Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.
Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice. All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021). Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.
Study Type
OBSERVATIONAL
Enrollment
150
Hospital Universitario Virgen del Rocío
Seville, Spain
Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.
FDA snapshot algorithm (ITT-exposed).
Time frame: Up to 96 weeks.
Rate of changes in renal biomarkers.
Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks.
Time frame: Up to 48 weeks.
Rate of changes in hepatic parameters.
Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin).
Time frame: Up to 48 weeks.
Rate of changes in lipid parameters.
Changes in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio.
Time frame: Up to 48 weeks
Tolerability rate of study patients.
Number of interactions, adverse events and toxicities.
Time frame: Up to 48 weeks.
Death rates among trial patients.
Number of patients who died during or after the trial.
Time frame: Up to 48 weeks.
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