Abstract
BackgroundLimited information is available on the relationship between nevirapine plasma concentrations and virologic response or liver toxicity in Chinese patients with HIV infection. The objective of this prospective study was to test this relationship and to determine the minimal therapeutic trough concentration of nevirapine for Chinese patients.MethodsA total of 227 HIV-infected, treatment naïve patients were enrolled into this study. Blood samples were taken at Ctrough (12 hr postdose) and C2 (2 hr postdose) for measurement of nevirapine concentrations 6 months after treatment initiation. Therapeutic outcomes, viral load and CD4 cell count, were assessed at 3 and 6 months after starting therapy, while the evaluation of hepatotoxicity was undertaken 12 months after nevirapine treatment.ResultsA significant correlation between nevirapine trough concentrations and viral load was noticed after 6 months of treatment, particularly in patients with partial response and viral failure (p<0.01). The therapeutic Ctrough of nevirapine for Chinese patients was determined to be 3.9 µg/ml using the receiver operating characteristic curve. Virologic failure was observed in 21% (6/29) of patients with low nevirapine concentrations (<3.9 µg/ml) versus 5% (4/87) in patients with concentrations higher than 3.9 µg/ml (p = 0.015). Hepatotoxicity was significantly associated with the median nevirapine trough concentrations among male patients (8.20 vs. 5.48 µg/ml, p = 0.015) and hepatitis C virus co-infection (p = 0.039).ConclusionsAmong Chinese patients with HIV infection, the therapeutic Ctrough of nevirapine was 3.9 µg/ml, higher than the recommended 3.0 µg/ml. The correlation between nevirapine concentrations, efficacy and hepatotoxicity suggests the benefit of dosage adjustment based on therapeutic drug monitoring among Chinese HIV-infected patients to optimize nevirapine containing antiretroviral therapy.
Highlights
Active antiretroviral therapy is considered an effective approach for the management of HIV/AIDS
The pharmacological characteristics of nevirapine make it an attractive candidate for therapeutic drug monitoring, as previous studies have indicated a significant relationship between nevirapine trough concentrations and virologic response [2,3,4]
High concentrations are linked to an increased risk of liver toxicity and hepatic injury in patients with chronic hepatitis C [5,6,7,8]
Summary
Active antiretroviral therapy is considered an effective approach for the management of HIV/AIDS. 80% Chinese patients receiving antiretroviral therapy are currently on nevirapine-containing regimens. The pharmacological characteristics of nevirapine make it an attractive candidate for therapeutic drug monitoring, as previous studies have indicated a significant relationship between nevirapine trough concentrations and virologic response [2,3,4]. Limited information is available on the relationship between nevirapine plasma concentrations and virologic response or liver toxicity in Chinese patients with HIV infection. The objective of this prospective study was to test this relationship and to determine the minimal therapeutic trough concentration of nevirapine for Chinese patients
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