AIDS TREATMENT NEWS No. 052 - March 11, 1988
John S. James
After the patients completed a double-blind placebo study of ribavirin, they were entitled to obtain the drug free if they wanted it, in return for their participation in the study. A total of 116 patients (from both the ribavirin and placebo groups) did choose to use the drug in this "open-label" phase of the study; 74 chose not to. In the 116 who did use ribavirin there were 6 deaths (5 percent), but in the 74 who did not use ribavirin there were 25 deaths, or 34 percent. Some of these patients had been on ribavirin for as long as 80 weeks; others, in the placebo group in the original study, had been using the drug for less time.
These figures look conclusive, but they could have happened by self selection. Suppose ribavirin didn't do anything. The patients who happened to be doing well while on ribavirin in the study would be likely to want to stay on the drug, since it would have seemed to be working for them. But those patients who happened to be doing poorly would be likely to drop the drug in order to switch to AZT, which cannot be combined with ribavirin. The result is that those who were doing well would tend to put themselves into the ribavirin group, while those doing poorly would go into the other group. This self selection of healthier patients into the ribavirin group during the open-label phase of the study could have caused a difference in death rates, even without any effect from the drug.
It may be possible to analyze the patient records to see how much of the difference in death rate could be attributed to self selection and how much to the drug. This analysis will almost certainly require subjective judgments. And ribavirin has become so politicized that it will be hard to trust this judgment to any researchers not truly independent of both the drug's manufacturer and the FDA. We don't know how such a study could be arranged.
In the absence of better information, it seems unlikely to us that this large difference in death rate could be explained solely by self selection--especially since all patients entering the trial had to meet medical inclusion criteria designed to give a fairly homogeneous group for the study. Instead, this information seems to fit with anecdotal reports that some persons have stopped using ribavirin and quickly deteriorated, whereas others stopped it and had no change. It is possible that ribavirin delays certain stages of progression of HIV infection, while having little or no effect at other stages. It may be possible to study this question by using newer diagnostic tools, such as the P-24 antigen test.
880311
ATN05202
Copyright © 1988 - AIDS Treatment News. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used. Subscription lists are kept confidential. AIDS Treatment News, Subscription and Editorial Office: 1233 Locust St., 5th floor Philadelphia, PA 19107 800/TREAT-1-2 toll-free email: aidsnews@critpath.org http://www.aidsnews.org
Subscription Information: Call 800/TREAT-1-2: Businesses, Institutions, Professionals: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. VISA, Mastercard, and purchase orders also accepted. ISSN # 1052-4207
AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 1988. 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, 1988. 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. .