What is ibalizumab?
- Ibalizumab is an experimental entry inhibitor being developed by Taimed Biologics. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
- Ibalizumab contains genetically engineered antibodies, known as monoclonal antibodies. These antibodies bind to the CD4 receptor on T-cells. Once ibalizumab binds to these receptors, HIV cannot successfully connect with the surface of T-cells, thus preventing the virus from infecting healthy cells.
- Ibalizumab will most likely need to be used in combination with other HIV drugs.
What is already known about ibalizumab?
- A dose for ibalizumab has not yet been determined. The drug is currently administered intravenously and has been tested using weekly, every-other-week and monthly dosing. A subcutaneous version of the drug, which will likely need to be administered using a hypodermic needle once a week, is being tested.
- Ibalizumab holds promise for HIV-positive patients who no longer respond to other HIV drugs. Because ibalizumab targets HIV differently than most currently available drugs, chances are that most people living with the virus—regardless of which drugs they have tried (and failed) in the past—will likely benefit from using ibalizumab.
- It is not known how quickly resistance to ibalizumab develops if resistance does occur.
- Ibalizumab might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
- Two Phase II studies of ibalizumab involving treatment-experienced people living with HIV have been completed. The first study, using weight-based dosing, showed statistically significant reductions in viral load, compared to placebo, when the drug was combined with an optimized background regimen of approved HIV meds. The second study, which used fixed dosing of the drug (800 mg every two weeks or 2,000 mg every four weeks), also resulted in significant reductions in viral load when added to an optimized background regimen, though no placebo was used for comparison purposes .
What about drug interactions?
- No studies have yet reported whether ibalizumab may interact with other drugs. Trials to determine potential drug interactions are planned or ongoing.
What is known about side effects?
- Ibalizumab has been generally well tolerated in clinical trials completed thus far. The most common side effects include headache, nausea, vomiting and some laboratory abnormalities, none of which have required people to prematurely discontinue treatment in studies.
Who should not take ibalizumab?
- It is not known whether ibalizumab will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
- It is not known whether ibalizumab passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Where can I learn more about clinical trials of ibalizumab?
- If you would like to find out if you are eligible for any clinical trials that include ibalizumab, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email firstname.lastname@example.org.