Once-daily Kaletra approved for some treatment-experienced adults

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Drug regulatory authorities in the US have approved once-daily dosing of Kaletra for some treatment experienced-patients.

The Food and Drug Administration (FDA) announced on April 27th that once-daily dosing of Kaletra (lopinavir/ritonavir) was an option for treatment-experienced patients with fewer than three lopinavir-associated resistance mutations. Kaletra once daily is already an option for patients naive to antiretroviral therapy.

Approval for the once-daily dose (800mg lopinavir combined with 200mg ritonavir) was based upon the results of the M06-802 study. This showed that the once- and twice-daily treatment with the drug had comparable safety and efficacy.

Glossary

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.

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.

paediatric

Of or relating to children.

naive

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

efficacy

How well something works (in a research study). See also ‘effectiveness’.

A total of 599 treatment-experienced patients were enrolled in this study, and at baseline mean viral load was 4.3 log10 copies/ml.

Patients were randomised to receive either Kaletra once daily in combination with NRTIs, or twice-daily Kaletra (400 mg lopinavir combined with 100mg ritonavir), again in combination with NRTIs.

After 48 weeks, 57% of patients taking Kaletra once daily had a viral load below 50 copies/ml, compared with 54% of those taking twice-daily therapy.

Similar proportions of patients in the two arms of the study experienced virologic failure (22% vs 24%), and discontinued because of adverse events (13% vs 12%).

CD4 cell count increases were similar in the two study arms.

Diarrhoea, a common side-effect of protease inhibitors, was reported by 50% of those taking once-daily Kaletra compared to 39% of those taking the twice-daily dose.

Although similar proportions of patients taking once- and twice-daily doses of the drug achieved an undetectable viral load, the FDA has cautioned that patients with three or more lopinavir-associated resistance mutations should not be treated with the once-daily dose of the drug.

These resistance mutations are L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V.

Approval for once-daily use extends to both the tablet and liquid formulations of the drug.

However, the FDA stressed that Kaletra once daily is not recommended for paediatric use.