Darunavir once-daily approved in Europe for treatment-experienced

This article is more than 11 years old. Click here for more recent articles on this topic

The European Medicines Agency has approved once-daily dosing of the HIV protease inhibitor darunavir (Prezista) for treatment-experienced adults without signs of potential resistance to the drug.

Once-daily dosing of darunavir requires patients to take two 400mg tablets with 100mg of ritonavir (Norvir) as a boosting agent.

The agency’s Committee on Medicinal Products for Human Use (CHMP) has approved Prezista 400mg tablets for use in treatment-experienced adults without daraunavir-associated resistance mutations. Patients should undergo resistance testing before starting treatment with darunavir, the committee recommends.

Glossary

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

boosting agent

Booster drugs are used to ‘boost’ the effects of protease inhibitors and some other antiretrovirals. Adding a small dose of a booster drug to an antiretroviral makes the liver break down the primary drug more slowly, which means that it stays in the body for longer times or at higher levels. Without the boosting agent, the prescribed dose of the primary drug would be ineffective.

European Medicines Agency (EMA)

Regulatory agency that evaluates medicines for safety and efficacy in Europe, performing a similar role to the Food and Drug Administration (FDA) in the United States. The EMA recommends to the European Commission that a medicine can be marketed in the European Union and European Economic Area.

resistance testing

Laboratory testing to determine if an individual’s HIV strain is resistant to anti-HIV drugs. 

However the committee has recommended that once-daily dosing should be restricted to those with CD4 counts above 100 cells/mm3 and viral load below 100,000 copies/ml.

Those with a lower CD4 count and/or high viral load should stick with the already-approved 600mg/100mg twice-daily dosing schedule.

Once-daily darunavir for treatment-experienced patients was approved in the United States in December 2010. Prezista is manufactured by Janssen-Cilag International.