Pharmacological and clinical evidence of nevirapine immediate- and extended-release formulations

HIV/AIDS - Research and Palliative Care

Volumn 4, Issue , 2012, Pages 169-179

  Ena, Javier ^a   Amador, Concepción ^a   Benito, Conxa ^a   Pasquau, Francisco ^a  

^a HOSPITAL MARINA BAIXA   (Spain)

Author keywords

Clinical practice; Efficacy; Nevirapine extended release; Resistance; Safety

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; ATAZANAVIR PLUS RITONAVIR; CARBAMAZEPINE; CLARITHROMYCIN; EFAVIRENZ; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; KETOCONAZOLE; LAMIVUDINE; LAMIVUDINE PLUS NEVIRAPINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; METHADONE; NEVIRAPINE; ORAL CONTRACEPTIVE AGENT; PHENOBARBITAL; PHENYTOIN; RIFABUTIN; RIFAMPICIN; RITONAVIR PLUS SAQUINAVIR; RNA DIRECTED DNA POLYMERASE; TENOFOVIR DISOPROXIL; VORICONAZOLE; ZIDOVUDINE;

ABDOMINAL PAIN; ANEMIA; ANGIONEUROTIC EDEMA; ANTIBIOTIC RESISTANCE; AREA UNDER THE CURVE; ARTHRALGIA; BLISTER; BODY MASS; CD4 LYMPHOCYTE COUNT; CLINICAL EFFECTIVENESS; CONJUNCTIVITIS; DIARRHEA; DISEASE ASSOCIATION; DOSAGE SCHEDULE COMPARISON; DOSE RESPONSE; DRESS SYNDROME; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSAGE FORM COMPARISON; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FEVER; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENTIATION; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; ERYTHEMA; EVIDENCE BASED MEDICINE; FATIGUE; FOOD AND DRUG ADMINISTRATION; FULMINANT HEPATIC FAILURE; GRANULOCYTOPENIA; HEPATITIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERTENSION; INFECTION PREVENTION; INFECTION RISK; JAUNDICE; KIDNEY DYSFUNCTION; LIVER FUNCTION TEST; LIVER TOXICITY; MALAISE; MAXIMUM PLASMA CONCENTRATION; MUCOSAL DISEASE; MYALGIA; NAUSEA; OUTCOME ASSESSMENT; PHOSPHATE BLOOD LEVEL; RACE DIFFERENCE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; REVIEW; SEX DIFFERENCE; SIDE EFFECT; SOMNOLENCE; STEVENS JOHNSON SYNDROME; TOXIC EPIDERMAL NECROLYSIS; TUBERCULOSIS; URTICARIA; VIRUS TRANSMISSION; VOMITING;

EID: 84872951901     PISSN: None     EISSN: 11791373     Source Type: Journal    
DOI: 10.2147/HIV.S35564     Document Type: Review

References (58)

1. Renaud-Théry F, Avila-Figueroa C, Stover J, et al. Utilization patterns and projected demand of antiretroviral drugs in low- and middle-income countries. AIDS Res Treat. 2011;2011:749041.
2. Bendavid E, Grant P, Talbot A, Owens DK, Zolopa A. Cost-effectiveness of antiretroviral regimens in the World Health Organization's treatment guidelines: a South African analysis. AIDS. 2011;25(2): 211-220.
3. Phillips E, Gutiérrez S, Jahnke N, et al. Determinants of nevirapine hypersensitivity and its effect on the association between hepatitis C status and mortality in antiretroviral drug-naive HIV-positive patients. AIDS. 2007;21(12):1561-1568.
4. Ngo-Giang-Huong N, Jourdain G, Amzal B, et al. Resistance patterns selected by nevirapine vs efavirenz in HIV-infected patients failing first-line antiretroviral treatment: a bayesian analysis. PLoS One. 2011;6(11):e27427.
5. Boehringer Ingelheim Pharmaceuticals. Highlights of prescribing information. Available from: http://bidocs.boehringer-Ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Viramune/Viramune.pdf. Accessed July 15, 2012.
6. Patel SS, Benfield P. New drug profile: nevirapine. Clin Immunother. 1986;6(4):307-317.
7. Ren J, Bird LE, Chamberlain P P, Stewart-Jones GB, Stuart DI, Stammers DK. Structure of HIV-2 reverse transcriptase at 2.35-A resolution and mechanism of resistance to non-nucleoside inhibitors. Proc Natl Acad Sci U S A. 2002;99(22):14410-14415.
8. Conway B, Wainberg MA, Hall D. Development of drug resistance in patients receiving combinations of zidovudine, didanosine and nevirapine. AIDS. 2001;15(10):1269-1274.
9. Duong M, Buisson M, Peytavin G, et al. Low trough plasma concentrations of nevirapine associated with virologic rebounds in HIV-infected patients who switched from protease inhibitors. Ann Pharmacother. 2005;39(4):603-609.
10. González de Requena D, Bonora 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(9):3966-3969.
11. Vidal C, Arnedo M, Garcia F. Genotypic and phenotypic resistance patterns in early-stage HIV-1-infected patients failing initial therapy with stavudine, didanosine and nevirapine. Antivir Ther. 2002;7(4):283-287.
12. Kiertiburanakul S, Wiboonchutikul S, Sukasem C, Chantratita W, Sungkanuparph S. Using of nevirapine is associated with intermediate and reduced response to etravirine among HIV-infected patients who experienced virologic failure in a resource-limited setting. J Clin Virol. 2010;47(4):330-334.
13. Gathe J, Andrade-Villanueva J, Santiago S, et al. Efficacy and safety of nevirapine extended-release once daily versus nevirapine immediate-release twice daily in treatment-naive HIV-1-infected patients. Antivir Ther. 2011;16(5):759-769.
14. Food and Drug Administration. Approval of Viramune XR (nevirapine) 400 mg extended release tablet. Available from: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm248800.htm. Accessed June 15, 2012.
15. Macha S, Yong CL, Darrington T, et al. In vitro-in vivo correlation for nevirapine extended release tablets. Biopharm Drug Dispos. 2009;30(9):542-550.
16. Battegay M, Arasteh K, Plettenberg A, et al. Bioavailability of extended- release nevirapine 400 and 300 mg in HIV-1: a multicenter, open label study. Clin Ther. 2011;33(9):1308-1320.
17. Riska P, Lamson M, MacGregor T, et al. Disposition and biotransfor- mation of the antiretroviral drug nevirapine in humans. Drug Metab Dispos. 1999;27(8):895-901.
18. Giaquinto C, Anabwani G, Feiterna-Sperling G, et al. Steady-state pharmacokinetic parameters of nevirapine extended release formulation tablets in children with HIV-1 infection: an open-label, multiple-dose, cross-over study. 18th CROI Conference on Retroviruses and Opportunistic Infections; February 27-March 2, 2011; Boston, MA; Abstract 716.
19. Violari A, Lindsey JC, Hughes MD, et al. Nevirapine versus rito- navir-boosted lopinavir for HIV-infected children. N Engl J Med. 2012;366(25):2380-2389.
20. McIntyre JA, Hopley M, Moodley D, et al. Efficacy of short-course AZT plus 3TC to reduce nevirapine resistance in the prevention of mother-to-child HIV transmission: a randomized clinical trial. PLoS Med. 2009;6(10):e1000172.
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(9417):1253-1263.
22. Lockman S, Hughes MD, McIntyre J, et al. Antiretroviral therapies in women after single-dose nevirapine exposure. N Engl J Med. 2010;363(16):1499-1509.
23. de Maat MM, Nellen JF, Huitema AD, et al. Race is not associated with nevirapine pharmacokinetics. Ther Drug Monit. 2004;26(4): 456-458.
24. Izzedine H, Launay-Vacher V, Aymard G, Legrand M, Deray G. Pharmacokinetic of nevirapine in haemodialysis. Nephrol Dial Transplant. 2001;16(1):192-193.
25. Dominguez S, Ghosn J, Peytavin G, et al. Impact of hepatitis C and liver fibrosis on antiretroviral plasma drug concentrations in HIV-HCV co-infected patients: the HEPADOSE study. J Antimicrob Chemother. 2010;65(11):2445-2449.
26. Lamorde M, Byakika-Kibwika P, Okaba-Kayom V, et al. Nevirapine pharmacokinetics when initiated at 200 mg or 400 mg daily in HIV-1 and tuberculosis co-infected Ugandan adults on rifampicin. J Antimicrob Chemother. 2011;66(1):180-183.
27. Manosuthi W, Sungkanuparph S, Tantanathip P, et al. A randomized trial comparing plasma drug concentrations and effcacies between 2 non-nucleoside reverse-transcriptase inhibitor-based regimens in HIV- infected patients receiving rifampicin: the N2R Study. Clin Infect Dis. 2009;48(12):1752-1759.
28. Swaminathan S, Padmapriyadarsini C, Venkatesan P, et al. Efficacy and safety of once-daily nevirapine- or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. Clin Infect Dis. 2011;53(7):716-724.
29. Mankhatitham W, Lueangniyomkul A, Manosuthi W. Hepatotoxicity in patients co-infected with tuberculosis and HIV-1 while receiving non-nucleoside reverse transcriptase inhibitor-based antiretroviral therapy and rifampicin-containing anti-tuberculosis regimen. Southeast Asian J Trop Med Public Health. 2011;42(3):651-658.
30. Podzamczer D, Andrade-Villanueva J, Clotet B, et al. Lipid profiles for nevirapine vs atazanavir/ritonavir, both combined with tenofovir disoproxil fumarate and emtricitabine over 48 weeks, in treatment-naïve HIV-1- infected patients (the ARTEN study). HIV Med. 2011;12(6):374-382.
31. Aslangul E, Assoumou L, Bittar R, et al. Rosuvastatin versus pravastatin in dyslipidemic HIV-1-infected patients receiving protease inhibitors: a randomized trial. AIDS. 2010;24(1):77-83.
32. Pelet A, Favrat B, Cavassini M, Eap CB, Besson J, Monnat M. Usefulness of methadone plasma concentration measurement in patients receiving nevirapine or efavirenz. Am J Drug Alcohol Abuse. 2011;37(4):264-268.
33. Clarke SM, Mulcahy FM, Tjia J, et al. Pharmacokinetic interactions of nevirapine and methadone and guidelines for use of nevirapine to treat injection drug users. Clin Infect Dis. 2001;33(9):1595-1597.
34. Negredo E, Moltó J, Burger D, et al. Lopinavir/ritonavir plus nevirapine as a nucleoside-sparing approach in antiretroviral-experienced patients (NEKA study). J Acquir Immune Defc Syndr. 2005;38(1):47-52.
35. Negredo E, Miró O, Rodríguez-Santiago B, et al. Improvement of mitochondrial toxicity in patients receiving a nucleoside reverse- transcriptase inhibitor-sparing strategy: results from the Multicenter Study with Nevirapine and Kaletra (MULTINEKA). Clin Infect Dis. 2009;49(6):892-900.
36. Soriano V, Arasteh K, Migrone H, et al. Nevirapine versus atazanavir/ ritonavir, each combined with tenofovir disoproxil fumarate/ emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN trial. Antivir Ther. 2011;16(3):339-348.
37. DeJesús E, Mills A, Bhatti L, et al. A randomised comparison of safety and efficacy of nevirpine vs atazanavir/ritonavir combined with tenofovir/emtricitabine in treatment-naïve patients. Int J Clin Pract. 2011;65(12):1240-1249.
38. Arasteh K, Ward D, Plettenberg A, et al. 24 Wk efficacy and safety of transitioning virologically stable HIV-1 patients from IR nevirapine 200 mg BID to nevirapine XR 400 mg QD (TRANxITION). 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 12-15, 2010; Boston, MA; Abstract H-207.
39. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012 randomised trial. Lancet. 1999;354(9181):795-802.
40. Eshleman SH, Mracna M, Guay LA, et al. Selection and fading of resistance mutations in women and infants receiving nevirapine to prevent HIV-1 vertical transmission (HIVNET 012). AIDS. 2001;15(15): 1951-1957.
41. Kesho Bora Study Group, de Vincenzi I. Triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis during pregnancy and breastfeeding for prevention of mother-to-child transmission of HIV-1 (Kesho Bora study): a randomised controlled trial. Lancet Infect Dis. 2011;11(3):171-180.
42. Coovadia HM, Brown ER, Fowler MG, et al. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. Lancet. 2012;379(9812):221-228.
43. Omer SB, Six Week Extended Dose Nevirapine (SWEN) Study Team. Twelve-month follow-up of Six Week Extended Dose Nevirapine randomized controlled trials: differential impact of extended-dose nevirapine on mother-to-child transmission and infant death by maternal CD4 cell count. AIDS. 2011;25(6):767-776.
44. Pollard RB, Robinson P, Dransfield K. Safety profile of nevirapine, a non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus infection. Clin Ther. 1998;20(6):1071-1092.
45. Dieterich DT, Robinson PA, Love J, Stern JO. Drug-induced liver injury associated with the use of non-nucleoside reverse-transcriptase inhibitors. Clin Infect Dis. 2004;38 Suppl 2:S80-S89.
46. Haas DW, Bartlett JA, Andersen J W, et al. Pharmacogenetics of nevirapine-associated hepatotoxicity: an Adult AIDS Clinical Trials Group collaboration. Clin Infect Dis. 2006;43(6):783-786.
47. Sanne I, Mommeja-Marin H, Hinkle J, et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis. 2005;191(6):825-829.
48. Stern JO, Robinson PA, Love J, Lanes S, Imperiale MS, Mayers DL. A comprehensive hepatic safety analysis of nevirapine in different populations of HIV infected patients. J Acquir Immune Defc Syndr. 2003;34 Suppl 1:S21-S33.
49. European Medicines Agency. Nevirapine - summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000183/WC500051481.pdf. Accessed June 14, 2012.
50. Kesselring AM, Wit F W, Sabin CA, et al. Risk factors for treatment- limiting toxicities in patients starting nevirapine-containing antiretroviral therapy. AIDS. 2009;23(13):1689-1699.
51. Mocroft A, Staszewski S, Weber R, et al. Risk of discontinuation of nevirapine due to toxicities in antiretroviral-naive and -experienced HIV-infected patients with high and low CD4+ T-cell counts. Antivir Ther. 2007;12(3):325-333.
52. Wit F W, Kesselring AM, Gras L, et al. Discontinuation of nevirapine because of hypersensitivity reactions in patients with prior treatment experience, compared with treatment-naive patients: the ATHENA cohort study. Clin Infect Dis. 2008;46(6):933-940.
53. Calmy A, Vallier N, Nguyen A, et al. Safety and efficacy of once-daily nevirapine dosing: a multicohort study. Antivir Ther. 2009;14(7): 931-938.
54. Manfredi R, Calza L. Nevirapine versus efavirenz in 742 patients: no link of liver toxicity with female sex, and a baseline CD4 cell count greater than 250 cells/microl. AIDS. 2006;20(17):2233-2236.
55. Antela A, Ocampo A, Gómez R, et al. Liver toxicity after switching or simplifying to nevirapine-based therapy is not related to CD4 cell counts: results of the TOSCANA study. HIV Clin Trials. 2010;11(1):11-17.
56. De Lazzari E, León A, Arnaiz JA, et al. Hepatotoxicity of nevirapine in virologically suppressed patients according to gender and CD4 cell counts. HIV Med. 2008;9(4):221-226.
57. Centers for Disease Control and Prevention (CDC). Serious adverse events attributed to nevirapine regimens for postexposure prophylaxis after HIV exposures - worldwide, 1997-2000. MMWR Morb Mortal Wkly Rep. 2001;49(51-52):1153-1156.
58. Ena J, Amador C, Benito C, Fenoll V, Pasquau F. Risk and determinants of developing severe liver toxicity during therapy with nevirapine- and efavirenz-containing regimens in HIV-infected patients. Int J STD AIDS. 2003;14(11):776-781.