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.
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 microg/mL, 0.8-3.5 microg/mL and >3.5 microg/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 C(trough) 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.
Uglietti
Alessia
A
Infectious Disease Dept., Foundation IRCCS Policlinico San Matteo Hospital - Pavia, Italy.
Ravasi
Giovanni
G
Meroni
Valeria
V
Narciso
Pasquale
P
Ladisa
Nicoletta
N
Martini
Salvatore
S
Perini
Paolo
P
Testa
Lucia
L
Masala
Alessandro
A
Malicarne
Lisa
L
Occhino
Cecilia
C
Donadel
Elena
E
Genco
Francesca
F
Chichino
Guido
G
Maserati
Renato
R
D000328:Adult; D019380:Anti-HIV Agents / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D019694:Hepatitis B, Chronic / Q000150:complications*; D019698:Hepatitis C, Chronic / Q000150:complications*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019888:Nelfinavir / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D010949:Plasma / Q000737:chemistry
D019380:Anti-HIV Agents; C517960:M8-nelfinavir; D019888:Nelfinavir