Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA).
Adverse events
CISAI
Darunavir/cobicistat
Dual
Durability
Tolerability
Journal
AIDS research and therapy
ISSN: 1742-6405
Titre abrégé: AIDS Res Ther
Pays: England
ID NLM: 101237921
Informations de publication
Date de publication:
26 08 2019
26 08 2019
Historique:
received:
06
06
2019
accepted:
08
08
2019
entrez:
28
8
2019
pubmed:
28
8
2019
medline:
29
2
2020
Statut:
epublish
Résumé
Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. 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. 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. DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.
Sections du résumé
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.
Identifiants
pubmed: 31451115
doi: 10.1186/s12981-019-0236-0
pii: 10.1186/s12981-019-0236-0
pmc: PMC6710858
doi:
Substances chimiques
Anti-Retroviral Agents
0
Cobicistat
LW2E03M5PG
Darunavir
YO603Y8113
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
21Investigateurs
Paolo Bonfanti
(P)
Antonio Di Biagio
(A)
Elena Ricci
(E)
E Sarchi
(E)
G Chichino
(G)
C Bellacosa
(C)
G Angarano
(G)
L Calza
(L)
B Menzaghi
(B)
M Farinazzo
(M)
G Angioni
(G)
M Gussio
(M)
B M Celesia
(BM)
K Falasca
(K)
A Mastroianni
(A)
G Guadagnino
(G)
F Vichi
(F)
E Salomoni
(E)
C Martinelli
(C)
A Di Biagio
(A)
L Nicolini
(L)
G Cenderello
(G)
P Bonfanti
(P)
C Molteni
(C)
G F Pellicanò
(GF)
G Nunnari
(G)
L Valsecchi
(L)
L Cordier
(L)
A Parisini
(A)
G Rizzardini
(G)
S Rusconi
(S)
F Conti
(F)
A Bandera
(A)
L Taramasso
(L)
A Gori
(A)
D Motta
(D)
M Puoti
(M)
N Squillace
(N)
G M Migliorino
(GM)
P Maggi
(P)
S Martini
(S)
A Cascio
(A)
M Trizzino
(M)
R Gulminetti
(R)
G V De Socio
(GV)
D Cibelli
(D)
G Parruti
(G)
C Dentone
(C)
G Madeddu
(G)
M S Mameli
(MS)
G Orofino
(G)
M Guastavigna
(M)
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