Background: Generic antiretroviral (ARV) medications have recently become available in many developing countries at costs that are far cheaper than discounted proprietary agents. There are currently no publicly available data describing the integrity (drug content vs. label claim) of these preparations. We analyzed the content of several generic and proprietary ARV formulations containing the non-nucleoside reverse transcriptase inhibitor nevirapine (NVP) as part of a pilot, quality assurance investigation. Methods: Tablets containing NVP (alone or in combination with other ARVs) were obtained from six international sources. NVP content of the six products was determined by HPLC. In total, six chromatographic analyses were performed for each individual tablet.

Results: NVP content and demographic data for the individual products are listed in the table.

Trade Name (Manufacturer)	Country of Origin	Product ingredient(s) and labeled amount	Mean NVP Content (% CV)
Triomune 30 (Cipla)	Kenya	NVP 200 mg; d4T 30 mg; 3TC 150 mg	194.2 mg  (3.1)
Viramune (Boehringer)	Lithuania	NVP 200 mg	201.9 mg  (3.0)
Viramune (Boehringer)	S. Africa	NVP 200 mg	196.6 mg  (2.2)
Triomune (Cipla)	Zambia	NVP 200 mg; d4T 40 mg; 3TC 150 mg	191.4 mg  (2.1)
Nevimune (Cipla)	Zambia	NVP 200 mg	197.8 mg  (3.0)
Nevirex (Aurobindo Pharma Ltd.)	Zambia	NVP 200 mg	205.5 mg  (2.1)

The average NVP content among the tested preparations was 197.9 mg (coefficient of variation [CV] = 3.4%). Average accuracy of NVP content in tested preparations versus labeled amounts (200 mg) was 99.0%.

Conclusions: To our knowledge, this data represents the first publicly available account of drug content among generic ARV preparations. The results are encouraging and consistent with stringent manufacturing standards (± 3% of labeled drug amount). These data are reassuring given the widespread use of NVP-containing products in the developing world. Quality assurance analyses such as this one, must be conducted on a large-scale basis and include all generically available ARVs. When this information is available, health care providers and governmental agencies can determine which ARV formulations are most likely to provide HIV-infected patients in the developing world with the greatest possibility for clinical benefit.