Printer Friendly

BURROUGHS WELLCOME STATEMENT ON ACTG 116A

 RESEARCH TRIANGLE PARK, N.C., Dec. 30 /PRNewswire/ -- Burroughs Wellcome Co. today issued the following statement regarding the recently released data on ACTG 116A:
 New data from a clinical study, ACTG 116A, show that Retrovir(R) brand zidovudine (AZT) is superior to the currently recommended dose of didanosine (ddI) in increasing survival for people with advanced HIV infection who had no previous antiretroviral therapy. The study, which was conducted by the National Institutes of Allergy and Infectious Diseases (NIAID), reaffirms Retrovir as first line therapy for people with HIV infection.
 This study was designed to compare Retrovir and ddI in individuals with AIDS or advanced ARC who had either no prior antiretroviral therapy or had received up to 16 weeks of therapy with Retrovir. Sixty-two percent of the 617 patients had no prior Retrovir therapy, 38 percent had received some Retrovir for less than 16 weeks. The study involved Retrovir, 500 mg/day and two doses of ddI, 750 mg/day and 500 mg/day. The 750 mg/day dose of ddI is above the currently labeled dose.
 Retrovir appeared to be more efficacious than ddI in both the 750 mg/day and the 500 mg/day arms among those patients who had not previously been treated with Retrovir. Among these patients, the one year death rates were 10 percent, 9 percent and 4 percent for the 500 mg/day ddI, 750 mg/day ddI and Retrovir arms respectively.
 Results favored ddI in the arms where patients had received 8-16 weeks of prior therapy with Retrovir. One possible interpretation of this finding is that people with advanced HIV infection may benefit from either taking ddI after first being on Retrovir therapy for a period of time or using additional therapeutic options after they have been on Retrovir monotherapy. However, the investigators made no recommendation about changing current therapy.
 The major side effects from ddI therapy included pancreatitis and elevation in serum amylase. Two patients died from pancreatitis in this study in the high dose ddI arm (750 mg). Rates of peripheral neuropathy were higher in the 750 mg ddI group than in the Retrovir group, but the difference was not statistically different. The only side effect that was more common with Retrovir was low white cell count, as has been observed in previous studies.
 The data from 116A must be place in the perspective of the emerging consensus that combination therapy will play an increasingly critical role in the management of HIV disease. In studies of combination antiretroviral therapy, Retrovir has been the proven therapy to which other compounds were added. Earlier this year, for example, the Food and Drug Administration (FDA) released for marketing a third antiretroviral agent zalcitabine (ddC) for use, but only in combination with Retrovir. There are a number of studies underway looking at the combination of Retrovir with other therapeutic agents, including the combination of Retrovir and ddI.
 Retrovir remains the only antiretroviral medication indicated for use in both early symptomatic and asymptomatic HIV infection (CD4 cell counts less than 500/mm3).
 -0- 12/30/92
 /CONTACT: Kathy S. Bartlett, 919-248-4302 or Karen Collins, 919-248-3231, both of Burroughs Wellcome Co./


CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU:

SB -- CH003 -- 0637 12/30/92 14:00 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 30, 1992
Words:544
Previous Article:KAISER ALUMINUM & CHEMICAL CORP. EXTENDS TENDER OFFER
Next Article:PRIMITIVE DEER HUNTING SEASON JAN. 7-9
Topics:


Related Articles
FIRST COMBINATION REGIMEN OF HIV DRUGS CLEARED BY FDA
BURROUGHS WELLCOME CO. SUPPORTS HURRICANE RELIEF EFFORT
BURROUGHS WELLCOME SUES NOVOPHARM FOR PATENT INFRINGEMENT
MISS AMERICA VISITS BURROUGHS WELLCOME CO.
FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF INJECTABLE ZYLOPRIM AS ADJUNCT TO CANCER CHEMOTHERAPIES
STUDIES REAFFIRM VALUE OF AZT IN EARLY HIV INFECTION AND DISEASE
BURROUGHS WELLCOME REACTION TO DATA INDICATING AZT REDUCES RATE OF MATERNAL TRANSMISSION OF HIV
NEW STUDY SUPPORTS EFFECTIVENESS OF AZT IN DELAYING PROGRESSION OF DISEASE; BENEFITS OF THERAPY LAST UP TO TWO YEARS
NEW STUDY SHOWS ACYCLOVIR REDUCES VIRAL SHEDDING IN ASYMPTOMATIC GENITAL HERPES PATIENTS
RESEARCH HIGHLIGHTS IMPORTANCE OF VIRAL LOAD AS PREDICTOR OF MATERNAL/FETAL HIV TRANSMISSION

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters