1. What Are HIV and AIDS?
https://www.hiv.gov/hiv-basics/overview/about-hiv-and-aids/what-are-hiv-and
-aids. Accessed March 11, 2019.
2. About HIV/AIDS. https://www.cdc.gov/hiv/basics/whatishiv.html. Accessed March 11, 2019.
3. 人類免疫缺乏病毒感染. 衛生福利部疾病管制署.
https://www.cdc.gov.tw/professional/knowdisease.aspx?treeid=beac9c103df95
2c4&nowtreeid=7b56e6f932b49b90&id=3013B7FC8F965336&did=651.
Accessed March 11, 2019.
4. 愛滋病統計資料. 衛生福利部疾病管制署.
https://www.cdc.gov.tw/list.aspx?nowtreeid=6c5ea6d932836f74&treeid=1f07e
8862ba550cf. Accessed March 11, 2019.
5. 臺灣愛滋病毒感染者抗愛滋病毒藥物的治療指引. 台灣愛滋病學會.
http://www.aids-care.org.tw/db/Jour/1/201811/2.pdf. Accessed March 11,
2019.6. Antiretroviral drugs used in the treatment of HIV infection. U.S. Food & Drug Administration.
https://www.fda.gov/forpatients/illness/hivaids/treatment/ucm118915.htm.
Accessed March 11, 2019.
7. Saag MS, Benson CA, Gandhi RT, et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2018 Recommendations of the International Antiviral Society–USA PanelAntiretroviral Drugs for Treatment and Prevention of HIV Infection in AdultsAntiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. JAMA 2018; 320(4): 379-396.
8. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach:
World Health Organization; 2016.
9. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. AIDSinfo.
https://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf.
Accessed March 11, 2019.
10. 愛滋用藥大利多，六月起與先進國家齊步. 衛生福利部疾病管制署.
https://www.cdc.gov.tw/professional/info.aspx?treeid=cf7f90dcbcd5718d&no
wtreeid=f94e6af8daa9fc01&tid=A5A80A4E91A853EC. Accessed March 11,
2019.11. 抗人類免疫缺乏病毒藥品處方使用規範. 衛生福利部疾病管制署.
https://www.cdc.gov.tw/professional/info.aspx?treeid=7b56e6f932b49b90&no
wtreeid=67ccccd371d8dd79&tid=E101D8EABB1B7AB7. Accessed March 11,
2019.12. ATC/DDD Index 2019. WHO Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_index/. Accessed March 11, 2019.
13. 西藥、醫療器材、含藥化妝品許可證查詢. 衛生福利部食品藥物管理署.
https://www.fda.gov.tw/mlms/h0001.aspx. Accessed March 11, 2019.
14. 本署代辦衛生福利部疾病管制署後天免疫缺乏症候群治療藥品. 衛生福 利部中央健康保險署.
https://www.nhi.gov.tw/Content_List.aspx?n=988B1E3F8C5279CE&topn=3F
C7D09599D25979. Accessed March 11, 2019.
15. bictegravir/emtricitabine/tenofovir alafenamide-Recommendations and Reasons. CADTH Common Drug Review.
https://www.cadth.ca/sites/default/files/cdr/complete/SR0567%20Biktarvy%2
0-%20CDEC%20Final%20Recommendation%20October%2029%2C%20201 8.pdf. Accessed March 11, 2019.
16. bictegravir/emtricitabine/tenofovir alafenamide-Clinical Report. CADTH Common Drug Review.
https://www.cadth.ca/sites/default/files/cdr/clinical/SR0567_Biktarvy_CL_Re
port.pdf. Accessed March 11, 2019.
17. Bictegravir + emtricitabine + tenofovir alafenamide fixed dose combination:
Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg and bictegravir 50 mg; Biktarvy® . PBAC.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2018-03/fi les/tenofovir-alafenamide-emtricitabine-bictegravir-psd-march-2018.pdf.
Accessed March 11, 2019.
18. bictegravir 50mg / emtricitabine 200mg / tenofovir alafenamide 25mg film-coated tablet (Biktarvy® ) Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/media/3687/bictegravir-biktarvy-final-a
ugust-2018-amended-310818-for-website.pdf. Accessed March 11, 2019.
19. 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 (London, England) 2017;
390(10107): 2063-2072.
20. 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
(London, England) 2017; 390(10107): 2073-2082.
21. HIV Glasgow 2018, 28–31 October 2018, Glasgow, UK. Journal of the
International AIDS Society 2018; 21(S8): e25187.
22. Molina JM, Ward D, Brar I, et al. Switching to fixed-dose bictegravir,
emtricitabine, and tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, phase 3,
non-inferiority trial. The lancet HIV 2018; 5(7): e357-e365.
23. Daar ES, DeJesus E, Ruane P, et al. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. The lancet HIV 2018; 5(7): e347-e356.
24. Kityo C, Hagins D, Koenig E, et al. Switching to
bictegravir/emtricitabine/tenofovir alafenamide in women. In: Conference on Retroviruses and Opportunistic Infections (CROI); 2018; 2018.
25. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. LB4. A Phase 3, Randomized, Controlled Clinical Trial of Bictegravir in a Fixed-Dose Combination,
B/F/TAF, vs. ABC/DTG/3TC in Treatment-Naïve Adults at Week 96. Open
Forum Infectious Diseases 2018; 5(Suppl 1): S760-S761.
26. Wohl D, Clarke A, Maggiolo F, et al. Patient-Reported Symptoms Over 48 Weeks Among Participants in Randomized, Double-Blind, Phase III Non-inferiority Trials of Adults with HIV on Co-formulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide versus Co-formulated Abacavir, Dolutegravir, and Lamivudine. The patient 2018; 11(5): 561-573.
27. DeJesus, E., H. Folse, and F. Altice, A cost-consequence analysis of
bictegravir/emtricitabine/ tenofovir alafenamide compared with other
antiretroviral regimens in a simulated model of adult HIV patients. Journal of
Managed Care and Specialty Pharmacy, 2018. 24(10 A): p. S20.28. 衛生福利部疾病管制署. 衛生福利部疾病管制署一零四年度科技研究發 展計畫–愛滋感染者醫療利用與防治成果.
https://www.cdc.gov.tw/uploads/files/f9b7bb95-404a-4626-b9c1-82fd4f44aa5 9.pdf
29. 衛生福利部疾病管制署. 愛滋防治第六期五年 107 年 9 月執行情形.
http://117.56.91.94/KMPublic/readdocument.aspx?documentId=289117
30. Deeks, E.D., Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection. Drugs, 2018.
31. 全國法規資料庫. 人類免疫缺乏病毒傳染防治及感染者權益保障條例.
https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0050004. Accessed
March 18, 2019.32. Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy. Geneva: World Health Organization; 2017. 3,
RECOMMENDATION FOR RAPID INITIATION OF ART. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK475972/
附錄
附錄一 抗反轉錄病毒藥品依機轉分類
分類 藥品
核苷反轉錄酶抑制劑
(nucleoside or nucleotide reverse transcriptase inhibitors, NRTI / NtRTI)
如 abacavir(ABC)*、didanosine(DDI)、emtricitabine(FTC)‡、lamivudine(3TC)*、
stavudine(d4T)、zidovudine(ZDV or AZT)*、tenofovir disoproxil fumarate(TDF)*、tenofovir alafenamide(TAF)‡、zalcitabine(DDC)
非 核 苷 反 轉 錄 酶 抑 制 劑 (non-nucleoside reverse transcriptase inhibitor, NNRTI)
如 delavirdine(DLV)、efavirenz(EFV)*、etravirine(ETV or ETR)*、nevirapine(NVP)*、
rilpivirine(RPV)*
蛋白酶抑制劑(protease inhibitors, PI) 如 atazanavir(ATV)*、darunavir(DRV)*、fosamprenavir(FPV)、indinavir(IDV)、
nelfinavir(NFV)、saquinavir(SQV)、tipranavir(TPV)*、ritonavir(RTV or r)*、amprenavir(APV) 嵌 合 酶 鏈 轉 移 抑 制 劑 (integrase strand
transfer inhibitor, INSTI) 或 嵌 合 抑 制 劑 (integrase inhibitor, II)
如 dolutegravir(DTG)*、elvitegravir(EVG)‡、raltegravir(RAL)*
融合抑制劑(fusion inhibitor, FI) 如 enfuvirtide(T20) CCR5 拮抗劑(C-C chemokine receptor type
5 antagonist, CCR5 antagonist) 如 maraviroc(MVC)
多 種 類 別 之 組 合 藥 品 (multi-class combination products)
如 zidovudine/lamivudine(AZT/3TC)*、lamivudine/abacavir(3TC/ABC)*、tenofovir disoproxil/emtricitabine(TDF/FTC)*、zidovudine/lamivudine /abacavir(AZT/3TC/ABC)、
zidovudine/lamivudine/nevirapine(AZT/3TC/NVP)*、emtricitabine/tenofovir
disoproxil/efavirenz(FTC/TDF/EFV)*、stavudine/lamivudine/nevirapin(d4T/3TC/NVP)、
emtricitabine/tenofovir disoproxil/ rilpivirine(FTC/TDF/RPV)*、emtricitabine/tenofovir disoproxil/elvitegravir/cobicistat(FTC/TDF/EVG/cobi)、lopinavir/ritonavir(LPV/r)*、
分類 藥品
lamivudine/tenofovir disoproxil/efavirenz(3TC/TDF/EFV)、lamivudine/tenofovir disoproxil(3TC/TDF)、lamivudine/abacavir/dolutegravir(3TC/ABC/DTG)*、
darunavir/cobicistat(DRV/Cobi)*、atazanavir/cobicistat(ATV/cobi)、lamivudine /raltegravir(3TC/RAL)、emtricitabine/tenofovir alafenamide(FTC/TAF)*、
emtricitabine/tenofovir alafenamide/elvitegravir/cobicistat(FTC/TAF/EVG/Cobi)*、
emtricitabine/tenofovir alafenamide/ rilpivirine(FTC/TAF/r)*、emtricitabine, tenofovir alafenamide/bictegravir(BIC/FTC/TAF)*、emtricitabine, tenofovir alafenamide/darunavir/
cobicistat(FTC/TAF/DRV/Cobi)以及 dolutegravir/rilpivirine(DTG/RPV) *
註*我國現有許可之治療用藥；‡目前臺灣無 FTC 單方製劑，只有 Truvada
®
(TDF/FTC)、Atripla®
(FTC/TDF/EFV)、Tenoem®
(TDF/FTC)、Complera®
(TDF/FTC/RPV)、Genvoya
®
(TAF/FTC/EVG/Cobi)、Descovy®
(FTC/TAF) 、Odefsey®
(FTC/TAF/r)及 Biktarvy®
(BIC/FTC/TAF)複方製劑；目前臺灣無 EVG 單方製劑，只有 Genvoya®
複方製劑(TAF/FTC/EVG/Cobi)；目前臺灣無 TAF 單方製劑，只有 Genvoya®
複方製劑(TAF/FTC/EVG/Cobi)、Descovy®
(FTC/TAF)複方製劑、Odefsey®
複方製劑 (FTC/TAF/r)及 Biktarvy®
複方製劑(BIC/FTC/TAF)。附錄二 2018 年美國衛生和公眾服務部（DHHS）愛滋病資訊網（AIDSinfo）根據良好的支持 證據列出轉換的治療方案
Three-Drug Regimens
Within-Class Switches
Within-class switches that are prompted by adverse events or the availability of ARVs within the same class hat offer a better safety profile, reduced dosing frequency, higher barrier to resistance, or lower pill burden usually maintain viral suppression, provided there is no drug resistance to the new ARV. Some examples of within-class switch strategies are switching from:
• TDF or abacavir (ABC) to TAF
• RAL to elvitegravir/cobicistat (EVG/c) or DTG
• DTG, EVG/c, or RAL to BIC
• Efavirenz (EFV) to RPV
• A ritonavir-boosted PI (PI/r) to a PI coformulated with cobicistat (PI/c)
• Boosted atazanavir (ATV/c or ATV/r) to unboosted ATV (when used with ABC/3TC)
Between-Class Switches
Between-class switches generally maintain viral suppression, provided there is no resistance to the other components of the regimen. Such switches should be avoided if there is any doubt about the activity of the other agents in the regimen. As noted earlier, prior resistance test results will be very informative in guiding this switch. Some examples of between-class switch strategies are:
• Replacing a boosted PI with an INST (e.g., DTG、BIC or EVG)
• Replacing a boosted PI with RPV
• Replacing an NNRTI with an INSTI
• Replacing a boosted PI with maraviroc (MVC).
Two-Drug Regimens
There is growing evidence that some two-drug regimens are effective in maintaining virologic control in patients who initiated therapy and achieved virologic suppression with three-drug regimens. However, caution should be taken in patients with HBV coinfection, as these simplified regimens may not have adequate anti-HBV activity. Below are examples of successful strategies for switching from three- to two-drug regimens in persons with suppressed HIV.
Dolutegravir plus Rilpivirine (AI)*
Ritonavir-Boosted Protease Inhibitor plus Lamivudine or Emtricitabine :
•ATV/r plus 3TC (CI)*
•Darunavir/ritonavir (DRV/r) plus 3TC (BI)*, or
•Lopinavir/ritonavir (LPV/r) plus 3TC (CI)*
縮寫 DHHS = Department of Health and Human Services；ARV= antiretroviral。
註* AI＝Rating of Recommendations＝A (Strong)，Rating of Evidence=I (Data from randomized controlled trials)；
CI＝Rating of Recommendations＝C (Optional)，Rating of Evidence=I (Data from randomized controlled trials)；
BI= Rating of Recommendations＝B (Moderate)，Rating of Evidence=I (Data from randomized controlled trials)。
附錄三 療效評估文獻回顧搜尋策略 1. Cochrane Library
搜尋時間 搜尋策略 期刊篇數
#1 2019/3/12 bictegravir 42
#2 2019/3/12 emtricitabine 1,289
#3 2019/3/12 tenofovir alafenamide 224
#4 2019/3/12 #1 and #2 and #3 32 納入篇數：0
2. Pubmed
搜尋時間 搜尋策略 期刊篇數
#1 2019/3/12 bictegravir[tiab] 43
#2 2019/3/12 emtricitabine[tiab] 2,151
#3 2019/3/12 "tenofovir alafenamide"[tiab] 273
#4 2019/3/12 #1 and #2 and #3 22
#5 2019/3/12
(#1 and #2 and #3) AND ("Systematic Review"
[Publication Type] OR "Meta-Analysis"
[Publication Type] OR "Randomized Controlled Trial" [Publication Type])
5
納入篇數：4
3. Embase
搜尋時間 搜尋策略 期刊篇數
#1 2019/3/12 'bictegravir':ab,ti 87
#2 2019/3/12 'emtricitabine':ab,ti 3,675
#3 2019/3/12 'tenofovir alafenamide':ab,ti 570
#4 2019/3/12 #1 AND #2 AND #3 49
#5 2019/3/12
#1 AND #2 AND #3 AND ([systematic review]/lim OR [meta analysis]/lim OR [randomized controlled trial]/lim)
23 納入篇數：6 (其中 4 篇與 Pubmed 搜尋結果重複)
附錄四 經濟文獻搜尋紀錄
資料庫 查詢日期 關鍵字 篇數
Embase 20190305 #1 “bictegravir plus emtricitabine plus tenofovir alafenamide” OR Biktarvy
#2 cost AND “cost analysis”
#3 #1 AND #2
55
815,921 4
Pubmed 20190305 #1 (bictegravir AND emtricitabine
AND tenofovir alafenamide) OR Biktarvy
#2 costs and cost analysis[MeSH Terms]
#3 #1 AND #2
23
222,337 0 Cochrane
Library
20190305 #1 (bictegravir AND emtricitabine
AND tenofovir alafenamide) OR Biktarvy
#2 cost-effective analysis OR cost-consequence analysis OR cost-utility analysis OR cost-benefit analysis OR cost-minimisation analysis
#3 #1 AND #2
33
12,401
0