The pharmaceutical company Abbott Laboratories announced last week that the United States Food and Drug Administration has approved once-daily dosing of their anti-HIV medication, Kaletra (lopinavir/ritonavir) for adult patients who have previously taken antiretroviral therapy (ART).

Kaletra belongs to a class of anti-HIV drugs known as protease inhibitors. It is used in combination therapy to reduce the amount of HIV in the blood and to increase the number of CD4 cells in the body.

Once-daily dosing of Kaletra was already indicated for adult HIV patients new to ART. However, it had not yet been approved for treatment-experienced patients.

Abbott hopes the new dosing regimen will be simpler and more convenient.

“Adherence to treatment is critical to the effective management of HIV,” said Dr. Joseph Gathe, clinical instructor in the Department of Internal Medicine at Baylor College of Medicine, in an Abbott press release. “A Kaletra once-daily regimen can simplify HIV treatment and offers greater flexibility for patients.”

Approval for once-daily dosing was supported by a Phase 3 clinical trial conducted over 48 weeks in almost 600 treatment-experienced adults with HIV. It compared once-daily and twice-daily dosing of Kaletra in combination with other antiretrovirals.

The trial indicated similar effectiveness, safety, and tolerability, as well as a similar rate of HIV resistance development between once-daily and twice-daily Kaletra regimens.

Abbott warns that once-daily treatment should only be used in adult patients with minimal HIV resistance to protease inhibitors. The company also notes that Kaletra should not be given once-daily in combination with carbamazepine (Tegretol or Epitol), phenobarbital (Luminol), or phenytoin (Dilantin).

For more information, please see the press release on Abbott’s website.