Clinical outcomes of once-daily darunavir in treatment-experienced patients with darunavir resistance-associated mutations through 48 weeks of treatment. (September 2020)

• Record Type: Journal Article
• Authors: Rolle, Charlotte-Paige; Marquez, Omar; Nguyen, Vu; Hinestrosa, Federico; DeJesus, Edwin
• Is Part Of: International journal of STD & AIDS. Volume 31:Number 10(2020)
• Page Start: 958
• Page End: 966
• Publication Date: 2020-09
• Subjects: Darunavir -- efficacy -- resistance; Sexually transmitted diseases -- Periodicals; AIDS (Disease) -- Periodicals; 616.951
• DOI: 10.1177/0956462420926405
• Languages: English
• ISSNs: 0956-4624

Abstract

Darunavir (DRV) is approved for once-daily use in patients with no DRV resistance-associated mutations (RAMs) and twice-daily use in those with DRV RAMs. Several studies suggest that once-daily DRV retains efficacy in the setting of 1–2 DRV RAMs whereas three or more DRV RAMs are needed for DRV resistance. There are few data to support the long-term use of once-daily DRV in patients with DRV RAMs. This observational study evaluated 48-week clinical outcomes of 22 treatment-experienced patients with ≥1 DRV RAMs switched to once-daily DRV between 2014 and 2017. The primary endpoint was HIV-1 RNA <50 copies/ml at week 48. Safety parameters were analyzed throughout the study. The median age of the sample was 53 years, 18 (82%) had baseline HIV-1 RNA <50 copies/ml, and the median number of historical DRV RAMs was 2. At week 48, 20 (91%) had HIV-1 RNA < 50 copies/ml, and 2 (9%) had HIV-1 RNA of 82 and 59, 637 copies/ml and reported non-adherence. No adverse drug reactions were observed through week 48. Once-daily DRV maintained virologic control in patients with ≥1 historical DRV RAMs and was safe and well-tolerated. Further data are needed to validate this as a viable treatment option in this population.