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Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project.

Abstract：

:Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce. Methods:We investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study. Results:We enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/μL, mean HIV-RNA 3.80 ± 1.15 log10 cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48 (p=0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 (p=0.0008) and 72 (p=0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 (p=0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation. Conclusion:In conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.

journal_name

Infect Drug Resist

journal_title

Infection and drug resistance

authors

Bagella P,De Socio GV,Ricci E,Menzaghi B,Martinelli C,Squillace N,Maggi P,Orofino G,Calza L,Carenzi L,Celesia BM,Penco G,Di Biagio A,Valsecchi L,Vichi F,Colombo V,Parruti G,Dentone C,Falasca K,Bonfanti P,Madeddu G

doi

10.2147/IDR.S152090

subject

Has Abstract

pub_date

2018-04-26 00:00:00

pages

615-623

issn

1178-6973

pii

idr-11-615

journal_volume

pub_type

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Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project.