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. 2020 Sep:130:104534.
doi: 10.1016/j.jcv.2020.104534. Epub 2020 Jul 11.

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

Daniele Armenia  1 , Yagai Bouba  2 , Roberta Gagliardini  3 , Caterina Gori  4 , Ada Bertoli  2 , Vanni Borghi  5 , William Gennari  6 , Valeria Micheli  7 , Anna Paola Callegaro  8 , Lidia Gazzola  9 , Bianca Bruzzone  10 , Alberto Giannetti  3 , Valentina Mazzotta  3 , Alessandra Vergori  3 , Ilaria Mastrorosa  3 , Manuela Colafigli  11 , Miriam Lichtner  12 , Antonio di Biagio  13 , Franco Maggiolo  14 , Giuliano Rizzardini  15 , Antonella d'Arminio Monforte  9 , Massimo Andreoni  16 , Cristina Mussini  5 , Andrea Antinori  3 , Francesca Ceccherini-Silberstein  2 , Carlo Federico Perno  2 , Maria Mercedes Santoro  17 ; Italian INI-Surveillance Group
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Free article

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

Daniele Armenia et al. J Clin Virol. 2020 Sep.
Free article

Abstract

Background: Virological response and resistance profile were evaluated in drug-naïve 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/mm3 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 pre-therapy 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.

Keywords: Antiretroviral therapy; Drug resistance; HIV-1; Integrase inhibitors; Virological response.

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