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Sheet Number 411

2002 ANTIRETROVIRAL

THERAPY GUIDELINES

NOTE: The full

text of these guidelines is available.


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WHY DO THE GUIDELINES

KEEP CHANGING?

We keep learning more about the best way to fight HIV. In

1998, the US Department of Health and Human Services created a

panel of physicians, researchers, and consumers to develop treatment

guidelines. They constantly review AIDS research results. The

guidelines are updated once or twice each year. The panel released

the latest guidelines in February 2002.

NOTE: These are guidelines, not rules. Patients should

receive individualized care from a doctor with experience treating

HIV infection. The full text of these guidelines is available

on the Internet at http://www.hivatis.org/trtgdlns.html


VIRAL LOAD AND T-CELL

TESTING

Viral load and T-cell tests provide critical information for

decisions on antiviral therapy. Before changing treatment, the

tests should be repeated to confirm the results. Fact

Sheet 412 has more information on T-cell

tests and Fact Sheet 413

covers viral load testing.

Viral load should be tested:

  • Before starting or changing medications. This provides a

    reference value;

  • About 2 to 8 weeks after starting or changing medications.

    This shows whether the new drugs are working;

  • Every 3 or 4 months. This helps make sure the medications

    are still working. For patients who haven’t started taking medications,

    it helps decide when to start.

T-cell counts should be done:

  • When someone first tests HIV-positive
  • Every 3 to 6 months to monitor the strength of the immune

    system


RESISTANCE TESTING

Viral resistance testing helps doctors choose the most effective

drugs. See Fact Sheet 414 for

more information. Resistance testing is recommended when viral

load is not controlled by new medications, or when it “breaks

through” a regimen that used to work. The guidelines say

that it’s reasonable to do resistance testing before treating

someone with a new HIV infection. This can show if the person

got infected with drug-resistant virus.


WHEN TO START TREATMENT

  • Patients with symptoms of HIV disease should all be

    treated.

  • Patients with no symptoms who have less than 350

    T-cells OR viral load over 55,000 should be offered treatment.

    Consider the risk of disease progression and the patient’s willingness

    to start therapy. Some experts would delay treatment for patients

    with 200 to 350 T-cells and viral loads under 55,000.

  • Patients with no symptoms, more than 350 T-cells AND a

    viral load below 55,000 do not need to start treatment.

    They should get regular viral load and CD4 tests. However, some

    experts would treat these patients.


GOALS OF THERAPY

The guidelines list the following goals for HIV therapy:

  • Reduce viral load as much as possible for as long as possible
  • Restore or preserve the immune system
  • Improve the patient’s quality of life
  • Reduce sickness and death due to HIV

The following tools are suggested to help achieve these goals:

  • Maximize adherence. Help the patient take medications correctly.
  • Think about future regimens when choosing drugs. Keep future

    options open

  • Use resistance testing when it will help.


WHAT DRUGS

SHOULD BE USED FIRST?

The guidelines recommend using 2 nucleoside analogs (nukes)

plus one of the following:

Other drugs and combinations are recommended as alternatives.

The guidelines do not comment on the use of hydroxyurea.

They discourage the use of a single drug (monotherapy), or of

two nukes.


INTERRUPTING

TREATMENT

A patient may need to interrupt treatment for several reasons:

  • side effects are intolerable
  • there’s a drug interaction
  • if they run out of any of the drugs
  • women might choose to stop treatment during the first 3 months

    of pregnancy.

If antiviral therapy is stopped, all drugs should be stopped

at the same time, and re-started together. This will reduce the

risk of the virus developing resistance to the medications.


WHEN TO CHANGE

Treatment should be changed due to treatment failure, or intolerance

of current drugs.

Treatment failure: Within 8 weeks after starting a treatment,

the viral load should drop by about “1 log” or 90%.

Within 6 months, the viral load should be less than 50 copies.

If the viral load does not drop this much, change the treatment.

Other signs of treatment failure include:

  • An increase in viral load from undetectable to detectable

    levels, or to more than 3 times its lowest level on the current

    drugs;

  • A viral load increase to more than 3 times its lowest level

    on the current durgs;

  • A continuing drop in T-cells; or
  • A new AIDS-related

    illness.

Intolerance: If a patient cannot take the prescribed

drugs because of their side effects or interactions with other

needed medications, the drugs should be changed.


WHAT TO CHANGE

TO?

Decisions to change antiviral therapy should be based on several

factors:

  • the reason for changing
  • how sick the patient is
  • medications previously used
  • other drugs currently available
  • the side effects the patient has had
  • other medications being used.

Changes due to drug intolerance: Reduce the dose of

the drug causing the problems. It could also be replaced with

one or more drugs from the same class and of the same strength.

Changes due to treatment failure:

  • Use at least two new drugs. A totally new regimen is preferred.

    If possible, avoid any drug a patient has used before.

  • Do not switch to any drug that has shown cross-resistance

    with a drug now being used. For example, don’t switch between

    ritonavir and indinavir, or between nevirapine and delavirdine.

  • If there are few options to change to, and viral load was

    reduced, it may make sense not to change medications. Another

    option is to use combinations that are more experimental.

  • Doctors who are less experienced in treating people with

    HIV should consult with a more experienced physician on decisions

    about changing antiviral therapies.


 Revised February 7, 2002

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