6533b830fe1ef96bd12970c4

RESEARCH PRODUCT

Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA).

Taramasso L.Ricci E.Cascio A.Valsecchi L.Menzaghi B.Squillace N.Maggi P.De Socio G. V.Dentone C.Madeddu G.Pellicano G. F.Calza L.Angioni G.Bonfanti P.Di Biagio A.Sarchi E.Chichino G.Bellacosa C.Angarano G.Calza L.Menzaghi B.Farinazzo M.Angioni G.Gussio M.Celesia B. M.Falasca K.Mastroianni A.Guadagnino G.Vichi F.Salomoni E.Martinelli C.Di Biagio A.Nicolini L.Cenderello G.Bonfanti P.Molteni C.Pellicano G. F.Nunnari G.Valsecchi L.Cordier L.Parisini A.Rizzardini G.Rusconi S.Conti F.Bandera A.Taramasso L.Gori A.Motta D.Puoti M.Squillace N.Migliorino G. M.Maggi P.Martini S.Cascio A.Trizzino M.Gulminetti R.De Socio G. V.Cibelli D.Parruti G.Dentone C.Madeddu G.Mameli M. S.Orofino G.Guastavigna M.

subject

0301 basic medicineMaleHIV Infections0302 clinical medicineDualMedicineHIV InfectionPharmacology (medical)030212 general & internal medicineProspective StudiesProspective cohort studyDarunavirCobicistatMiddle AgedViral LoadTolerabilityTolerabilityAnti-Retroviral AgentsCohortMolecular MedicineDrug Therapy CombinationFemaleDarunavir/cobicistatHumanmedicine.drugAdverse eventAdultlcsh:Immunologic diseases. Allergymedicine.medical_specialty030106 microbiologyContext (language use)Durability03 medical and health sciencesDarunavir/cobicistat Dual Durability Tolerability CISAI Adverse eventsVirologyInternal medicineHumansDarunavirbusiness.industryResearchHypertriglyceridemiamedicine.diseaseCISAIDiscontinuationProspective StudieAdverse eventsHIV-1Anti-Retroviral AgentCobicistatbusinesslcsh:RC581-607

description

Abstract Background Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13–20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

10.1186/s12981-019-0236-0http://hdl.handle.net/11585/704890