New & experimental HIV treatments

New heat-stable ritonavir tablet approved in Europe

Keith Alcorn
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The new heat-stable formulation of ritonavir (Norvir) has been approved in the European Union, manufacturer Abbott announced this week.

Ritonavir, one of the first protease inhibitors to be developed, is now used for boosting other protease inhibitors. The drug is now available as a 100mg heat-stable tablet that does not require refrigeration.

Abbott says that European approval is a crucial step in expediting approval for the new formulation around the world, especially in developing countries, where a heat-stable form of the drug is especially needed.

Glossary

assay

A test used to measure something.

antigen

Something the immune system can recognise as 'foreign' and attack.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

window period

In HIV testing, the period of time after infection and before seroconversion during which markers of infection are still absent or too scarce to be detectable. All tests have a window period, the length of which depends on the marker of infection (HIV RNA, p24 antigen or HIV antibodies) and the specific test used. During the window period, a person can have a negative result on an HIV test despite having HIV.

Abbott has also announced that a combined antibody/antigen assay for early detection of HIV infection, approved in Europe since 2004, has been submitted to the US Food and Drug Administration for approval. The ARCHITECT HIV Ag/Ab Combo assay is intended to shorten the 'window period' between infection and the development of antibodies. HIV antigen may become detectable up to a week before antibodies are detectable. Tests of this type are already recommended for routine use in the United Kingdom and some European countries.

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