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- Title
High effectiveness of recommended first-line antiretroviral therapies in Germany: a nationwide, prospective cohort study.
- Authors
Bickel, Markus; Hoffmann, Christian; Wolf, Eva; Baumgarten, Axel; Wyen, Christoph; Spinner, Christoph D.; Jäger, Hans; Postel, Nils; Esser, Stefan; Mueller, Markus; Stoehr, Albrecht; Preis, Stefan; Klauke, Stephan; Schewe, Knud; for the PROPHET study group of dagnae e.V.; Kreuzberg, Practice; Schulbin, Hubert; Mayr, Christoph; Schmidt, Wolfgang; Rockstroh, Jürgen
- 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.
- Subjects
GERMANY; CLINICAL trials; HIV infections; LONGITUDINAL method; SCIENTIFIC observation; PATIENT safety; DECISION making in clinical medicine; ANTIRETROVIRAL agents; TREATMENT effectiveness; CD4 lymphocyte count; EVALUATION
- Publication
Infection, 2020, Vol 48, Issue 3, p453
- ISSN
0300-8126
- Publication type
Article
- DOI
10.1007/s15010-020-01428-1