Abstract
BackgroundThe objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosted-darunavir (RPV + bDRV) in real-life patients.MethodsObservational, retrospective, multi-center study in HIV+ patients who had received RPV + bDRV for 24 weeks to optimize/simplify their previous antiretroviral treatment. We determined the percentage of patients without virologic failure (2 consecutive viral loads > 50 copies/mL) at 24 weeks of treatment.ResultsThe study included 161 patients from 15 hospitals with median age of 49 years; 29.3% had previous AIDS stage and median CD4+ lymphocyte nadir of 170 cells/uL. They had been diagnosed with HIV for a median of 17 years and had received 14 years of ART, with five previous treatment combinations, and 36.6% had a history of virological failure. The reasons for the switch were simplification/optimization (49.7%), toxicity/intolerance (17.4%), or inadequate effectiveness of previous ART (10.6%).Baseline VL of 50–1000 copies/mL was recorded in 25.5% of the patients. In the“intention-to-treat” analysis at 24 weeks, 87.6% of 161 patients continued the study treatment without virologic failure criteria.In the “on treatment” analysis (excluding patients who discontinued treatment with dual therapy for any reason other than virologic failure) the efficacy was 94.6% (141/149 patients).ConclusionsDual therapy with RPV + DRVb proved to be effective and safe in patients with advanced HIV infection, long exposure to ART, low CD4 nadir, previous virologic failure, and/or history of ineffective ART.
Highlights
The objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosteddarunavir (RPV + boosted darunavir (bDRV)) in real-life patients
Study design An observational, retrospective, multi-center study was conducted in HIV-infected patients who switched to dual therapy (DT) with rilpivirine (RPV) (25 mg, once daily) and boosted darunavir (800 mg, once daily)
General description of study population One hundred and eighty-nine patients switched to RPV + bDRV: 28 did not meet inclusion criteria (20 with baseline Viral load (VL) > 1000 copies/mL and 8 with follow-up of < 24 weeks)
Summary
The objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosteddarunavir (RPV + bDRV) in real-life patients. The main concerns over antiretroviral therapy (ART) are no longer efficacy and tolerance, but antiretroviral drug-related toxicity [1], especially over the long term This toxicity tends to be subclinical and cumulative and has the potential to interact with comorbidities, aging, and other processes related to immune activation and inflammation in HIV infection. Reverse Transcriptase Inhibitors (NRTI) [2–8], whose frequent use in pairs in classic Triple Therapy (TT) exerts a synergic antiviral effect and increases the potential toxicity. For this reason, nuke-sparing regimens (NSRs), that do not include one or both NRTIs, have been developed to reduce and prevent ART-related toxicity [9]. Permanent TT may no longer be necessary and safe simplification strategies are available to simplify ART [12]
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