Last July, an Important Drug Warning was issued to healthcare providers concerning a high rate of virologic failure with a once-daily, 3-drug combination of Viread, Epivir, and Ziagen. Data from study ESS30009, which compared Sustiva versus Viread in combination with once-daily Ziagen/Epivir, revealed poor performance in patients taking Viread plus Ziagen/Epivir arm. Data from a pilot study presented at the 2nd IAS Conference in Paris also indicated a high rate of failure (inability to lower and keep viral load undetectable) with this combination. The warning recommended that this combination not be used in HIV+ patients and that patients experiencing good control of virus on this therapy should be closely monitored. Changing or strengthening treatment should be considered in the patients. The warning also recommended that the use of this triple-drug combination with any other HIV drugs be closely monitored in patients as well. Because the combination of Viread and Epivir has been widely used already, the problem is likely between Viread and Ziagen. Researchers from Gilead (maker of Viread) and GlaxoSmithKline (maker of Epivir and Ziagen) are working to try to determine the reason behind this "perfect storm" of a bad HIV regimen. In addition, at the time this issue of HIV Treatment ALERTS! went to press, a "Dear Healthcare Professional" letter was issued by Gilead warning about the once-daily combination of Viread, Videx, and Epivir.
Bottom Line: Avoid therapy that is made up of all nucleoside reverse transcriptase inhibitors ("nukes"). The one possible exception right now is Retrovir, Epivir, and Ziagen (available in one pill as Trizivir), but even this combination is considered weaker than other options using non-nukes or protease inhibitors (see "Bottom Lines" in May 2003 issue of HIV Treatment ALERTS!). If you are taking a triple-nuke HIV regimen, talk to your doctor immediately about the possibility of switching to another combination -- even if it is working for you.
The Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents is published and updated by the U.S. Department of Health and Human Services (DHHS). The Guidelines Panel is made up of researchers, physicians, community advocates, and other experts who meet regularly to review the guidelines, incorporate new knowledge, make changes, etc. The latest round of updates happened in July. The most striking change was the removal of a Chinese-menu-style list of HIV medications from which a doctor could choose a main "anchor" drug (a protease inhibitor or non-nuke) and two "background" drugs (usually nukes) for treating a patient. This was replaced with the actual recommendation of preferred regimens. The two preferred regimens were either:
Alternative regimens were also listed under each preferred regimen. This marks a major change in philosophy for the DHHS guidelines, which have undergone other changes over the years such as recommending to wait until 350 T cells or lower to consider HIV treatment and that treatment definitely be started at 200 T cells or lower. (These thresholds were much higher just a few years ago.) The 96-page guidelines document offers a great deal of information and is available online at www.aidsinfo.nih.gov/guidelines.
Bottom Line: HIV treatment must be individualized to take into account disease stage, co-infection, gender, age, other health conditions, etc. There is no universally perfect HIV regimen, and each medication has its good and bad points. Just because you are not on a "preferred" regimen does not mean you arent being treated for HIV effectively. Talk to your healthcare provider about any questions you might have concerning HIV treatment.
This article was provided by The Center for AIDS. It is a part of the publication HIV Treatment ALERTS!. Visit CFA's website to find out more about their activities and publications.