More Than Half of HIV-Infected Patients Have CD4 Counts Below 350 at First Presentation

Becky McCall

November 16, 2009

November 16, 2009 (Cologne, Germany) — New data from the Italian Cohort of Antiretroviral Naïve Patients (ICONA) study reveal that 61% of newly diagnosed HIV-infected patients in Italy have CD4 counts below 350 cells/mL at the time of diagnosis and meet the definition of late presenters.

Antonella d'Arminio Monforte, MD, from the University of Milan in Italy and coordinator of ICONA, presented the study findings here at the 12th European AIDS Conference/European AIDS Clinical Society.

"In Europe, the problem with therapy is not related to a lack of drugs or the cost of drugs. The issue is that therapy initiation is late because HIV is diagnosed later. Late presenters are at risk of a more severe course of illness and, additionally, are at higher risk of transmitting HIV because they typically have a high viral load and are unaware of their HIV-positive status," said Dr. d'Arminio Monforte.

In Italy, health professionals are only obliged to document AIDS cases, not HIV infections. There is no registry of individuals infected with HIV, so the magnitude of the problem is difficult to estimate, she noted. "We studied all newly diagnosed patients enrolled in the ICONA study. The first test had to be positive within 3 months of enrolment, and we looked at late diagnosis. There are different definitions of late presentation. We studied patients who fell into the 2 definitions: patients with a diagnosis of AIDS and with baseline CD4 counts of 200 cells/mL or less, and those with CD4 counts of 350 cells/mL or less."

Study objectives included identification of determinants of late presentation, according to the definition from the 2009 HIV in Europe initiative, and the identification of which of the 2 late-presenter definitions was associated with the greatest risk for death, regardless of treatment.

Dr. D'Arminio Monforte reported that 61% of patients were late presenters, (≤350 cells/mL or less), with 43% showing advanced disease (≤200 cells/mL), and 16% were AIDS presenters (a diagnosis of AIDS concomitant with a diagnosis of an HIV-positive test).

"This is a huge percentage of late-presenting patients. We also found that this proportion did not vary by calendar year; there was neither an increase nor a reduction in the proportion of late presenters over the past decade," said Dr. D'Arminio Monforte.

The main predictors of late presentation were being non-Italian, being older, and having a high viral load. Men who have sex with men were found to have a lower risk of presenting late than heterosexual HIV-infected patients. "It is likely that [men who have sex with men] are more aware of the risks involved or they are perceived to be at greater risk," noted Dr. D'Arminio Monforte.

"We also wanted to relate late presentation to death risk as an end point. We found that late presenters all had a higher risk of death than people who are AIDS-free with a CD4 count above 350 cells/mm3 (control group). Finally, 58% of those patients who died did so within 1 year of diagnosis," added Dr. D' d'Arminio Monforte.

This analysis supports the view, Dr. D'Arminio Monforte said, that increased efforts should be made to improve HIV testing and treatment in Italy, especially in older people, those of foreign nationality, and those who are at risk of acquiring HIV heterosexually, according to HIV in Europe initiatives and recommendations.

Anders Sönnerborg, MD, from the Karolinska Institute in Stockholm, Sweden, explained that HIV in Europe deals with 4 main issues that are intertwined: the number of unknown infected patients in Europe (including Eastern and Central Asian states), management strategies for this, stigmatization, and criminalization of HIV.

Dr. Sönnerborg presented a new definition of late presentation based on T-cell counts. According to the new definition, patients with a CD4 count of less than 350 cells/mL or with AIDS at diagnosis (despite a CD4 count above 350 cells/mL) are classified as late presenters.

"The reason for changing the definition is obvious; the mortality and morbidity is much higher below a count of 350 [cells/mL] than above. By this time, the person has usually had HIV for several years and they can unknowingly contribute to the spread of disease."

Dr. Sönnerborg and colleagues with the HIV in Europe initiative announced findings from a survey of several thousand patients from 10 countries across Europe that showed that approximately 50% of patients met the new definition of a late presenter at initial presentation.

"In the Swedish cohort over the years 2005 to 2008, we see 48% to 55% are late presenters, and this has not changed over time," Dr. Sönnerborg reported. "[In] other countries, such as Russia, 60% to 70% of patients at diagnosis were late presenters. . . . Effectively, we see that a huge number of patients require therapy."

Researchers hope that knowledge of the levels of late presenters will encourage countries to identify reasons for delayed presentation and to implement quality control of disease management strategies. "This survey shows us we do not have control over this epidemic; [there is] too little monitoring and screening differs between countries," Dr. Sönnerborg noted.

"The HIV in Europe initiative hopes to develop a way for indicator diseases to facilitate doctors finding people with HIV, for example, or herpes zoster or malignant lymphoma. We also hope to release results in mid-2010 that show [whether], if a patient has another [sexually transmitted infection], . . . it is cost effective to test patients for HIV."

The HIV in Europe initiative is independent in study design and management but receives funding from Gilead, Tibotec, Merck, Abbott, BMS, Boehringer Ingelheim, Pfizer, Schering-Plough, GSK. Dr. D' d'Arminio Monforte has disclosed no relevant financial relationships. Dr. Sönnerborg reports receiving grants from Gilead Sciences and Tibotec, and acting as a consultant to Gilead, BMS, GSK, Abbott Scandinavia, Medivir, and Pfizer.

12th European AIDS Conference/European AIDS Clinical Society (EACS): Abstract LS2/2. Presented November 13, 2009.


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