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Antiretroviral Therapy

Antiretroviral therapy (ART) is now recommended for all people with HIV infection, regardless of CD4 count, by all major treatment guidelines including those issued by the World Health Organization (WHO), the European AIDS Clinical Society (EACS), and the United States (US) Department of Health and Human Services (DHHS).1-3

Goals of ART include

• Durable suppression of plasma HIV RNA (viral load)
• Restoring and preserving immunologic function
• Reducing HIV-associated morbidity, prolonging survival, and improving quality of life
• Preventing HIV transmission

The recommendation for all HIV-infections individuals to be on ART regardless of CD4 count is the result of an expert consensus that emerged over time but was confirmed by results from START and TEMPRANO, two large, randomized controlled trials, both of which demonstrated approximately a 50% reduction in morbidity and mortality among HIV-infected patients with CD4 counts >500 cells/mm3 who were randomized to initiate ART immediately versus delaying initiation of ART until their CD4 counts fell below a predetermined cutoff.4,5

The START and TEMPRANO results ended a long-running debate about when to initiate ART in HIV-positive patients on immunologic grounds: earlier is definitely better, and immediate is definitely best. But these clinical results did not occur in a vacuum; that is, patients did better on immediate therapy not only because of their more intact immunologic function, but also because ART is now safer, more tolerable, and more convenient that it was in the past.
In recent years, the efficacy of ART has been recognized for prevention of HIV transmission from infected patients to uninfected sexual partners. This strategy, known as treatment as prevention (TasP), was validated by two large clinical trials (HIV Prevention Treatment Network (HPTN) Study 052 and the PARTNER study) that showed minimal to no transmission when the HIV-positive partner had viral suppression on ART.6,7

However, adherence is a key to treatment success. Poor adherence may result in treatment failure and emergence of drug resistance. A number of factors may impact adherence to ART, including psychiatric disorders, neurocognitive impairment, active substance abuse, unstable housing, other unfavorable social circumstances, patient concerns about side effects, and irregular attendance at scheduled clinic visits. Providers should be confident that patients are ready to initiate ART from an adherence perspective.2

In rare cases, it may be advisable to delay initiation of ART to resolve issues that may seriously impact adherence. Note, however, that ART has benefit even in patients with relatively poor adherence and established drug resistance. Thus, serious mental illness, substance dependency, and psychosocial challenges are not reasons to withhold ART from a patient for who it is clinically indicated and who is willing to adhere to treatment.  Rather, these issues indicate the need for multidisciplinary adherence support, and may impact choice of regimen.2


  1. World Health Organization. Guideline on When to Start Antiretroviral Therapy and on Pre-Exposure Prophylaxis for HIV. Geneva: World Health Organization; 2015 Sep.
  2. European AIDS Clinical Society. Guidelines Version 8.0. October 2015.
  3. Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. January 2016.
  4. INSIGHT START Study Group. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20. 
  5. TEMPRANO ANRS 12136 Study Group. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20. 
  6. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011 Aug 11;365(6):493-505. doi: 10.1056/NEJMoa1105243. Epub 2011 Jul 18.
  7. Rodger A,  Bruun T, Cambiano V, et al. HIV transmission risk through condomless sex if HIV+ partner on suppressive ART: PARTNER Study. 21st CROI, 3-6 March 2014, Boston. Oral late breaker abstract 153LB.