Long-term improvement in renal, bone, lipid parameters, and CD4/CD8 ratio in HIV-infected patients switching to a dual therapy with lamivudine plus boosted darunavir

Background: Dual therapies have been tested in selected patients, but there is no evidence for its advantages in clinical practice. The aim of this study was to evaluate in the clinical setting the long-term outcomes and the impacts on comorbidities of a dual therapy based on lamivudine plus darunavir boosted with ritonavir (DRV/r). Methods: A prospective cohort study of 106 patients who were switched to this dual regimen from April 2014 to December 2017 because of renal and bone toxicity, intolerance, or physician's decision was conducted. The primary study endpoint was the proportion of patients who were free of treatment failure at 48 and 96 weeks. Results: The mean age was 50 years, and 64% were hepatitis C virus-coinfected. At 48 weeks, the efficacy was 95% (95% confidence interval, 91-99%; ITT-e analysis; two changes due to toxicity, three because of drug-drug interactions -DDIs-). At week 96, 26 patients (25%) had discontinued this therapy (two virologic failures, one additional adverse event, 18 therapy changes to avoid DDIs). An increase in lipid parameters was observed during the first 6-12 months in the group discontinuing tenofovir disoproxil fumarate (p < .01), which was partly corrected at 96 weeks. Improvements in CD4/CD8 ratio (p = .04), bone mineral density (+1.17%; p = .07), estimated glomerular filtration rate (+7.7 mL/min in CKD patients; p = .02), urinary parameters (proteinuria, -23%), and overall cost (-43%) were observed. Conclusions: Our results demonstrated the long-term efficacy and safety of an antiretroviral regimen based on dual therapy with lamivudine plus boosted darunavir in the clinical setting.