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Date of Report: 07/22/2003
Author: Susa Coffey, MD, Medical Editor, AETC NRC
Source: National Resource Center
The U.S. Department of Health and Human Services has updated the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.
The new guidelines contain several important revisions and additions:
Treatment Naive Patients
Treatment recommendations for previously untreated patients have been revised, based on current clinical trial data, to emphasize complete regimens rather than component parts. (Table 12a)
Two combination antiretroviral regimens are suggested as "Preferred Regimens":
 | Efavirenz + lamivudine + (zidovudine or tenofovir or stavudine) |
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| Lopinavir/ritonavir + lamivudine + (zidovudine or stavudine) |
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Several non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) based regimens are listed as "Alternative Regimens." Two triple nucleoside reverse transcriptase inhibitor (NRTI) regimens are considered as "Alternative Regimens," with the recommendation that they be avoided in patients with HIV viral loads of greater than 100,000 copies/ml.
The guidelines recommend the NRTI combination of lamivudine + zidovudine as the preferred NRTI "backbone pair" to be used in combination therapy, and suggest lamivudine + stavudine or lamivudine + tenofovir as preferred alternatives.
The protease inhibitor atazanavir and the nucleoside analog emtricitabine received FDA approval after drafting of the guidelines, and are not included in the guidelines.
Advantages and disadvantages of these treatment components are discussed in the text and in Table 12b.
Treatment Experienced Patients
Management of the treatment-experienced patient has been revised to include a discussion of treatment regimen failure, strategies for changing antiretroviral regimens, and strategies for patients with few treatment options.(Tables 23-25) A discussion of the potential use of therapeutic drug monitoring is presented in this context.
Regimens or Components to Avoid
Two new sections recommend drugs to be avoided:
| Certain medications should not be used in initial therapy. These include individual medications or combinations with:
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 | high incidence of toxicity, e.g. stavudine + didanosine |
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| high pill burdens, e.g. amprenavir or saquinavir soft gel capsules as sole PIs |
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| inadequate potency, e.g. delavirdine |
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| Certain regimens or components should be avoided at any time (Table 13) these are:
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| saquinavir hard gel capsules as a single PI |
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| hydroxyurea |
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| efavirenz, amprenavir oral solution, or stavudine + didanosine in pregnant women |
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Other New Sections
The updated guidelines include new discussions of once-daily therapy, drug interactions, and initiating therapy in women of reproductive age and pregnant women.
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