European Journal of Medical Research - Deutsche AIDS ...

88 EUROPEAN JOURNAL OF MEDICAL RESEARCH
June 27, 2007
D.24 (Poster)
Effect of switch from lopinavir soft gel capsules to
lopinavir meltrex formulation on gastrointestinal
side effects, quality of life, lipid, virologic and
immunologic parameters
Schewe K. 1 , Fenske S. 2 , Schmeisser N. 3 , Weitner L. 1 ,
Adam A. 1 , Buhk T. 2 , Stellbrink H.J. 2 , Hansen S. 4 ,
Gellermann H. 4
1 Infektionsmedizinisches Centrum Hamburg, St. Georg,
Hamburg, Germany, 2 Infektionsmedizinisches Centrum
Hamburg, Grindelpraxis, Hamburg, Germany, 3 University of
Cologne, 1st. Department of Internal Medicine, Division of
Infectious Diseases, Cologne, Germany, 4 IPM-Studycenter,
Hamburg, Germany
Objective: Lopinavir (LPV) tablets have been available in
Germany since July 2006. Compared with soft gel capsules
LPV tablets have no need for refrigeration, no food restrictions
and a reduced number of pills. We prospectively assessed
the gastrointestinal side effects, quality of life, lipid,
virologic and immunologic parameters before and after switch
to LPV tablet formulation.
Methods: Multicentre, prospective, observational cohort
study. All patients (pts) on LPV softgel capsules were given
the augmented symptom distress module questionnaire
(ADSM) within one month before and 1-2 months after
switch to LPV tablets. ADSM documents the presence and
severity of 22 symptoms during the previous 4 weeks. Lipid,
virologic and immunologic parameters were collected as part
of clinical routine. Pts were required to have taken LPV soft
gel capsules for at least one month prior to enrollment and no
changes in concomitant antiretroviral medication was allowed.
Paired T test and Signed-rank test were performed.
Results: As of July 2006, 261 pts were on treatment with
LPV soft gel capsules in the participating centres. 139 pts participated
in this study: m=128, f=11, mean age 44yrs, mean
duration of HIV infection 10yrs, mean duration of antiretroviral
treatment 6,2 yrs, mean duration of LPV treatment 39
months. 62 pts had advanced disease. HI viral load, CD4 cell
count, fasting cholesterol and triglycerides did not change after
switch. 127 pts completed both ASDM questionnaires.
During the period of one month prior to switch disturbing
nausea or vomiting was present in 18% of pts and in 16%
thereafter (n.s.). Disturbing swelling, abdominal pain or flatulence
was present in 39% of pts before switch and in 36%
thereafter (n.s.). Disturbing loose stool or diarrhoea was present
in 64% of pts before switch and in 49% thereafter
(p