Table 1. Initial Treatment for Established HIV Infection
This table provides a guide to the use of available treatment regimens for patients with limited or no prior experience on HIV therapy. In accordance with the established goals of HIV therapy, priority is given to regimens for which clinical trials data suggest the following: sustained suppression of HIV plasma RNA (particularly in patients with high baseline viral load) and sustained increase in CD4+ T cell count (in most cases over 48 weeks), and favorable clinical outcome (i.e., delayed progression to AIDS and death). Particular emphasis is given to regimens that have been compared directly with other regimens that perform sufficiently well with regard to these parameters to be included in the "Strongly Recommended" category. Additional consideration is given to the regimen's pill burden, dosing frequency, food requirements, convenience, toxicity, and drug interaction profile compared with other regimens.
It is important to note that all antiretroviral agents, including those in the "Strongly Recommended" category, have potentially serious toxic and adverse events associated with their use. The reader is strongly encouraged to consult the HHS HIV Treatment Guidelines while formulating an antiretroviral regimen.
Antiretroviral drug regimens are comprised of one choice each from columns A and B. Drugs are listed in alphabetical, not priority, order.
| ||Column A||Column B|
|Strongly Recommended||Efavirenz (Sustiva, EFV)|
Indinavir (Crixivan, IDV)
Nelfinavir (Viracept, NFV)
**Ritonavir (Norvir, RTV) + Indinavir(a, b)
Ritonavir + Saquinavir(a) (SGC(c) or HGC)
|Stavudine (Zerit, d4T) + Didanosine (Videx, ddI, ddi EC)(d)|
Stavudine + Lamivudine (Epivir, 3TC)
Zidovudine (Retrovir, ZDV) + Didanosine
Zidovudine + Lamivudine (Combivir)
|Recommended as Alternatives||Abacavir (Ziagen, ABC)|
Amprenavir (Agenerase, AMP)
Delavirdine (Rescriptor, DLV)
Nelfinavir + Saquinavir
Nevirapine (Viramune, NVP)
Trizivir (Abacavir, Lamivudine, Zidovudine)
|Didanosine + Lamivudine|
Zidovudine + Zalcitabine (Hivid, ddC)
Hydroxyurea in combination with antiretroviral drugs|
**Ritonavir + Amprenavir(a)
Ritonavir + Nelfinavir(a)
|Not Recommended: Should Not Be Offered||All monotherapies, whether from Column A or B(f)|
|Stavudine + Zidovudine|
Zalcitabine + Didanosine
Zalcitabine + Lamivudine
Zalcitabine + Stavudine
- See Guidelines for more information on optimizing protease inhibitor exposure with ritonavir.**
- Based on expert Opinion**
- Saquinavir-SGC, soft-gel capsule (Fortovase); Saquinavir-HGC. Hard-gel capsule (Invirase).**
- Pregnant women may be at increased risk for lactic acidosis and liver damage when treated with the combination of stavudine and didanosine. This combination should be used in pregnant women only when the potential benefit clearly outweighs the potential risk.
- This category includes drugs or combinations for which information is too limited to allow a recommendation for or against use.**
- Zidovudine monotherapy may be considered for prophylactic use in pregnant women with low viral load and high CD4+ T cell counts to prevent perinatal transmission, as discussed under "Considerations in the Pregnant Woman" in the Guidelines.
- Use of Saquinavir-HGC (Invirase) is not recommended, except in combination with ritonavir.
**Changes from last year's guidelines are starred.
Table 2. Indications for the Initiation of Antiretroviral Therapy in the Chronically HIV-1 Infected Patient
|Clinical Category||CD4+ T Cell Count||Plasma HIV RNA||Recommendation|
|Symptomatic||Any Value||Any Value||Treat|
|Asymptomatic, AIDS||<200/mm3||Any Value||Treat|
|Asymptomatic||>200/mm3 but <350/mm3||Any Value||Treatment should generally be offered, thought controversy exists.*|
|Asymptomatic||>350/mm3||>30,000 (bDNA) or >55,000 (RT-PCR)||Some experts would recommend initiating therapy, recognizing that the three-year risk of developing AIDS in untreated patients is >30%. In the absence of very high levels of plasma HIV RNA, some would defer therapy and monitor the CD4+ T cell count and level of plasma HIV RNA more frequently. Clinical outcomes data after initiating therapy are lacking.|
|Asymptomatic||>350/mm3||<30,000 (bDNA) or <55,000 (RT-PCR)||Many experts would defer therapy and observe, recognizing that the three-year risk of developing AIDS in untreated patients is <15%.|
|*Clinical benefit has been demonstrated in controlled trials only for patients with CD4+ T cells <200/mm3. However, most experts would offer therapy at a CD4+ T cell threshold <350/mm3. All decisions to initiate therapy should be based on prognosis for disease-free survival in the absence of treatment, as determined by the CD4+ T cell count and level of plasma HIV RNA shown in Table 5, the potential benefits and risks of therapy shown in Table 4, and the willingness of the patient to accept therapy. For further information, see "Considerations for Initiating Therapy in the Patient with Asymptomatic HIV Infection," in the HHS Guidelines.|
These tables were taken from U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents. Washington, DC: US Dept of Health and Human Services; February 2001. P44 and 38.
Back to the HEPP News February 2001 contents page.