New & experimental HIV treatments

New tablet formulation of Kaletra approved in US

Michael Carter
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A new formulation of the protease inhibitor Kaletra (Lopinavir/ritonavir) has been approved by the US Food and Drug Administration. The new Kaletra tablet is thought to have several advantages over the existing capsule formulation.

Unlike the Kaletra capsule, the new tablet formulation:

  • Does not require refrigeration.
  • Can be taken with or without food.
  • Does not require dose adjustment when taken with certain other anti-HIV medicines.
  • Has a lower pill burden. The dose for the Kaletra capsule was three capsules containing lopinavir/ritonavir 133.3mg/33.3mg twice daily (or, in the US in treatment-naïve patients only, six 133.3mg/33.3mg capsules once daily). The new formulation reduces the dose to two 200mg/50mg lopinavir/ritonavir tablets twice daily (or, in the US in treatment-naïve patients, four 200/mg/50mg tablets once daily).

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.

treatment-naive

A person who has never taken treatment for a condition.

naive

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

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.

pill burden

The number of tablets, capsules, or other dosage forms that a person takes on a regular basis. A high pill burden can make it difficult to adhere to an HIV treatment regimen.

Approval for the new Kaletra tablet formulation is expected in Europe by the early summer of 2006.

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