抗HIV治療ガイドライン(2023年3月発行)

V初回治療に用いる抗HIV薬の選び方

文献

  1. Bartlett JA, Fath MJ, Demasi R, et al. An updated systematic overview of triple combination therapy in antiretroviral- naïve HIV-infected adults. AIDS 20:2051-64. 2006.
  2. Riddler SA, Haubrich R, DiRienzo AG, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med 358:2095-106. 2008.
  3. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV (米国DHHS, Sep 21, 2022).
    https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/whats-new-guidelines
  4. European AIDS Clinical Society (EACS) Guidelines. Version 11.1-October 2022. https://eacs.sanfordguide.com
  5. Gibas,KM, Kelly SG, Arribas JR, Cahn P, et al. Two-drug regimens for HIV treatment. Lancet HIV.9:e868-83.2022.
  6. Rockstroh JK, DeJesus E, Lennox JL, et al. Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naïve HIV-1-infected patients: final 5-year results from STARTMRK. J Acquir Immune Defic Syndr. 63(1):77-85. 2013.
  7. Lennox JL, Landovitz RJ, Ribaudo HJ, et al. Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naïve volunteers infected with HIV-1: a randomized, controlled equivalence trial. Ann Intern Med 161(7):461-471. 2014.
  8. Cahn P, Kaplan R, Sax PE, et al. Raltegravir 1200 mg once daily versus raltegravir 400 mg twice daily, with tenofovir disoproxil fumarate and emtricitabine, for previously untreated HIV-1 infection: a randomised, double-blind, parallel-group, phase 3, non-inferiority trial. Lancet HIV. 4: e486-e494. 2017.
  9. Cahn P, Sax PE, Squires K, et al. Raltegravir 1200 mg once daily vs 400 mg twice daily, with emtricitabine and tenofovir disoproxil fumarate, for previously untreated HIV-1 infection: Week 96 results from ONCEMRK, a randomized, double-blind, non-inferiority trial. J Acquir Immune Defic Syndr.78(5): 589-98. 2018.
  10. Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naïve adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis.13:927-35.2013.
  11. Walmsley S, Antela A, Clumeck N, et al. Dolutegravir plus Abacavir-Lamivudine for the Treatment of HIV-1 Infection. N Engl J Med.369:1807-18. 2013.
  12. Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naïve adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 383: 2222-31. 2014.
  13. Cahn P, Madero JS, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve adults with HIV-1 infection(GEMINI-1 and GEMINI-2): week 48 results from two multicenter, double-blind, randpmised, non-inferiority, phase 3 trials. Lancet. 2019; 393(10167):143-155.
  14. Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir plus lamivudine in antiretroviral treatment-naïve adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune defic Syndr. 83(3):310-318. 2020.
  15. Cahn P, Madero JS, Arribas JR, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 36(1):39-48. 2022.
  16. Ait-Khaled, Madero JS, Estrada V, et al. Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine :pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies. HIV Res Clin Pract. 2021 Dec 16:1-6.
  17. Ciccullo A, Baldin G, Dusina A, et al. Short Communication: Efficacy and safety of dolutegravir plus lamivudine as a first-line regimen in clinical practice. AIDS Res Hum Retroviruses. 2021; 37(6):486-488.
  18. Martínez-Sanz J, Ron R, Moreno E, et al. Similar CD4/CD8 ratio recovery after initiation of dolutegravir plus lamivudine versus dolutegravir or bictegravir-based three-drug regimens in naive adults with HIV. Front Immunol. 13:873408, 2022.
  19. Cabello A, J.C.Lopez de Quiros , CCarbonero LM F, et al. 48 weeks effectiveness and tolerability of dolutegravir (DTG) + lamivudine (3TC) in antiretroviral-naïve adults living with HIV: A multicenter real-life cohort. Plos One, 17(11):e0277606. 2022.
  20. Schneider S, Burke C, Ward D, et al. REAL-WORLD TREATMENT EXPERIENCE OF SINGLE TABLET DOLUTEGRAVIR/LAMIVUDINE IN THE US: RESULTS FROM THE TANDEM STUDY. Presented at AIDS 2022.
  21. Pierone G, Fusco J, Brunet L, et al. REAL WORLD USE OF DOLUTEGRAVIR/LAMIVUDINE IN TREATMENT NAÏVE PEOPLE LIVING WITH HIV DURING THE COVID PANDEMIC. Presented at HIV Glasgow 2022.
  22. Sax PE, Eron JJ, Radtchenko J, et al. WHAT INFLUENCES SWITCHING TO DTG/3TC VS B/F/TAF IN CLINICAL PRACTICE? Presented at Conference on Retroviruses and Opportunistic Infections (CROI); 2023; Seattle,WA.
  23. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 390: 2073-82. 2017.
  24. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 390: 2063-72. 2017.
  25. Wohl D, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV;6:e355-63. 2019.
  26. Stellbrink HJ, Arribas J, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir infection: week 96 results from a randomized, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV; 6:e364-72.2019.
  27. Orkin C, Dejesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomized, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV; 7:e389-400. 2020.
  28. Sax PE, Erlandson KM, Lake JE st al. Weight gain following initiation of antiretroviral therapy: risk factors in randomized comparative clinical trials. Clin Infect Dis. 2019.
  29. Bourgi K, Jenkins C, Rebeiro PF, et al. Weight gain among treatment-naïve persons with HIV starting integrase inhibitors compared to non-nucleoside reverse transcriptase inhibitors or protease inhibitors in a large observational cohort in the United States and Canada. J Int AIDS Soc. 23(4): e25484. 2020.
  30. Sax PE, Erlandson KM, Lake JE, et al. Weight gain following Initiation of antiretrovial therapy: risk factors in randomized comparative clinical trials. Clin Infect Dis. 71(6):1379.2020.
  31. Mills AM, Nelson M, Jayaweera D, et al. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naïve, HIV-1-infected patients: 96-week analysis. AIDS 23:1679-88. 2009.
  32. Tashima K, Crofoot G, Tomaka F, et al. Cobicistat-boosted darunavir in HIV-1-infected adults: week 48 results of a Phase IIIb, open-label single-arm trial. AIDS Research and Therapy; 11:39. 2014.
  33. Echeverría P, Bonjoch A, Puig J, et al. Significant improvement in triglyceride levels after switching from ritonavir to cobicistat in suppressed HIV-1-infected subjects with dyslipidaemia. HIV Med.18(10):782-786. 2017.
  34. Eron JJ, Orkin C, Molina JM, Negredo E, Antinori A, Mills A, Reynes J, Van Landuyt E, Lathouwers E, Hufkens V, Vanveggel S, Opsomer M; AMBER study group. A week-48 randomized phase-3 trial of darunavir/cobicistat/ emtricitabine/tenofovir alafenamide in treatment-naïve hiv-1 patients. AIDS 2018 Jul 17, 32(11):1431-1442
  35. Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vavggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1(EMERALD): a phase 3, randomized, non-inferiority trial. Lancet HIV 2018 Jan; 5(1):323-e34.
  36. Cohen C, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naïve adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet; 378: 229-237. 2011
  37. Molina JM, Cahn P, Grinsztejn B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment- naïve adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet; 378: 238-246. 2011
  38. Molina JM, Squires K, Sax PE, et al. Doravrine versus ritonavir-boosted darunavir in antiretroviral-naïve adults with HIV-1(DRIVE-FORWARD): 48-week results of a randomized, double-blind, phase 3, non-inferiority trial. Lancet HIV. 5(5): e211-e220. 2018.
  39. Molina JM, Squires K, Sax PE, et al. Doravrine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1(DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial. Lancet HIV. 7(1): e16-e26. 2020.
  40. Orkin C, Squire KE, Molina JM, et al. Doravirine/Lamivudine/Tenofovor Disoproxil Fumarate is Non-inferior to Efavirenz/Emtricitabine/ Tenofovir Disoproxil Fumarate in Treatment-naïve Adults With Human Immunodeficiency Virus-I Infection: Week 48 Results of the DRIVE-AHEAD Trial. Clin Infect Dis ; 68(4):535-544. 2019.
  41. Orkin C, Squire KE, Molina JM, et al. Doravirine/lamivudine/tenofovor disoproxil fumarate(TDF) versus efavirenz/emtricitabine/TDF in Treatment-naive adults with human immunodeficiency virus-type1 infection: Week 96 results of the DRIVE-AHEAD noninferiority trial. Clin Infect Dis. 73(1): 33-42. 2021.
  42. Karras A, Lafaurie M, Furco A, et al. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, Fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis 36:1070-3. 2003.
  43. Zimmermann AE, Pizzoferrato T, Bedford J, et al. Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. Clin Infect Dis 42:283-90. 2006.
  44. Gallant JE, and Moore RD. Renal function with use of a tenofovir-containing initial antiretroviral regimen. AIDS 23:1971-5. 2009.
  45. Horberg M, Tang B, Towner W, et al. Impact of tenofovir on renal function in HIV-infected, antiretroviral-naïve patients. J Acquir Immune Defic Syndr 53:62-9. 2010.
  46. Kinai E, and Hanabusa H. Progressive renal tubular dysfunction associated with longterm use of tenofovir DF. AIDS Res Hum Retroviruses 25:387-94. 2009.
  47. Nishijima T, Komatsu H, Gatanaga H, et al. Impact of small body weight on tenofovir-associated renal dysfunction in HIV-infected patients: a retrospective cohort study of Japanese patients. PLoS One. 2011;6(7):e22661.
  48. Stellbrink HJ, Orkin C, Arribas JR, et al. Comparison of changes in bone density and turnover with abacavir-lamivudine versus tenofovir-emtricitabine in HIV-infected adults: 48-week results from the ASSERT study. Clin Infect Dis. 2010;51(8):963-972.
  49. MacComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naïve persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trial Group A5224s, a substudy of ACTG 5202. J Infect Dis. 2011; 203(12):1791-1801.
  50. Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 385: 2606-15. 2015.
  51. Wohl D, Oka S, Climeck N, et al. Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr.72:58-64. 2016.
  52. Arribas JR, Thompson M, Sax PE, et al. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr.75(2):211-8. 2017.
  53. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV (米国DHHS, Jan. 18, 2023).
    https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection
  54. Lockman S, Brummel SS, Ziemba L, et al. Efficacy and safety of dolutegravir with emtricitabine and tenofovir alafenamide fumarate or tenofovir disoproxil fumarate, and efavirenz, emtricitabine, and tenofovir disoproxil fumarate HIV antiretroviral therapy regimens started in pregnancy (IMPAACT 2010/VESTED): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet 397:1276-1292, 2021.
  55. Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med. 2019; 381(9):803-815.
  56. Sax PE, Tierney C, Collier AC, et al. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med 361:2230-40. 2009.
  57. Daar E, Tierney C, Fischl, M, et al. ACTG 5202: Final Results of ABC/3TC or TDF/FTC with either EFV or ATV/r in Treatment-naïve HIV-infected Patients. 17th Conference on Retroviruses & Opportunistic Infections (CROI 2010). San Francisco. February 16-19, 2010. Abstract 59LB.
  58. Smith KY, Patel P, Fine D, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS 23:1547-56. 2009.
  59. Post F, Moyle G, Stellbrink HJ, et al. Randomized comparison of renal effects, efficacy, and sefety with once-daily Abcavir/Lamivudine versus Tenofovir/ Emtricitabine, administered with Efavirenz, in antiretroviral-naïve, HIV-1infected adults: 48-week results from ASSERT study. JIADS 55 49-57. 2010.
  60. Nishijima T, Komatsu H, Teruya K, et al. Once-daily darunavir/ritonavir and abacavir/lamivudine versus tenofovir/emtricitabine for treatment-naïve patients with a baseline viral load of more than 100 000 copies/ml. AIDS.27:839-48.2013.
  61. Sabin CA, Worm SW, Weber R, et al. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multicohort collaboration. Lancet 371:1417-26. 2008.
  62. Worm SW, Sabin C, Weber R, et al. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study. J Infect Dis. 201:318-30. 2010.
  63. Ding X, Andraca-Carrera E, Cooper C, et al. No Association of Abacavir Use with Myocardial Infarction:Findings of an FDA Metaanalysis. J Acquir Immune Defic Syndr.61:441-7. 2012.
  64. Jaschinski N, Greenberg L, Neesgaard B, et al. Recent abacavir use and incident cardiovascular disease in contemporary treated people living with HIV. AIDS Aug 24. 2022.
  65. Tanaka H, Akaza T, Juji T. Report of the Japanese Central Bone Marrow Data Center. Clin Transpl:139-44. 1996.
  66. Sun HY, Hung CC, Lin PH, et al. Incidence of abacavir hypersensitivity and its relationship with HLA-B*5701 in HIV-infected patients in Taiwan. J Antimicrob Chemother 60:599-604. 2007.
  67. Mallal S. Nolan D, Witt C, et al. Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet 359:727-32. 2002.
  68. Yoshino M, Nagai S, Kuwahara T, et al. The clinical experience of abacavir in HIV-infected Japanese. 7th International Congress on AIDS in Asia, abstract # MoPB0088.
  69. Mollan KR, Smurzynski M, Eron JJ, et al. Association Between Efavirenz as Initial Therapy for HIV-1 Infection and Increased Risk for Suicidal Ideation or Attempted or Completed Suicide. Ann Intern Med.161:1-10.2014.
  70. Hamada Y, Nishijima T, Watanabe K, et al. High Incidence of Renal Stones Among HIV-Infected Patients on Ritonavir-Boosted Atazanavir Than in Those Receiving Other Protease Inhibitor-Containing Antiretroviral Therapy. Clin Infect Dis. 55(9):1262-19, 2012.
  71. Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naïve subjects with CCR5-tropic HIV-1 infection. J Infect Dis.201:803-13. 2010.
  72. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 133:21-30. 2000.
  73. Gordon LL, Gharibian D, Chong K, Chun H. Comparison of HIV virologic failure rate between patients with variable adherence to three antiretroviral regimen types. AIDS Patient Care STDS. 29(7):384-8. 2015.
  74. Kathy K Byrd. John G Hou, Ron Hazen,et al. Antiretroviral Adherence Level Necessary for HIV Viral Suppression Using Real-World Data. J Acqui Immune Defic Syndr.82(3):245-251. 2019.
  75. Nachega JB, Parienti JJ, Uthman OA, et al. Lower pill burden and once-daily antiretroviral treatment regimens for HIV infection: A meta-analysis of randomized controlled trials. Clin Infect Dis 58(9):1297-1307. 2014.
  76. Suárez-García I, Alejos B, Ruiz-Algueró M, et al. Effectiveness and tolerability of dolutegravir and abacavir/lamivudine administered as two separate pills compared to their equivalent single-tablet regimen in a multicentre cohort in Spain. J Int AIDS Soc. 24(7):e25758. 2021.
  77. HIV診療における外来チーム医療マニュアル改訂第3版(厚生労働行政推進調査事業費補助金(エイズ対策政策研究事業)「HIV感染症及びその合併症の課題を克服する研究」班:https://osaka-hiv.jp/pdf/team_medical_manual_3.pdf
  78. 澤田暁宏、関根祐介、増田純一、小島賢一.抗HIV療法と服薬援助の為の基礎的調査–治療開始時の抗HIV 薬処方動向調査(2022年)– 第36回日本エイズ学会学術集会・総会、抄録番号O-C14-6.日本エイズ学会誌. 24(4): 422, 2022.
  79. Recommendations for the Use of Antiretroviral Drugs during pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
    (米国DHHS、Jan. 31, 2023). https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new
  80. Zash R, Makhema J, Shapiro RL. Neural-tube defects with doltegravir treatment from the time of conception. N Engl J Med. 379(10):979-981. 2018.
  81. Zash R, Holmes L, Diseko M, et al. Update on neural tube defects with antiretroviral exposure in the Tsepamo study, Botswana. 11th IAS Conference on HIV Science;July 18-21,2021.
  82. 「国内流行HIV及びその薬剤耐性株の長期的動向把握に関する研究」班(https://www.hiv-resistance.jp/howto02.htm)
  83. 日本におけるHIV感染予防のための曝露前予防(PreExposue Prophylaxis)利用の手引き (https://jaids.jp/wpsystem/wp-content/uploads/2022/11/tebiki-1Pver.)
  84. Guidance for COVID-19 and People with HIV. (米国DHHS, Feb. 22, 2022).
    https://clinicalinfo.hiv.gov/en/guidelines/guidance-covid-19-and-people-hiv/whats-new-covid-19-and-hiv-guidance
  85. CDC:HIV and COVID-19 Basics
    (https://www.cdc.gov/hiv/basics/covid-19.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fspecific-groups%2Fhiv.html)

PAGE TOP