrained settings where 90% of people living with HIV/AIDS live. However, in spite of massive scale-up efforts, as of June 2005, only an estimated 12% of people in urgent medical need were receiving treatment. Nevertheless, this represents roughly one million people, and monitoring the effectiveness and safety of antiretroviral medications is crucial, both for the best clinical management of patients, and on a programmatic level to best inform the continued roll-out of treatment. New Research Collaboration In 2003, funding was provided by the National Institutes of Health (NIH) Office of AIDS Research and the French Agence National de Recherches sur le SIDA (ANRS) to set up a research collaboration among HIV treating clinics in Africa, Latin America, and Asia. The purpose of this ‘operational research collaboration’ is to identify what works, what doesn’t work, and why, with regards to the delivery and consumption of antiretrovirals. The Principal Investigators are Prof. Francois Dabis (University of Bordeaux, France), Prof. Matthias Egger (University of Bern, Switzerland), and Prof. Mauro Schechter (Universidad de Rio de Janeiro, Brazil). Definition of the participating Countries The specific objectives of the collaboration are to define the effect on survival in people initiating HAART in resource-constrained settings, to compare that effect with survival in high income settings, and to describe program-level factors that influence survival. The main criterion for participating in the ART-LINC Collaboration was that a clinic had to be in a low or middle income country, treating people with HIV, and prospectively and electronically be collecting basic clinical data on their patients. Potential sites were identified through contacting people presenting research at international conferences, and through personal contacts of the PI’s. A total of 31 centres in 18 lower income settings were contacted. Twenty-three agreed to participate and 18 sent data, together representing 8714 patients from Africa (Botswana, Burundi, Cameroon, Democratic Republic of the Congo, Cote d’Ivoire, Kenya, Malawi, Morocco, Nigeria, Rwanda, Senegal, South Africa, and Uganda), Brazil (2 centres), Thailand and India. The database was closed at the end of 2004, and the data are from the period 2003 and before. Introduction of HAART HAART was introduced earliest in Brazil and India (1996), then West and North Africa (1997-1999), Thailand (2000), and East and Southern Africa (2001). Most of the centres (n=9, 39%) were publicly funded clinics or clinics set up by a non-governmental organization (NGO) (40%). The remaining sites were private-for-profit clinics. The average number of patients being treated with HAART in a clinic was 542, although it ranged from 70-3,000. Most treated children as well as adults. In nine centres treatments were paid for by the government; 16 reported having access to generics. How much patients had to pay, if anything varied. 12 programmes (52%) charged an average of $31 US per month, 14 for CD4 counts at an average cost of $23.5 US; while viral load testing was available in 17 (74%) of centres, it was expensive. As a result, only 22% of patients in ART-LINC had both a CD4 and viral load measure both at baseline and at 6-months following HAART initiation. Eleven centres provided completely free treatment and care (or charged a locally minimal fee). Eligibility criteria and treatment regimens were generally consistent with the guidelines of the World Health Organization. 41% of all prescriptions were for d4T, 3TC, and nevirapine, but were given as separate drugs (i.e. not in a fixed dose regimen) is 22% of all prescriptions. Patients Data Of the 8,734 patients for whom any data were transferred, only 81% had completely recorded age and sex, start of HAART date, and had at least one follow-up visit. The vast majority of patients (92%) were treatment naïve when they started HAART (i.e. they had never before received any antiretroviral treatment). Compared to treatment naive patients, those people who had previously received antiretroviral treatment were more likely to be male, to have received treatment before 2002, and to have gone to private clinics. Only 75% of people had a documented baseline CD4 count. People with a CD4 measure at baseline were more likely to be women, and to be attending public clinics and receiving free care. One of the key findings is that the more recently people start treatment, the less likely they are to have a documented baseline CD4, the less likely they are to have any follow-up, and the more likely they are to be lost to follow-up. These data suggest that clinic infrastructures (including laboratory processing, data entry, and following up missing patients) may not be able to keep up with the rate that new patients are starting HAART. Follow up There is much that the ART-LINC Collaboration may be able to contribute. The current phase of the collaboration (November, 2005) has over 40 centres participating, including the MTCT+ Network, and over 40,000 patients from roughly 20 countries. Although large, it may not be representative. For example, there are few clinics from rural areas participating, and in order to participate in the collaboration, clinics had already to be electronically collecting data, and so may overrepresent ‘centres of excellence’. There are approximately 15% of patients who are lost-to-follow-up; not knowing what is happening to patients makes it impossible to conduct high impact research into clinical outcomes. For more information, please contact ART-LINC-Info.