Tolerance and quality of life improvements: Kaletra® soft-gel capsules vs Kaletra® tablets: the KaleVie study
Abstract number: P789
Terrail N., Guessant S., Akkari H., Michel L., Laribii B., Guillin L., Becker A., Hansel-esteller S.
Background: Kaletra® tablets were introduced in september 2006 in France to replace soft gel capsules (SGC) with no need for refrigeration or dosing with food, and a new excipients formulation. The aim of this study was to evaluate in real life the tolerance, the change of comfort of drug intake, and quality of life between the end of the last month on SGC (M0) and the first month on tablets (M1).
Methods: From september 2006 to february 2007, an open investigation, multicentre prospective study was conducted on HIV patients (pts) switching from Kaletra® SGC to tablets to compare the course of comfort of drug intake, quality of life, confidentiality, with or without food intake, preservation of drug, tolerance, and impact of new tablet formulation on everydaylife between M0 and M1.
Results: 81 pts were included (59 males, 22 females); mean age: 44 (2977 years). Seropositivity detections dated back to 11 years (1 month 21 years). Mean duration of antiretroviral treatment was 9 years: 2 years on Kaletra® (1 month 6 years).
Comfort of drug intake evaluated on a 0 to 10 graduated scale went up from 7.9 to 8.6 (p < 0.05), and 73% at M1 compared to 64% at M0 did not have quality of life affected with HIV infection and treatment. Removing food restrictions was very important for 50% of pts; no need for refrigerate upgraded confidentiality for 65% of pts and was considered as very important for 94%. Food intake with SGC or tablets increased gastro-intestinal tolerance in 75% pts. Diarrhoeas and gas were less frequent and severe when switching to tablets (p < 0.05) and were not more associated with a regimen including AZT (p > 0.05) or a first month of Kaletra© treatment (p > 0.05). There was less dislike with the yellow tablets than orange SGC (p < 0.05). Observance did not increase (p > 0.05) but no patient encountered any confidentiality problem leading to miss an intake and 23% had the feeling tablets were more efficient; 18% declared they would change their travel habits at M1.
Conclusion: Following switch from SGC to tablets, subjects reported an increased quality of life and confidentiality, and a better tolerance. Food intake lowered gastro-intestinal adverse events with either SGC or tablet formulation.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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