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Virological response and resistance profile in HIV-1-infected patients starting darunavir-containing regimens.

  • Armenia, D1
  • Di Carlo, D1
  • Maffongelli, G2
  • Borghi, V3
  • Alteri, C1
  • Forbici, F4
  • Bertoli, A1, 5
  • Gori, C4
  • Giuliani, M6
  • Nicastri, E7
  • Zaccarelli, M7
  • Pinnetti, C7
  • Cicalini, S7
  • D'Offizi, G7
  • Ceccherini-Silberstein, F1
  • Mussini, C3
  • Antinori, A7
  • Andreoni, M2
  • Perno, C F4
  • Santoro, M M1
  • 1 Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy. , (Italy)
  • 2 Infectious Diseases Division, University Hospital Tor Vergata, Rome, Italy. , (Italy)
  • 3 Infectious Diseases Division, Modena University Hospital, Modena, Italy. , (Italy)
  • 4 Antiretroviral Therapy Monitoring Unit, L Spallanzani Hospital, Rome, Italy. , (Italy)
  • 5 Molecular Virology Division, University Hospital Tor Vergata, Rome, Italy. , (Italy)
  • 6 Infectious Dermatology Unit, San Gallicano Hospital, Rome, Italy. , (Italy)
  • 7 Infectious Diseases Division, L Spallanzani Hospital, Rome, Italy. , (Italy)
Published Article
HIV medicine
Publication Date
Jan 01, 2017
DOI: 10.1111/hiv.12388
PMID: 27353061


We evaluated the virological response in patients starting a regimen based on darunavir/ritonavir (DRV/r), which is currently the most widely used ritonavir-boosted protease inhibitor. Data from 206 drug-naïve and 327 PI-experienced patients starting DRV/r 600/100 mg twice daily (DRV600) or 800/100 mg once daily (DRV800) were examined. The probabilities of virological success (VS) and virological rebound (VR) were evaluated in survival analyses. Baseline DRV/r resistance and its evolution at failure were also examined. DRV600 was preferentially administered in patients with complex requirements (older age, higher viraemia, lower CD4 cell count and DRV/PI resistance) compared with DRV800. By 12 months, the probability of achieving VS was 93.2% and 84.3% in drug-naïve and PI-experienced patients, respectively. The higher the baseline viraemia, the longer was the time required to achieve VS, both in drug-naïve patients [>500 000 HIV-1 RNA copies/mL: median [interquartile range (IQR)] 6.1 (5.1-10.3) months; 100 000-500 000 copies/mL: median (IQR) 4.9 (3.8-6.1) months; <100 000 copies/mL: median (IQR) 3.9 (3.5-4.8) months; P < 0.001] and in PI-experienced patients [≥100 000 copies/mL: median (IQR) 7.2 (5.7-11.6) months; <100 000 copies/mL: median (IQR) 2.8 (2.4-3.3) months; P < 0.001]. In PI-experienced patients, the probability of VR was higher for higher viraemia levels (22.3% for ≥100 000 copies/ml vs. 9.7% for <100 000 copies/mL; P = 0.007). Baseline resistance did not affect the virological response. At failure, a high percentage of patients maintained virus susceptible to all PIs (drug-naïve: 95%; PI-experienced: 80%). Despite being used more often in patients with more complex requirements, DRV600 performed as well as DRV800. In clinical practice, use of DRV/r (with its flexible dosage) results in high rates of virological response. These data support the use of PI/r in patients whose characteristics require potent drugs with a high genetic barrier. © 2016 British HIV Association.

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