Safety and efficacy after switch to a saquinavir-containing antiretroviral regimen in protease inhibitor pretreated HIV-positive patients.
OBJECTIVE
the RAINBOW survey is a multinational observational study assessing the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r), using the 500 mg film-coated SQV formulation, in routine clinical practice. This analysis presents data from the German subgroup of protease inhibitor (PI)-pretreated, but SQV-naive patients.


METHODS
multicenter, prospective, open-label, 48 week cohort study. Efficacy assessments included the proportion of patients with HIV-1 RNA <50 and <400 copies/mL and changes in CD4 cell count from baseline to week 48. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 48.


RESULTS
a total of 426 patients were included in the analysis. The proportion of patients with HIV RNA levels <50 copies/mL at week 48 was 60.3 % (compared with 31.7% at switch to SQV/r) (intent-to-treat, last observation carried forward analysis). After 48 weeks, median CD4 count increased by +61 cells/mm3 from baseline (p<0.01) and 60.3% of patients achieved HIV-1 RNA <50 copies/mL. Median changes in fasting triglyceride levels (stratified according to baseline level) at week 48 were: +14 mg/dL (IQR -8; 57) for patients with baseline triglyceride <200 mg/dL; -50 mg/dL (IQR -139; 0) for baseline triglyceride 200-750 mg/dL, and -656 mg/dL (IQR -1024; 0) for baseline triglyceride >750 mg/dL (p<0.01 for all). Median changes in fasting total cholesterol (TC) levels (stratified according to baseline) were +16 mg/dL (IQR -3; 43) for patients with baseline TC <200 mg/dL (p<0.01), -3 mg/dL (IQR -25; 25) for baseline TC 200-300 mg/dL (p = 0.4), and -47 mg/dL (IQR -87; -4) for baseline TC >300 mg/dL (p<0.01). No significant changes in liver enzymes or bilirubin were observed. SQV treatment was discontinued in 22% of patients, 6% due to side effects.


CONCLUSIONS
these data confirm the efficacy and tolerability of SQV/r in PI-experienced, SQV-naive patients treated in a real-life clinical setting. Of particular relevance are the improvements in triglycerides and TC levels observed in patients with baseline grade III-IV elevations.
Stephan
C
C
Klinikum der Johann-Wolfgang-Goethe-Universität, Theodor-Stern-Kai 7, 60590 Frankfurt, Germany. C.Stephan@em.uni-frankfurt.de
Jaeger
H
H
Carganico
A
A
Knecht
G
G
Lutz
T
T
Mayr
C
C
Mosthaf
F A
FA
Koeppe
S
S
Mueller
M
M
Wolf
E
E
Tappe
A
A
Wellmann
E
E
Knechten
H
H
D000328:Adult; D002626:Chemistry, Pharmaceutical / Q000379:methods; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D015331:Cohort Studies; D005260:Female; D005858:Germany; D015658:HIV Infections / Q000188:drug therapy* / Q000378:metabolism; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D006306:Health Surveys / Q000379:methods*; D006801:Humans; D008049:Lipase / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019258:Saquinavir / Q000008:administration & dosage* / Q000009:adverse effects*
D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D017320:HIV Protease Inhibitors; D008049:Lipase; D019258:Saquinavir