Kaletra in multi-PI experienced: new data

Keith Alcorn
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This article is more than 24 years old.

Encouraging short-term data on the response of multi-PI experienced individuals to lopinavir/ritonavir (Kaletra) were presented at the British HIV Association 7th Annual Conference last weekend in Brighton.

Data were presented on 65 patients from the Chelsea and Westminster Hospital, London, who received Kaletra through an expanded access programme prior to licensing.

Patients were highly treatment experienced, with a mean CD4 count of 70 (range 27-161), and 58% had a prior AIDS diagnosis. The median viral load was 5.0 log (100,000 copies/ml).

Glossary

intent to treat analysis

All participants in a clinical trial are included in the final analysis, in the groups they were originally assigned to, whether or not they actually completed their course of treatment. This method provides a better estimate of the real-world effect of a treatment than an ‘on treatment’ analysis.

triglycerides

A blood fat (lipid). High levels are associated with atherosclerosis and are a risk factor for heart disease.

 

cholesterol

A waxy substance, mostly made by the body and used to produce steroid hormones. High levels can be associated with atherosclerosis. There are two main types of cholesterol: low-density lipoprotein (LDL) or ‘bad’ cholesterol (which may put people at risk for heart disease and other serious conditions), and high-density lipoprotein (HDL) or ‘good’ cholesterol (which helps get rid of LDL).

naive

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

log

Short for logarithm, a scale of measurement often used when describing viral load. A one log change is a ten-fold change, such as from 100 to 10. A two-log change is a one hundred-fold change, such as from 1,000 to 10.

Eleven were NNRTI-naive, but the majority had taken an NNRTI previously and had thus been exposed to all three classes of antiretrovirals. The average protease inhibitor exposure was 1280 days, and patients had taken an average of 2.8 protease inhibitors. Sixty nine per cent had taken a boosted protease inhibitor previously.

The other components of the regimen were selected by Virtual Phenotype.

No. of active drugs (excl lopinavir)

Number of individuals

0

7

1

11

2

22

3

23

4

4

After 24 weeks, 58% had viral load below 50 copies by intent to treat analysis (74% by on treatment analysis; 19 individuals stopped treatment, 4 due to virological failure). Ninety per cent had a viral load reduction of at least one log sustained to week 24.

No significant difference in response between the NNRTI-naive and NNRTI-experienced individuals was detected (83% vs 70% had viral load below 500 copies at week 24), and the only significant determinant of viral load below 50 copies at month 6 was the number of protease mutations at baseline (p=0.047).

Cholesterol and triglyceride elevations were reported in a substantial minority of patients; 16% had triglyceride levels greater than 100mmol/L at week 24 (compared to 3.6% at baseline), and 22% had cholesterol levels greater than 6.7mmol/L at week 24 (compared to 4.9% at baseline).

Reference

Gilleece Y et al. The efficacy of lopinavir (ABT378) in individuals experiencing protease inhibitor failure. Seventh Annual Conference of the British HIV Association, abstract O6, 2001.

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