Sustiva™ licensed in European Union

This article is more than 23 years old.

On June 1st, efavirenz (Sustiva™) was given formal approval

for marketing in the European Union and is now available on prescription for use

in combination with other antiretrovirals in the treatment of HIV-infected

Glossary

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. 

treatment-naive

A person who has never taken treatment for a condition.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

naive

In HIV, an individual who is ‘treatment naive’ has never taken anti-HIV treatment before.

adults, adolescents and children three years or older, weighing more than

13kg.

Efavirenz is a once-daily drug which has been shown to have

a potent effect on viral load in treatment naïve patients when combined with two

nucleoside analogues. The early results from a head-to-head study comparing

efavirenz/AZT/3TC with indinavir/AZT/3TC led the authors of US guidelines on the

use of antiretrovirals to recommend an efavirenz-based regimen as the only

alternative to protease inhibitor-based regimens in first line therapy.

A factsheet and research findings on efavirenz are available

elsewhere on aidsmap.com For an overview go to

href="http://www.aidsmap.com/article.asp?articleID=683&heading3=Efavirenz+%2D+overview">http://www.aidsmap.com/article.asp?articleID=683&heading3=Efavirenz+%2D+overview

For more detailed coverage of research findings see

href="http://www.aidsmap.com/article.asp?articleID=1687&heading3=Efavirenz+%2D+key+research">http://www.aidsmap.com/article.asp?articleID=1687&heading3=Efavirenz+%2D+key+research

Manufacturers DuPont Pharma have priced efavirenz (an NNRTI)

at a level equivalent to the protease inhibitor indinavir, and significantly

above the cost of the only other NNRTI licensed in the EU,

nevirapine.