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).
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.