Vol.:(0123456789) 1 3 Infection https://doi.org/10.1007/s15010-020-01428-1 ORIGINAL PAPER High efectiveness of recommended frst‑line antiretroviral therapies in Germany: a nationwide, prospective cohort study Markus Bickel 1  · Christian Hofmann 2,3  · Eva Wolf 4  · Axel Baumgarten 5,6  · Christoph Wyen 7,8  · Christoph D. Spinner 9  · Hans Jäger 10  · Nils Postel 11  · Stefan Esser 12  · Markus Mueller 13  · Albrecht Stoehr 14  · Stefan Preis 15  · Stephan Klauke 1,6  · Knud Schewe 2,6  · for the PROPHET study group of dagnae e.V. Received: 8 February 2020 / Accepted: 13 April 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020 Abstract Purpose Current German/Austrian antiretroviral treatment guidelines recommend more than 20 combination regimens for frst-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 frst-line ART in Germany. Methods This nationwide observational study included treatment-naïve chronically HIV-1 infected patients receiving one of the recommended frst-line regimens. Patients were allocated to three arms (INSTI, NNRTI, PI) and were prospectively followed for 24 months. Delayed treatment initiation was defned by a baseline CD4 T-cell count of < 350/µl or CDC clini- cal 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 modifcations 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 efcacy and low virological failure rates were observed with recommended frst-line regimens independ- ent of delayed treatment initiation, chosen regimen and subsequent treatment modifcations, demonstrating the validity of the current treatment guidelines. Keywords HIV · Antiretroviral therapy · First-line treatment · Efectiveness · Treatment modifcation Introduction Current German-Austrian antiretroviral treatment guidelines recommend numerous combination antiretroviral therapy (ART) regimens for treatment-naïve patients infected with HIV-1. Regimens consist of two nucleoside reverse-tran- scriptase inhibitors (NRTI) plus either an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse-tran- scriptase inhibitor (NNRTI) or a protease inhibitor boosted with ritonavir or cobicistat (PI/r or PI/c). In 2014, 27 dif- ferent frst-line ART regimens were included in the recom- mendations without a clear preference. Treatment guidelines of the European AIDS society were similar. Despite some modifcations in recent updates, both German and European guidelines still recommend a broad range of frst-line thera- pies [1, 2]. Though considered comparable in efcacy, these regimens vary substantially with regard to pill count, poten- tial drug–drug interactions, possible side efects, dietary restrictions and costs. Although initial antiretroviral treatment efcacy in rand- omized clinical trials (RCTs) continues to improve, there is evidence that its efectiveness in the real-world setting may Markus Bickel, Christian Hofmann equally contributed. The members of the investigators of the PROPHET study group are listed in acknowledgements. * Markus Bickel bickel@infektiologikum.de Extended author information available on the last page of the article