Markus Bickel1, Christian Hoffmann2,3, Eva Wolf4, Axel Baumgarten5,6, Christoph Wyen7,8, Christoph D Spinner9, Hans Jäger10, Nils Postel11, Stefan Esser12, Markus Mueller13, Albrecht Stoehr14, Stefan Preis15, Stephan Klauke16,6, Knud Schewe2,6. 1. Infektiologikum Frankfurt, Stresemannallee 3, 60596, Frankfurt, Germany. bickel@infektiologikum.de. 2. ICH Study Center, Hamburg, Germany. 3. University of Schleswig-Holstein Campus Kiel, Kiel, Germany. 4. MUC Research, Munich, Germany. 5. Center for Infectiology Berlin Prenzlauer Berg GmbH (Zibp), Berlin, Germany. 6. dagnae e.V., Berlin, Germany. 7. Praxis Ebertplatz, Cologne, Germany. 8. Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany. 9. School of Medicine, Technical University of Munich, Munich, Germany. 10. MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany. 11. prinzmed, Practice for Infectious Diseases, Munich, Germany. 12. Department of Dermatology and Venerology, University Hospital, University HIV/STD Center Essen, Essen, Germany. 13. , Practice Schwabstrasse 26, Stuttgart, Germany. 14. ifi Studien und Projekte GmbH an der Asklepios Klinik St. Georg, Hamburg, Germany. 15. Clinovate NET, Munich, Germany. 16. Infektiologikum Frankfurt, Stresemannallee 3, 60596, Frankfurt, Germany.
Abstract
PURPOSE: Current German/Austrian antiretroviral treatment guidelines recommend more than 20 combination regimens for first-line therapy, without a preference. Regimens include two nucleoside reverse transcriptase inhibitors (NRTIs) plus either an integrase strand transfer inhibitor (INSTI), a non-NRTI (NNRTI) or a boosted protease inhibitor (PI). The objective was to examine the outcomes of recommended first-line ART in Germany. METHODS: This nationwide observational study included treatment-naïve chronically HIV-1 infected patients receiving one of the recommended first-line regimens. Patients were allocated to three arms (INSTI, NNRTI, PI) and were prospectively followed for 24 months. Delayed treatment initiation was defined by a baseline CD4 T-cell count of < 350/µl or CDC clinical stage C. RESULTS: Among a total of 434 patients enrolled, virologic failure was rare and occurred in 4.3% (6/141) in the PI arm, in 3.3% (4/122) in the NNRTI arm and in 0.6% (1/171) in the INSTI arm (p = 0.10). De novo drug resistance mutations developed in only two patients in the NNRTI arm. Nonetheless, treatment modifications were frequent (51%) and mostly performed for strategic reasons. Retention on all initial compounds at month 24 was 64%, 49%, and 22% in the INSTI, NNRTI and PI arms respectively. Delayed treatment initiation was common (47%) and more frequently observed in patients in the PI arm. It was not associated with virological failure. CONCLUSION: High efficacy and low virological failure rates were observed with recommended first-line regimens independent of delayed treatment initiation, chosen regimen and subsequent treatment modifications, demonstrating the validity of the current treatment guidelines.
PURPOSE: Current German/Austrian antiretroviral treatment guidelines recommend more than 20 combination regimens for first-line therapy, without a preference. Regimens include two nucleoside reverse transcriptase inhibitors (NRTIs) plus either an integrase strand transfer inhibitor (INSTI), a non-NRTI (NNRTI) or a boosted protease inhibitor (PI). The objective was to examine the outcomes of recommended first-line ART in Germany. METHODS: This nationwide observational study included treatment-naïve chronically HIV-1 infectedpatients receiving one of the recommended first-line regimens. Patients were allocated to three arms (INSTI, NNRTI, PI) and were prospectively followed for 24 months. Delayed treatment initiation was defined by a baseline CD4 T-cell count of < 350/µl or CDC clinical stage C. RESULTS: Among a total of 434 patients enrolled, virologic failure was rare and occurred in 4.3% (6/141) in the PI arm, in 3.3% (4/122) in the NNRTI arm and in 0.6% (1/171) in the INSTI arm (p = 0.10). De novo drug resistance mutations developed in only two patients in the NNRTI arm. Nonetheless, treatment modifications were frequent (51%) and mostly performed for strategic reasons. Retention on all initial compounds at month 24 was 64%, 49%, and 22% in the INSTI, NNRTI and PI arms respectively. Delayed treatment initiation was common (47%) and more frequently observed in patients in the PI arm. It was not associated with virological failure. CONCLUSION: High efficacy and low virological failure rates were observed with recommended first-line regimens independent of delayed treatment initiation, chosen regimen and subsequent treatment modifications, demonstrating the validity of the current treatment guidelines.