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- Document type:
- Article; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
- Author(s):
- Wolf, Eva; Boesecke, Christoph; Balogh, Annamaria; Bidner, Helen; Cordes, Christiane; Heiken, Hans; Krznaric, Ivanka; Kümmerle, Tim; Stellbrink, Hans-Jürgen; Schneider, Jochen; Spinner, Christoph D
- Title:
- Virologic outcomes of switching to boosted darunavir plus dolutegravir with respect to history of drug resistance.
- Abstract:
- OBJECTIVE: The DUALIS study showed that switching to boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR) was non-inferior to continuous bDRV plus 2 nucleoside/nucleotide reverse-transcriptase inhibitors (NRTIs; 3DR) in treatment-experienced virologically suppressed people living with HIV (PLWH). We analyzed virologic outcomes with respect to treatment history and HIV drug resistance. DESIGN: Post hoc analysis of a randomized trial. METHODS: Main inclusion criteria were an HIV RNA level < 50 copies/mL for ≥ 24 weeks and no resistance to integrase strand transfer inhibitors or bDRV. Resistance-associated mutations (RAMs) were interpreted using the Stanford HIVdb mutation list. Outcomes measures were 48-week virologic response (HIV RNA < 50 copies/mL, FDA snapshot) and HIV RNA ≥ 50 copies/mL (including discontinuation due to a lack of efficacy or reasons other than adverse events and HIV RNA ≥ 50 copies/mL, referred to as snapshot non-response). RESULTS: The analysis population included 263 patients (2DR: 131, 3DR: 132): 90.1% males; median age, 48 years; CD4 + T-cell nadir < 200/µl, 47.0%; ≥ 2 treatment changes, 27.4%; NRTI, non-NRTI (NNRTI), and major protease inhibitor (PI) RAMs in 9.5%, 14.4%, and 3.4%, respectively. In patients with RAMs in the 2DR and 3DR groups, virologic response rates were 87.8% and 96.0%, respectively; the corresponding rates in those without RAMs were 85.7% and 81.8%. RAMs were unrelated to virologic non-response in either group. No treatment-emergent RAMs were observed. CONCLUSIONS: DTG + bDRV is an effective treatment option without the risk of treatment-emergent resistance for PLWH on suppressive first- or further-line treatment with or without evidence of pre-existing NRTI, NNRTI, or PI RAMs. TRIAL REGISTRATION: EUDRA-CT Number 2015-000360-34; registered 07 April 2015; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000360-34/DE .
- Journal title abbreviation:
- AIDS Res Ther
- Year:
- 2021
- Journal volume:
- 18
- Journal issue:
- 1
- Fulltext / DOI:
- doi:10.1186/s12981-021-00384-6
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/34496848
- Print-ISSN:
- 1742-6405
- TUM Institution:
- Klinik und Poliklinik für Innere Medizin II, Gastroenterologie; Kliniken und Institute
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