Kaletra Tablet

The long-term efficacy of antiretroviral regimens including lopinavir/ritonavir (Kaletra) has not been extensively assessed in treatment-experienced patients with HIV.

As reported in the November 2006 issue of AIDS Research and Human Retroviruses, Italian researchers conducted a study of 452 consecutive HIV positive outpatients who started lopinavir/ritonavir before May 2003 after experiencing virological failure (HIV RNA > 1000 copies/mL) on a prior HAART regimen.

Four groups were considered according to CD4 cell counts at the time of lopinavir/ritonavir initiation:

• Group 1 (n = 115): < 100 cells/mm3;
• Group 2 (n = 113): 100-199 cells/mm3;
• Group 3 (n = 115): 200-349 cells/mm3;
• Group 4 (n = 109): >/= 350 cells/mm3.

The majority of patients were men (n = 320; 70.8%), the median age was 38 years, and 180 (39.6%) had CDC stage C HIV disease. The median duration of previous HAART was 51.1 months (range 12-81.7). Subjects had used a median of 7 antiretroviral regimens and had 3 protease inhibitors changes before starting lopinavir/ritonavir.

Results

• The mean CD4 cell count increases in Groups 1 through 4 were 105, 113, 128, and 144 cells/mm3, respectively, after 12 months (P < 0.01 for each group).

• At Month 48, the corresponding increases were 128, 106, 90, and 100 cells/mm3 (P < 0.01 for each group).

• The mean increase in CD4 count was comparable among the four groups.

• An on-treatment analysis showed a better immunological response among patients with lower initial CD4 cell counts (Groups 1 and 2) starting from Month 36.

• 47 patients (10.4%), mainly in Groups 1 and 2, maintained lopinavir/ritonavir despite persistent HIV RNA levels above 1000 copies/mL.

Conclusion

In conclusion, the authors wrote, "A mean increase of 64 and 65 cells/mm3 and of 88 and 56 cells/mm3 at month 12 and 48 was observed in Group 1 and Group 2, respectively. The use of lopinavir/ritonavir-based regimens also provided a durable immunologic recovery in highly pretreated HIV-infected subjects."

Clinic of Infectious Diseases, San Paolo Hospital, University of Milan, Italy.

01/05/07

Reference
T Bini, M Casana, P Cicconi, and others. Long-term immunologic outcome in HAART-experienced subjects receiving lopinavir/ritonavir. AIDS Research & Human Retroviruses 22 (11): 1096-105. November 2006.