Important note: Information in this article was accurate in October 2000. The state of the art may have changed since the publication date.
The bone marrow stimulant GM-CSF (granulocyte-macrophage colony-stimulating factor) is used to increase levels of several types of white blood cells including neutrophils and lymphocytes. In lab experiments with cells, GM-CSF appears to help cells of the immune system resist attack by HIV. Results from some studies also suggest that GM-CSF may also reduce levels of that virus in people taking anti-HIV medication.
Researchers in Brazil conducted a six-month study to examine the effect of regular injections of GM-CSF on people living with HIV/AIDS (PHAs) who were also taking one or two nukes (such as AZT and similar drugs). According to their results, GM-CSF may help some subjects reduce their viral load.
Researchers enrolled 105 subjects (24 female, 81 male) for their study. All had fewer than 300 CD4+ cells and had previously experienced an AIDS-related illness. No subject had less than six months exposure to AZT before entering the study. Researchers randomly assigned subjects to receive either GM-CSF (125 micrograms) injected under the skin twice weekly for six months or fake GM-CSF (placebo) given in the same dose and schedule. During the study about 2/3 of the subjects used two nukes - generally AZT and ddI. The remaining third used only one nuke, usually AZT. At the start of the study the breakdown of lab values among the two groups was as follows:
Compared to their pre-study values, subjects receiving GM-CSF had their viral load decrease throughout the study by about 0.5 log. Subjects on placebo did not have such a decrease. This difference in viral load changes between the two groups was statistically significant; that is, not likely due to chance alone.
The following proportions of subjects in each group had their viral load decrease to at least 1/10th of their pre-study level after six months:
This difference was statistically significant.
On average, subjects receiving GM-CSF had increased cell counts compared to subjects receiving placebo, but this difference was not significant.
The following subjects in each groups developed AIDS-related infections during the study:
This difference between the two groups was not statistically significant. It should be noted that the proportion of subjects with fewer than 50 CD4+ cells at the start of the study was as follows:
The proportion of subjects hospitalized in each group was as follows:
This difference was also not significant.
Two deaths occurred during the study, one from suicide and the other from complications due to AIDS, both among subjects receiving GM-CSF. One year after subjects entered the study about 67% in each group remained alive.
Not surprisingly, subjects given GM-CSF were more likely to experience symptoms such as fever, muscle aches, fatigue, compared to subjects on placebo.
Overall the results from this study suggest that six months of twice weekly GM-CSF injections may be useful in some people with AIDS who are taking nukes as their only anti-HIV therapy. The immune booster appears to help some PHAs maintain or lower their viral load. It's important to note, however, that despite six months of GM-CSF use, both groups had the same survival rates a year after the study began. Thus, at least in this study, reduced viral load and perhaps viral resistance, as a result of GM-CSF use did not result in a survival advantage.
Other studies using larger numbers of subjects need to find out the effect of this drug in PHAs who use it for more than six consecutive months. The designers of such studies will have to contend with the willingness and ability of people to inject themselves twice weekly for prolonged periods of time.
1. Brites C, Gilbert MJ, Pedral-Sampaio D, et al. A randomized placebo-controlled trial of granulocyte-macrophage colony-stimulating factor and nucleoside analogue therapy in AIDS. J Infect Dis 2000 Nov;182(5):1531-5.
20001009
CATE11101
Copyright © 2000 - TreatmentUpdate. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Editor, The Canadian AIDS Treatment Information Exchange, 555 Richmond St. West, Suite 505, Box 1104, Toronto, ON, M5V 3B1 • Phone: 416-203-7122 • Toll Free: 1-800-263-1638 • Fax: 416-203-8284 http://www.catie.ca.
ÆGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.
ÆGiS 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 ©1990, 2000. ÆGiS & the Sisters of Saint Elizabeth of Hungary. All materials appearing on ÆGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of ÆGIS, or the party credited as the provider of the content.