Generic nevirapine: quality control reports show good results

Keith Alcorn
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This article is more than 22 years old.

A study carried out by the US National Institutes of Health and the University of Alabama at Birmingham has shown that samples of generic nevirapine manufactured in four different forms contain equivalent levels of nevirapine to the originator product, Viramune, manufactured by Boehringer-Ingelheim.

Samples of Triomune (nevirapine combined with d4T and 3TC) and Nevimune (nevirapine alone) manufactured by Cipla, and Nevirex (manufactured by Aurobindo Pharma) were compared with samples of Viramune obtained in South Africa and Lithuania. The Viramune samples were obtained from resource-limited countries partly in order to detect any problems with faking of branded medications, a common problem.

Researchers found that the average nevirapine content of a 200mg tablet was 197.9mg, a variation within the plus or minus 3% window of variation considered permissible in pharmaceutical quality control. No sample varied by more than 3.1% from the labelled amount.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

sample

Studies aim to give information that will be applicable to a large group of people (e.g. adults with diagnosed HIV in the UK). Because it is impractical to conduct a study with such a large group, only a sub-group (a sample) takes part in a study. This isn’t a problem as long as the characteristics of the sample are similar to those of the wider group (e.g. in terms of age, gender, CD4 count and years since diagnosis).

The findings were described as reassuring by the research team, but they recommend that large-scale quality control exercises should be carried out as a routine part of expanding access to antiretroviral treatment, given the likely dependence of many countries and treatment programmes on generic antiretrovirals.

References

Penzak S et al. Quality-control analysis of generic nevirapine formulations in the developing world: an initial report. Tenth Conference on Retroviruses and Opportunistic Infections, Boston, abstract 549a, 2003.

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