elvitegravir
belongs to a class of anti-HIV drugs called Integrase Inhibitors. For a description of the life-cycle of the AIDS virus, and the targets of each class of drugs, click here.
Elvitegravir is being developed by Gilead Sciences. They have a useful web site that includes the latest news & research reports on this and other drugs in development: click here.
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Elvitegravir is an experimental integrase inhibitor being developed by Gilead Sciences.
After HIV's genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV's DNA inside the cell's DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as elvitegravir, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from entering healthy cell DNA.
Elvitegravir will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including those currently approved for the treatment of HIV.
What is already known about elvitegravir?
The elvitegravir dose, to be explored in advanced Phase II and III clinical trials, will be 150mg twice daily, combined with 100mg Norvir® (ritonavir). Norvir is used to boost elvitegravir in the bloodstream, making it more effective against HIV.
Elvitegravir, especially when combined with Norvir, 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.
Elvitegravir holds promise for HIV-positive patients who have taken other anti-HIV drugs in the past. Because elvitegravir targets HIV differently than currently available drugs, chances are that most people living with the virus – regardless of their treatment history – will likely benefit from using elvitegravir.
What do we know about elvitegravir from clinical trials?
One small study enrolled 40 HIV-positive patients, half of whom had tried and failed other anti-HIV treatments in the past. Study volunteers were randomly assigned to receive one of five doses of elvitegravir or a placebo, without any other anti-HIV drugs. After ten days of treatment, all patients who took elvitegravir had viral loads that were significantly lower than those who took a placebo. The greatest viral load reduction was seen in patients who took 50mg of elvitegravir in combination with 100mg Norvir, both once a day.
A Phase II clinical trial randomized 278 treatment-experienced patients to receive one of three twice-daily doses of elvitegravir (20mg, 50mg, or 125mg), combined with 100mg Norvir, or an approved Norvir-boosted protease inhibitor (control group). All patients completed their regimens with the use of approved nucleoside reverse transcriptase inhibitors (NRTIs) with or without Fuzeon® (enfuvirtide). The 20mg dose of elvitegravir was stopped after eight weeks due to poor efficacy. Approximately 30% of patients in the control group had viral loads below 50 copies after 16 weeks, compared to 38% of patients in the 50mg elvitegravir group and 40% of patients in the 125mg elvitegravir group.
Additional Phase II studies of elvitegravir are being conducted; Phase III clinical trials are being planned.
What is known about side effects?
Very little is known about the side effects of elvitegravir. However, in the 278-patient study, side effects after 16 weeks of treatment were similar in the elvitegravir groups and the control group, meaning that no additional short-term side effects associated with elvitegravir use were documented.
Additional data from studies evaluating the short- and long-term safety of elvitegravir are needed.
Who should not take elvitegravir?
It is not known whether elvitegravir 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 elvitegravir 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 elvitegravir?
If you would like to find out if you are eligible for any clinical trials that include elvitegravir, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).
Last Revised: March 15, 2007
This content is written by the editorial team at AIDSmeds.com.
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elvitegravir
belongs to a class of anti-HIV drugs called 
Check My Meds
Elvitegravir, especially when combined with Norvir, 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.
It is not known whether elvitegravir 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 elvitegravir 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.