About 300 slots are available in an early expanded access program for ABT-378/ritonavir, announced by Abbott Laboratories.
ABT-378 is an experimental protease inhibitor formulated with a small amount of ritonavir to increase bioavailabilty, the amount of a drug which reaches the bloodstream. Because ABT-378 is combined with ritonavir, all other drug interactions with ritonavir apply.
Due to a limited supply of ABT-378/ritonavir, the program is limited to those individuals most in need. The requirements are as follows:
All individuals enrolled in the program will continue to receive the drug until it is approved. As more drug becomes available early next year, Abbott plans to expand this program. According to the Department of Health and Human Services, changes made to an antiretroviral regimen should include switching as many medications as possible. Many people who meet the program eligibility may have developed resistance to all currently approved antiretroviral medications. If a new regimen cannot be constructed with currently approved medications, one option is to wait until a new regimen can be constructed using experimental medications.
Medications which may become available include the fusion inhibitor T-20 or the nucleotide reverse transcriptase inhibitor tenofovir (PMPA). For more information about ABT-378/ritonavir call (888) 711-7193.
A 48-week, randomized, double-blind study of 162 HIV-infected patients tested a drug cocktail involving Triangle Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, Coactinon. The therapy, which also included d4T and 3TC, was found to significantly suppress HIV replication. After 24 weeks, 83 percent of those given the combination therapy had undetectable levels of the virus.
Triangle reported that the drug had mostly mild side effects, including nausea, headache, dizziness, diarrhea, and rash.