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To the Editor: Combination antiretroviral therapy (CART) can dramatically improve the prognosis of patients with human immunodeficiency virus (HIV), but 90% of infected individuals worldwide do not have access to these drugs.¹ Although generic drugs are now available in many countries at costs that are considerably lower than those of discounted proprietary agents, there have been anecdotal reports of generic antiviral medications that contain little or no active ingredients.^2-3 As part of a quality-assurance investigation, we analyzed the content of several generic and proprietary antiretroviral formulations containing the non-nucleoside reverse transcriptase inhibitor nevirapine.

Methods
Tablets containing nevirapine (alone or in combination with other antiretroviral agents) were obtained from 6 international sources, representing 4 countries and 3 manufacturers (Table 1). Medications were obtained in April 2002 from physicians from South Africa, Zambia, Lithuania, and Kenya who were attending an HIV educational training program at the National Institutes of Health in Bethesda, Md. All tablets were obtained from local pharmacies. The nevirapine content of the 6 products was determined by high-performance liquid chromatography.⁴ Calibration and quality control standards of known concentrations were prepared for quantitative analysis from nevirapine pure standard provided by Boehringer-Ingelheim (Ingelheim, Germany). In total, 6 kinds of tablets were assayed with 6 replicates per tablet, comprising a total of 36 chromatographic injections; no 2 tablets originated from the same lot.

View this table: [in this window] [in a new window] Table. Sources for Tablets Containing Nevirapine

Results
All nevirapine-containing products in this study were labeled as containing 200 mg of the drug. Nevirapine content and demographic data for the individual products are listed in Table 1. The average nevirapine content among the tested preparations was 197.9 mg (coefficient of variation [CV], 3.4%). Average accuracy of nevirapine content in tested preparations versus labeled amounts was 99.0%.

Comment
To our knowledge, these data represent the first published account of drug content among generic antiretroviral preparations. Although our sample size is small, the products were representative of the companies that supply the majority of this drug. Given relatively stringent manufacturing standards, it is unlikely that there would be significant variability between lots. Further studies documenting bioequivalence between generic and proprietary antiretroviral medications are necessary.

Scott R. Penzak, PharmD
Department of Pharmacy
Warren G. Magnuson Clinical Center
National Institutes of Health
Bethesda, Md

Edward P. Acosta, PharmD; Michele Turner
Division of Clinical Pharmacology
University of Alabama at Birmingham

Jorge A. Tavel, MD
National Institute of Allergy and Infectious Disease
Bethesda

Henry Masur, MD
Warren G. Magnuson Clinical Center
National Institutes of Health
Bethesda

1. Joint United Nations Program on HIV/AIDS. Fact Sheet 2002: Accelerating access to treatment and care. Available at: http://www.unaids.org/barcelona/presskit/factsheets/fsaccess%5Fen.doc. Accessibility verified April 22, 2003. 2. Apoola A, Sriskandabalan PS, Wade AA. Self-medication with zidovudine that was not. Lancet. 2001;357:1370. ISI | PUBMED 3. Newton PN, White NJ, Rozendaal JA, Green MD. Murder by fake drugs. BMJ. 2002;324:800-801. FREE FULL TEXT 4. Tribut O, Arvieux C, Michelet C, Chapplain JM, Allain H, Bentue-Ferrer D. Simultaneous quantitative assay of six HIV protease inhibitors, one metabolite, and two non-nucleoside reverse transcriptase inhibitors in human plasma by isocratic reversed-phase liquid chromatography. Ther Drug Monit. 2002;24:554-562. FULL TEXT | ISI | PUBMED

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;289:2648-2649.

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