Antiretroviral Regimens Recommended for Treatment of HIV-1 Infection in Antiretroviral Naïve Patients

This table is a guide to treatment regimens for patients who have no previous experience with HIV therapy. Regimens should be individualized based on the advantages and disadvantages of each combination such as pill burden, dosing frequency, toxicities, and drug-drug interactions, and patient variables, such as pregnancy, co-morbid conditions, and level of plasma HIV-RNA. Clinicians should refer to review the pros and cons of different components of a regimen and for adverse effects and dosages of individual antiretroviral agents. Preferred regimens are in bold type; regimens are designated as “preferred” for use in treatment naïve patients when clinical trial data suggests optimal and durable efficacy with acceptable tolerability and ease of use.

Alternative regimens are those where clinical trial data show efficacy, but it is considered alternative due to disadvantages compared to the preferred agent, in terms of antiviral activity, demonstrated durable effect, tolerability or ease of use. In some cases, based on individual patient characteristics, a regimen listed as an alternative regimen in the table may actually be the preferred regimen for a selected patient. Clinicians initiating antiretroviral regimens in the HIV-1-infected pregnant patient should refer to Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States”, at http://www.aidsinfo.nih.gov/guidelines/

NNRTI-Based Regimens # of pills per day
Preferred Regimensefavirenz + lamivudine + (zidovudine or tenofovir DF or stavudine*) – except for pregnant women or women with pregnancy potential**3–5
Alternative Regimensefavirenz + emtricitabine + (zidovudine or tenofovir DF or stavudine*) – except for pregnant women or women with pregnancy potential**3–4
efavirenz + (lamivudine or emtricitabine) + (didanosine or abacavir) - except for pregnant women or women with pregnancy potential**3-5
nevirapine + (lamivudine or emtricitabine) + (zidovudine or stavudine* or Didanosine or abacavir) [Note: High incidence (11%) of symptomatic hepatic events observed in women with prenevirapine CD4+ T cell count > 250 cells/mm3 and men with CD4 > 400 cells/mm3 (6.3%). Use with caution in these patients, with close clinical and laboratory monitoring, especially during the first 18 weeks of therapy] 4-5
PI-Based Regimens # of pills per day
Preferred Regimenslopinavir/ritonavir (co-formulated) + lamivudine + (zidovudine orstavudine*)8–10
Alternative Regimensatazanavir + (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)4-5
fosamprenavir + (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)6-8
fosamprenavir/ritonavir† + (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)6-8
indinavir/ritonavir†+ (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)8-11
lopinavir/ritonavir (co-formulated) + emitricitabine + (zidovudine or stavudine* or abacavir)8-9
lopinavir/ritonavir (co-formulated) + lamivudine + abacavir8-9
nelfinavir§ + (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)12-14
saquinavir (sgc or hgc)f /ritonavir† + (lamivudine or emtricitabine) + (zidovudine or stavudine* or abacavir)14-16
Triple NRTI Regimen – Only when a preferred or alternative NNRTI- or a PI-based regimen cannot or should not be used as first line therapy# of pills per day
abacavir + lamivudine + zidovudine (or stavudine*)2-6

* Higher incidence of lipoatrophy, hyperlipidemia, and mitochondrial toxicities reported with stavudine than with other NRTIs.

** Women with child bearing potential implies women who want to conceive or those who are not using effective contraception
† Low-dose (100–200 mg) ritonavir

f sgc = soft gel capsule; hgc = hard gel capsule

Adapted from DHHS guidelines, March 23, 2004