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No evidence of reduced efficacy or increased side-effects when patients switch to generic drugs, comparison study finds
Roger Pebody, 2017-08-24 10:00:00

An analysis of 440 people switched to generic antiretroviral drugs at an Italian clinic and a matched cohort of patients who remained on their branded medication has found no evidence of generic drugs being less effective or causing more side-effects, Nicola Gianotti and colleagues report in an article recently published in PLOS ONE.

In many high-income countries, health services are under increasing financial pressures. At the same time, the patents on several antiretroviral drugs have expired and cheaper, generic versions of the same drugs have been made available. Doctors and pharmacists are expected to use generic drugs when possible as they generally work as well as branded drugs, and the money saved can pay for other treatments and services. (For more information on generic medicines, click here).

Nonetheless some people question the quality and efficacy of generic drugs. Generic manufacturers must prove that their products have the same pharmacokinetic properties as the original formulation, with comparable drug levels of the active ingredients, but are not required to run clinical trials with head-to-head comparisons of generic and branded medicines. Furthermore, small differences in a medicine’s non-active ingredients and manufacturing processes could potentially have an impact for a minority of patients.

Previous studies on generic antiretrovirals have all been conducted in low or middle-income countries. Moreover only one previous study has compared outcomes between patients prescribed branded and generic drugs – in an observational cohort of almost 15,000 Zambian patients beginning HIV treatment, half received branded zidovudine and half generic zidovudine. There were no differences in mortality, weight gain or CD4 response, but virological response was not assessed.