The Added Value of a CD4 Count to Identify Patients Eligible for Highly Active Antiretroviral Therapy Among HIV-Positive Adults in Cambodia Lut Lynen, MD,* Sopheak Thai, MD,† Paul De Munter, MD,† Bunse Leang, MD,† An Sokkab, MD,† Ward Schrooten, MD, PhD,‡ Veerle Huyst, MD,* Luc Kestens, PhD,* Gary Jacques, MD,† Robert Colebunders, MD, PhD,*§ Joris Menten, MSc,* and Jef van den Ende, MD, PhD*§ Summary: In a retrospective study of 648 persons with HIV infection in Cambodia, we determined the sensitivity, specificity, and accuracy of the 2003 World Health Organization (WHO) criteria to start antiretroviral treatment based on clinical criteria alone or based on a combination of clinical symptoms and the total lymphocyte count. As a reference test, we used the 2003 WHO criteria, including the CD4 count. The 2003 WHO clinical criteria had a sensitivity of 96%, a specificity of 57%, and an accuracy of 89% to identify patients who need highly active antiretroviral therapy (HAART). In our clinic, with a predominance of patients with advanced disease, the 2003 WHO clinical criteria alone was a good predictor of those needing HAART. A total lymphocyte count as an extra criterion did not improve the accuracy. Nine percent of patients were wrongly identified to be in need of HAART. Among them, almost 50% had a CD4 count of more than 500 cells/KL, and 73% had weight loss of more than 10% as a stage- defining condition. Our data suggest that, in settings with limited access to CD4 count testing, it might be useful to target this test to patients in WHO stage 3 whose staging is based on weight loss alone, to avoid unnecessary treatment. KeyWords: clinical criteria, HAART, total lymphocyte count, WHO, CD4 count (J Acquir Immune Defic Syndr 2006;42:322Y324) T he CD4 lymphocyte count (CD4 count) is an important predictor of progression to AIDS. In the developed world, this parameter is used to identify patients who need prophylaxis for opportunistic infections and highly active antiretroviral therapy (HAART). In countries with limited resources, despite the increased access to HAART, CD4 count testing is often not available. CD4 count testing methods, whether flow cytometry based or manual, are still relatively complex and costly, need regular maintenance, and require trained staff. Moreover, quality assessment and assurance are generally not available in district hospitals. 1,2 Studies have shown an association between total lymphocyte counts (TLCs) and absolute CD4 counts. 3 Total lymphocyte count correlates with disease stage and predicts survival. 4,5 As TLC testing is more readily available, it has been suggested to use the TLC to decide when to start HAART. 6,7 Once a patient’s TLC is less than 1200 cells/KL, the like- lihood that the CD4 count will be less than 200 cells/KL is more than 90%. However, there is no TLC cutoff value that has both a high specificity and sensitivity for detecting patients with a CD4 count of less than 200 cells/KL. 5,8Y10 Clinical algorithms that combine clinical manifestations and basic laboratory test results seem to increase the sensitivity to identify patients with low CD4 counts. 7,10 The World Health Organization (WHO) has published guidelines for initiating HAART in resource-poor settings, in situations where CD4 count testing is not available. 11 In our cohort of HIV-positive patients, we studied the sensitivity, specificity, and accuracy of the 2003 WHO guidelines for detecting patients in need of HAART by using clinical criteria, with or without TLC. As a reference test, we used the 2003 WHO criteria, including a CD4 count. METHODS Study Setting and Population The study was conducted at the Sihanouk Hospital Center of HOPE (SHCH), a nongovernment organization hospital in Phnom Penh that provides free HIV care. Data on HIV-positive patients, including clinical diagnoses, WHO stage, weight, and laboratory data such as CD4 count and complete blood count, were entered in a Microsoft Access database in May 2003. At the end of 2004, a total of 1298 patients living with HIV/AIDS were registered in the database, of which 1073 were still in active follow-up in the SHCH and 225 were dead or lost to follow-up. Only 276 of the active patients were receiving HAART. Laboratory Measurements CD4 count was initially measured with a FACSCount (Becton Dickinson, Franklin Lakes, NJ) at Institut Pasteur du BRIEF REPORT:CLINICAL SCIENCE 322 J Acquir Immune Defic Syndr & Volume 42, Number 3, July 2006 Received for publication October 17, 2005; accepted March 20, 2006. From the *Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium; †Sihanouk Hospital Center of HOPE, Phnom Penh, Cambodia; ‡Ziekenhuis Oost-Limburg, Genk, Belgium; and §University of Antwerp, Antwerp, Belgium. This study was sponsored by DGDC (Belgian Directorate-General for Development Corporation). Reprints: Robert Colebunders, MD, PHD, Prince Leopold Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium (e-mail: bcoleb@itg.be). Copyright * 2006 by Lippincott Williams & Wilkins Copyr ight © Lippincott Williams & Wilkins. Unauthor iz ed reproduction of this article is prohibited.