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AIDS/HIV
MDAdvice.com Home > Health Topics > Informative Material >

Emerging Guidelines for Antiviral Therapy

This document has been reviewed by CATIE's treatment information staff, but not yet by an external reviewer.

General:
The Canadian HIV Trials Network (CTN) held a workshop in Toronto in order to produce a consensus document of guidelines for the use of antiretroviral drugs in the treatment of people with HIV/AIDS. This document will be published in a medical journal in early 1997. What follows is a summary of the workshop based on notes taken by CATIE staff. Most of the participants were physician-researchers and there was a smaller number of family doctors and a few people from AIDS Service Organizations. Combination therapy was clearly preferred over monotherapy in most cases, and changes in viral load were seen as the key to making treatment decisions. The CTN divided the participants into the following working groups:

  1. Primary Infection
  2. Initial Therapy
  3. Continuing Therapy
  4. The mother-fetus/infant
  5. Post-exposure Prophylaxis

Some abbreviations and terms used:

Antiviral therapy and antiretroviral therapy both mean anti-HIV therapy
NNRTI - non-nucleoside reverse transcriptase inhibitors; delavirdine, loviride and nevirapine
RTIs - reverse transcriptase inhibitors; AZT, ddC, ddI, d4T, 3TC and NNRTIs
PIs - protease inhibitors; indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase)
'Nukes' - (nucleoside analogue RTIs; AZT, ddC, ddI, d4T, 3TC)
PHAs - people with HIV/AIDS

1. Primary Infection
The working group recommended that treatment be offered to all people in an informed setting (with counselling). Treatment should consist of a combination of 2 or 3 anti-HIV drugs such as 2 RTIs and a PI. The goal of therapy should be to reduce the amount of HIV in the blood so much that it becomes "unquantifiable." This means that the virus is found in very small quantities, but technicians are not able to measure exactly how much HIV is present. Therapy has failed if the viral load rises above 30,000 copies/ml or has increased by more than half a log of the pre-therapy viral load measure.

2. Initial Therapy
The goals of initial therapy included maintaining quality of life and prolonging survival. This group suggested that therapy be started when the CD4+ cell count fell below 350 cells, even if the viral load was less than 10,000 copies/ml, and regardless of whether or not PHAs had symptoms.

Which drugs to use?
The answer to this question depends on the viral load. PHAs with a viral load between 10,000 and 100,000 copies/ml should receive combination therapy with 2 drugs. Those with viral loads greater than 100,000 copies could receive 3 drug combinations. The drugs used ought to reduce viral load by at least 1 log. Although the group felt that there was not enough data to recommend specific drug combinations, some classes of combinations seem logical; 2 RTIs and a protease inhibitor are one example. They did, however, recommend that the following two-drug combinations NOT be used:

one nuke and an NNRTI
AZT and d4T
ddC and 3TC
ddC and ddI

3. Continuing Therapy
The goal of working group was to get maximum suppression of viral activity for as long as possible. Changes in viral load are be the critical element in making decisions about changes in antiviral therapy.

The doctors felt that PHAs whose viral load remained below 5,000 copies did not need to change their current therapy.

PHAs with a viral load between 5,000 and 20,000 copies should be intensely monitored but not have changes made to their regimen.

PHAs whose viral load rose to 20,001 copies or greater should change their anti-HIV therapy.

The regimen of choice for people receiving continuing therapy should contain 3 drugs, one of which should be indinavir or ritonavir. The group felt that there was not enough known about the combination of ritonavir-saquinavir (or any other combination of PIs) for which they could make recommendations.

4. The Mother-Fetus/Infant
The consensus was that the current standard of care (AZT monotherapy during pregnancy for all HIV-infected women) for reducing the risk of infection to the fetus was simply not up to date.

Women who were diagnosed with HIV infection during pregnancy should have their viral load measured and, depending on its level and the CD4+ cell count, they should receive:

monotherapy if viral load was 'low'
combination therapy if the viral load does not decrease with monotherapy

HIV-positive women who become pregnant while using anti-HIV drugs, should continue to use combination therapy, even though the risk of mutations to the fetus is increased than if they had used AZT monotherapy.

Which drugs to use?
The consensus of the working group was that AZT, 3TC and nevirapine were relatively safe for the fetus. The effect of PIs on the health of the fetus is not known. Anti-HIV treatment of the infant hould be given for at least the first 6 weeks after birth. After 6 weeks therapy may continue, depending on the infant's health.

For HIV-infected infants with few or no symptoms of HIV infection, the working group appeared somewhat reluctant to prescribe antiretrovirals. It was agreed that those infants with moderate to severe symptoms of HIV/AIDS should receive treatment. This group felt that AZT-monotherapy should be reserved for the first 6 weeks after birth. Therapy should be changed if life-threatening infections appeared or the child's brain development is less than normal. Finally, the group felt that a national registry of HIV-infected mothers and their infants be established to collect data for research.

5. Post-Exposure Prophylaxis
To help heath care workers judge the risk of certain activities, the term "dangerous fluids" should be defined. At first, the working group suggested that 2-drug therapy be used to treat post-exposure prophylaxis. On reflection, they realized that if they were exposed they would want triple-drug therapy and then suggested that this be offered instead of 2-drug therapy. Treatment should continue for 4 weeks.

Has therapy worked?
Therapy has failed in those people who develop anti-HIV antibodies.

Disclaimer
The Community AIDS Treatment Information Exchange (CATIE) provides information resources to help people living with HIV/AIDS who wish to manage their own health care in partnership with their care providers. We do not recommend or advocate particular treatments and we urge users to consult as broad a range of sources as possible. While we update our material regularly, users should be aware that information changes rapidly. Additional information may be available from CATIE at 1-800-263-1638 or at our website at http://www.catie.ca. Users relying on the information do so entirely at their own risk. Neither CATIE nor Health Canada accept responsibility for any damage that may result from the use or misuse of this information. Decisions about particular treatments should be made in consultation with a health care professional knowledgeable about HIV-related illnesses and the treatments in question.

Permission to Reproduce
©This document is copyrighted by the Community AIDS Treatment Information Exchange (CATIE). All CATIE materials may be reprinted and/or distributed without prior permission. However, reprints may not be edited and must include the following text: "From Community AIDS Treatment Information Exchange (CATIE). For more information contact CATIE's Information Network at 1-800-263-1638." For permission to edit any CATIE material for further publication, please call the CATIE office.

Call us! 1-800-263-1638 or 416-944-1916

or write us at CATIE/The Network
420-517 College Street
Toronto, ON M6G 4A2 Canada
email: info@catie.ca

This publication was funded by the AIDS Care, Treatment and Support Program under the National AIDS Strategy, Health Canada.

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