144-week outcomes of lopinavir/ritonavir (LPV/r)-based first-line ART in 1,409 HIV-infected patients: data from the German STAR/STELLA cohort.
BACKGROUND
STAR/STELLA is a prospective[TS1] cohort of HIV patients initiated on LPV/r-based ART in routine clinical practice. Here, virologic/immunologic outcomes and safety data of LPV/r-based first-line ART over a period of 144 weeks are presented.


METHODS
Analysis included ART-naïve patients who started on LPV/r before July 2011 (i.e. patients with ≥144 weeks since ART initiation). Safety evaluation included adverse events (AEs), discontinuations (disc.) due to AEs, and symptoms assessed with the self-report ACTG Symptom Distress Module (ASDM; high score=high distress).


RESULTS
1409 patients were included (84% men; 76% on TDF+FTC), with a large proportion in advanced stages of HIV disease at ART initiation: 48% had a CD4 count <200/µL, 55% had HIV RNA levels >100,000 c/mL. 53% of patients (n=746) remained on LPV/r for at least 144 weeks. Time on drug was longer for patients initiated before 2008 than in subsequent years (HRadj, 1.2; 95% CI, 1.0-1.4; p=0.04; hazard ratio adjusted for CD4 <200/µL and HIV RNA >100,000 c/mL). Main reasons for d/c were: AEs (19.3%), patient wish (9.2%), virologic/immunologic failure (4.1%), and noncompliance (2.8%); 1.6% of patients died. By week 144, 33% of patients had >750 CD4/µL (Kaplan-Meier estimate): time to CD4 count >750 c/ µL, stratified by BL CD4 count, is shown in Figure 1.


CONCLUSIONS
In the STAR/STELLA observational cohort, LPV/r-based ART demonstrated good virologic outcomes and immune recovery in ART-naïve patients over 144 weeks, with significant improvements in symptom distress. Over three years, <5% of patients discontinued LPV/r due to virologic/immunologic failure, and 19% of patients discontinued for tolerability reasons.
HIV Research and Clinical Care Centre, MVZ Karlsplatz, Munich, Germany.
Eva
E
Wolf
HIV Center (Drs A. Schaffert/E. Schnaitmann/A. Trein), Stuttgart, Germany.
Andreas
A
Trein
HIV Practice (Drs S. Dupke/A. Baumgarten/A. Carganico), Berlin, Germany.
Axel
A
Baumgarten
HIV Center, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
Christoph
C
Stephan
HIV Research and Clinical Care Centre, MVZ Karlsplatz, Munich, Germany.
Hans
H
Jaeger
MVZ PraxisCityOst (Drs. H. Hillenbrand, H. Karcher), Berlin, Germany.
Heribert
H
Hillenbrand
Gemeinschaftspraxis (Drs S. Koeppe/P. Kreckel), Berlin, Germany.
Siegfried
S
Koeppe
Infektiologikum Frankfurt-City, Frankfurt am Main, Germany.
Thomas
T
Lutz
Medical Department, AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany.
Bettina
B
Koenig
Study Center, Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany.
Hans-Juergen
HJ
Stellbrink