Guidelines for Starting HIV Therapy in Adults

Recommendations from the U.S. Department of Health and Human Services

Stribild (elvitegravir + cobicistat + tenofovir + emtricitabine). Courtesy Gilead Sciences

In May 2014, the U.S. Department of Health and Human Services (DHHS) revised its HIV treatment guidelines, recommending the implementation of antiretroviral therapy (ART) in all adults diagnosed with HIV, irrespective of CD4 counts or the stage of disease.

The recommendations previously called for ART at CD4 counts below 500 cells/mL, with a moderate recommendation for ART at counts over 500 cells/mL.

Rationale for HIV Treatment on Diagnosis

The DHHS decision is supported by evidence that early treatment is associated with a number of positive outcomes, namely:

  • a reduction in the risk of death and illnesses associated with HIV disease progression.
  • a reduction in the risk of transmission from mother to child.
  • a reduction in the risk of transmission from a person infected with HIV.

The latter recommendation is supported by evidence that the use of ART can significantly reduce the infectivity of a person with HIV, a strategy popularly known as Treatment as Prevention (TasP)

It has been further shown that persons provided immediate ART are 53% less likely to develop serious illness, both HIV-related and non-related, than someone in whom ART is delayed.

Moreover, early ART confers not only to better outcomes but longer life. According to researchers with the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), a 20-year-old person with HIV can now expect to live into his or her early 70s if treated at the time of diagnosis.

By contrast, deferring ART until a person's CD4 count drops below 200 cells/mL can reduce that person's life expectancy by an average of 15 years.

Recommendations for First-Line Therapy in Untreated Adults

For previously untreated ("treatment naive") patients, the U.S. panel currently recommends one of six drug regimens as their preferred options for first-line therapy:

  • Triumeq (dolutegravir + abacavir + lamivudine), taken once daily
  • Tivicay (dolutegravir) + Truvada (tenofovir + emtricitabine), taken once daily
  • Stribild (elvitegravir + cobicistat + tenofovir + emtricitabine), taken once daily
  • Genvoya (elvitegravir + cobicistat + tenofovir AF + emtricitabine), taken once daily
  • Isentress (ratelgravir) + Truvada (tenofovir + emtricitabine), taken once daily
  • Prezista (darunavir) + Norvir (ritonavir) + Truvada (tenofovir + emtricitabine), taken once daily

The primary rationale for the DHHS preferred status includes a regimen's low pill burden, easy dosing schedule, reduced side effect profile, and high barrier to drug resistance.

Since certain conditions may exclude some from taking the preferred options (such as Truvada in patients with kidney impairment), the DHHS lists six alternative regimens for first-line therapy as follow:

  • Atripla (efavirenz + tenofovir + emtricitabine), taken once daily
  • Complera (rilpivirine + tenofovir + emtricitabine), taken once daily
  • Evotaz (atazanavir + cobicistat) + Truvada (tenofovir + emtricitabine), taken once daily
  • Reyataz (atazanavir) + Norvir (ritonavir) + Truvada (tenofovir + emtricitabine), taken once daily
  • Prezcobix (darunavir + cobicistat) OR Prezista (darunavir) + Norvir (ritonavir) taken in conjunction with Epzicom (abacavir + lamivudine), once daily
  • Prezcobix (darunavir + cobicistat) + Truvada (tenofovir + emtricitabine), once daily

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Department of Health and Human Services (DHHS). "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents." Rockville, Maryland; accessed February 15, 2016.

Hogg, R.; Althoff, K.; Samji, H.; et al. Increases in life expectancy among treated HIV-positive individuals in the United States and Canada, 2000-2007." 7th International AIDS Society (IAS) Conference on Pathogenesis, Treatment and Prevention. Kuala Lumpur, Malaysia. June 30-July 3, 2013; Abstract TUPE260.

Skarbinski, J.; Furlow-Parmley, C.; and Frazie, E. "Nationally Representative Estimates of the Number of HIV+ Adults who Received Medical Care, Were Prescribed ART, and Achieved Viral Suppression-Medical Monitoring Project, 2009 to 2010-US." 19th Conference on Retroviruses and Opportunistic Infections (CROI); Seattle, Washington; March 8, 2013; oral abstract #138.

Lasry, A; Sansom, S.;  Wolitski,R.; et al. "HIV sexual transmission risk among serodiscordant couples: assessing the effects of combining prevention strategies." AIDS. June 14, 2014; 28(10):1521-1529.

Kitahata, M.; Gange, S.; Abraham, A., et al. "Effect of early versus deferred antiretroviral therapy for HIV on survival." New England Journal of Medicine. April 30, 2009; 360(18):1815-1826.

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