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Darunavir-based dual therapy of treatment-experienced HIV-infected patients: analysis from a national multicenter database

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Abstract

Background

We assessed the virological response of dual therapy with DRV/r, plus raltegravir, maraviroc or etravirine, in virological failure patients and in virologically suppressed patients collected in the Italian Antiretroviral Resistance Database (ARCA).

Material and methods

The primary endpoint was the percentage of patients remaining free of virological failure (confirmed >50 copies/mL or any change in the regimen). Subjects had a resistance test and at least one follow-up visit. Observation was censored at last visit under dual therapy and survival analysis and proportional hazard models were used.

Results

Sixty-seven percent of the 221 patients started DRV/r with RAL, 20.4 % with ETV, and 12.2 % with MAR; 31.2 % virological failures were observed. At survival analysis, the overall proportion of failure was 29.2 % at 1 year and 33.8 % at 2 years. The proportion of failure was lower in patients starting with undetectable vs. detectable viral load (13.3 and 25.2 % vs. 37.4 and 38.8 % at 1 and 2 years, respectively, p = 0.001 for both analyses) and in patients treated with DRV 600 BID vs. 800 QD (HR: 0.56, 95 % CI: 0.31–0.99, p < 0.05). By regimen, the adjusted proportional model showed no significant difference among the three regimens. A significant lower risk of failure was associated with higher GSS (HIV-DB HR: 0.53, 95 % CI: 0.32–0.88, p = 0.014; Rega 0.60, 0.40–0.88, p < 0.01; ANRS 0.55, 0.34–0.90, p = 0.017), while a higher risk of failure with detectable HIV-RNA (3.02, 1.70–5.72, p < 0.001).

Conclusions

Among experienced patients, the best candidates for dual-therapy regimens including DRV/r are those with undetectable viral load and higher GSS.

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Acknowledgments

The authors wish to thank all patients that participated at this study. The authors wish to thank B. Bruzzone, A. Rosi, P. Cicconi, T. Carli, and D. Bartolozzi who enrolled patients and collected data and all the other members of the ARCA Database Study Group for providing the data used in this study

Conflict of interest

None.

Informed consent

Patients participating in this study signed informed consent. All authors read and approved the final manuscript.

Author information

Authors and Affiliations

  1. Malattie Infettive e Tropicali, Azienda Ospedaliera Universitaria Careggi, Largo Brambilla 3, 50134, Florence, Italy

    Gaetana Sterrantino

  2. Dipartimento Clinico, Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” I.R.C.C.S, Rome, Italy

    Mauro Zaccarelli & Andrea Antinori

  3. Malattie Infettive e Tropicali, Azienda Ospedaliera Universitaria San Martino, Genoa, Italy

    Antonio Di Biagio

  4. Diagnostica Molecolare Infettivologica, Azienda Ospedaliera San Paolo, Milan, Italy

    Maria Luisa Biondi

  5. Malattie Infettive, Ente Ospedaliero Ospedali Galliera, Genoa, Italy

    Giovanni Penco

Authors
  1. Gaetana Sterrantino
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  2. Mauro Zaccarelli
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  3. Antonio Di Biagio
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  4. Maria Luisa Biondi
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  5. Andrea Antinori
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  6. Giovanni Penco
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Consortia

ARCA Study Group

Corresponding author

Correspondence to Gaetana Sterrantino.

Additional information

The data of this work come from the Italian Antiretroviral Resistance Database (ARCA), and the work was performed at the Malattie Infettive e Tropicali, Azienda Ospedaliera Universitaria Careggi, Florence, Italy.

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Sterrantino, G., Zaccarelli, M., Di Biagio, A. et al. Darunavir-based dual therapy of treatment-experienced HIV-infected patients: analysis from a national multicenter database. Infection 43, 339–343 (2015). https://doi.org/10.1007/s15010-015-0764-z

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  • DOI: https://doi.org/10.1007/s15010-015-0764-z

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