The Department of Health and Human Services (DHHS)

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents November 3, 2008

Beginning HAART

• Antiretroviral therapy should be initiated in patients with a history of an AIDS-defining illness or with a CD4 T-cell count <350 cells/mm³. The data supporting this recommendation are stronger for those with a CD4 T-cell count <200 cells/mm3 and with a history of AIDS than for those with CD4 T-cell counts between 200 and 350 cells/mm³.
• Antiretroviral therapy should also be initiated in the following groups of patients regardless of CD4 T-cell count:
  a. Pregnant women; (for details)
  b. Patients with HIV-associated nephropathy; and
  c. Patients coinfected with HBV when treatment is indicated.
• Antiretroviral therapy may be considered in some patients with CD4 T-cell counts >350 cells/mm³.

Selecting an initial regimen

Selecting the appropriate components of a HAART regimen for an individual patient is guided by a number of variables.

• comorbid conditions (e.g., cardiovascular disease, chemical dependency, liver disease, psychiatric disease, renal diseases, or tuberculosis);
• potential adverse drug effects;
• potential drug interactions with other medications;
• pregnancy or pregnancy potential;
• results of genotypic drug resistance testing;
• gender and pretreatment CD4 T-cell count if considering nevirapine;
• HLA-B*5701 testing if considering abacavir;
• patient adherence potential; and convenience (e.g., pill burden, dosing frequency, and food and fluid considerations).

Adult and adolescent patients naïve to antiretroviral therapy should be started on a combination regimen that consists of either 1-NNRTI + 2 NRTI or PI (preferably boosted with ritonavir) + 2NRTI.

Protease Inhibitor–Based Regimens:
• Once-daily ritonavir-boosted darunavir has been added as a preferred PI component .
• Once-daily ritonavir-boosted lopinavir has been moved from alternative to preferred PI component (except for pregnant women).

Dual-NRTI Options:
• Abacavir + lamivudine has been moved from a preferred to an alternative dual-NRTI component because of concerns regarding an increased risk of myocardial infarction in patients with high cardiac risk factors, as suggested by large observational cohort studies, and concerns regarding virologic potency in patients with baseline viral loads >100,000 copies/mL.

Combinations Not to Use or to Use with Caution:
• A combination of unboosted atazanavir + didanosine + emtricitabine (or lamivudine) is not recommended because of efficacy concerns.