Background: Virological response and resistance profile were evaluated in drug-naive patients starting their first-line integrase inhibitors (INIs)-based regimen in a clinical setting.Study design: Virological success (VS) and virological rebound (VR) after therapy start were assessed by survival analyses. Drug-resistance was evaluated at baseline and at virological failure.Results: Among 798 patients analysed, 38.6 %, 27.1 % and 34.3 % received raltegravir, elvitegravir and dolutegravir, respectively. Baseline resistance to NRTIs, NNRTIs, PIs and INIs was: 3.9 %, 13.9 %, 1.6 % and 0.5 %, respectively. Overall, by 12 months of treatment, the probability of VS was 95 %, while the probability of VR by 36 months after VS was 13.1 %. No significant differences in the virological response were found according to the INI used. The higher pre-therapy viremia strata was (< 100,000 vs. 100,000-500,000 vs. > 500,000 copies/mL), lower was the probability of VS (96.0 % vs. 95.2 % vs. 91.1 %, respectively, P < 0.001), and higher the probability of VR (10.2 % vs. 15.8 % vs. 16.6 %, respectively, P = 0.010). CD4 cell count < 200 cell/min' was associated with the lowest probability of VS (91.5 %, P < 0.001) and the highest probability of VR (20.7 %, P = 0.008) compared to higher CD4 levels. Multivariable Cox-regression confirmed the negative role of high pretherapy viremia and low CD4 cell count on VS, but not on VR. Forty-three (5.3 %) patients experienced VF (raltegravir: 30; elvitegravir: 9; dolutegravir: 4). Patients failing dolutegravir did not harbor any resistance mutation either in integrase or reverse transcriptase.Conclusions: Our findings confirm that patients receiving an INI-based first-line regimen achieve and maintain very high rates of VS in clinical practice.

Evaluation of virological response and resistance profile in HIV-1 infected patients starting a first-line integrase inhibitor-based regimen in clinical settings / D. Armenia, Y. Bouba, R. Gagliardini, C. Gori, A. Bertoli, V. Borghi, W. Gennari, V. Micheli, A.P. Callegaro, L. Gazzola, B. Bruzzone, A. Giannetti, V. Mazzotta, A. Vergori, I. Mastrorosa, M. Colafigli, M. Lichtner, A. di Biagio, F. Maggiolo, G. Rizzardini, A. d'Arminio Monforte, M. Andreoni, C. Mussini, A. Antinori, F. Ceccherini-Silberstein, C.F. Perno, M.M. Santoro. - In: JOURNAL OF CLINICAL VIROLOGY. - ISSN 1386-6532. - 130(2020), pp. 104534.1-104534.9. [10.1016/j.jcv.2020.104534]

Evaluation of virological response and resistance profile in HIV-1 infected patients starting a first-line integrase inhibitor-based regimen in clinical settings

Micheli, Valeria;Callegaro, Anna Paola;Gazzola, Lidia;d'Arminio Monforte, Antonella;Perno, Carlo Federico;
2020

Abstract

Background: Virological response and resistance profile were evaluated in drug-naive patients starting their first-line integrase inhibitors (INIs)-based regimen in a clinical setting.Study design: Virological success (VS) and virological rebound (VR) after therapy start were assessed by survival analyses. Drug-resistance was evaluated at baseline and at virological failure.Results: Among 798 patients analysed, 38.6 %, 27.1 % and 34.3 % received raltegravir, elvitegravir and dolutegravir, respectively. Baseline resistance to NRTIs, NNRTIs, PIs and INIs was: 3.9 %, 13.9 %, 1.6 % and 0.5 %, respectively. Overall, by 12 months of treatment, the probability of VS was 95 %, while the probability of VR by 36 months after VS was 13.1 %. No significant differences in the virological response were found according to the INI used. The higher pre-therapy viremia strata was (< 100,000 vs. 100,000-500,000 vs. > 500,000 copies/mL), lower was the probability of VS (96.0 % vs. 95.2 % vs. 91.1 %, respectively, P < 0.001), and higher the probability of VR (10.2 % vs. 15.8 % vs. 16.6 %, respectively, P = 0.010). CD4 cell count < 200 cell/min' was associated with the lowest probability of VS (91.5 %, P < 0.001) and the highest probability of VR (20.7 %, P = 0.008) compared to higher CD4 levels. Multivariable Cox-regression confirmed the negative role of high pretherapy viremia and low CD4 cell count on VS, but not on VR. Forty-three (5.3 %) patients experienced VF (raltegravir: 30; elvitegravir: 9; dolutegravir: 4). Patients failing dolutegravir did not harbor any resistance mutation either in integrase or reverse transcriptase.Conclusions: Our findings confirm that patients receiving an INI-based first-line regimen achieve and maintain very high rates of VS in clinical practice.
Antiretroviral therapy; Drug resistance; HIV-1; Integrase inhibitors; Virological response; Drug Resistance, Viral; Humans; Raltegravir Potassium; Viral Load; Anti-HIV Agents; HIV Infections; HIV Integrase; HIV Integrase Inhibitors; HIV-1
Settore MED/17 - Malattie Infettive
Article (author)
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S1386653220302766-main.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 1.37 MB
Formato Adobe PDF
1.37 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/929281
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 4
  • ???jsp.display-item.citation.isi??? 5
social impact