Testmiljö
Observera att detta är en testmiljö för utveckling som inte ska användas som underlag för klinisk bedömning. Besök Janusmed här: https://janusmed.se

11/21/2024

Janusmed kön och genus

Janusmed kön och genus – Efavirenz Teva

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Efavirenz Testmiljö

Efavirenz

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  1. Efavirenz Teva (efavirenz). Summary of Product Characteristics. European Medicines Agency (EMA); 2013.

  2. Nyakutira C, Röshammar D, Chigutsa E, Chonzi P, Ashton M, Nhachi C et al. High prevalence of the CYP2B6 516G-->T(*6) variant and effect on the population pharmacokinetics of efavirenz in HIV/AIDS outpatients in Zimbabwe. Eur J Clin Pharmacol. 2008;64(4):357-65.

  3. Anderson GD. Gender differences in pharmacological response. Int Rev Neurobiol. 2008;83(0):1-10.

  4. Nicolson TJ, Mellor HR, Roberts RR. Gender differences in drug toxicity. Trends Pharmacol Sci. 2010;31:108-14.

  5. Dhoro M, Zvada S, Ngara B, Nhachi C, Kadzirange G, Chonzi P et al. CYP2B6*6, CYP2B6*18, Body weight and sex are predictors of efavirenz pharmacokinetics and treatment response: population pharmacokinetic modeling in an HIV/AIDS and TB cohort in Zimbabwe. BMC Pharmacol Toxicol. 2015;16(0):4.

  6. Mukonzo JK, Nanzigu S, Rekić D, Waako P, Röshammar D, Ashton M et al. HIV/AIDS patients display lower relative bioavailability of efavirenz than healthy subjects. Clin Pharmacokinet. 2011;50(8):531-40.

  7. Burger D, van der Heiden I, la Porte C, van der Ende M, Groeneveld P, Richter C et al. Interpatient variability in the pharmacokinetics of the HIV non-nucleoside reverse transcriptase inhibitor efavirenz: the effect of gender, race, and CYP2B6 polymorphism. Br J Clin Pharmacol. 2006;61(2):148-54.

  8. Ibarra M, Magallanes L, Lorier M, Vázquez M, Fagiolino P. Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets. Eur J Pharm Sci. 2016;85(1):106-11.

  9. Wester CW, Stitelman OM, deGruttola V, Bussmann H, Marlink RG, van der Laan MJ. Effect modification by sex and baseline CD4+ cell count among adults receiving combination antiretroviral therapy in Botswana: results from a clinical trial. AIDS Res Hum Retroviruses. 2012;28(9):981-8.

  10. Puthanakit T, Kerr S, Ananworanich J, Bunupuradah T, Boonrak P, Sirisanthana V. Pattern and predictors of immunologic recovery in human immunodeficiency virus-infected children receiving non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy. Pediatr Infect Dis J. 2009;28(6):488-92.

  11. Chawana TD, Reid A, Bwakura T, Gavi S, Nhachi CF. Factors influencing treatment failure in HIV positive adult patients on first line antiretroviral therapy. Cent Afr J Med. 2014;60(5):29-36.

  12. Bienczak A, Denti P, Cook A, Wiesner L, Mulenga V, Kityo C et al. Plasma Efavirenz Exposure, Sex, and Age Predict Virological Response in HIV-Infected African Children. J Acquir Immune Defic Syndr. 2016;73(2):161-8.

  13. Annan NT, Nelson M, Mandalia S, Bower M, Gazzard BG, Stebbing J. The nucleoside backbone affects durability of efavirenz- or nevirapine-based highly active antiretroviral therapy in antiretroviral-naive individuals. J Acquir Immune Defic Syndr. 2009;51(2):140-6.

  14. Hodder S, Arasteh K, De Wet J, Gathe J, Gold J, Kumar P et al. Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. HIV Med. 2012;13(7):406-15.

  15. Castelnuovo B, Kiragga A, Mubiru F, Kambugu A, Kamya M, Reynolds SJ. First-line antiretroviral therapy durability in a 10-year cohort of naïve adults started on treatment in Uganda. J Int AIDS Soc. 2016;19(1):20773.

  16. Kuritzkes DR, Ribaudo HJ, Squires KE, Koletar SL, Santana J, Riddler SA et al. Plasma HIV-1 RNA dynamics in antiretroviral-naive subjects receiving either triple-nucleoside or efavirenz-containing regimens: ACTG A5166s. J Infect Dis. 2007;195(8):1169-76.

  17. Johnson M, Walmsley S, Haberl A. A systematic review of the use of atazanavir in women infected with HIV-1. Antivir Ther. 2014;19(3):293-307.

  18. Hunt GM, Dokubo EK, Takuva S, de Oliveira T, Ledwaba J, Dube N et al. Rates of virological suppression and drug resistance in adult HIV-1-positive patients attending primary healthcare facilities in KwaZulu-Natal, South Africa. J Antimicrob Chemother. 2017;72(11):3141-3148.

  19. Kumar PN, Rodriguez-French A, Thompson MA, Tashima KT, Averitt D, Wannamaker PG et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med. 2006;7(2):85-98.

  20. Smith KY, Tierney C, Mollan K, Venuto CS, Budhathoki C, Ma Q et al. Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine. Clin Infect Dis. 2014;58(4):555-63.

  21. Mocroft A, Lundgren JD, Ross M, Law M, Reiss P, Kirk O et al. Development and validation of a risk score for chronic kidney disease in HIV infection using prospective cohort data from the D:A:D study. PLoS Med. 2015;12(3):e1001809.

  22. Dlamini J, Ledwaba L, Mokwena N, Mokhathi T, Orsega S, Tsoku M et al. Lactic acidosis and symptomatic hyperlactataemia in a randomized trial of first-line therapy in HIV-infected adults in South Africa. Antivir Ther. 2011;16(4):605-9.

  23. Dhoro M, Ngara B, Kadzirange G, Nhachi C, Masimirembwa C. Genetic variants of drug metabolizing enzymes and drug transporter (ABCB1) as possible biomarkers for adverse drug reactions in an HIV/AIDS cohort in Zimbabwe. Curr HIV Res. 2013;11(6):481-90.

  24. Martín-Carbonero L, Núñez M, González-Lahoz J, Soriano V. Incidence of liver injury after beginning antiretroviral therapy with efavirenz or nevirapine. HIV Clin Trials. 2003;4(2):115-20.

  25. Sonderup MW, Maughan D, Gogela N, Setshedi M, Wainwright H, Meintjes G et al. Identification of a novel and severe pattern of efavirenz drug-induced liver injury in South Africa. AIDS. 2016;30(9):1483-5.

  26. Sanne I, Mommeja-Marin H, Hinkle J, Bartlett JA, Lederman MM, Maartens G et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis. 2005;191(6):825-9.

  27. Ocama P, Castelnuovo B, Kamya MR, Kirk GD, Reynolds SJ, Kiragga A et al. Low frequency of liver enzyme elevation in HIV-infected patients attending a large urban treatment centre in Uganda. Int J STD AIDS. 2010;21(8):553-7.

  28. Tashima KT, Bausserman L, Alt EN, Aznar E, Flanigan TP. Lipid changes in patients initiating efavirenz- and indinavir-based antiretroviral regimens. HIV Clin Trials. 2003;4(1):29-36.

  29. Ombeni W, Kamuhabwa AR. Lipid Profile in HIV-Infected Patients Using First-Line Antiretroviral Drugs. J Int Assoc Provid AIDS Care. 2015;15(2):164-71.

  30. Dave JA, Lambert EV, Badri M, West S, Maartens G, Levitt NS. Effect of nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy on dysglycemia and insulin sensitivity in South African HIV-infected patients. J Acquir Immune Defic Syndr. 2011;57(4):284-9.

  31. Firnhaber C, Smeaton LM, Grinsztejn B, Lalloo U, Faesen S, Samaneka W et al. Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials. 2015;16(3):89-99.

  32. Svedhem-Johansson V, Pugliese P, Brockmeyer NH, Thalme A, Michalik C, Esser S et al. Long-term gender-based outcomes for atazanavir/ritonavir (ATV/r)- containing regimens in treatment-experienced patients with HIV. Curr HIV Res. 2013;11(4):333-41.

  33. Eluwa GI, Badru T, Agu KA, Akpoigbe KJ, Chabikuli O, Hamelmann C. Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. BMC Clin Pharmacol. 2012;12(1):7.

  34. Bandeira ACPCS, Elias DBD, Cavalcante MG, Lima DGL, Távora LGF. Antiretroviral changes during the first year of therapy. Rev Assoc Med Bras (1992). 2017;63(7):606-612.

  35. Spire B, Carrieri P, Garzot MA, L'henaff M, Obadia Y, TRT-5 Group. Factors associated with efavirenz discontinuation in a large community-based sample of patients. AIDS Care. 2004;16(5):558-64.

  36. Fabbiani M, Zaccarelli M, Grima P, Prosperi M, Fanti I, Colafigli M et al. Single tablet regimens are associated with reduced Efavirenz withdrawal in antiretroviral therapy naïve or switching for simplification HIV-infected patients. BMC Infect Dis. 2014;14(1):26.

  37. Shikuma CM, Ribaudo HJ, Zheng Y, Gulick RM, Meyer WA, Tashima KT et al. Change in high-sensitivity c-reactive protein levels following initiation of efavirenz-based antiretroviral regimens in HIV-infected individuals. AIDS Res Hum Retroviruses. 2011;27(5):461-8.

  38. Else LJ, Taylor S, Back DJ, Khoo SH. Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the male and female genital tract. Antivir Ther. 2011;16(8):1149-67.

  39. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]

  1. Efavirenz Teva (efavirenz). Summary of Product Characteristics. European Medicines Agency (EMA); 2013.
  2. Nyakutira C, Röshammar D, Chigutsa E, Chonzi P, Ashton M, Nhachi C et al. High prevalence of the CYP2B6 516G-->T(*6) variant and effect on the population pharmacokinetics of efavirenz in HIV/AIDS outpatients in Zimbabwe. Eur J Clin Pharmacol. 2008;64(4):357-65.
  3. Anderson GD. Gender differences in pharmacological response. Int Rev Neurobiol. 2008;83(0):1-10.
  4. Nicolson TJ, Mellor HR, Roberts RR. Gender differences in drug toxicity. Trends Pharmacol Sci. 2010;31:108-14.
  5. Dhoro M, Zvada S, Ngara B, Nhachi C, Kadzirange G, Chonzi P et al. CYP2B6*6, CYP2B6*18, Body weight and sex are predictors of efavirenz pharmacokinetics and treatment response: population pharmacokinetic modeling in an HIV/AIDS and TB cohort in Zimbabwe. BMC Pharmacol Toxicol. 2015;16(0):4.
  6. Mukonzo JK, Nanzigu S, Rekić D, Waako P, Röshammar D, Ashton M et al. HIV/AIDS patients display lower relative bioavailability of efavirenz than healthy subjects. Clin Pharmacokinet. 2011;50(8):531-40.
  7. Burger D, van der Heiden I, la Porte C, van der Ende M, Groeneveld P, Richter C et al. Interpatient variability in the pharmacokinetics of the HIV non-nucleoside reverse transcriptase inhibitor efavirenz: the effect of gender, race, and CYP2B6 polymorphism. Br J Clin Pharmacol. 2006;61(2):148-54.
  8. Ibarra M, Magallanes L, Lorier M, Vázquez M, Fagiolino P. Sex-by-formulation interaction assessed through a bioequivalence study of efavirenz tablets. Eur J Pharm Sci. 2016;85(1):106-11.
  9. Wester CW, Stitelman OM, deGruttola V, Bussmann H, Marlink RG, van der Laan MJ. Effect modification by sex and baseline CD4+ cell count among adults receiving combination antiretroviral therapy in Botswana: results from a clinical trial. AIDS Res Hum Retroviruses. 2012;28(9):981-8.
  10. Puthanakit T, Kerr S, Ananworanich J, Bunupuradah T, Boonrak P, Sirisanthana V. Pattern and predictors of immunologic recovery in human immunodeficiency virus-infected children receiving non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy. Pediatr Infect Dis J. 2009;28(6):488-92.
  11. Chawana TD, Reid A, Bwakura T, Gavi S, Nhachi CF. Factors influencing treatment failure in HIV positive adult patients on first line antiretroviral therapy. Cent Afr J Med. 2014;60(5):29-36.
  12. Bienczak A, Denti P, Cook A, Wiesner L, Mulenga V, Kityo C et al. Plasma Efavirenz Exposure, Sex, and Age Predict Virological Response in HIV-Infected African Children. J Acquir Immune Defic Syndr. 2016;73(2):161-8.
  13. Annan NT, Nelson M, Mandalia S, Bower M, Gazzard BG, Stebbing J. The nucleoside backbone affects durability of efavirenz- or nevirapine-based highly active antiretroviral therapy in antiretroviral-naive individuals. J Acquir Immune Defic Syndr. 2009;51(2):140-6.
  14. Hodder S, Arasteh K, De Wet J, Gathe J, Gold J, Kumar P et al. Effect of gender and race on the week 48 findings in treatment-naïve, HIV-1-infected patients enrolled in the randomized, phase III trials ECHO and THRIVE. HIV Med. 2012;13(7):406-15.
  15. Castelnuovo B, Kiragga A, Mubiru F, Kambugu A, Kamya M, Reynolds SJ. First-line antiretroviral therapy durability in a 10-year cohort of naïve adults started on treatment in Uganda. J Int AIDS Soc. 2016;19(1):20773.
  16. Kuritzkes DR, Ribaudo HJ, Squires KE, Koletar SL, Santana J, Riddler SA et al. Plasma HIV-1 RNA dynamics in antiretroviral-naive subjects receiving either triple-nucleoside or efavirenz-containing regimens: ACTG A5166s. J Infect Dis. 2007;195(8):1169-76.
  17. Johnson M, Walmsley S, Haberl A. A systematic review of the use of atazanavir in women infected with HIV-1. Antivir Ther. 2014;19(3):293-307.
  18. Hunt GM, Dokubo EK, Takuva S, de Oliveira T, Ledwaba J, Dube N et al. Rates of virological suppression and drug resistance in adult HIV-1-positive patients attending primary healthcare facilities in KwaZulu-Natal, South Africa. J Antimicrob Chemother. 2017;72(11):3141-3148.
  19. Kumar PN, Rodriguez-French A, Thompson MA, Tashima KT, Averitt D, Wannamaker PG et al. A prospective, 96-week study of the impact of Trizivir, Combivir/nelfinavir, and lamivudine/stavudine/nelfinavir on lipids, metabolic parameters and efficacy in antiretroviral-naive patients: effect of sex and ethnicity. HIV Med. 2006;7(2):85-98.
  20. Smith KY, Tierney C, Mollan K, Venuto CS, Budhathoki C, Ma Q et al. Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine. Clin Infect Dis. 2014;58(4):555-63.
  21. Mocroft A, Lundgren JD, Ross M, Law M, Reiss P, Kirk O et al. Development and validation of a risk score for chronic kidney disease in HIV infection using prospective cohort data from the D:A:D study. PLoS Med. 2015;12(3):e1001809.
  22. Dlamini J, Ledwaba L, Mokwena N, Mokhathi T, Orsega S, Tsoku M et al. Lactic acidosis and symptomatic hyperlactataemia in a randomized trial of first-line therapy in HIV-infected adults in South Africa. Antivir Ther. 2011;16(4):605-9.
  23. Dhoro M, Ngara B, Kadzirange G, Nhachi C, Masimirembwa C. Genetic variants of drug metabolizing enzymes and drug transporter (ABCB1) as possible biomarkers for adverse drug reactions in an HIV/AIDS cohort in Zimbabwe. Curr HIV Res. 2013;11(6):481-90.
  24. Martín-Carbonero L, Núñez M, González-Lahoz J, Soriano V. Incidence of liver injury after beginning antiretroviral therapy with efavirenz or nevirapine. HIV Clin Trials. 2003;4(2):115-20.
  25. Sonderup MW, Maughan D, Gogela N, Setshedi M, Wainwright H, Meintjes G et al. Identification of a novel and severe pattern of efavirenz drug-induced liver injury in South Africa. AIDS. 2016;30(9):1483-5.
  26. Sanne I, Mommeja-Marin H, Hinkle J, Bartlett JA, Lederman MM, Maartens G et al. Severe hepatotoxicity associated with nevirapine use in HIV-infected subjects. J Infect Dis. 2005;191(6):825-9.
  27. Ocama P, Castelnuovo B, Kamya MR, Kirk GD, Reynolds SJ, Kiragga A et al. Low frequency of liver enzyme elevation in HIV-infected patients attending a large urban treatment centre in Uganda. Int J STD AIDS. 2010;21(8):553-7.
  28. Tashima KT, Bausserman L, Alt EN, Aznar E, Flanigan TP. Lipid changes in patients initiating efavirenz- and indinavir-based antiretroviral regimens. HIV Clin Trials. 2003;4(1):29-36.
  29. Ombeni W, Kamuhabwa AR. Lipid Profile in HIV-Infected Patients Using First-Line Antiretroviral Drugs. J Int Assoc Provid AIDS Care. 2015;15(2):164-71.
  30. Dave JA, Lambert EV, Badri M, West S, Maartens G, Levitt NS. Effect of nonnucleoside reverse transcriptase inhibitor-based antiretroviral therapy on dysglycemia and insulin sensitivity in South African HIV-infected patients. J Acquir Immune Defic Syndr. 2011;57(4):284-9.
  31. Firnhaber C, Smeaton LM, Grinsztejn B, Lalloo U, Faesen S, Samaneka W et al. Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials. 2015;16(3):89-99.
  32. Svedhem-Johansson V, Pugliese P, Brockmeyer NH, Thalme A, Michalik C, Esser S et al. Long-term gender-based outcomes for atazanavir/ritonavir (ATV/r)- containing regimens in treatment-experienced patients with HIV. Curr HIV Res. 2013;11(4):333-41.
  33. Eluwa GI, Badru T, Agu KA, Akpoigbe KJ, Chabikuli O, Hamelmann C. Adverse drug reactions to antiretroviral therapy (ARVs): incidence, type and risk factors in Nigeria. BMC Clin Pharmacol. 2012;12(1):7.
  34. Bandeira ACPCS, Elias DBD, Cavalcante MG, Lima DGL, Távora LGF. Antiretroviral changes during the first year of therapy. Rev Assoc Med Bras (1992). 2017;63(7):606-612.
  35. Spire B, Carrieri P, Garzot MA, L'henaff M, Obadia Y, TRT-5 Group. Factors associated with efavirenz discontinuation in a large community-based sample of patients. AIDS Care. 2004;16(5):558-64.
  36. Fabbiani M, Zaccarelli M, Grima P, Prosperi M, Fanti I, Colafigli M et al. Single tablet regimens are associated with reduced Efavirenz withdrawal in antiretroviral therapy naïve or switching for simplification HIV-infected patients. BMC Infect Dis. 2014;14(1):26.
  37. Shikuma CM, Ribaudo HJ, Zheng Y, Gulick RM, Meyer WA, Tashima KT et al. Change in high-sensitivity c-reactive protein levels following initiation of efavirenz-based antiretroviral regimens in HIV-infected individuals. AIDS Res Hum Retroviruses. 2011;27(5):461-8.
  38. Else LJ, Taylor S, Back DJ, Khoo SH. Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the male and female genital tract. Antivir Ther. 2011;16(8):1149-67.
  39. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2017 [cited 2018-07-24.]