Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: A postauthorization noninterventional study

Andrea Antinori, Paola Meraviglia, Antonella D. Monforte, Antonella Castagna, Cristina Mussini, T. Bini, Nicola Gianotti, Stefano Rusconi, Elisa Colella, Giuseppe Airoldi, Daniela Mancusi, Roberta Termini

Research output: Contribution to journalArticle

Abstract

Current antiretroviral (ARV) therapy for the treatment of human immunodeficiency virus (HIV-1)-infected patients provides long-term control of viral load (VL). Darunavir (DRV) is a nonpeptidomimetic protease inhibitor approved for use with a ritonavir booster (DRV/r). This study evaluated the effectiveness of DRV/r in combination with other ARV agents in routine clinical practice in Italy. In this descriptive observational study, data on utilization of DRV/r, under the conditions described in the marketing authorization, were collected from June 2009 to December 2012. Effectiveness (VL + cell count. CD4+ cell count increased from study entry to last study visit in all the four groups. DRV/r was well tolerated, with few discontinuations due to study-emergent nonfatal adverse events (3.0% overall, including 2.1% drug-related) or deaths (3.0% overall, all non-drug-related); 35.3% of patients reported ≥1 adverse events. These observational data show that DRV/r was effective and well tolerated in the whole patient population described here. The DRV/r-containing regimen provided viral suppression in a high percentage of patients in all group, with low rates of discontinuation due to virological failure.

Original languageEnglish
Pages (from-to)1589-1603
Number of pages15
JournalDrug Design, Development and Therapy
Volume10
DOIs
Publication statusPublished - May 6 2016

Keywords

  • Darunavir/ritonavir
  • Durable
  • Efficacy
  • Observational
  • Safe

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Pharmacology
  • Drug Discovery

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