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Massive Change in U.S. Treatment Guidelines

January 2010

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What to Use for Initial Therapy

In previous versions of the guidelines, the panel presented readers with recommendations for the use of individual drugs. Now the panel has taken the bold step of recommending specific regimens for the initial treatment of HIV.

The panel asks physicians to consider the following factors so that treatment can be individualized for each patient:

  • co-existing health conditions -- such as cardiovascular, kidney, liver and psychiatric diseases, addiction and tuberculosis (TB)
  • potential drug side effects
  • results of HIV drug resistance testing
  • if considering nevirapine (Viramune), take into account the person's gender and CD4+ count (this is explained later)
  • if considering maraviroc (Celsentri), consider the use of tropism testing
  • adherence
  • convenience

Here are some medicines that are mentioned throughout this issue of TreatmentUpdate:


Nukes

  • AZT (zidovudine, Retrovir)
  • 3TC (lamivudine)
  • AZT + 3TC in one pill (Combivir)
  • abacavir (Ziagen)
  • abacavir + 3TC in one pill (Kivexa)
  • FTC (emtricitabine, Emtriva)
  • tenofovir (Viread)
  • tenofovir + FTC in one pill (Truvada)


Non-Nukes

  • efavirenz (Sustiva)
  • efavirenz + tenofovir + FTC in one pill (Atripla)
  • nevirapine (Viramune)
  • etravirine (Intelence)


Protease Inhibitors

  • atazanavir (Reyataz)
  • darunavir (Prezista)
  • fosamprenavir (Telzir)
  • lopinavir + ritonavir in one pill (Kaletra)
  • ritonavir (Norvir)
  • saquinavir (Invirase)


Integrase Inhibitors

  • raltegravir (Isentress)


Preferred Regimens

The panel recommends any one of these three specific regimens for the initial treatment of HIV infection:

  • Atripla
  • atazanavir-ritonavir + Truvada
  • raltegravir + Truvada

For pregnant women, the panel recommends this combination:

  • Kaletra + Combivir, where Kaletra is dosed twice daily


Caution

Here are some concerns noted by the panel:

  • Because efavirenz (found in Sustiva and Atripla) can cause birth defects when given during the first three months of pregnancy, the panel warns that this drug should not be used during that time or by women who want to become pregnant.
  • Atazanavir-ritonavir should not be used in patients taking more than 20 mg/day of the acid-reducing agent omeprazole (Losec) or similar drugs.


Alternative Regimens

The panel defines alternative regimens as ones that are tolerable and effective but have potential disadvantages compared to preferred regimens.

Here are the alternative regimens proposed by the panel:

  • efavirenz + Combivir
  • efavirenz + Kivexa
  • nevirapine + Combivir
  • atazanavir-ritonavir + Combivir
  • atazanavir-ritonavir + Kivexa
  • fosamprenavir-ritonavir + one of these: Combivir or Kivexa or Truvada
  • Kaletra + one of these: Combivir or Kivexa or Truvada
  • saquinavir (Invirase) + Truvada
  • tipranvir (Aptivus)


Caution

The panel warns that nevirapine should not be used in people with moderate or severe liver damage. It should not be used in women who have more than 250 CD4+ cells or in men who have more than 400 CD4+ cells because of the risk for severe or life-threatening side effects.

Abacavir should not be used in people who test positive for abacavir hypersensitivity. The panel also warns that it should be used cautiously in patients at high risk for cardiovascular disease or in those who have high pre-therapy viral loads (more than 100,000 copies.


Issues to Consider -- Protease Inhibitors

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A large European database called DAD has found that the use of lopinavir-ritonavir (Kaletra) or indinavir (Crixivan) was associated with an increased risk of heart attack, heart disease and stroke.

Another large database, the French Hospital Database (FHDB), has found that the use of fosamprenavir (Telzir) or Kaletra was linked to an increased risk of heart attack.


Issues to Consider -- Abacavir

The DAD study has found an association between the recent use (within the first six months) of abacavir and an increased risk of heart attack, particularly among people with pre-existing cardiovascular disease. Some clinical trials have also found this association, while others have not. The FHDB's most recent analysis linked heart attacks in people taking abacavir to the use of cocaine and other illicit substances.

Because of these different findings in different databases and studies, the panel notes that "no consensus has been reached yet on the association or possible mechanism to explain why abacavir might be associated with a heart attack."

What's more, the panel also underscored the issue of confounding or "channeling bias" -- a problem with observational studies that makes drawing firm and accurate conclusions when interpreting the data difficult. Such confounding may explain why different research teams have reached different conclusions about abacavir and its possible relation to cardiovascular disease.

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This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 
See Also
Read the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
More News and Analysis on HIV Treatment Guidelines


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