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Abstract
Objectives: Darunavir/ritonavir (DRV/r) in mono or dual therapy has proven efficacy in selected patients. The aim of this study was to evaluate the efficacy of switching from DRV/r to DRV/cobicistat (DRV/c) in patients under mono or dual therapy.
Methods: This was a prospective multicenter cohort study of patients using DRV/r under mono or dual therapy plus lamivudine who changed to DRV/c maintaining the previous regimen. All patients had a controlled HIV viral load (<50 copies/ml) when switched and were examined every 12 weeks. The primary end-point was the percentage of participants without virological failure (VF) at week 48 in the intent-to-treat analysis. The CD4 cell count and concentrations of cholesterol, triglyceride, and creatinine were measured from baseline to week 48.
Results: A total of 162 patients were included: 68.5% were men, and their mean age was 46 ± 12 years. Seventy (43.2%) patients were treated with DRV/r monotherapy, and 92 (56.8%) were treated with DRV/r plus lamivudine. The efficacy at week 48 was 95.1% (95% CI: 90.6%–97.5%) in the intent-to-treat analysis and 98.7% (95.5–99.6%) in the on-treatment analysis. Two VFs were documented but without development of resistance mutations. No significant changes were found in the lipid profile. Creatinine concentration increased significantly by 0.07 mg/dl (0.04–0.10, P < 0.001).
Conclusions: Switching from DRV/r to DRV/c in patients under mono or dual therapy is safe and effective.
Conflict of interest
The authors report no declarations of interest.
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Notes on contributors
Álvaro Mena
Álvaro Mena coordinated the study, performed research, collected, analyzed and interpreted the data, and wrote the manuscript.
Purificación Cid
Purificación Cid contributed to the design of the study, the analysis and interpretation of the data, and writing of the manuscript.
Carlos Dueñas
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
María Ángeles Garcinuño
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
Juan Francisco Lorenzo
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
Luis Margusino
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
Marina Quiñones
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
Carmen Grande
Carlos Dueñas, María Ángeles Garcinuño, Juan FranciscoLorenzo, Luis Margusino, Marina Quiñones and Carmen Grande contributed to the collection of the data and writing of the manuscript.
Iria Rodríguez-Osorio
Iria Rodríguez-Osorio contributed to the analysis and interpretation of the data.
Ángeles Castro
Ángeles Castro contributed to the design of the study, the analysis and interpretation of the data, writing of the manuscript and was responsible for the overall supervision.