Nelfinavir+M8 Plasma Levels Determined with an ELISA Test in HIV Infected Patients with or without HCV and/or HBV Coinfection: The VIRAKINETICS II Study

Title: Nelfinavir+M8 Plasma Levels Determined with an ELISA Test in HIV Infected Patients with or without HCV and/or HBV Coinfection: The VIRAKINETICS II Study

Volume: 7 Issue: 3

Author(s): Alessia Uglietti, Giovanni Ravasi, Valeria Meroni, Pasquale Narciso, Nicoletta Ladisa, Salvatore Martini, Paolo Perini, Lucia Testa, Alessandro Masala, Lisa Malicarne, Cecilia Occhino, Elena Donadel, Francesca Genco, Guido Chichino and Renato Maserati

Affiliation:

Keywords: Nelfinavir, Therapeutic drug monitoring, HIV therapy, Pharmacokinetics, ELISA

Abstract: Virakinetics II was designed as an observational, multicenter cohort study conducted in HIV-positive patients treated with NFV-based combinations. Trough (pre-dose) concentrations of NFV+M8 in plasma were determined using a novel ELISA test (NFV TDM-ELISA®) and analyzed using clinical and laboratory parameters. Drug levels were sorted as below, within or above a given interval ( < 0.8 μg/mL, 0.8-3.5 μg/mL and > 3.5 μg/mL, respectively). Longitudinal analysis was performed in a subset of patients who underwent two or more determinations. Ninety patients on NFV-containing HAART were enrolled and 43 were coinfected with HCV and/or HBV. Among coinfected patients, 10 subjects had a clinical or histological diagnosis of cirrhosis. Compared to the HIV-monoinfected, the coinfected patients were significantly older, more treatment-experienced, with higher frequency of lipodystrophy and altered liver function test values (all p values: < 0.05). Coinfected patients were also more likely to be on a reduced dose of NFV than monoinfected (p=0.03). No significant difference was observed between the two groups with regard to NFV+M8 trough values and concentration range distribution. Median NFV+M8 Ctrough concentrations were higher in coinfected patients, but without reaching statistical significance (p=0.2). This new ELISA test proved to be a rapid, convenient and reliable tool for assessing NFV+M8 plasma levels in HIV-positive patients. It could be suitable for use within the framework of routine clinical practice even in peripheral centers without specialized laboratories.

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Uglietti Alessia, Ravasi Giovanni, Meroni Valeria, Narciso Pasquale, Ladisa Nicoletta, Martini Salvatore, Perini Paolo, Testa Lucia, Masala Alessandro, Malicarne Lisa, Occhino Cecilia, Donadel Elena, Genco Francesca, Chichino Guido and Maserati Renato, Nelfinavir+M8 Plasma Levels Determined with an ELISA Test in HIV Infected Patients with or without HCV and/or HBV Coinfection: The VIRAKINETICS II Study, Current HIV Research 2009; 7 (3) . https://dx.doi.org/10.2174/157016209788347967