Study Finds DDC Effective by Itself in Treating AIDS : Health: Antiviral drug is reported as beneficial as DDI and offers an option to patients who cannot tolerate AZT.
A major new study comparing two antiviral AIDS drugs shows that DDC is as effective--and possibly better--than DDI in patients who are unable to take the most widely prescribed AIDS drug, AZT, according to sources familiar with the research.
The study, expected to be released today by the federal government’s National Institute of Allergy and Infectious Diseases, is the first to show that DDC is beneficial when used alone.
It will likely be regarded as a major finding because it signals another treatment option for AIDS patients who cannot medically tolerate AZT, or for whom AZT has proved ineffective.
“This is great news because it will give AIDS patients who are intolerant to AZT another option,” said FDA Commissioner David A. Kessler. He said the agency would review the data and “consider revising the (DDC) label.” So far the FDA has approved DDC to be used only in combination with AZT.
He said the FDA would also consider “urging insurance companies to pay for single agent use.”
The institute is expected to issue a “clinical alert” to physicians across the country to make them aware of the new data, sources said.
“What I would want to do, as a doctor, would be to choose the drug--either DDI or DDC--with the least toxicities for my patient,” one researcher said.
The major side effect of DDI is pancreatitis, or inflammation of the pancreas. The chief problem associated with DDC is peripheral neuropathy--painful hands and feet.
Even though DDC has not been sanctioned by the FDA for anything other than combination therapy with AZT, the agency has been flexible in allowing doctors to prescribe certain drugs--particularly for life-threatening conditions--for “off-label” uses. Moreover, the FDA has even argued in favor of insurance reimbursement in these cases.
The nationwide study, which began in December, 1990, and ended last September, involved 467 patients. About two-thirds had been diagnosed as having fully developed AIDS, sources said.
The study was sponsored by the institute’s Community Programs for Clinical Research on AIDS, a research program based in such primary health care settings as private doctors’ practices and substance abuse clinics.
This type of research differs from traditional formal trials, which typically have strict entry criteria that limit participation and are usually conducted in large academic research centers.
The researchers examined disease progression, including the onset of opportunistic infections and deaths, and found them almost the same among both groups of patients.
Survival time was slightly longer among patients on DDC. There were 100 deaths in the DDI group, compared to 87 in the DDC group.
“DDC was found to be at least as efficacious as DDI in delaying disease progression, including death, and may provide a survival advantage,” according to a memo summarizing the research that was obtained by the Times.
DDC is manufactured by Hoffmann-La Roche Inc.
When DDC was approved last year for use with AZT, it became the third antiviral drug in the AIDS arsenal. AZT, manufactured by Burroughs Wellcome Co., was approved in 1987 and DDI, made by Bristol-Myers Squibb Co., was approved last year.
Antiviral drugs, which are considered the “big guns” in the fight against AIDS, treat the underlying viral condition, compared to other drugs which fight the opportunistic infections and other conditions that result from an impaired immune system. Most researchers believe that the key to ultimately controlling AIDS lies in developing a successful combination of antiviral therapies.
