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Incidence and risk factors for rash in Thai patients randomized to regimens with nevirapine, efavirenz or both drugs

Ananworanich, Jintanata; Moor, Zewlana; Siangphoe, Umaporna; Chan, Jasona; Cardiello, Petera; Duncombe, Chrisa; Phanuphak, Praphana,b; Ruxrungtham, Kiata,b; Lange, Joepa,c; Cooper, David Aa

Epidemiology and Social

Objective: To determine the incidence and risk factors for rash in Thai patients taking four different non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens.

Methods: HIV-positive, antiretroviral-naive patients enrolled in the 2NN study in Thailand and followed for at least 1 week were included. Patients were randomized to efavirenz (EFV) 600 mg once daily (OD) versus nevirapine (NVP) 200 mg twice daily (BD) versus NVP 400 mg OD versus NVP 400 mg OD + EFV 800 mg OD with stavudine/lamivudine.

Results: Of 202 patients, 95 (47%) and 69 (34.2%) developed a rash from all reasons and from NNRTI, respectively. For NNRTI-related rash the incidences were EFV (20%), NVP BD (21%), NVP OD (38%) and NVP + EFV (67%). The proportions of patients with grade I, II and III within the four treatment arms are as follows: EFV, 4.3, 13 and 2.9%; NVP BD, 2.3, 15.9 and 2.3%; NVP OD, 12.8, 19.1 and 6.4%; and NVP + EFV, 11.9, 47.6 and 7.1%. Multivariate analyses showed females with CD4 cell count ≥250 × 106 cells/l, high body mass index (>21.3 kg/m2), and a rise in CD4 (≥53 × 106 cells/l) and alanine aminotransferase (ALT) (≥34 U/l) at week 4 to be risk factors for rash.

Conclusions: Thai patients had a high incidence of NNRTI-related rash when treated with NVP + EFV or NVP OD. NVP if used BD had the same rash incidence as EFV for rash of all grades. Females, and persons with earlier HIV disease or with a large rise in CD4+ cell count after starting therapy are at greater risk for NNRTI-related rash

From the aHIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) and the Thai Red Cross AIDS Research Center

bChulalongkorn University, Bangkok Thailand

cInternational AIDS Therapy Evaluation Center, Amsterdam, The Netherlands and the dNational Centre in HIV Epidemiology and Clinical Research and University of New South Wales, Sydney, Australia.

Received 22 September, 2004

Revised 2 November, 2004

Accepted 25 November, 2004

Correspondence to Jintanat Ananworanich, MD, HIV-NAT, The Thai Red Cross AIDS Research Center, 104 Rajdumri Road, Pathumwan, Bangkok, Thailand 10330. E-mail:

© 2005 Lippincott Williams & Wilkins, Inc.