Once-daily nevirapine dosing: A pharmacokinetics, efficacy and safety review

HIV Medicine

Volumn 8, Issue 1, 2007, Pages 1-7

  Cooper, Curts L ^a,b   van Heeswijk, R P G ^a  

^a OTTAWA HOSPITAL RESEARCH INSTITUTE   (Canada)

^b UNIVERSITY OF OTTAWA   (Canada)

Author keywords

HIV; Nevirapine; OD dosing

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIRETROVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; DIDANOSINE; EFAVIRENZ; LAMIVUDINE; LIVER ENZYME; NEVIRAPINE; STAVUDINE; TENOFOVIR; VIRUS RNA; ZIDOVUDINE;

ABNORMAL LABORATORY RESULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERANCE; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; HEPATOBILIARY SYSTEM EXAMINATION; HIV ASSOCIATED LIPODYSTROPHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IC 50; LIVER DISEASE; LIVER FUNCTION TEST; LIVER TOXICITY; LOW DRUG DOSE; LYMPHOCYTE COUNT; MONOTHERAPY; OUTCOME ASSESSMENT; PANCREATITIS; PATIENT COMPLIANCE; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PRIORITY JOURNAL; RACE DIFFERENCE; RECOMMENDED DRUG DOSE; REVIEW; RISK BENEFIT ANALYSIS; SEX DIFFERENCE; SIDE EFFECT; TOXIC HEPATITIS; VIRUS INHIBITION; VIRUS LOAD; XEROSTOMIA;

ANTI-HIV AGENTS; DRUG TOLERANCE; EXANTHEMA; HIV INFECTIONS; HIV-1; HUMANS; LIVER DISEASES; NEVIRAPINE; REVERSE TRANSCRIPTASE INHIBITORS; TREATMENT OUTCOME;

EID: 33846272175     PISSN: 14642662     EISSN: 14681293     Source Type: Journal    
DOI: 10.1111/j.1468-1293.2007.00426.x     Document Type: Review

References (31)

1. Casado JL, Sabido R, Perez-Elias MJ et al. Percentage of adherence correlates with the risk of protease inhibitor (PI) treatment failure in HIV-infected patients. Antiviral Ther 1999; 4: 157-161.
2. Paterson DL, Swindells S, Mohr J et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133: 21-30.
3. Kruse W, Rampmaier J, Ullrich G et al. Patterns of drug compliance with medications to be taken once- and twice-daily assessed by continuous electronic monitoring in primary care. Int J Clin Pharm Ther 1994; 32: 452-457.
4. Paes AH, Bakker A, Soe-Agnie CJ. Impact of dosage frequency on patient compliance. Diabetes Care 1997; 20: 1512-1517.
5. Boehringer Ingelheim Pharmaceuticals Inc. Nevirapine (Viramine®) Product Monography. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc., 2004.
6. van Heeswijk RP, Veldkamp AI, Mulder JW et al. The steady-state pharmacokinetics of nevirapine during once daily and twice daily dosing in HIV-1-infected individuals. AIDS 2000; 14: F77-F82.
7. de Maat MM, Huitema AD, Mulder JW et al. Population pharmacokinetics of nevirapine in an unselected cohort of HIV-1-infected individuals. Br J Clin Pharmacol 2002; 54: 378-385.
8. Kappelhoff BS, Huitema AD, van Leth F et al. Pharmacokinetics of nevirapine: Once-daily versus twice-daily dosing in the 2NN study. HIV Clin Trials 2005; 6: 254-261.
9. Zhou XJ, Sheiner LB, D'Aquila RT et al. Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Antimicrob Agents Chemother 1999; 43: 121-128.
10. Dailly E, Billaud E, Reliquet V et al. No relationship between high nevirapine plasma concentration and hepatotoxicity in HIV-1-infected patients naive of antiretroviral treatment or switched from protease inhibitors. Eur J Clin Pharmacol 2004; 60: 343-348.
11. de Maat MM, Nellen JF, Huitema AD et al. Race is not associated with nevirapine pharmacokinetics. Ther Drug Monit 2004; 26: 456-458.
12. Veldkamp AI, Weverling GJ, Lange JM et al. High exposure to nevirapine in plasma is associated with an improved virological response in HIV-1-infected individuals. AIDS 2001; 15: 1089-1095.
13. de Vries-Sluijs TE, Dieleman JP, Arts D et al. Low nevirapine plasma concentrations predict virological failure in an unselected HIV-1-infected population. Clin Pharmacokinet 2003; 42: 599-605.
14. Gonzalez de Requena D, Bonora S, Garazzino S et al. Nevirapine plasma exposure affects both durability of viral suppression and selection of nevirapine primary resistance mutations in a clinical setting. Antimicrob Agents Chemother 2005; 49: 3966-3969.
15. Acosta EP, Gerber JG. Position paper on therapeutic drug monitoring of antiretroviral agents. AIDS Res Hum Retroviruses 2002; 18: 825-834.
16. Veldkamp AI, van Heeswijk RP, Mulder JW et al. Limited sampling strategies for the estimation of the systemic exposure to the HIV-1 nonnucleoside reverse transcriptase inhibitor nevirapine. Ther Drug Monit 2001; 23: 606-611.
17. de Maat MM, ter Heine R, Mulder JW et al. Incidence and risk factors for nevirapine-associated rash. Eur J Clin Pharmacol 2003; 59: 457-462.
18. Montaner J, Cahn P, Zala C et al. Randomized, controlled study of the effects of a short course of prednisone on the incidence of rash associated with nevirapine in patients infected with HIV-1. J Acquir Immune Defic Syndr 2003; 33: 41-46.
19. Launay O, Roudiere L, Boukli N et al. Assessment of cetirizine, an antihistamine, to prevent cutaneous reactions to nevirapine therapy: results of the viramune-zyrtec double-blind, placebo-controlled trial. Clin Infect Dis 2004; 38: E66-e72.
20. Kappelhoff BS, van Leth F, Robinson PA et al. Are adverse events of nevirapine and efavirenz related to plasma concentrations? Antiviral Ther 2005; 10: 489-498.
21. van Leth F, Phanuphak P, Ruxrungtham K et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: A randomised open-label trial, the 2NN Study. Lancet 2004; 363: 1253-1263.
22. Garcia F, Knobel H, Sambeat MA et al. Comparison of twice-daily stavudine plus once- or twice-daily didanosine and nevirapine in early stages of HIV infection: The scan study. AIDS 2000; 14: 2485-2494.
23. Raffi F, Reliquet V, Ferre V et al. The VIRGO study: Nevirapine, didanosine and stavudine combination therapy in antiretroviral-naive HIV-1-infected adults. Antiviral Ther 2000; 5: 267-272.
24. Negredo E, Molto J, Munoz-Moreno JA et al. Safety and efficacy of once-daily didanosine, tenofovir and nevirapine as a simplification antiretroviral approach. Antiviral Ther 2004; 9: 335-342.
25. Havlir D, Cheeseman SH, McLaughlin M et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J Infect Dis 1995; 171: 537-545.
26. Barreiro P, Soriano V, Casas E et al. Prevention of nevirapine-associated exanthema using slow dose escalation and/or corticosteroids. AIDS 2000; 14: 2153-2157.
27. Shenton JM, Teranishi M, Abu-Asab MS et al. Characterization of a potential animal model of an idiosyncratic drug reaction: nevirapine-induced skin rash in the rat. Chem Res Toxicol 2003; 16: 1078-1089.
28. Gonzalez de Requena D, Nunez M, Gallego O et al. Does an increase in nevirapine plasma levels cause complete virologic suppression in patients experiencing early virological failure? HIV Clin Trials 2002; 3: 463-467.
29. Nunez M, Gonzalez de Requena D, Gonzalez-Lahoz J et al. Interactions between nevirapine plasma levels, chronic hepatitis C, and the development of liver toxicity in HIV-infected patients. AIDS Res Hum Retroviruses 2003; 19: 187-188.
30. Gonzalez de Requena D, Nunez M, Jimenez-Nacher I et al. Liver toxicity caused by nevirapine. AIDS 2002; 16: 290-291.
31. Almond LM, Boffito M, Hoggard PG et al. The relationship between nevirapine plasma concentrations and abnormal liver function tests. AIDS Res Hum Retroviruses 2004; 20: 716-722.