NDLI: Virologic outcomes of switching to boosted darunavir plus dolutegravir with respect to history of drug resistance

Content Provider	Springer Nature : BioMed Central
Author	Wolf, Eva Boesecke, Christoph Balogh, Annamaria Bidner, Helen Cordes, Christiane Heiken, Hans Krznaric, Ivanka Kümmerle, Tim Stellbrink, Hans-Jürgen Schneider, Jochen Spinner, Christoph D.
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 .
Related Links	https://aidsrestherapy.biomedcentral.com/counter/pdf/10.1186/s12981-021-00384-6.pdf
Ending Page	5
Page Count	5
Starting Page	1
File Format	HTM / HTML
ISSN	17426405
DOI	10.1186/s12981-021-00384-6
Journal	AIDS Research and Therapy
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2021-09-08
Access Restriction	Open
Subject Keyword	Infectious Diseases Virology Dolutegravir Darunavir HIV drug resistance Integrase inhibitors Protease inhibitors
Content Type	Text
Subject	Molecular Medicine Virology Pharmacology (medical)
Journal Impact Factor	2.1/2023
5-Year Journal Impact Factor	2.4/2023

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4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
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