Important note: Information in this article was accurate in June 2000. The state of the art may have changed since the publication date.
Researchers in Northern Italy recruited 1,207 HIV-positive subjects (27% female, 73% male) to investigate side effects that occurred while they used protease inhibitors. The profile of subjects at the start of the study was as follows:
Over the course of the study, specific protease inhibitors (PI) were used by the following numbers of subjects:
Readers will note that these numbers do not total 1,207. This is due to the fact that subjects switched therapies during the study. Of course all subjects used their PI in combination with nucleoside analogues (nukes). It should also be noted that subjects in this study used the original, hard-gel formulation of saquinavir (Invirase).
On average, subjects were monitored for about 11 months, during which time the following events occurred:
Changing Therapy
Within six months of the appearance of a side effect, 11% of subjects had switched to another PI to avoid this problem. The second reason subjects switched therapy was inefficacy, as indicated by rising viral load or decreasing CD4+ cell counts.
Some subjects were more likely than others to develop side effects. According to their analysis of the data, the researchers found that the following groups of people were likely to develop side effects:
As well, researchers made the following associations:
Who interrupted therapy?
After 12 months of therapy, the following proportion of people in each group interrupted therapy:
The huge difference in therapy interruptions between subjects taking ritonavir and subjects taking other therapies was statistically significant; that is, not likely due to chance alone.
PIs have been widely available in North American since 1996, and their most prominent side effects are well known. As a result, we will focus on unusual and rare side effects, some of which have recently raised concerns.
These side effects were not commonly seen even, among this population of over 1,000 subjects. Doctors noted the following rare side effects in users of ritonavir:
Rare side effects in indinavir users were as follows:
Rare side effects in saquinavir users were as follows:
Rare side effects in nelfinavir users were as follows:
Rare side effects reported in users of ritonavir and saquinavir were as follows:
In women, high levels of prolactin can cause changes in the menstrual cycle. In men, they can lead to decreased sex drive, impotence and breast enlargement.
All of these side effects were relatively uncommon during the short period subjects were observed. Since PHAs are expected to take these therapies for the rest of their lives, these and perhaps other side effects may become more frequent over time as the toxicity of the drug(s) builds up.
20000601
CATE10804
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.