AIDSWEEKLY Plus; Monday, December 21, 1998
Daniel J. DeNoon, Senior Editor
Recommended highly active antiretroviral therapy (HAART) regimens have always been based on the use of at least one protease inhibitor. But a head-to-head clinical trial showed that one member of a different class of anti-HIV drugs can be as potent - for 36 weeks at least.
The new drug, the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz, attracted intense interest when these results were announced at the 1998 World AIDS Conference. The findings paved the way for so-called "protease-sparing" HAART regimens intended to reserve protease inhibitors - and their nasty side effects - for later use in the event of first-line treatment failure.
The new treatment guidelines list efavirenz and all approved protease inhibitors (indinavir, nelfinavir, ritonavir, and saquinavir) as Class-A agents. They also break new ground in proposing as a Class-A option the ritonavir/saquinavir combination.
Class-A drugs must be combined with Class-B drugs to make a HAART regimen. Class B includes nucleoside reverse-transcriptase inhibitors (NRTIs) in various combinations: zidovudine/didanosine (AZT/ddI), stavudine/didanosine (d4T/ddI), zidovudine/zalcitabine (AZT/ddC), zidovudine/lamivudine (AZT/3TC), and d4T/3TC.
Questions remain about the durability of efavirenz's efficacy, as little data exists on patients treated for more than a year with protease-sparing, efavirenz-based HAART. And the HHS guidelines warn that the use of any NNRTI in initial treatment regimens may preclude future use of any other drug in the class due to cross resistance.
In addition to recommending initial treatment regimens the guidelines set forth consensus opinions on:
* The use of testing for plasma HIV RNA levels (viral load) and CD4+ T cell count.
* Considerations for when to initiate therapy in established HIV infection;
* Special considerations for therapy in patients with advanced stage disease;
* Interruption of therapy;
* Considerations for changing therapy and available therapeutic options;
* The treatment of acute HIV infection;
* Considerations for antiretroviral therapy in adolescents;
* Considerations for antiretroviral therapy in the pregnant woman.
As in the previous guidelines, the new recommendations advise physicians whose patients have exhausted most treatment options to explore the use of as-yet-unapproved medications via patient enrollment in clinical trials or expanded access programs. They also note that patients do better when their physicians are more experienced in managing HIV disease, and they recommend that inexperienced health-care workers consult with or refer to such experts.
The guidelines also include tables listing the properties of the three approved classes of antiretroviral medications - NNRTIs, NRTIs, and protease inhibitors - and known drug interactions with these medications.
Copies of the guidelines are available from the HIV/AIDS Treatment Information Service (1-800-448-0440; TTY: 1-888-480-3739; Fax: 301- 519-6616) and on the ATIS Web site <http://www.hivatis.org>. They are also available from the National Prevention Information Network (NPIN) Web site: <http://www.cdcnpin.org>. These recommendations are not intended to substitute for the judgment of a physician who is an expert in the care of HIV infected individuals.
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