Research on HIV cure: Mapping the ethics landscape
In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.
Vyšlo v časopise:
Research on HIV cure: Mapping the ethics landscape. PLoS Med 14(12): e32767. doi:10.1371/journal.pmed.1002470
Kategorie:
Essay
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1002470
Souhrn
In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.
Zdroje
1. UNAIDS. Global AIDS Update. 2016. Available from: http://www.unaids.org/sites/default/files/media_asset/global-AIDS-update-2016_en.pdf
2. UNAIDS. UNAIDS Data 2017. 2017. Available from: http://www.unaids.org/sites/default/files/media_asset/20170720_Data_book_2017_en.pdf
3. Deeks SG, Lewin SR, Ross AL, Ananworanich J, Benkirane M, Cannon P, et al. International AIDS Society Global Scientific Strategy: Towards an HIV Cure 2016. Nat Med. 2016;22: 839–50. doi: 10.1038/nm.4108 27400264
4. Allers K, Hütter G, Hofmann J, Loddenkemper C, Rieger K, Thiel E, et al. Evidence for the Cure of HIV Infection by CCR5Δ32/Δ32 Stem Cell Transplantation. Blood. 2011;117: 2791–9. doi: 10.1182/blood-2010-09-309591 21148083
5. FDA. Backgrounder for FDA’s HIV Patient-Focused Drug Development and HIV Cure Research Public Meeting. 2013. Available from: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM354549.pdf
6. Fauci AS, Marston HD, Folkers GK. An HIV Cure: Feasibility, Discovery, and Implementation. JAMA. 2014;312: 335–336. doi: 10.1001/jama.2014.4754 25038345
7. Lo B, Grady C. Ethical Considerations in HIV Cure Research: Points to Consider. Curr Opin HIV AIDS. 2013;8: 243–9. doi: 10.1097/COH.0b013e32835ea1c5 23422260
8. Khoury MJ, Gwinn M, Yoon PW, Dowling N, Moore C a, Bradley L. The Continuum of Translation Research in Genomic Medicine: How Can We Accelerate the Appropriate Integration of Human Genome Discoveries into Health Care and Disease Prevention? Genet Med. 2007;9: 665–674. doi: 10.1097/GIM.0b013e31815699d0 18073579
9. Kagarise MJ, Sheldon GF. Translational Ethics: A Perspective for the New Millennium. Arch Surg. 2000;135: 39. doi: 10.1001/archsurg.135.1.39 10636345
10. Bærøe K, Cribb A, Woolf S, Maienschein J, Sunderland M, Ankeny R, et al. Translational Ethics: An Analytical Framework of Translational Movements between Theory and Practice and a Sketch of a Comprehensive Approach. BMC Med Ethics. 2014;15: 71. doi: 10.1186/1472-6939-15-71 25267434
11. Archin N, Sung J, Garrido C, Soriano-Sarabia N, Margolis D. Eradicating HIV-1 Infection: Seeking to Clear a Persistent Pathogen. Nat Rev Microbiol. 2014;12: 750–64. doi: 10.1038/nrmicro3352 25402363
12. Kumar N, Chahroudi A, Silvestri G. Animal Models to Achieve an HIV Cure. Curr Opin HIV AIDS. 2016;11: 432–441. doi: 10.1097/COH.0000000000000290 27152962
13. Worp HB Van Der, Howells DW, Sena ES, Porritt MJ, Rewell S, Collins O, et al. Can Animal Models of Disease Reliably Inform Human Studies? PLoS Med. 2010;7(7). doi: 10.1371/journal.pone.0040308
14. Kimmelman J, London AJ. Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty. PLoS Med. 2011;8(3). doi: 10.1371/journal.pmed.1001010 21423344
15. Festing S, Wilkinson R. Talking Point on the Use of Animals in Scientific Research. EMBO Rep. 2007;8: 526–30. doi: 10.1038/sj.embor.7400993 17545991
16. Joffe S, Miller FG. Bench to Bedside. Mapping the Moral Terrain of Clinical Research. Hastings Cent Rep. 2008; 30–42.
17. Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ, et al. Phase 0 Clinical Trials: Conceptions and Misconceptions. Cancer J. 2008;14: 133–7. doi: 10.1097/PPO.0b013e318172d6f3 18536551
18. Dubé K, Dee L, Evans D, Sylla L, Taylor J, Brown B, et al. Perceptions of Equipoise, Risk–Benefit Ratios, and “Otherwise Healthy Volunteers” in the Context of Early-Phase HIV Cure Research in the United States: A Qualitative Inquiry. J Empir Res Hum Res Ethics. 2017; 1–15. doi: 10.1177/1556264617734061 28984168
19. Nakagawa F, Lodwick RK, Smith CJ, Smith R, Cambiano V, Lundgren JD, et al. Projected Life Expectancy of People with HIV According to Timing of Diagnosis. AIDS. 2012;26: 335–43. doi: 10.1097/QAD.0b013e32834dcec9 22089374
20. Dubé K, Henderson GE, Margolis DM. Framing Expectations in Early HIV Cure Research. Trends Microbiol. 2014;22: 547–9. doi: 10.1016/j.tim.2014.08.003 25280965
21. Henderson GE. The Ethics of HIV “Cure” Research: What Can We Learn from Consent Forms? AIDS Res Hum Retroviruses. 2014;31: 1–14. doi: 10.1089/AID.2014.0219 25406579
22. Margolis DM, Hazuda DJ. Combined Approaches for HIV Cure. Curr Opin HIV AIDS. 2013;8: 230–5. doi: 10.1097/COH.0b013e32835ef089 23446138
23. Dubé K, Taylor J, Sylla L, Evans D, Dee L, Burton A, et al. “Well, It's the Risk of the Unknown… Right?’: A Qualitative Study of Perceived Risks and Benefits of HIV Cure Research in the United States. PLoS ONE. 2017:12(1). doi: 10.1371/journal.pone.0170112 28122027
24. U.S. DHHS. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. Available from: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
25. Gianella S, Tsibris A, Barr L, Godfrey C. Barriers to a Cure for HIV in Women. J Int AIDS Soc. 2016;19: 1–10. doi: 10.7448/IAS.19.1.20706 26900031
26. Curno MJ, Rossi S, Hodges-Mameletzis I, Johnston R, Price MA, Heidari S. A Systematic Review of the Inclusion (or Exclusion) of Women in HIV Research: from Clinical Studies of Antiretrovirals and Vaccines to Cure Strategies. JAIDS. 2016;71: 181–188. doi: 10.1097/QAI.0000000000000842 26361171
27. Brown B, Galea JT, Davidson P, Khoshnood K. Transparency of Participant Incentives in HIV Research. Lancet HIV. Elsevier Ltd; 2016;3: e456–e457. doi: 10.1016/S2352-3018(16)30150-3 27687034
28. Rossouw T, Tucker JD, van Zyl GU, Sikwesi K, Godfrey C. Barriers to HIV Remission Research in Low- and Middle-Income Countries. J Int AIDS Soc. Taylor & Francis; 2017;20: 1–9. doi: 10.1002/jia2.25010
29. Brown R, Evans NG. The Social Value of Candidate HIV Cures: Actualism versus Possibilism. J Med Ethics. 2017;43: 118–23. doi: 10.1136/medethics-2015-103125 27402887
30. Treatment Action Group (TAG). Research Toward a Cure Trials. 2017. Available from: http://www.treatmentactiongroup.org/cure/trials
31. Shah SK. When to Start Paediatric Testing of the Adult HIV Cure Research Agenda? J Med Ethics. 2017;43: 82–6. doi: 10.1136/medethics-2015-103116 27259546
32. Sugarman J, Lewin SR, Henrich TJ, Rasmussen TA. Ethics of ART Interruption after Stem-Cell Transplantation. Lancet HIV. 2016;3: e8–10. doi: 10.1016/S2352-3018(15)00248-9 26762996
33. Garner SA, Rennie S, Ananworanich J, Dube K, Margolis DM, Sugarman J, et al. Interrupting Antiretroviral Treatment in HIV Cure Research: Scientific and Ethical Considerations. J Virus Erad. 2017;3: 82–4. 28435691
34. Dubé K, Evans D, Dee L, Sylla L, Taylor J, Weiner BJ, et al. “We Need to Deploy Them Very Thoughtfully and Carefully”: Perceptions of Analytical Treatment Interruptions in HIV Cure Research in the United States. AIDS Res Hum Retroviruses. 2017;0. doi: 10.1089/aid.2017.0067 28562069
35. Forum for Collaborative HIV Research. Regulatory Pathway for HIV Cure Research: Developing Consensus Part 1. 2014. Available from: http://www.hivforum.org/storage/documents/2014/HIVCure/forum_hiv_cureproject_june17th_meeting_agenda.pdf
36. Li JZ, Smith DM, Mellors JW. The Need for Treatment Interruption Studies and Biomarker Identification in the Search for an HIV Cure. AIDS. 2015;29: 1429–32. doi: 10.1097/QAD.0000000000000658 25870989
37. Tucker J, Volberding P, Margolis D, Rennie S, Barré-Sinoussi F. Words Matter: Discussing Research towards an HIV Cure in Research and Clinical Contexts. JAIDS J Acquir Immune Defic Syndr. 2014;67: 110–111.
38. Lederman M, Cannon P, Currier J, June C, Kiem H, Kuritzkes D, et al. A Cure for HIV Infection: “Not in My Lifetime” or “Just Around the Corner”? Pathog Immun. 2016;1: 154–64. doi: 10.20411/pai.v1i1.133 27668293
39. Kuritzkes DR. Why Cure, Why Now? J Med Ethics. 2016; 1–4. doi: 10.1136/medethics-2015-103294
40. Dubé K, Evans D, Sylla L, Taylor J, Weiner BJ, Skinner A, et al. Willingness to Participate and Take Risks in HIV Cure Research: Survey Results from 400 People Living with HIV in the US. J Virus Erad. 2017;3: 40–50. 28275457
41. MacQueen KM, Cates W. The Multiple Layers of Prevention Science Research. Am J Prev Med. 2005;28: 491–495. doi: 10.1016/j.amepre.2005.02.020 15894154
42. MacQueen KM, McLellan E, Metzger DS, Kegeles S, Strauss RP, Scotti R, et al. What is Community? An Evidence-Based Definition for Participatory Public Health. Am J Public Health. 2001;91: 1929–1938. doi: 10.2105/AJPH.91.12.1929 11726368
43. Rich ZC, Liu C, Ma Q, Hu F, Cai W, Tang X, et al. Physician Perceptions of HIV Cure in China: A Mixed Methods Review and Implications for HIV Cure Research. Asian Pacific J Trop Dis. 2015;5: 687–690. doi: 10.1016/S2222-1808(15)60913-6 26877974
44. Brown B, LeComte-Hinely J, Brinkman D, MacCarthy S, Sullivan G. Barriers to Routine HIV Testing in Healthcare Settings and Potential Solutions from the Get Tested Coachella Valley Campaign. J Acquir Immune Defic Syndr. 2016;71: 127–7.
45. INSIGHT. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015;373: 795–807. doi: 10.1056/NEJMoa1506816 26192873
46. Bhattacharyya O, Reeves S, Zwarenstein M. What is Implementation Research? Res Soc Work Pract. 2009;19: 491–502.
47. Shytaj IL, Savarino A. A Cure for AIDS: A Matter of Timing? Retrovirology. 2013;10: 145. doi: 10.1186/1742-4690-10-145 24267982
48. Adair JE, Waters T, Haworth KG, Kubek SP, Trobridge GD, Hocum JD, et al. Semi-Automated Closed System Manufacturing of Lentivirus Gene-Modified Haematopoietic Stem Cells for Gene Therapy. Nat Commun. Nature Publishing Group; 2016;7: 13173. doi: 10.1038/ncomms13173 27762266
49. Sereti I, Folkers GK, Meintjes G, Boulware DR. Towards a Scalable HIV Cure Research Agenda: The Role of Co-Infections. J Virus Erad. 2015;1: 269–271. 26855972
50. Henrich TJ, Hatano H, Bacon O, Hogan LE, Rutishauser R, Hill A, et al. HIV-1 Persistence Following Extremely Early Initiation of Antiretroviral Therapy (ART) during Acute HIV-1 Infection: An Observational Study. PLoS Med. 2017;14(11): e1002417. doi: 10.1371/journal.pmed.1002417 29112956
51. Moodley K, Rossouw T, Staunton C, Colvin CJ. Synergies, Tensions and Challenges in HIV Prevention, Treatment and Cure Research: Exploratory Conversations with HIV Experts in South Africa. BMC Med Ethics. BMC Medical Ethics; 2016;17: 26. doi: 10.1186/s12910-016-0109-1 27137204
Štítky
Interné lekárstvoČlánok vyšiel v časopise
PLOS Medicine
2017 Číslo 12
- Statinová intolerance
- Očkování proti virové hemoragické horečce Ebola experimentální vakcínou rVSVDG-ZEBOV-GP
- Parazitičtí červi v terapii Crohnovy choroby a dalších zánětlivých autoimunitních onemocnění
- Metamizol v liečbe pooperačnej bolesti u detí do 6 rokov veku
- Co dělat při intoleranci statinů?
Najčítanejšie v tomto čísle
- Shortages of benzathine penicillin for prevention of mother-to-child transmission of syphilis: An evaluation from multi-country surveys and stakeholder interviews
- Internet-accessed sexually transmitted infection (e-STI) testing and results service: A randomised, single-blind, controlled trial
- The vaginal microbiome and sexually transmitted infections are interlinked: Consequences for treatment and prevention
- Estimating the impact of antiretroviral treatment on adult mortality trends in South Africa: A mathematical modelling study