AEGiS-PRn: Once-Daily Zerit (stavudine) QD Capsules Safe and Effective PRNewswireImportant note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
Click here to return to PRNewswire main menu
Print this article

Once-Daily Zerit (stavudine) QD Capsules Safe and Effective

PRNewswire - October 31, 2001


ATHENS, Greece, Oct. 31 /PRNewswire/ -- Data presented today at the 8th European Conference on Clinical Aspects and Treatment of HIV Infection show that a new once-daily Zerit (stavudine or d4T) QD (extended release or prolonged release) formulation can be used safely and effectively in combination HAART (highly active antiretroviral therapy) regimen. This demonstration of efficacy for the once-daily formulation of Zerit opens the way to more simple, once-daily treatment regimens.

"Clinicians are constantly attempting to construct simpler regimens for their patients to improve adherence, and reduce the potential problems caused by missed doses," said Dr. Julio Montaner, Professor at the University of British Columbia and Director, Clinical Activities at the British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada. "This data shows that once-daily Zerit can be a key part of this regimen."

The randomized, double-blind study included 150 treatment-naive patients who were followed for 48 weeks. Patients were randomized to receive once- daily Zerit QD capsules (n=74) or the twice-daily (BID) formulation (n=76) in combination with standard doses of Epivir and Sustiva.

The study was powered to assess the change from baseline in viral load. At 48 weeks, the median decrease in HIV RNA for the QD group was 2.9 log10, versus 2.7 log10 for the BID group. The mean increase in CD4 cell count over 48 weeks was +232 for the QD group and +195 for the BID group. In an intention to treat analysis of all subjects who started treatment, proportions achieving an HIV RNA < 400 c/mL at 48 weeks were 78 percent for Zerit extended release in the once-daily (QD) group and 67 percent in the Zerit twice daily (BID) group. Toxicities including laboratory abnormalities in both groups were comparable and generally mild to moderate in severity.

"An effective, all-QD regimen will mean an improvement in the quality of life for patients who are looking at a lifetime of therapy," said Dr. Montaner. "We should be looking at all current HIV drug classes to find other once-daily options that will enable physicians to create simpler, user- friendly and highly effective regimens."

The British Columbia Centre for Excellence in HIV/AIDS is located at St. Paul's Hospital, which is part of Providence Health Care. It is affiliated with the University of British Columbia.


011031
PR011060


Copyright © 2001 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019  http://www.PRNewswire.com.

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2001. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2001. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .