HIV patients' gastrointestinal tolerability and treatment satisfaction after switching from lopinavir/ritonavir (LPV/r) SGC to co-formulated LPV/r tablets
© Borras-Blasco et al; licensee BioMed Central Ltd. 2008
Published: 10 November 2008
Purpose of the study
The purpose of the study was to evaluate patient GI tolerability and perceived Tx satisfaction after switching from LPV/r SGC to LPV/r tablets.
Adult patients under LPV/r SGC Tx for at least 6 months, and with >95% adherence, were included. Following data were collected: overall GI side-effects; presence and gradation of diarrhea according to WHO severity scale; antidiarrheal drugs administration during the last month under LPV/r SGC Tx, and during 2nd and 6th month after switching to LPV/r tablets. Also, patient Tx satisfaction grade and preferences data were gathered.
Summary of results
Forty patients (28 male), mean age 39.9 ± 5.6 years, were evaluated. Two patients withdrew from the study: one due to grade 4 diarrhea and the other due to hair loss. GI effects such abdominal pain, flatulence and nausea were mild grade. However, during the last month under SGC Tx, 16 (40%) patients did not suffer diarrhea; and 24 did show diarrhea, of them 14 (35%) individuals suffered grade 1, eight (22.5%) grade 2 and one (2.5%) grade 4. During the 2nd month under LPV/r tablets Tx, diarrhea disappeared or decreased in intensity in 75% of patients. During 6th month under tablet Tx, 28 patients (70%) did not have diarrhea. From the 12 remaining patients (30%) with diarrhea at month 6, nine (22.5%) had grade 1, two (5%) grade 2, and one (2.5%) grade 4. During the last month of LPV/r SGC Tx, five patients were taking antidiarrheal drugs in contrast to only one patient during the 6th month under tablet Tx. 83% of the individuals answered the Tx satisfaction questionnaire: 98% of them referred to be Extremely satisfied, Very satisfied or Satisfied switching from LPV/r SGC to LPV/r tablets; 89% of patient preferred LPV/r tablets and 11% liked both equally.
New co-formulated LPV/r formulation (tablets) has been well appreciated and tolerated by our patients, with a considerable decrease in GI effects, especially in the drug-related diarrhea severity.
This article is published under license to BioMed Central Ltd.