Steady-State Pharmacokinetics of Nevirapine in HIV-1 Infected Adults in India

Background and Objectives: A variety of demographic factors, sex, and degree of immunosuppression can influence antiretroviral drug concentrations. The authors studied the influence of immune status, sex, and body mass index (BMI) on the steady-state pharmacokinetics of nevirapine delivered as a fixed-dose combination in HIV-1-infected patients in India. Methods: Twenty-six HIV-1-infected adult patients undergoing treatment with nevirapine-based highly active antiretroviral therapy regimens participated in the study. Pharmacokinetic variables were compared between patients divided based on CD4 cell counts, sex, and BMI. Results: Patients with higher BMI had lower peak and trough concentration and exposure of nevirapine than those with lower BMI; none of the differences in the pharmacokinetic variables of nevirapine between the various patient groups was statistically significant. Conclusions: Patients' immune status, sex, or BMI had no impact on the pharmacokinetics of nevirapine. Plasma nevirapine concentrations were maintained within the therapeutic range of the drug in the majority of the patients.

[1]  M. Hosseinipour,et al.  Pharmacokinetic comparison of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian adults , 2007, AIDS.

[2]  N. Ford,et al.  Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort , 2006, AIDS.

[3]  T. Flanigan,et al.  The changing natural history of HIV disease: before and after the introduction of generic antiretroviral therapy in southern India. , 2005, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  F. van Leth,et al.  Are Adverse Events of Nevirapine and Efavirenz Related to Plasma Concentrations? , 2005, Antiviral therapy.

[5]  James Curran,et al.  Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach , 2005 .

[6]  E. Naik,et al.  Effectiveness of Generic Fixed-Dose Combinations of Highly Active Antiretroviral Therapy for Treatment of HIV Infection in India , 2004, Journal of acquired immune deficiency syndromes.

[7]  S. Swaminathan,et al.  Decreased Bioavailability of Rifampin and Other Antituberculosis Drugs in Patients with Advanced Human Immunodeficiency Virus Disease , 2004, Antimicrobial Agents and Chemotherapy.

[8]  M. Peeters,et al.  Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon: open-label multicentre trial , 2004, The Lancet.

[9]  G. Ramachandran,et al.  Decreased bioavailability of rifampicin and other anti‐tb drugs in patients with advanced HIV disease , 2004 .

[10]  H. Kessler,et al.  Therapeutic Drug Monitoring of the HIV/AIDS Drugs Abacavir, Zidovudine, Efavirenz, Nevirapine, Indinavir, Lopinavir, and Nelfinavir , 2003, Pharmacology.

[11]  J. Beijnen,et al.  Population pharmacokinetics of nevirapine in an unselected cohort of HIV-1-infected individuals. , 2002, British journal of clinical pharmacology.

[12]  S. Jurriaans,et al.  Stable Concentrations of Zidovudine, Stavudine, Lamivudine, Abacavir, and Nevirapine in Serum and Cerebrospinal Fluid during 2 Years of Therapy , 2002, Antimicrobial Agents and Chemotherapy.

[13]  I. Ocaña,et al.  Pharmacokinetic interaction between nevirapine and rifampicin in HIV-infected patients with tuberculosis. , 2001, Journal of acquired immune deficiency syndromes.

[14]  P. Reiss,et al.  The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals , 2000, AIDS.

[15]  T. Moyer,et al.  Drug monitoring of antiretroviral therapy for HIV-1 infection: method validation and results of a pilot study. , 1999, Clinical chemistry.

[16]  B. Gazzard,et al.  Intestinal absorptive capacity, intestinal permeability and jejunal histology in HIV and their relation to diarrhoea. , 1995, Gut.

[17]  T. Greenough,et al.  High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. , 1995, The Journal of infectious diseases.