HIV+ Issue 9 - Federal HIV treatment guidelines

June 2000 July

NUMBER NINE

FEDERAL HIV TREATMENT GUIDELINES

Uncle Sam Says
Federal HIV treatment guidelines at a glance.

The overall goal of HIV highly active antiretroviral therapy (HAART) is to drive HIV to below detectable levels in the blood. The impact of HAART is measured by viral load, T-cell counts and clinical state.

Revised Health and Human Services (HHS) guidelines now state that for some people, it may be better to stay on combination therapy even when viral load becomes detectable than to stop drugs all together; it also expands the goals of therapy to include quality of life and safeguarding the immune system, and discusses resistance testing as a tool for selecting drugs. The guidelines also define undetectable as below 50 copies - the limit of today's tests.

The following recommendations are culled from HHS guidelines. Recent changes are printed in red type.

The following recommendations have been culled from current federal treatment guidelines and represent the prevailing view of frontline physicians.

Best first-line therapy: One strong protease inhibitor (PI) plus two "nukes" (NRTIs), or two PIs: Norvir and Fortovase, or Sustiva and two "nukes.".
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
	Crixivan		AZT plus ddI
	Viracept		d4T plus ddI
	Norvir plus Fortovase or Invirase		AZT plus 3TC
	Sustiva		d4T plus 3TC
	Alternative:
	Ziagen		AZT plus ddC
	Agenerase		ddI plus 3TC
	Rescriptor Viramune Norvir Fortovase

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: Any monotherapy. This leads to HIV resistance; adding a new drug to a failing combination; Invirase without Norvir; d4T plus AZT; ddC plus ddI; ddC plus d4T; ddC plus 3TC.

Short-term goals: 0.5-0.75 log drop in viral load within four weeks; one log (tenfold) by eight weeks. Undetectable by six months.

Long-term goals: 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. Other goals: restoration and/or preservation of the immune system; improved quality of life.

Tip: Use full-dose therapy.

Tip:Consult a doctor with experience in HIV care before starting

Federal HHS Guidelines for Anti-HIV Treatment

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 should be offered. Strength of recommendation is based on p[rognosis for disease-free survival and patient's willingness to accept therapy.*
Asymptomatic	T-cell above 500/ml and viral load is below 10,000 (bDNA) or below 20,000 (RT-PCR)	Many doctors would delay and observe; some would treat.
* 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. 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. International AIDS Society (search at jama.ama-assn.org) guildelines say HAART treatment should begin when viral load is above 30,000 or T-cell count is below 350. To get the full HHS guidelines, call 800-448-0440 or download from www.hivatis.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 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 four to six 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." Note: It may sometimes be preferable to use a combination that doesn’t provide complete suppression. 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.

HIV PLUS