DEC. 1998/JAN. 1999NUMBER TWO

STANDARD OF CARE

Uncle Sam Says
Federal HIV treatment guidelines at a glance.

The goal of HIV highly active antiretroviral therapy (HAART) is to drive HIV to below detectable levels in the blood. That does not mean that there is no HIV in the body; it means the test results are below the threshold of detection of currently available viral-load tests (see "New HIV Tests").

The impact of HAART is measured by clinical state, T-cell, and viral-load tests.

The following recommendations have been culled from the federal treatment guidelines printed below and represent the prevailing view of frontline physicians and advocates. They may be updated in the near future.

  • Best first-line therapy: One strong protease inhibitor (PI) plus two "nukes" (NRTIs), or two PIs: Norvir and Fortovase.

  • Strong evidence of clinical benefit and/or sustained suppression of plasma viral load is suggested by choosing one drug from Column A and one from Column B. (Drugs are listed in random order.)

     Column A    Column B 
    CrixivanAZT plus ddI
    Viraceptd4T plus ddI
    NorvirAZT plus ddC
    Norvir plus FortovaseAZT plus 3TC
    Fortovased4T plus 3TC
     

  • Alternative first-line therapy: One NNRTI (Sustiva) plus two "nukes" (column B). This may be an option for those with no prior anti-HIV treatment, high stable T-cells, and a low viral load. Also Fortovase (soft-gel saquinavir) and two nukes (column B).

  • Not generally recommended: Using only two "nukes" (column B). They may not be potent enough to suppress HIV and may lead to drug resistance. Avoid Invirase (hard-gel saquinavir); it has been replaced by Fortovase (soft-gel saquinavir).

  • Avoid: Any monotherapy: This leads to HIV resistance.

  • Avoid: Adding a protease inhibitor to a failing combination.

  • Bad combinations (drugs that interact poorly): d4T and AZT; ddC and ddI; ddC and d4T; ddC and 3TC.

  • Short-term goal: 0.5-0.75-log drop in viral load within four weeks; one log (90 percent) by eight weeks.

  • Long-term goal: Driving HIV viral load to below the limit of detection ("undetectable") or keeping viral load as low as possible for as long as possible. This prevents drug resistance and allows the drugs to work longer. There is a health benefit to lowering viral load even as little as threefold.

  • Tip: Use full-dose therapy.

  • Tip: Consult a doctor with experience in HIV care before starting or changing therapy. Local AIDS organizations have lists of area specialists.

  • Tip: Discuss side effects, adherence, and drug interactions with your doctor before starting or changing a drug regimen.
      Federal HHS Guidelines for Anti-HIV Treatment (June 1998)
      When to Start Therapy:
      Clinical State CD4 + T-cell Count & Viral Load Recommendation
      Symptomatic (Sick: AIDS, thrush, unexplained fever) Any level Treat
      Asymptomatic (no symptoms) T-cells below 500/ml or viral load above 10,000 (bDNA) or above 20,000 (RT-PCR) Treatment optional*
      Asymptomatic T-cell above 500/ml and viral load is below 10,000 (bDNA) or below 20,000 (RT-PCR) Many doctors would delay; some would treat and abserve.

      * Some experts observe patients with 350-500 T-cells and viral-load levels below 10,000 (by bDNA) or below 20,000 (by RT-PCR).

      (+) Federal HHS guidelines are created by doctors, researchers, and industry representatives. They differ slightly from recent International AIDS Society guidelines created only by doctors. IAS guidelines say HAART treatment should begin when viral load is 5,000-10,000, regardless of T-cell count. To get the full HHS guidelines, call 800-458-5231 or download from www.cdcnpin.org.

      When to Interrupt Therapy: There are reasons such as drug interactions or pregnancy that may lead you to delay or interrupt HIV therapy. If you stop, stop all anti-HIV drugs at the same time to reduce the risk of developing drug-resistant HIV.

      When to Change Therapy: There are several reasons to consider changing a drug regimen, including drug failure, poor absorption, adherence problems, and serious drug toxicity. Bad side effects are a good reason to substitute one or more drugs from the same class (replace AZT with d4T to avoid anemia, for example). If your regimen is failing, a drug-resistance test (see diagnostic tests) may help you determine why a given drug regimen is failing and help you select an alternative regimen. Consider changing your regimen when:

      • Viral load does not fall below "undetectable" level within 4-6 months of HAART.
      • Viral load is reduced by less than tenfold after eight weeks of HAART. If absorption appears normal and a person is adhering to the regimen, change in therapy is warranted.
      • Viral load increases ("rebounds") to above the level of detection after becoming "undetectable."
      • Viral load increases threefold or more above the lowest measurement.
      • CD4 T-cell count continues to fall.
      • Clinical symptoms of HIV disease develop or get worse.
      • When switching: change at least two drugs in your regimen. Ideally, a new regimen should include at least two new drugs that you've never taken before.

      When to Delay or Defer Therapy: Since HIV can become resistant to all HIV drugs, your initial and secondary treatment choices may limit future treatment options. Deferring treatment is an option for those with high, stable T-cell counts, but it's important to get regular medical checkups and monitor your health with viral-load and T-cell tests. If a person is clinically stable, has a detectable viral load, and possesses no good options for changing therapy, it may be best to delay changing therapy in the hope that better drugs will be available in the future.

  Dec 1998 Jan 1999
  Copyright © 1999 HIV Plus. All rights reserved.
  Last modified 1/5/99.
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