V初回治療に用いる抗HIV薬の選び方
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- Bartlett JA, Fath MJ, Demasi R, et al. An updated systematic overview of triple combination therapy in antiretroviral- naïve HIVinfected adults. AIDS 20:2051-64. 2006.
- 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.
- Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (米国DHHS、Feb. 24, 2021) https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-arv/whats-new-guidelines
- The European Guidelines for Treatment of HIV Infected Adults in Europe (European AIDS Clinical Society, version 10.1 – October, 2020). https://eacs.sanfordguide.com
- 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.
- 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.
- 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, noninferiority trial. Lancet HIV. 4: e486-e494. 2017.
- 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.
- 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.
- 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.
- Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 383: 2222-31.2014.
- 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.
- 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.
- Cahn P, Madero JS, Arribas JR, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatmentnaïve adults with HIV-1 infection 3-year results from the GEMINI studies. HIV Glasow 2020. Abstr P018
- Ait-Khaled, Madero JS, Perez VE, et al. Impact of treatment adherence on efficacy of DTG+3TC and DTG+TDF/FTC:pooled analysis of the GEMINI-1 and -2 clinical studies. IDWeek 2020; Virtual. Poster 1024.
- 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, doubleblind, multicentre, phase 3, non-inferiority trial. Lancet. 390: 2073-82.2017.
- 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.
- 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.
- 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.
- Orkin C, Dejesus E, Sax PE, et al. Fixed-dose combination boctegravir, 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.
- 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.
- 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 ihibitors in a large observational cohort in the United States and Canada. J Int AIDS Soc. 23(4): e25484. 2020.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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:e16-e26.2020.
- 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. 2019; 68(4):535-544.
- 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. Dec 18:ciaa822. doi: 10.1093/cid/ciaa822. Online ahead of print.2020.
- 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.
- 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.
- Gallant JE, and Moore RD. Renal function with use of a tenofovir-containing initial antiretroviral regimen. AIDS 23:1971-5. 2009.
- 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.
- Kinai E, and Hanabusa H. Progressive renal tubular dysfunction associated with longterm use of tenofovir DF. AIDS Res Hum Retroviruses 25:387-94. 2009.
- Nishijima T, Komatsu H, Gatanaga H, et al. Impact of small body weight on tenofovir-associated renal dysfunction in HIVinfected patients: a retrospective cohort study of Japanese patients. PLoS One. 2011;6(7):e22661.
- 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.
- 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.
- 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.
- 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.
- Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis.16: 43-52.2016.
- 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.
- Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents (米国DHHS, Aug. 18, 2020). https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection/whats-new-guidelines
- Chinula L, Brummel SS, Ziemba L, et al. Safety and efficacy of DTG vs EFV and TDF vs TAF in pregnancy: IMPAACT 2010 trial. CROI 2020. Abstr 130LB.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- Hughes AR, Mosteller M, Bansal AT, et al. Association of genetic variations in HLA-B region with hypersensitivity to abacavir in some, but not all, populations. Pharmacogenomics 5:203-11. 2004.
- Tanaka H, Akaza T, Juji T. Report of the Japanese Central Bone Marrow Data Center. Clin Transpl:139-44. 1996.
- 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.
- 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.
- 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.
- 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.
- 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.
- Raffi F, Babiker AG, Richert L, et al. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised noninferiority trial. Lancet. 384(9958):1942-51.2014.
- Taiwo B, Zheng L, Gallien S, et al. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatmentnaïve HIV-1-infected patients (ACTG A5262). AIDS. 25(17):2113-2122. 2011
- Bedimo RJ, Drechsler H, Jain M, et al. The RADAR study: week 48 safety and efficacy of RAltegravir combined with boosted DARunavir compared to tenofovir/emtricitabine combined with boosted darunavir in antiretroviralnaive patients. Impact on bone health. PloS one. 9(8):e106221. 2014.
- 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.
- 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.
- 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.
- 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.
- Vrijens B, Tousset E, Rode R, et al. Successful projection of the time course of drug concentration in plasma during a 1-year period from electronically compiled dosing-time data used as input to individually parameterized pharmacokinetic models. J Clin Pharmacol 45:461-467.2005.
- HIV診療における外来チーム医療マニュアル改訂第2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://www.haart-support.jp/manual/index.htm
- 日笠 聡、小島賢一、増田純一、関根祐介.抗HIV療法と服薬援助のための基礎的調査–治療開始時の抗HIV 薬処方動向調査(2020年)–2020年 第34回日本エイズ学会学術集会・総会(熊本)、抄録番号O-C6-8
- Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.
(米国DHHS、Feb. 10, 2021). https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines - 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.
- Zash R, Holmes L, Jacobson DL, et al. Neural-Tube Defects by Antiretroviral Treatment in Botswana. N Engl J Med. 381(9):827-840. 2019.
- Zash R, Holmes L, Diseko M, et al. Update on neural tube defects with antiretroviral expo sure in the Tsepamo study, Botswana. 23rd International AIDS Conference 2020. #OAXLB0102.
- Interim Guidance for COVID-19 and Persons with HIV. (米国DHHS、Feb. 26, 2021). https://clinicalinfo.hiv.gov/en/guidelines/covid-19-and-persons-hiv-interim-guidance/interim-guidance-covid-19-and-persons-hiv