PMID- 25397514 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160121 LR - 20181023 IS - 1758-2652 (Electronic) IS - 1758-2652 (Linking) VI - 17 IP - 4 Suppl 3 DP - 2014 TI - 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. PG - 19770 LID - 10.7448/IAS.17.4.19770 [doi] LID - 19770 [doi] AB - INTRODUCTION: 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-naive 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/microL, 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/microL 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/microL (Kaplan-Meier estimate): time to CD4 count >750 c/ microL, stratified by BL CD4 count, is shown in Figure 1. CONCLUSION: In the STAR/STELLA observational cohort, LPV/r-based ART demonstrated good virologic outcomes and immune recovery in ART-naive 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. FAU - Wolf, Eva AU - Wolf E AD - HIV Research and Clinical Care Centre, MVZ Karlsplatz, Munich, Germany. FAU - Trein, Andreas AU - Trein A AD - HIV Center (Drs A. Schaffert/E. Schnaitmann/A. Trein), Stuttgart, Germany. FAU - Baumgarten, Axel AU - Baumgarten A AD - HIV Practice (Drs S. Dupke/A. Baumgarten/A. Carganico), Berlin, Germany. FAU - Stephan, Christoph AU - Stephan C AD - HIV Center, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. FAU - Jaeger, Hans AU - Jaeger H AD - HIV Research and Clinical Care Centre, MVZ Karlsplatz, Munich, Germany. FAU - Hillenbrand, Heribert AU - Hillenbrand H AD - MVZ PraxisCityOst (Drs. H. Hillenbrand, H. Karcher), Berlin, Germany. FAU - Koeppe, Siegfried AU - Koeppe S AD - Gemeinschaftspraxis (Drs S. Koeppe/P. Kreckel), Berlin, Germany. FAU - Lutz, Thomas AU - Lutz T AD - Infektiologikum Frankfurt-City, Frankfurt am Main, Germany. FAU - Koenig, Bettina AU - Koenig B AD - Medical Department, AbbVie Deutschland GmbH & Co. KG, Wiesbaden, Germany. FAU - Stellbrink, Hans-Juergen AU - Stellbrink HJ AD - Study Center, Infektionsmedizinisches Centrum Hamburg, Hamburg, Germany. LA - eng PT - Journal Article DEP - 20141102 PL - Switzerland TA - J Int AIDS Soc JT - Journal of the International AIDS Society JID - 101478566 PMC - PMC4225449 EDAT- 2014/11/15 06:00 MHDA- 2014/11/15 06:01 PMCR- 2014/11/02 CRDT- 2014/11/15 06:00 PHST- 2014/11/15 06:00 [entrez] PHST- 2014/11/15 06:00 [pubmed] PHST- 2014/11/15 06:01 [medline] PHST- 2014/11/02 00:00 [pmc-release] AID - 19770 [pii] AID - 10.7448/IAS.17.4.19770 [doi] PST - epublish SO - J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19770. doi: 10.7448/IAS.17.4.19770. eCollection 2014.