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Why the "When to Start" Question Is Complex and Informed by Limited Evidence: A Response to Dr. Myron Cohen

March/April 2013

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Patient Choice and the Decision to Start

To further emphasise the urgency of immediate treatment, Dr. Cohen says that the concept of a person being "ready to start" treatment suggests that a doctor-patient discussion to arrive at this position might project "a false sense of security" that "all is well."

This central tenet of treatment guidelines -- readiness to start -- is one that activists have demanded and supported because of a high risk of failure when the need for treatment and how to use it is not understood. Whether someone is starting treatment on diagnosis, using a CD4 threshold of 500, 350 or 200 -- for their personal health or to reduce the risk to their partner -- it needs to be an informed choice.

Throughout the interview, language is used that increases anxiety, rather than providing information for an informed choice. This includes the "urgency" discussed above, but also emphasises the fear of the unknown. An HIV diagnosis is still traumatic for most people. It is a life-changing event. The decision to start treatment is similarly important.

Scaring people into the decision, whether for future health risks or on a public health agenda, will help no-one.


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Conclusion

The plausibility of potential benefits of treatment on diagnosis has been argued since AZT monotherapy. No virus is better than virus. But at high CD4 counts there is too little evidence to know whether lifelong treatment is better than asymptomatic HIV.

Currently, the evidence (and expert interpretation of the same evidence in different guidelines) still supports equipoise for many people on the question of whether benefits outweigh the risks of earlier treatment at CD4 counts above 350. Results from the START study, expected in 2016, will provide the strongest real data to inform this question.2

This doesn't mean nothing can be done until then, but guessing the results -- or worst still, pretending the evidence already exists -- has a serious risk for being wrong.

HIV positive people should have the option to start treatment at any CD4 count, especially to reduce the risk of transmission to sexual partners. But to be an informed choice, this needs to acknowledge that the evidence for personal health benefits at high CD4 counts has plausibility, but limited data.

Until 2016, a wide range of studies suggest both a low absolute risk from starting earlier treatment if this is an individual's choice and a low absolute risk from deferring until 350 if that is an individual's choice. This is especially important to remember for people enrolled in the START study, who will ultimately help settle this key question.

Simon Collins is a member of the Community Advisory Board for the INSIGHT group that is currently running the START study. This article was based on a previous weblog.25 Thanks to the HTB editorial board for support and comments.


References

  1. Smith M. Interview with Dr. Myron Cohen: When to start therapy, a clinical context report. MedPage Today. (5 January 2013).
  2. Strategic Timing of Anti Retroviral Therapy (START).
  3. May M et al. Impact of late diagnosis and treatment on life expectancy in people with HIV-1: UK Collaborative HIV Cohort (UK CHIC) study. BMJ 343, doi: 10.1136/bmj.d6016, 2011.
  4. Severe P et al. Early versus Standard Antiretroviral Therapy for HIV-Infected Adults in Haiti. N Engl J Med 2010;363:257-65.
    www.natap.org/2010/HIV/HAARTHaiti.pdf
  5. Emery S et al. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. Apr 15 2008;197(8):1133-1144.
  6. Cohen MS et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365: 493-505.
  7. Sterne JA et al. When To Start Consortium. Timing of initiation of antiretroviral therapy in AIDS-free HIV-1-infected patients: a collaborative analysis of 18 HIV cohort studies. Lancet. 2009;373(9672):1352-1363.
  8. Kitahata MM et al. NA-ACCORD Investigators. Effect of early versus deferred antiretroviral therapy for HIV on survival. N Engl J Med. 30 April 2009;360(18):1815-1826.
    http://www.natap.org/2009/HIV/051109_04.htm
  9. Cain LE et al. When to initiate combined antiretroviral therapy to reduce mortality and AIDS- defining illness in HIV-infected persons in developed countries: an observational study. Ann Intern Med. Apr 19 2011;154(8):509-515.
  10. Writing Committee for the CASCADE Collaboration. Timing of HAART Initiation and Clinical Outcomes in Human Immunodeficiency Virus Type 1 Seroconverters. Arch Intern Med. 2011;171(17):1560-1569.
  11. Opportunistic Infections Project Team of the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE) in EuroCoord. CD4 cell count and the risk of AIDS or death in HIV-Infected adults on combination antiretroviral therapy with a suppressed viral load: a longitudinal cohort study from COHERE. PLoS Med. 2012;9(3):e1001194.
  12. Mugavero MJ et al. Viremia copy-years predicts mortality among treatment-naive HIV-infected patients initiating antiretroviral therapy. Clin Infect Dis. Nov 2011;53(9):927-935.
  13. Guiguet M, Boue F, Cadranel J, Lang JM, Rosenthal E, Costagliola D. Effect of immunodeficiency, HIV viral load, and antiretroviral therapy on the risk of individual malignancies (FHDH-ANRS CO4): a prospective cohort study. Lancet Oncol. Oct 7 2009;10(12):1152-1159.
  14. U.S. DHHS. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. February 2013.
    http://aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf
  15. IAS-USA. Antiretroviral Treatment of Adult HIV Infection 2012 Recommendations of the International Antiviral Society-USA Panel. JAMA, July 25, 2012-Vol 308, No. 4.
  16. British HIV Association guidelines for the treatment of HIV-1-positive adults with antiretroviral therapy 2012. HIV Medicine (2012), 13 (Suppl. 2), 1-85. DOI: 10.1111/j.1468-1293.2012.01029_1.x.
    http://www.bhiva.org/documents/Guidelines/Treatment/2012/hiv1029_2.pdf
  17. WHO. Rapid advice. Antiretroviral therapy for HIV infection in adults and adolescents. November 2009.
  18. WHO. Guidance on couples HIV testing and counsApril 2012.elling -- including antiretroviral therapy for treatment and prevention in serodiscordant couples.
  19. Cohen M. The HIV "test and treat" movement: the details really matter, and now. BHIVA Autumn Conference 2010. Web cast online.
  20. Lodi S. et al. Time from Human Immunodeficiency Virus seroconversion to reaching CD4+ cell count thresholds <200, <350, and <500 cells/mm3: assessment of need following changes in treatment guidelines. Clin Infect Dis. (2011) 53 (8): 817-825. doi: 10.1093/cid/cir494.
  21. Geffen N. Implications if WHO guidelines increase CD4 threshold for starting ART to 500. HIV Treatment Bulletin. January/February 2013.
  22. Sued O et al. HIV drug and supply stock-outs in Latin America. The Lancet Infectious Diseases, Volume 11, Issue 11, Pages 810-811, November 2011. doi:10.1016/S1473-3099(11)70301-2.
  23. Pasquet A et al. Impact of drug stock-outs on death and retention to care among HIV-infected patients on combination antiretroviral therapy in Abidjan, Côte d'Ivoire. PLoS One 5(10): e13414. 15 October 2010. doi:10.1371/journal.pone.0013414.
  24. Bangsberg D. The Achilles' heel of HIV treatment in resource-limited settings. JAIDS, 1 February 2008 - Volume 47 - Issue 2 - pp 266-267. doi: 10.1097/QAI.0b013e31815b2142.
  25. Collins S. The importance of evidence for "When to Start": a response to Dr. Myron Cohen. Web Blog (12 February 2013).

Links to other websites are current at date of posting but not maintained.

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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 
See Also
HIV Medications: When to Start and What to Take -- A Guide From TheBody.com
More Research on When to Start Treatment
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