Nevirapine extended-release for the treatment of HIV-1 infection

References

• Merluzzi VJ, Hargrave KD, Labadia M et al. Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Science250(4986), 1411–1413 (1990).
   PubMed Web of Science ®Google Scholar
• Grob PM, Wu JC, Cohen KA et al. Nonnucleoside inhibitors of HIV-1 reverse transcriptase: nevirapine as a prototype drug. AIDS Res. Hum. Retrovir.8(2), 145–152 (1992).
   PubMed Web of Science ®Google Scholar
• Skoog MT, Hargrave KD, Miglietta JJ, Kopp EB, Merluzzi VJ. Inhibition of HIV-1 reverse transcriptase and virus replication by a non-nucleoside dipyridodiazepinone BI-RG-587 (Nevirapine). Med. Res. Rev.12(1), 27–40 (1992).
   PubMedGoogle Scholar
• Cheeseman SH, Havlir D, McLaughlin MM et al. Phase 1/2 evaluation of nevirapine alone and in combination with zidovudine for infection with human immunodeficiency virus. J. Acquir. Immu. Defic. Syndr. Hum. Retrovirol.8(2), 141–151 (1995).
   PubMedGoogle Scholar
• Montaner JS, Reiss P, Cooper D et al. A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. JAMA279(12), 930–937 (1998).
   PubMed Web of Science ®Google Scholar
• Podzamczer D, Fumero E. The role of nevirapine in the treatment of HIV-1 disease. Exp. Opin. Pharmacother.2(12), 2065–2078 (2001).
   PubMedGoogle Scholar
• Podzamczer D, Ferrer E, Consiglio E et al. A randomized clinical trial comparing nelfinavir or nevirapine associated to zidovudine/lamivudine in HIV-infected naive patients (the Combine Study). Antivir. Ther.7(2), 81–90 (2002).
   PubMed Web of Science ®Google Scholar
• 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. Immu. Defic. Syndr.34(Suppl. 1), S21–S33 (2003).
   PubMed Web of Science ®Google Scholar
• Bangsberg DR, Acosta EP, Gupta R et al. Adherence-resistance relationships for protease and non-nucleoside reverse transcriptase inhibitors explained by virological fitness. AIDS20(2), 223–231 (2006).
   PubMed Web of Science ®Google Scholar
• Lima VD, Harrigan R, Bangsberg DR et al. The combined effect of modern highly active antiretroviral therapy regimens and adherence on mortality over time. J. Acquir. Immu. Defic. Syndr.50(5), 529–536 (2009).
   PubMed Web of Science ®Google Scholar
• Lima VD, Bangsberg DR, Harrigan PR et al. Risk of viral failure declines with duration of suppression on highly active antiretroviral therapy irrespective of adherence level. J. Acquir. Immu. Defic. Syndr.55(4), 460–465 (2010).
   PubMed Web of Science ®Google Scholar
• Haubrich RH, Little SJ, Currier JS et al. The value of patient-reported adherence to antiretroviral therapy in predicting virologic and immunologic response. California Collaborative Treatment Group. AIDS13(9), 1099–1107 (1999).
   PubMed Web of Science ®Google Scholar
• Mannheimer S, Friedland G, Matts J, Child C, Chesney M. The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. Clin. Infect. Dis.34(8), 1115–1121 (2002).
   PubMed Web of Science ®Google Scholar
• Garcia de OP, Knobel H, Carmona A, Guelar A, Lopez-Colomes JL, Cayla JA. Impact of adherence and highly active antiretroviral therapy on survival in HIV-infected patients. J. Acquir. Immu. Defic. Syndr.30(1), 105–110 (2002).
   PubMedGoogle Scholar
• Flandre P, Peytavin G, Meiffredy V et al. Adherence to antiretroviral therapy and outcomes in HIV-infected patients enrolled in an induction/maintenance randomized trial. Antivir. Ther.7(2), 113–121 (2002).
   PubMed Web of Science ®Google Scholar
• Hawkins T. Impact of once- and twice-daily dosing regimens on adherence and overall safety. AIDS Read.14(6), 320–334 (2004).
   PubMedGoogle Scholar
• Street E, Curtis H, Sabin CA, Monteiro EF, Johnson MA. British HIV Association (BHIVA) national cohort outcomes audit of patients commencing antiretrovirals from naive. HIV Med.10(6), 337–342 (2009).
   PubMed Web of Science ®Google Scholar
• Molina JM. Efficacy and safety of once-daily regimens in the treatment of HIV infection. Drugs68(5), 567–578 (2008).
   PubMed Web of Science ®Google Scholar
• 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. Lancet363(9417), 1253–1263 (2004).
   PubMed Web of Science ®Google Scholar
• van Leth F, Huisamen CB, Badaro R et al. Plasma HIV-1 RNA decline within the first two weeks of treatment is comparable for nevirapine, efavirenz, or both drugs combined and is not predictive of long-term virologic efficacy: a 2NN substudy. J. Acquir. Immu. Defic. Syndr.38(3), 296–300 (2005).
   PubMed Web of Science ®Google Scholar
• Kappelhoff BS, Huitema AD, van LF et al. Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study. HIV Clin. Trials6(5), 254–261 (2005).
   PubMed Web of Science ®Google Scholar
• Kappelhoff BS, van LF, MacGregor TR, Lange J, Beijnen JH, Huitema AD. Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study. Antivir. Ther.10(1), 145–155 (2005).
   PubMed Web of Science ®Google Scholar
• Johnson M, Soriano V, Brockmeyer N et al. Early virological and immunological response is comparable for nevirapine and RTV-boosted atazanavir: an ARTEN sub-analysis. Presented at: 49th ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy). San Francisco, CA, USA, September 12–15 2009 (Abstract H-924c).
   Google Scholar
• van Leeuwen R, Katlama C, Murphy RL et al. A randomized trial to study first-line combination therapy with or without a protease inhibitor in HIV-1-infected patients. AIDS17(7), 987–999 (2003).
   PubMed Web of Science ®Google Scholar
• 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. AIDS14(16), 2485–2494 (2000).
   PubMed Web of Science ®Google Scholar
• Raffi F, Reliquet V, Ferre V et al. The VIRGO study: nevirapine, didanosine and stavudine combination therapy in antiretroviral-naive HIV-1-infected adults. Antivir. Ther.5(4), 267–272 (2000).
   PubMed Web of Science ®Google Scholar
• 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. AIDS14(8), F77–F82 (2000).
   PubMed Web of Science ®Google Scholar
• Macha S, Yong CL, Darrington T et al.In vitro–in vivo correlation for nevirapine extended release tablets. Biopharm. Drug Dispos.30(9), 542–550 (2009).
   PubMed Web of Science ®Google Scholar
• Julg B, Bogner JR. Atripla™ – HIV therapy in one pill. Ther. Clin. Risk Manag.4(3), 573–577 (2008).
   PubMedGoogle Scholar
• Staszewski S, Morales-Ramirez J, Tashima KT et al. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. N. Engl. J. Med.341(25), 1865–1873 (1999).
   PubMed Web of Science ®Google Scholar
• Maggiolo F, Migliorino M, Maserati R et al. Virological and immunological responses to a once-a-day antiretroviral regimen with didanosine, lamivudine and efavirenz. Antivir. Ther.6(4), 249–253 (2001).
   PubMed Web of Science ®Google Scholar
• van Leth F, Phanuphak P, Stroes E et al. Nevirapine and efavirenz elicit different changes in lipid profiles in antiretroviral-therapy-naive patients infected with HIV-1. PLoS Med.1(1), e19 (2004).
   PubMed Web of Science ®Google Scholar
• Kappelhoff BS, van LF, Robinson PA et al. Are adverse events of nevirapine and efavirenz related to plasma concentrations? Antivir. Ther.10(4), 489–498 (2005).
   PubMed Web of Science ®Google Scholar
• van Leth F, Andrews S, Grinsztejn B et al. The effect of baseline CD4 cell count and HIV-1 viral load on the efficacy and safety of nevirapine or efavirenz-based first-line HAART. AIDS19(5), 463–471 (2005).
   PubMed Web of Science ®Google Scholar
• Santos J, Palacios R, Lopez M et al. Simplicity and efficacy of a once-daily antiretroviral regimen with didanosine, lamivudine, and efavirenz in naive patients: the VESD study. HIV Clin. Trials6(6), 320–328 (2005).
   PubMed Web of Science ®Google Scholar
• Barragan P, Fisac C, Podzamczer D. Switching strategies to improve lipid profile and morphologic changes. AIDS Rev.8(4), 191–203 (2006).
   PubMed Web of Science ®Google Scholar
• Quinson A-M, Arasteh K, Plettenberg A et al. Steady state evaluation of two extended release (XR) nevirapine (NVP) tablets 400 mg QD compared with immediate release (IR) NVP tablets 200 mg BID in HIV-1 infected patients. Presented at: 49th ICAAC. San Francisco, CA, USA, 11–15 September 2009 (Paper #2879[A1-1310]).
   Google Scholar
• 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.16(5), 759–769 (2011).
   PubMed Web of Science ®Google Scholar
• Soriano V, Koppe S, Mingrone H et al. Prospective comparison of nevirapine and atazanavir/ritonavir both combined with tenofovir DF/emtricitabine in treatment-naive HIV-1 infected patients: ARTEN study week 48 results. Presented at: 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Cape Town, South Africa, 19–22 July 2009 (Abstract LBPEB07) (2010).
   Google Scholar
• Soriano V, Arastéh K, Migrone H et al. ARTEN investigators. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir disoproxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Antivir. Ther.16(3), 339–348 (2011).
   PubMed Web of Science ®Google Scholar
• Sax PE. Report from the 5th IAS Conference on HIV Pathogenesis Treatment and Prevention. Nevirapine vs. boosted atazanavir – the ARTEN Study. J. Watch. AIDS Clin. Care21(10), 80 (2009).
   PubMedGoogle Scholar
• Gunthard HF, Wong JK, Ignacio CC et al. Human immunodeficiency virus replication and genotypic resistance in blood and lymph nodes after a year of potent antiretroviral therapy. J. Virol.72(3), 2422–2428 (1998).
   PubMed Web of Science ®Google Scholar
• 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). Presented at: ICAAC 2010. Boston, MA, USA, 12–15 September 2010.
   Google Scholar
• Nettles RE, Kieffer TL, Kwon P et al. Intermittent HIV-1 viremia (Blips) and drug resistance in patients receiving HAART. JAMA293(7), 817–829 (2005).
   PubMed Web of Science ®Google Scholar
• Sungkanuparph S, Overton ET, Seyfried W, Groger RK, Fraser VJ, Powderly WG. Intermittent episodes of detectable HIV viremia in patients receiving nonnucleoside reverse-transcriptase inhibitor-based or protease inhibitor-based highly active antiretroviral therapy regimens are equivalent in incidence and prognosis. Clin. Infect. Dis.41(9), 1326–1332 (2005).
   PubMed Web of Science ®Google Scholar
• Sungkanuparph S, Groger RK, Overton ET, Fraser VJ, Powderly WG. Persistent low-level viraemia and virological failure in HIV-1-infected patients treated with highly active antiretroviral therapy. HIV Med.7(7), 437–441 (2006).
   PubMed Web of Science ®Google Scholar
• Molto J, Deig E, Valle M et al. Effect of nevirapine on the steady-state trough concentrations of atazanavir in HIV-infected patients receiving atazanavir/ritonavir. Ther. Drug Monit.32(1), 93–96 (2010).
   PubMed Web of Science ®Google Scholar
• Perelson AS, Essunger P, Cao Y et al. Decay characteristics of HIV-1-infected compartments during combination therapy. Nature387(6629), 188–191 (1997).
   PubMed Web of Science ®Google Scholar
• Powderly WG, Saag MS, Chapman S, Yu G, Quart B, Clendeninn NJ. Predictors of optimal virological response to potent antiretroviral therapy. AIDS13(14), 1873–1880 (1999).
   PubMed Web of Science ®Google Scholar
• 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. AIDS14(8), F77–F82 (2000).
   PubMed Web of Science ®Google Scholar
• Bergersen BM. Cardiovascular risk in patients with HIV infection: impact of antiretroviral therapy. Drugs66(15), 1971–1987 (2006).
   PubMed Web of Science ®Google Scholar
• Elzi L, Marzolini C, Furrer H et al. Treatment modification in human immunodeficiency virus-infected individuals starting combination antiretroviral therapy between 2005 and 2008. Arch. Intern. Med.170(1), 57–65 (2010).
   PubMed Web of Science ®Google Scholar
• Gathe J, Bogner JR, Santiago S et al. Comparison of 48 week efficacy and safety of 400mg QD nevirapine (NVP) extended release formulation (Viramune XR) versus 200mg BID nevirapine immediate release formulation (Viramune IR) in combination with emtricitabine/tenofovir in antiretroviral (ARV) naive HIV-1 infected patients (VERxVE). Presented at: 18th International AIDS Society (IAS) Conference. Vienna, Austria, July 18–23 2010.
   Google Scholar