Abbott Expands ABT-378/Ritonavir Early-Access Program
Abbott Laboratories announced that it plans to expand CD4 criteria for its early-access program for ABT-378/ritonavir, a new protease inhibitor.
The new criteria will allow more advanced HIV patients in North and South America, Australia, South Africa and some European countries to access the drug, which is currently in Phase III clinical trials.
Due to limited supply, the early-access program begun in September 1999 has been focused on making the drug available to patients with very high viral loads and a CD4-cell count less than or equal to 50 cells/mm3. Now, as more of the drug becomes available, patients with up to 200 CD4 cells/mm3 will be allowed access. According to Abbott, by February, "any patient who cannot construct a viable treatment regimen with currently approved antiretroviral therapies will have an opportunity to access ABT-378/ritonavir without regard to viral load levels, CD4 counts or previous protease inhibitor use."
Often referred to as expanded access, early-access programs are a result of HIV treatment advocates and government health agencies working with pharmaceutical companies to make investigational compounds available to patients in advance of regulatory submission or approval.
For information about the program, call (888) 711-7193.
Shawn Hinds is a treatment advocate in the AIDS Project Los Angeles' Client Health Education and Advocate Unit. He can be reached by calling (323) 993-1459 or by e-mail at shhinds@APLA.org.
This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).
This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.