Clinical outcomes of HIV-1 infected patients switched from complex multi-tablet regimens to tenofovir alafenamide based single-tablet regimens plus a boosted protease inhibitor in a real-world setting

BACKGROUND: Multi-tablet regimens (MTRs) are associated with increased adverse events and non-adherence. Single tablet regimens (STRs) plus boosted protease inhibitors (PIs) are a simplification option for MTR-treated patients; however, data is needed to validate this therapeutic strategy. METHODS: This retrospective analysis included all HIV-1 infected patients seen at a single center from March 2016 to December 2017 who were switched from twice-daily (BID) regimens or regimens containing ​≥ ​3 pills daily to elvitegravir/cobicistat/emtricitabine/tenofovir-alafenamide (E/C/F/TAF) plus darunavir (DRV) or rilpivirine/emtricitabine/tenofovir-alafenamide (RPV/F/TAF) plus DRV boosted with ritonavir or cobicistat (DRV/r-c). Eligible patients had baseline HIV-1 RNA<200 copies/mL and were followed for 48 weeks. The primary endpoint was HIV-1 RNA≥50 copies/mL at Week 48. Adherence and safety data were recorded throughout the study. RESULTS: Of 61 patients included, median age was 53 years, the median number of pills taken daily (range) was 5 (3–9), 80% were taking BID regimens, 97% had baseline HIV-1 RNA<50 copies/mL, 56 (92%) were switched to E/C/F/TAF plus DRV and 5 (8%) to RPV/F/TAF plus DRV/r-c. At Week 48, 2 patients (3%) had HIV-1 RNA≥ 50 copies/mL, both were treated with E/C/F/TAF plus DRV and neither had evidence of treatment-emergent resistance. Fifty-nine (97%) had an HIV-1 RNA<50 copies/mL. Adverse drug reactions (ADRs) occurred in 3/61 (5%) (all Grade 2) leading to 3/61 (5%) ADR-related discontinuations. CONCLUSION: In this real-world cohort of MTR-treated patients, switching to a TAF-based STR plus boosted PI maintained virologic control in 97% and was well-tolerated, supporting potential use of this strategy for regimen simplification.