New & experimental HIV treatments

Two new formulations receive European go-ahead

Michael Carter
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A positive marketing opinion has been granted in Europe to a new formulation of a protease inhibitor, and European marketing approval has been granted to a once-daily “nuke” combination pill.

A new formulation of the protease inhibitor saquinavir has received a positive marketing opinion from the European Committee for Medicinal Products for Human Use.

The new 500mg formulation of Roche’s hard gel saquinavir (InviraseTM) has a twice-daily dose of two tablets, boosted by 100mg of ritonavir. The previous dose of boosted-Invirase was five 200mg capsules twice-daily, each dose taken with 100mg of ritonavir.

Glossary

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.

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. 

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.

Marketing approval has been granted by the European Commission for Gilead’s TruvadaTM, a co-formulation of the nucleoside analogue FTC (emtricitabine, EmtirvaTM) and the nucleoside analogue tenofovir (VireadTM).

TruvadaTM is taken once daily and includes 300mg of tenofovir and 200mg of FTC in a single pill.

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