Background: In clinical trials, toxicity leading to tenofovir disoproxil fumarate (TDF) discontinuation is rare (3% by 2 years); however in clinical practice it seems to be higher, particularlywhen TDF is co-administered with ritonavir-boosted protease inhibitors (PI/r). Aims of this study were to assess the rate of TDF discontinuations in clinical practice and to identify factors associated with the risk of stopping TDF. Methods: All antiretroviral treatment (ART)-naive patients initiating a TDF-based regimen were selected from the ICONA Foundation Study cohort. The primary outcome was TDF discontinuation regardless of the reason; secondary outcome measures were TDF discontinuation due to toxicity and selective TDF discontinuation (that is, TDF discontinuation or substitution, maintaining unchanged the remaining antiretroviral treatment). Results: 3,618 ART-naïve patients were included: 54% started a PI/r-based and 46% a NNRTIbased based regimen. Two-hundred-seventy-seven patients discontinued TDF and reintroduced ART within 30 days without TDF. The probability of TDF discontinuation regardless of the reason was of 7.4% (95%CI:6.4-8.5) by 2 years and 14.1% (95%CI:12.2-16.1) by 5 years. The 5-year KM estimates in the PI/r vs. NNRTI group were 20.4% vs. 7.6%, respectively (log-rank p = 0.0001), for the outcome of stopping regardless of the reason, and 10.7% vs. 4.7% (p = 0.0001) for discontinuation due to toxicity. PI/r use and lower eGFR were associated with an increased risk of discontinuing TDF. Conclusion: In our cohort, the frequency of TDF discontinuations was higher than that observed in clinical trials. Co-administration of TDF with PI/r was associated with an increased rate of TDF discontinuations. Further studies are needed to clarify the mechanisms that might have led to this outcome.
Costarelli, S., Cozzi-Lepri, A., Lapadula, G., Bonora, S., Madeddu, G., Maggiolo, F., et al. (2016). Long-term durability of tenofovir-based antiretroviral therapy In relation to the Co-administration of other drug classes in routine clinical practice. PLOS ONE, 11(10) [10.1371/journal.pone.0160761].
|Citazione:||Costarelli, S., Cozzi-Lepri, A., Lapadula, G., Bonora, S., Madeddu, G., Maggiolo, F., et al. (2016). Long-term durability of tenofovir-based antiretroviral therapy In relation to the Co-administration of other drug classes in routine clinical practice. PLOS ONE, 11(10) [10.1371/journal.pone.0160761].|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||Si|
|Titolo:||Long-term durability of tenofovir-based antiretroviral therapy In relation to the Co-administration of other drug classes in routine clinical practice|
|Autori:||Costarelli, S; Cozzi-Lepri, A; Lapadula, G; Bonora, S; Madeddu, G; Maggiolo, F; Antinori, A; Galli, M; Di Perri, G; Viale, P; D'Arminio Monforte, A; Gori, A; Moroni, M; Andreoni, M; Angarano, G; Castelli, F; Cauda, R; Iardino, R; Ippolito, G; Lazzarin, A; Perno, C; Von Schloesser, F; Castagna, A; Ceccherini-Silberstein, F; Girardi, E; Lo Caputo, S; Mussini, C; Puoti, M; Ammassari, A; Balotta, C; Bonfanti, P; Borderi, M; Capobianchi, M; Cingolani, A; Cinque, P; De Luca, A; Di Biagio, A; Gianotti, N; Guaraldi, G; Lichtner, M; Marchetti, G; Marcotullio, S; Monno, L; Quiros Roldan, E; Rusconi, S; Saracino, A; Cicconi, P; Fanti, I; Galli, L; Lorenzini, P; Tavelli, A; Giacometti, A; Costantini, A; Mazzoccato, S; Santoro, C; Suardi, C; Vanino, E; Verucchi, G; Minardi, C; Quirino, T; Abeli, C; Manconi, P; Piano, P; Vecchiet, J; Falasca, K; Sighinolfi, L; Segala, D; Mazzotta, F; Cassola, G; Viscoli, C; Alessandrini, A; Piscopo, R; Mazzarello, G; Mastroianni, C; Belvisi, V; Caramma, I; Chiodera, A; Castelli, A; Rizzardini, G; Ridolfo, A; Piolini, R; Salpietro, S; Carenzi, L; Moioli, M; Tincati, C; Puzzolante, C; Abrescia, N; Chirianni, A; Guida, M; Gargiulo, M; Baldelli, F; Francisci, D; Parruti, G; Ursini, T; Magnani, G; Ursitti, M; Vullo, V; D'Avino, A; Gallo, L; Nicastri, E; Acinapura, R; Capozzi, M; Libertone, R; Tebano, G; Cattelan, A; Sasset, L; Mura, M; Rossetti, B; Caramello, P; Orofino, G; Sciandra, M; Bassetti, M; Londero, A; Pellizzer, G; Manfrin, V|
|Data di pubblicazione:||2016|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1371/journal.pone.0160761|
|Appare nelle tipologie:||01 - Articolo su rivista|