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Médecine et santé

Monitoring and understanding combined treatments for AIDS

 
 
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Collecting biological samples. These make it possible to understand the origins of potential side effects from treatments.

By combining different treatments (1), AIDS need no longer be fatal. The epidemic is, however, far from over, and new medical problems are emerging which may be consequences of the therapies used. The EuroSIDA network comprises the hospitals of 20 European countries monitoring the outcome of thousands of patients receiving combined treatments. Every six months it provides data for public health authorities on the progression of the disease and its treatments and centralises medical data which will make it possible to improve these therapies

     

For patients suffering from acquired immunodeficiency syndrome (AIDS), 1995 signalled a return to hope. Up to that time, infection with the human immunodeficiency virus (HIV), at the origin of the disease, was fatal in the more or less long term. The emergence of tritherapies, which combine three antiviral drugs, at last made it possible to witness a drop in the mortality figures associated with AIDS in Europe. This innovation was a turning point in the history of the epidemic, but did not signal its end. Some patients have been unable to tolerate the treatment and severe side effects have sometimes been noted. The EuroSIDA network, supported by €450 000 from the Union for the period 1997-2000, was launched to examine the results of these tritherapies more closely.

A pan-European network

The power of EuroSIDA resides in the fact that it brings together 63 hospitals specialised in treating the disease, located in all the countries of the Union (except Luxembourg) and also in Switzerland, Norway, Israel and some of the accession countries (Poland, Czechoslovakia and Hungary). This task force, which is in the vanguard of medical research, makes it possible to associate specialists from fields as diverse as virology, clinical research or statistics in one big, multidisciplinary team.

Patients are chosen at random but once included in the study their medical history (treatments, diseases, biological analysis, etc.) is carefully monitored for several years. At this time, more than 8 500 patients are enrolled in the EuroSIDA study, making it one of the greatest studies world-wide. The medical data concerning these patients are centralised every six months in an anonymous form by the central coordinating body of EuroSIDA, based in Denmark. The quality of the data that are gathered is regularly monitored through visits to the participating centres.

A protocol of this kind makes it possible both to monitor the progress of the epidemic on a large scale, to evaluate the effectiveness of treatments in different conditions and to detect, with no foregone conclusions, the undesirable effects of combined therapies. Specialists of infectious diseases who are interested in epidemiology call this a prospective study. Jens D. Lundgren, from Hvidovre University Hospital in Copenhagen (Denmark), the project coordinator, sums up the advantages as follows: "Since there are no strict inclusion or exclusion criteria for the study, our cohort of patients is representative of the different geographical regions affected by the epidemic, and where the ways in which the disease is treated often vary considerably, as do the different ways in which contamination can occur".

Describing and preventing disease

The EuroSIDA network, which was launched in 1994 to follow on from the European AIDS programme, has made it possible to monitor the more widespread use of combined therapies in Europe almost on a real-time basis. Unknown in 1995, such treatments concerned 10% of patients in 1996, 40% in 1997 and 90% nowadays, including combined treatments in which more than three drugs are associated. (This kind of dissemination of a medical innovation, which EuroSIDA made it possible to follow the progress of, had been unheard of up till then). The prospective follow-up of patients has also improved our comprehension of the way in which combined therapies operate.

Patients infected by HIV are exposed to so-called opportunistic diseases - such as tuberculosis - which profit from the weakening of the immune system. 10 to 20% of seropositive patients are also infected by the hepatitis virus. To combat this, systematic recourse is had to heavy preventive treatments which often carry with them side effects. The work of the EuroSIDA network has shown that these treatments can be suspended as soon as the combined therapies make it possible for the concentration of CD4 white blood cells, which are the first to be affected by HIV, to return to a certain threshold. This finding resulted in a review of treatment guidelines by US and European public health authorities.

Priority to knowledge

The data accumulated by the EuroSIDA network make it possible, five years on, to weigh up the side effects associated with combined treatments. Diseases habitually associated with HIV infection have regressed, but others are being carefully monitored, such as malignant lymphomas and the risks of cardiovascular diseases. Biological samples taken from patients in the study now constitute unique research material for understanding the origins of possible side effects. This research is of major interest to pharmaceutical groups producing antiviral medicines. That is why Glaxo-Wellcome, Roche, Pharmacia&Upjohn and Merck have recently agreed to finance the network. The major merit of the study is, however, to have yielded knowledge and to have disseminated such knowledge. Several international encounters have been organised and a seminar on the topic was held at the Lisbon Conference in October 1999. Since 1994, 13 articles relating the progress of the EuroSIDA project have been published in medical journals, including The Lancet, one of the most prestigious publications. "Now our priority is to determine how long tritherapies are effective", states Jens Lundgren. "We know that they work for at least three years. But what happens afterwards?"

 

(1) The expression tritherapy is often used, but this expression is sometimes inappropriate as the treatment referred to employs an antiretroviral therapy or a highly active antiretroviral therapy (HAART) which may consist of more than three agents.

 
Project
EuroSIDA

Reference
BMH4-CT972713

Contact
Jens D. Lundgren
Infectious Diseases Department
University Hospital of Hvidovre
2650 Hvidovre, Denmark
Fax : +45 36 47 33 40
E-mail : eurosida@inet.uni2.dk
http://www.cphiv.dk/

Partners
A network of 63 hospitals in about 20 European countries and Israel.

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The EuroSIDA data bank. Medical data concerning patients are regularly centralised there in anonymous form.

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