GAITHERSBURG, Md. _ An FDA advisory committee votedunanimously Wednesday to recommend approval of the drug ddI foruse as an "initial therapy" in AIDS sufferers who have taken no otherantiretroviral drugs.
The FDA's Antiretroviral Drugs Advisory Committee also foundthere was insufficient evidence to suggest that ddI given incombination with AZT worked better than ddI alone, althoughlaboratory evidence seemed to suggest the dual therapy wassomewhat effective in AIDS sufferers who had been previouslytreated with another antiretroviral drug.
The committee took two votes on whether Hoffmann-La Roche Inc.'sddC should be used in combination with AZT. All nine membersvoted to recommend that AZT and ddC be administered together topeople who had not previously taken antiretroviral drugs. They alsovoted unanimously against recommending the combination for use bypeople who had taken other drugs.
"This is the first time in a long time we've had unanimous votes onthis committee," said the group's chairman, Fred Valentine, aprofessor of medicine at New York University Medical Center.
The committee based its decisions on five studies involving nearly7,000 patients and complex treatment regimens, pitting combinationsof antiretroviral drugs against the drugs given alone.
Among them was the largest controlled trial of the effectiveness ofantiretroviral drugs in children. The study compared therapy withddI, made by Bristol-Myers Squibb Co., of New York, againsttherapy with a combination of ddI and AZT. It also compared ddIwith AZT.
The trial, involving 831 children, found that ddI delays progressionof AIDS and may be more effective than AZT. The children, whoranged in age from 3 months to 18 years, were less likely to developserious infections or suffer severe side effects than those than thosereceiving AZT.
AZT is made by London-based Glaxo Wellcome plc. Roche, ofNutley, N.J., makes ddC, also called Hivid. ddI's brand name isVidex.
The results of the other trials have been reported previously. Theyare:
* ACTG 175l involved 2,457 patients who received AZT, ddI, andddC in different combinations. The study showed that combinationtherapy was more effective than single-drug therapy in patients whohadn't taken AZT. AZT and ddC proved the best primary therapy.
* Delta One and Two involved more than 3,000 patients who tookAZT, AZT and ddI, and AZT and ddC. Again, AZT and ddC provedmore effective than AZT alone.
* CPCRA 007 involved 1,113 severely ill patients, 77 percent ofwhom had previously been given AZT. The trial compared AZTalone with combinations of AZT and ddC and AZT and ddI. Thestudy found that combination therapy was slightly better than single-drug therapy in this population.
* CPCRA 002 was a study of 467 patients who were resistant to, orcould not tolerate, AZT. The study showed that ddI and ddC wereabout as effective at staving off disease progression and death. n
-- Steve Sternberg Special to BioWorld Today
(c) 1997 American Health Consultants. All rights reserved.