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May 2005 Two new factors to consider when initiating HIV treatment with non-nucleoside reverse transcriptase inhibitors (NNRTIs) are the patient’s pretreatment CD4 T-cell counts and the patient’s gender, according to updated “Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents.”
The Department of Health and Human Services (HHS) recently released the revised guidelines, which not only updates the recommendations for the initiation of NNRTI therapy, but also highlights information on nevirapine (Viramune, Boehringer Ingelheim) hepatotoxicity risks, the interaction between rifampin (Rifadin, Aventis) and ritonavir (Norvir, Abbott) boosted saquinavir (Fortovase, Roche) and new pregnancy data for efavirenz (Sustiva, Bristol-Myers Squibb). It further provides updated information on contraindications and warnings for ritonavir and lopinavir/ritonavir (Kaletra, Abbott) use. Several tables have been updated to offer more current information, and a table on the tipranavir (Aptivus, Boehringer Ingelheim) expanded access program was added. While the panel continues to recommend efavirenz as the preferred NNRTI, delavirdine (Rescriptor, Agouron Pharmaceuticals) “appears to have the least potent antiviral activity. As such, it is not recommended as part of an initial regimen,” according to the guidelines. The panel recommended nevirapine-based regimens as alternatives, NNRTI-based regimens for adult females with HIV when their pre-treatment CD4 T-cell counts are 250 cells/mm3 or less. For adult males with HIV, nevirapine-based regimens are recommended when their pre-treatment CD4 T-cell counts are 400 cells/mm3 or less. The panel does not recommend initiation of nevirapine in adult females with CD4 T-cell counts greater than 250 cells/mm3 or in adult males with CD4 T-cell counts greater than 400 cells/mm3, “unless the benefit clearly outweighs the risk.” This recommendation is based on clinical trials and post-marketing reports that indicate “symptomatic, sometimes serious or life-threatening hepatic events” observed with higher frequency in such women and men. The panel further wrote, “in nevirapine-naive pregnant women with CD4 T-cell counts [less than] 250 cells/mm3, nevirapine should not be initiated as a component of a combination regimen unless the benefit clearly outweighs the risk.” A 14-day lead in period at a dose of 200 mg once a day before increasing the prescription dose to 200 mg twice a day was recommended for all patients beginning nevirapine therapy. Furthermore, health care professionals should obtain serum transaminases at baseline, prior to and two weeks after dose escalation with monthly follow-up for the first 18 weeks to monitor for hepatic toxicity. “Close monitoring for elevated liver enzymes and skin rash should be undertaken for all patients during the first 18 weeks of nevirapine therapy,” the panel suggested in the guidelines. The recommendation for the use of rifampin with ritonavir boosted saquinavir was removed “based on reports of significant elevation (up to 20 x upper limit of normal) of serum transaminases in a phase 1 study evaluating the pharmacokinetic interaction of this drug combination in healthy volunteers.” The guidelines serve to assist health care professionals as they make important treatment recommendations for patients living with HIV. They are evidence-based, providing clinicians with the most current available information on how to use antiretroviral therapy to treat adolescent and adult patients with HIV. The Panel on Clinical Practices for the Treatment of HIV, convened by the DHHS, prepared the report. The guidelines have been updated frequently since the first publication in 1998, based on the availability of new therapies, new data and clinical experience. Changes have also been made to improve document organization and readability. The April 2005 revision updates the Oct. 29, 2004, version of the guidelines. For more information: |
